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The FUJIFILM Biopsy Positioner (FDR-1000BPY) is an optional accessory for the Aspire HD (FDR MS-1000) digital mammography system. It is designed to allow for accurate determination of three dimensional lesion locations in the breast using information extracted from stereotactic pairs of two-dimensional images. It is intended to provide guidance for interventional purposes (such as biopsy, presurgical localization or treatment devices).

The FUJIFILM Biopsy Positioner is an optional accessory for the Aspire HD (FDR MS-1000) full field digital mammography system and future Fujifilm digital mammography exposure stands. It is designed for positioning the needle when performing stereotactic biopsies, fine needle aspirations, core needle, and vacuum assisted biopsies in an upright position. The Biopsy Positioner uses a stereo pair of images, taken with the tube arm angled to +1 5° from vertical (orthogonal to the plane of the image receptor). The position of the three coordinates (X, Y, and Z) is computed using the position of the object on each of the two images, as indicated by the operator, and the known geometry of the system.

The Biopsy Positioner is composed of the following elements:

• The Positioner that supports and positions the needle .
• The Operation panel which displays the distance between the compression plate and target ● pathology, the distance between the target pathology and the needle, and also electrically drives the positioner in the X, Y and Z directions.
• The Positioner Control Unit which supplies power to the positioner

The provided text describes a 510(k) premarket notification for the FUJIFILM Biopsy Positioner (FDR-1000BPY) but does not contain a specific study proving the device meets quantitative acceptance criteria for performance. The document focuses on demonstrating substantial equivalence to a predicate device and compliance with various safety and electrical standards.

However, based on the information provided regarding the device's function, we can infer a key performance metric and a potential acceptance criterion for its primary function.

Primary Function of the Device:
The device's core purpose is to calculate the three-dimensional coordinates of a target pathology with position accuracy. The document states: "The software calculates the three-dimensional coordinates of the target pathology with position accuracy of -/+1.0mm or less." This statement itself implies an acceptance criterion.

Here's a breakdown of the requested information based on the provided text, with an acknowledgment of missing details:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document does not explicitly state other quantitative acceptance criteria, nor does it provide a detailed report of a study directly demonstrating the device's performance against this (or any other) criterion. The statement "The software calculates... with position accuracy of -/+1.0mm or less" is a claim about the device's capability rather than a report of a verification study result with a measured mean or standard deviation.

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

• Sample Size: Not specified.
• Data Provenance: Not specified. The document outlines the device's design and intended use but does not describe a clinical or technical test set used to verify its accuracy.

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

• Number of Experts: Not applicable, as no described test set or ground truth establishment process is detailed for performance verification.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as no described test set or adjudication process is detailed.

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

• Was an MRMC study done? No. The document does not describe an MRMC study. The device is a "Biopsy Positioner," which is an accessory for guidance, not a diagnostic AI system directly interpreting images alongside human readers.

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

• Was a standalone study done? The document states: "The software calculates the three-dimensional coordinates of the target pathology with position accuracy of -/+1.0mm or less." While this implies an internal validation of the software's accuracy, the text does not describe the methodology or results of a standalone study to prove this claim. It's a statement of capability rather than a report of a study's findings.

7. Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated for performance verification. For a device that measures physical dimensions and positions, the ground truth would typically be established through precise metrological measurements using phantom objects or calibrated systems, not clinical pathology or outcomes data. However, the document does not detail how the stated accuracy was verified.

8. Sample Size for the Training Set

• Sample Size: Not applicable. The "Biopsy Positioner" is described as a system that calculates coordinates based on known geometry and operator input from stereo images. It is not presented as an AI/ML device that requires a training set in the typical sense (e.g., for image interpretation). Its function is more akin to precise geometric calculation rather than pattern recognition learning.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth Was Established: Not applicable. As noted above, the device's functionality does not appear to involve a "training set" in the context of machine learning. Its accuracy would be verified based on its computational precision relative to physical measurements rather than learned patterns.

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