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The Affirm Breast Biopsy Guidance System is an optional accessory for the Selenia Dimensions Mammography System. It is designed to allow the accurate localization of lesions in three dimensions. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices).

This submission introduces the optional Affirm Lateral Arm Upright Biopsy Accessory which attaches to the Affirm Breast Biopsy Guidance System used with the Selenia Dimensions 2D/3D Mammography System, software version 1.8.4 and higher.

The optional Affirm Lateral Arm Upright Biopsy Accessory attaches to the Affirm Biopsy Guidance Module (BGM) to enable lateral needle approach procedures. The Lateral Arm can only be used when the Selenia Dimensions C-arm is positioned at 0 degrees. When using the Lateral Arm, the X- Y- and Z-axis movement is the same as for the Affirm standard (upright) needle approach. For the lateral approach, the biopsy needle is manually advanced into the breast along its own X-axis, referred to as "Lat X".

When performing lateral approach biopsies, the biopsy device is installed onto the lateral arm in the same manner as when performing standard (upright biopsies).

New components used with the Affirm Lateral Arm Upright Biopsy Accessory include: lateral biopsy paddle, lateral arm stand, case, and QC phantom specifically to be used for Lateral approach biopsies.

The document provided describes the Affirm Lateral Arm Upright Biopsy Accessory, an optional accessory for the Selenia Dimensions Mammography System. This device is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization, or treatment devices) with a lateral needle approach.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criterion for this device appears to be its targeting accuracy, which is compared to existing predicate devices.

2. Sample Size for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated as a number of patient cases or images. The testing focused on functional and performance characteristics using test reports.
• Data Provenance: Not applicable, as no clinical studies were performed. The testing was non-clinical.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Number of Experts: Not applicable. Ground truth was established through physical measurements and engineering tests.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. The testing described is primarily engineering and performance verification, not an interpretation of medical findings requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• MRMC Study Done? No. The document explicitly states: "No clinical studies were performed. Substantial equivalence has been demonstrated by nonclinical testing." Therefore, no MRMC study comparing human readers with and without AI assistance was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Standalone Study Done? Yes, in essence, the "Lateral Arm Targeting Accuracy Test" and "Default Needle Parameter Validation Test Report" represent standalone performance tests of the device's mechanical and software accuracy without direct human intervention in the targeting process during the test. The device provides guidance, but the testing assesses the accuracy of that guidance mechanism itself.

7. Type of Ground Truth Used:

• Type of Ground Truth: Physical measurement and engineering specifications. For target accuracy, this would involve precise measurements of the actual needle tip position relative to the intended target point within a phantom or test setup.

8. Sample Size for the Training Set:

• Sample Size: Not applicable. The device is a mechanical accessory with integrated software for guidance. It does not appear to use machine learning or AI models that require a "training set" in the conventional sense. Its function is based on pre-programmed algorithms and physical calibration.

9. How the Ground Truth for the Training Set Was Established:

• Ground Truth for Training Set: Not applicable, as there is no "training set" for an AI model. The system's accuracy and functionality were verified through engineering tests and validation against established standards.

Summary of Testing:

The document highlights that the device underwent system design control verification and validation tests, conforming to FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (moderate level of concern).

Specific tests included:

• Lateral Arm Targeting Accuracy Test: This directly addresses the core function of the device to accurately guide interventions.
• Default Needle Parameter Validation Test Report: Ensures correct operation with needle parameters.
• Updated Affirm CB test report (including Lateral Arm Accessory): Likely refers to a comprehensive test suite for the combined system.
• Third-party testing on:
  • Tensile Safety Factor (IEC 60601-1, Clause 9.8.2)
  • Strength of Compression Plates (IEC 60601-2-45, Subclause 203.8.5.4.102.5)
  • Biopsy Needle Positioning Accuracy of Mammographic Stereotactic Devices (IEC 60601-2-45, Subclause 201.9.2.1013 a,b,c)

The conclusion states that substantial equivalence was demonstrated by nonclinical testing, and no clinical studies were performed. The device's design, operation, construction, and materials were deemed substantially equivalent to the predicate and reference devices.

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