Search Results

For use In Screening Mammographic Imaging as a Specialty Paddle for Full Breast Compression, as an alternative to conventional breast compression paddles.

AMERICAN MAMMOGRAPHICS, INC. intends to construct a full breast compression device from gamma stabilized LEXAN® or polycarbonate equivalent plastic currently used in the manufacture of numerous radiological and medical devices. The compression device will readily adapt to existing paddle arms from current OEMs and will also be available as a complete device with compression plate, yoke and mounting arm/shaft; The proposed device is a special octimized full breast compression tray called S.O.F.T. Paddle™ and will allow the targeted area to be imaged accurately, will allow more breast tissue to be imaged, and permit thinning of tissue where it is needed most. The S.O.F.T. Paddle™ proposes to offer full breast coverage with the compression plate set at an angle, downward from the chest wall toward the nipple, for better compression of anterior structures; thus it is a Special Optimized Full Compression Trav . When used for screening views, additional breast tissue can be compressed from the mid-breast to the nipple with improvement to the imaged area.

The provided text describes a medical device, the AMERICAN MAMMOGRAPHICS S.O.F.T. PADDLE™, which is a specialized full breast compression tray for mammography. However, the document is a 510(k) summary for a premarket notification to the FDA, asserting substantial equivalence to existing devices. It does not contain information about specific acceptance criteria or a study that rigorously proves the device meets those criteria in the context of algorithm performance or clinical outcomes.

This document focuses on the mechanical and functional equivalence of the compression paddle to existing devices, with claims about improved patient comfort, better tissue compression, extended imaging area, and enhanced contrast resolution. These are functional benefits rather than performance metrics of a diagnostic algorithm or AI system.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: The document does not define specific, quantifiable acceptance criteria for a diagnostic performance study, nor does it provide performance metrics like sensitivity, specificity, or accuracy.
2. Sample size used for the test set and the data provenance: No test set is mentioned for evaluating diagnostic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment is not relevant as no diagnostic performance study is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable, as this device is a physical compression paddle, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document is a regulatory submission for a physical medical device, not a report on the clinical validation or performance study of a diagnostic algorithm. Its purpose is to demonstrate that the S.O.F.T. PADDLE™ is substantially equivalent to other legally marketed mammographic compression devices, rather than to present results from a clinical trial measuring diagnostic accuracy or reader improvement.

Ask a specific question about this device