Germany - Medical software package

Description

The study is to be carried out as part of the German National Mammography Screening Program (MSP) in up to 24 screening units (SE) (complete offer for all sites).

A validated, fully automated breast density software should be made available to anyone up to 24 SE. The software should be installed on a given hardware once per SE for use by 2-3 sites or mammography systems. The company guarantees a remote support (included in the overall offer) during the study period. The supplier must have ISO 13485 certified quality management and be CE certified to demonstrate compliance with metrological requirements for software-based breast density measurement in accordance with Annex II (93/42 / EEC). The software must have a US FDA 510 (k) approval. The above-mentioned quality management must meet the requirements of the US FDA QM regulation (21 CFR part 820).

Within six months, the density software in the SE is to be set up in such a way that the density of all patients at the sites involved in the fully digital mammogram is measured in the screening operation. The measured value should be made directly available to the location by the software. When reporting to the site, a threshold exceedance (85% percentile with respect to the population surveyed) must also be reported immediately. The result of the density measurements must be electronically exportable and available for further evaluation.

Density software must enable density determination in fully digital mammograms of the following device types: Siemens (Inspiration, Inspiration Prime, Revelation, Fusion), Hologic (Lorad Selenia, Lorad Selenia Dimensions), GE (Pristina, Senographe Essential). In the intended clinical application, the software must automatically recognize the device type and apply the correct calculation algorithm to the "for presentation" image data routed through the central screening PACS. The software has to be adapted within 6 months (not later than 30.11.2019) so that comparable density values ​​are calculated by the software when examining the same woman on different types of devices mentioned above. Previously existing experience with comparability is necessary and must be proven when applying.

In order to enable a correct threshold calculation (determination of the 85% percentile based on the examined total population of study participants) on all mammography systems of the participating locations in a timely manner (before the start of the clinical study from 1.1.2020), retrospective density measurements on studies (mammograms of 2000-4000 patients per device type) necessary. Therefore, the density software offered must allow a retrospective density determination on fully digital DICOM ("for presentation") images per breast and per woman.

The density (BI-RADS4-Lexikon) must be displayed on a scale from 1 to 100 for the above-mentioned device types. It is also desirable to have a second density indication (scale 1-100) which, in addition to the exclusive density distribution, also includes the so-called masking factor (BI-RADS-5 Lexicon).

Within the study period until 31.12.2021, a remote service must ensure the function of the software in the 24 SE Monday to Friday between 8-18 h (Central European Time) in order to minimise any downtimes (<3%).

The study software must be available after 31.12.2021 until all data has been transferred to the study database.

The total cost of the above-mentioned requirements in the study may not exceed the total amount of 431 000 EUR net (fixed price). The application should detail the installation, customisation, leasing and service items for each attached screening unit (with 2 to 3 sites). The payment of the amount will be gradual according to the level of performance.

Opportunity closing date

24 May 2019

Value of contract

£100k-1m