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syngo.Breast Care is a dedicated softcopy review environment for both screening and diagnostic mammography as well as digital breast tomosynthesis. Its user interface and workflow have been optimized to support experienced mammography and tomosynthesis reviewers in both screening and diagnostic reading. Efficiency and reading quality are supported by various specialized features.

syngo.Breast Care provides visualization and image enhancement tools to aid a qualified radiologist in the review of digital mammography images and digital breast tomosynthesis datasets. The radiologist is responsible for making the diagnosis of the images presented.

syngo.Breast Care is a software application dedicated to the special needs in breast cancer detection and assessment. syngo.Breast Care consists of several software engines, syngo.Breast Care Reading, syngo.Breast Care CAD Display and syngo.Breast Care Tomo, all based on the syngo.Breast Care Reading module.

syngo.Breast Care is an optional application for syngo.via VA20 (K123375 cleared on November 20, 2012). Syngo.via (a Siemens product) offers multimodality applications and feature sets to support customers in diagnostic imaging for various clinical areas (e.g. general Radiology, Cardiology, Oncology, Neurology, Orthopedics and Women's Health's). Additionally to a multi-client installation, synqo.Breast Care may also be configured with syngo.via as a single workplace.

The provided 510(k) summary for Siemens syngo.Breast Care Software does not contain the detailed information necessary to fully answer all of the questions regarding acceptance criteria and the study proving device performance. The document is a 510(k) summary, which focuses on establishing substantial equivalence to a predicate device rather than providing a detailed clinical study report with acceptance criteria and performance data.

Here's what can be extracted and what is missing, based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy, workflow efficiency targets). The document focuses on demonstrating substantial equivalence to the predicate "MammoReportPlus" and mentions general safety and effectiveness.
• Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, reading time reduction) are reported for the syngo.Breast Care software. The document states that the user interface and workflow are "optimized to support experienced mammography and tomosynthesis reviewers" and that "Efficiency and reading quality are supported by various specialized features," but no quantitative data is provided to back these claims in the context of acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• This information is not provided in the 510(k) summary. The document does not describe a specific clinical study with a test set of images.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not provided in the 510(k) summary, as no specific test set and ground truth establishment process are detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not provided in the 510(k) summary, as no specific test set and adjudication process are detailed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This information is not provided in the 510(k) summary. The document does not mention any MRMC study comparing human readers with and without AI assistance. The syngo.Breast Care software is described as providing "visualization and image enhancement tools to aid a qualified radiologist," implying human-in-the-loop, but no comparative effectiveness data is presented.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This information is not provided in the 510(k) summary. The device's description and indications for use explicitly state that it "provides visualization and image enhancement tools to aid a qualified radiologist in the review," and "The radiologist is responsible for making the diagnosis," indicating it's not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• This information is not provided, as no specific study data or ground truth establishment process is detailed.

8. The sample size for the training set

• This information is not provided. The document does not describe the development or training of any AI or CAD component that would require a training set. The device is primarily a software review environment with image enhancement tools.

9. How the ground truth for the training set was established

• This information is not provided, as no training set or ground truth establishment for it is mentioned.

Summary of what the document does state regarding acceptance and equivalence:

The 510(k) summary focuses on demonstrating substantial equivalence to a previously cleared predicate device, "MammoReportPlus" (K042868).

• Intended Use Equivalence: syngo.Breast Care has a "similar intended use" to the predicate. Both are described as dedicated softcopy review environments for mammography and digital breast tomosynthesis, aiding radiologists in diagnosis.
• Technological Equivalence (with differences): syngo.Breast Care is a "software only solution to run on compatible client server environment together with monitor displays cleared for Mammography," whereas the predicate was a "complete hardware and software package." An optional module for tomosynthesis display is also noted for the subject device.
• Safety and Effectiveness Concerns: The document states that "Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner." It also mentions "Several safety features including visual and audible warnings are incorporated into the system design" and that "the syngo.Breast Care is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed." This broadly implies that the safety and effectiveness are established through design controls and comparison to the predicate, rather than by a specific performance study with explicit acceptance criteria.

In conclusion, this 510(k) summary does not contain the detailed clinical study information, specific acceptance criteria, or quantitative performance metrics typically found in a clinical study report. Its purpose is to demonstrate substantial equivalence based on intended use and technological characteristics to a predicate device, as required for 510(k) clearance.

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