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the intended use and the indications of use of the MAM-CH22S with the Automatic Filter Selection Option are identical to those of the MAM-CH22S. With the Automatic Filter Selection mode, dense or thick breasts can be imaged with improved contrast and/or less radiation dose when the mammography system automatically selects the rhodium filter.

The 510(k) premarket notification for the Automatic Filter Selection Option for the MAM-CH22S mammography system describes a modification of the legally marketed mammography system (K941353/S1) by the addition of the optional filter assembly (including molybdenum and rhodium filters) and its automatic mode of operation.

This document (K960381) is a 510(k) premarket notification for a modification to an existing mammography system, the Automatic Filter Selection Option for the MAM-CH22S. It focuses on demonstrating substantial equivalence to a legally marketed device (MAM-CH22S, K941353/S1) rather than presenting a performance study with detailed acceptance criteria for a new device's diagnostic performance. Therefore, most of the requested information regarding acceptance criteria, performance studies, sample sizes, ground truth, and expert involvement is not available in this specific document.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Not applicable / Not provided. This document does not describe a clinical performance study using a test set of patient data to evaluate a diagnostic algorithm. It's about a hardware/software modification to an existing device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable / Not provided. No diagnostic performance test set is described.

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

• Not applicable / Not provided. No diagnostic performance test set is described.

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:

• Not applicable / Not provided. This document describes an automated hardware/software feature for optimal imaging, not an AI diagnostic algorithm assisting human readers.

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

• Not applicable / Not provided. The "Automatic Filter Selection Option" is a feature that optimizes image acquisition parameters. While it makes an "automatic" selection, it's not a standalone diagnostic algorithm that produces a finding or diagnosis independent of a human. Its performance is implicitly tied to the quality of the image produced for human interpretation.

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

• Not applicable / Not provided. No diagnostic performance study is described that would require a ground truth for diagnostic accuracy. The "effectiveness" mentioned refers to improving image quality/dose, which would be assessed by technical metrics and potentially subjective radiologist review of image quality rather than a definitive diagnostic truth.

8. The sample size for the training set:

• Not applicable / Not provided. No machine learning algorithm requiring a "training set" in the modern sense is described. The "automatic" selection logic for the filters would be based on predefined rules or parameters related to breast density/thickness, not learned from a large dataset.

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

• Not applicable / Not provided. No training set is described.

Study Description (as per K960381):

The "study" described in the 510(k) is a design and risk analysis to demonstrate the safety and effectiveness of the modification.

• Safety: The device was designed to comply with International Standard IEC 601-1. An analysis was performed to determine if the modification added significant risk, and preventive measures were taken. The conclusion was that it "does not add a significant risk that can cause a safety hazard."
• Effectiveness: The effectiveness is based on the claim that the intended use and indications of use remain identical to the predicate device (MAM-CH22S). The specific benefit of the automatic filter selection is highlighted: "dense or thick breasts can be imaged with improved contrast and/or less radiation dose when the mammography system automatically selects the rhodium filter." This is a claim of technical improvement rather than diagnostic accuracy improvement demonstrated through a clinical study with patient outcomes.

In summary, this 510(k) is a regulatory submission for a device modification, not a clinical trial report. It relies on demonstrating substantial equivalence and compliance with safety standards rather than presenting a detailed diagnostic performance study with statistical endpoints.

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