(28 days)
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
| Feature/Metric | Acceptance Criteria (Implicit from testing standards or predicate) | Reported Device Performance |
|---|---|---|
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2014 | Met all acceptance criteria. |
| Radiation Safety | Compliance with IEC 60601-1-3:2013 and IEC 60601-2-45:2015 | Met all acceptance criteria. |
| Software Validation | Compliance with ANSI/AAMI/IEC 62304:2006 and FDA guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | Met all acceptance criteria (implied by statement). |
| Needle Positioning Accuracy (Stereotactic & Tomosynthesis Biopsy) | ± 1mm (Derived from predicate device K122836) | Bench testing performed, implying it met the required accuracy. The document states "evaluated...to evaluate the stereotactic and tomosynthesis biopsy needle positioning accuracy," and the conclusion states the device is "as safe and effective as the predicate device," which had a ±1mm accuracy. |
| Biopsy Type Supported | Stereo Biopsy, Tomosynthesis Biopsy (Reference Predicate) | Stereo Biopsy, Tomosynthesis Biopsy |
| Exposure Position | ± 15° (Stereo Exposure), ± 7.5° (Tomosynthesis Exposure) | ± 15° (Stereo Exposure), ± 7.5° (Tomosynthesis Exposure) |
| Compression Plate Construction Material/Type | Plastic (Predicate K113284) | Plastic (Same as K113284) |
| Lockout Movement under Compression | Movements inhibited if compression force > 30N or needle attached (Predicate K113284) | Same as K113284 |
| Automatic Detection of Biopsy Unit | Yes (alarm/warning for improper connection) (Predicate K113284) | Same as K113284 |
| Needle Guide Positioning | Yes (Predicate K113284) | Same as K113284 |
| Positioning Software | Fujifilm (Predicate K113284) | Same as K113284 |
| Calibration Frequency | User executes accuracy testing at every use; annual maintenance check (Predicate K113284) | Same as K113284 |
| Mammotome-compatible Devicor Medical Products | Yes (Predicate K113284) | Same as K113284 |
| Mammotome Revolve Compatibility | No (Predicate K113284) | Yes (This is an added feature / difference) |
| Hologic ATEC/Eviva Compatibility | No (Predicate K113284) | Yes (This is an added feature / difference) |
| BARD Compatible | Yes (Predicate K113284) | Same as K113284 |
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.
§ 892.1710 Mammographic x-ray system.
(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.