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The FUJIFILM Biopsy Positioner (FDR-2000BPY) is an optional accessory for the Aspire Cristalle (FDR MS-3500) 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 and/or Digital Breast Tomosynthesis (DBT) images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices).

The Biopsy Positioner (FDR-2000BPY) is an optional accessory for the Digital Mammography system. It is designed for positioning the needle when performing Stereotactic and/or Tomosynthesis Biopsies, fine needle aspirations, core needle, and vacuum assisted biopsies in an upright position. The Biopsy Positioner uses a Stereo pair of images and/or Tomosynthesis images. The position of the three coordinates (X, Y, and Z) is computed using the position of the object on each of the images, as indicated by the operator, and the known geometry of the system.

FDR-2000BPY is mainly composed of the following elements:

• The Positioner that supports and positions the needle .
• The Positioner Control Cabinet which supplies power to the positioned .
• 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 subject of this Special 510(k) premarket notification is addinq use of Digital Breast Tomosynthesis (DBT) images for extracting information to determine three dimensional lesion locations in the breast.

This document describes the Biopsy Positioner (FDR-2000BPY) for determining 3D lesion locations in the breast for interventional purposes using stereotactic and/or Digital Breast Tomosynthesis (DBT) images.

There is no information in the provided text regarding a study on "AI" performance or human reader improvement with AI assistance. The device described is a biopsy positioner and not an AI algorithm for image interpretation.

Here's the information that can be extracted based on the provided text, focusing on the device itself and its performance:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states "Bench testing was performed... to evaluate the stereotactic and tomosynthesis biopsy needle positioning accuracy." It does not specify a numerical sample size for this bench testing.

• Data Provenance: Bench testing, so it is synthetic/physical testing, not patient data. No country of origin is specified for the bench testing.

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

• This device is a biopsy positioner, not an image interpretation or diagnostic AI device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of diagnostic performance is not directly applicable.
• The accuracy of the device (e.g., needle positioning) would be verified against physical measurements or established calibration standards during bench testing. No human experts are mentioned for establishing ground truth in this context.

4. Adjudication Method for the Test Set

• Not applicable as the testing involves physical performance metrics (e.g., positioning accuracy) rather than subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The device is a biopsy positioner accessory, not an image reader or an AI diagnostic tool. There is no mention of human readers or AI assistance in the document.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This question is built on the premise that the device is an "algorithm." The FDR-2000BPY is a physical "Biopsy Positioner," an accessory to a mammography system. While it has software and computes 3D coordinates, it is not described as a standalone diagnostic algorithm. Its performance is integrated with the mammography system and involves human operation for marking targets.
• The "performance data" section focuses on hardware-related compliance (EMC, radiation safety) and "needle positioning accuracy" via bench testing, not autonomous algorithmic performance.

7. The Type of Ground Truth Used

• For the needle positioning accuracy, the ground truth would likely be physical measurements against known target coordinates or established calibration standards in a bench test environment. It is not expert consensus, pathology, or outcomes data, as these relate to diagnostic accuracy, not the accuracy of a physical positioning system itself.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical accessory with integrated software for coordinate calculation, not a machine learning model that requires a "training set" in the conventional sense. The "training" for such a system would involve engineering and calibration, not data-driven model training.

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

• Not applicable, as there is no "training set" for an AI model. For the device's development and calibration, ground truth would be established through engineering specifications, precise physical measurements, and system calibration procedures.

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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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