Search Results

The Affirm Prone Biopsy System combines the function of a standard x-ray mammography unit with that of a lesion localization system to produce a device that has specific application in first accurately localizing lesions in the breast in two and/or three dimensions, and then providing guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices) for lesions determined to be suspicious through prior mammographic examination.

It is intended for lesion location for biopsy while the patient is in the prone position to provide guidance for interventional purposes (such as biopsy, presurgical localization or treatment devices).

The Affirm Prone Biopsy Table is a mammographic x-ray system intended for lesion location while the patient is in the prone position. The subject device will be capable of both 2D and 3D imaging methods to calculate the target location. The system localizes suspicious lesions, as determined through prior mammographic examinations, using either stereotactic or tomosynthesis techniques. The system then affords a physician the capacity of performing vacuum assisted or needle core biopsy, or wire localization of the lesion.

Localization can be accomplished either via conventional 2D stereotactic imaging, or by use of a 3D data set. With the 3D data set, the image plane or "slice" most fully containing the suspected lesion is chosen by the physician from the data set to compute the lesion depth within the breast.

Here's an analysis of the provided text to extract information about acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, specific quantitative acceptance criteria or a direct performance table are not explicitly stated or presented. The document focuses on regulatory compliance and substantial equivalence to predicate devices.

However, the "Performance Testing" section (Page 4, Section 7) indirectly points to an acceptance criterion:

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

The document does not specify a sample size for a test set in the context of clinical performance or diagnostic accuracy. The testing mentioned appears to be primarily engineering verification and validation against safety and quality standards.

The data provenance (e.g., country of origin, retrospective/prospective) related to any clinical test set is not mentioned.

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

This information is not provided in the document. The type of testing described (compliance with IEC standards, design control) does not typically involve expert-established ground truth in the same way a clinical performance study would.

4. Adjudication Method for the Test Set:

An adjudication method (e.g., 2+1, 3+1) for a clinical test set is not mentioned because a clinical test set for diagnostic performance is not described.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not mentioned in this document. The device is a "Biopsy System" for guidance, not a diagnostic AI interpretation tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The document describes the "Affirm Prone Biopsy System" as a physical mammographic x-ray system that provides guidance for interventional procedures. While it utilizes "2D and 3D imaging methods to calculate the target location" (Page 4, Section 4), it is fundamentally a system that aids a physician. Therefore, a standalone (algorithm only) performance, separate from human operation or decision-making, is not described or implied. The device's function is to guide a human operator.

7. The Type of Ground Truth Used:

The document focuses on engineering and regulatory ground truth:

• Compliance with IEC 60601-2-45 standards: This implies meeting established technical specifications and safety requirements.
• Compliance with 21 CFR Part 820 (Design Controls): This refers to documented evidence that the device design meets user needs and intended uses.
• Equivalence to Predicate Devices: The "ground truth" for its performance is its demonstrated similarity in technology, operation, and functional performance to previously cleared devices.

There is no mention of clinical ground truth such as pathology, expert consensus on lesions, or outcomes data for a diagnostic or interventional accuracy claim. The device's purpose is localization and guidance, not diagnostic interpretation.

8. The Sample Size for the Training Set:

The document does not mention a training set size. This is consistent with the nature of the device being an imaging and guidance system, rather than a machine learning or AI algorithm requiring a training set for feature learning. The image processing for 2D/3D localization would be based on established algorithms, not necessarily a trained machine learning model.

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

Since a training set is not mentioned, the method for establishing its ground truth is also not applicable/provided.

Ask a specific question about this device