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The Healix Advance™ Knotless Anchors are indicated for use in the following procedures for reattachment of soft tissue to bone: Shoulder - Rotator Cuff . - . Biceps Tenodesis

Suture Anchor Healix Advance™ Knotless PEEK Anchor (4.75mm) Healix Advance™ Knotless PEEK Anchor (5.5mm)

This document is a 510(k) premarket notification for a medical device called the "Healix Advance™ Knotless PEEK Anchor." It is a regulatory submission to the FDA, not a study demonstrating the device meets acceptance criteria derived from clinical performance measures (e.g., accuracy, sensitivity, specificity for an AI algorithm).

The document is a submission for a new medical device seeking clearance based on substantial equivalence to existing predicate devices, not an evaluation of an AI or diagnostic algorithm's performance against predefined clinical metrics. It focuses on the physical and material characteristics, safety, and functionality of a medical implant, not "device performance" in terms of clinical accuracy or effectiveness in a diagnostic sense (like for an imaging AI).

Therefore, I cannot extract the information required by your prompt, as the prompt's categories (Acceptance Criteria for AI/diagnostic algorithms, MRMC studies, ground truth establishment, training set details) are irrelevant to this type of medical device submission.

Here's a breakdown of why the information cannot be provided based on the input document:

• Acceptance Criteria and Reported Device Performance (Table 1): The document does not define "acceptance criteria" in terms of clinical performance (e.g., sensitivity, specificity, accuracy). Instead, it discusses demonstrating substantial equivalence through various device performance characteristics like material properties (PEEK), anchorage strength (implied through comparison to predicates), and changes in design. The success metric is FDA clearance based on substantial equivalence, not a clinical performance threshold.
• Sample Size and Data Provenance (2): This applies to AI/diagnostic test sets. For a physical implant, "sample size" refers to the number of devices tested for mechanical properties (e.g., tensile strength, pull-out force), not for diagnostic accuracy on patient data. The document mentions "various device performance characteristics were tested and evaluated," but does not provide specific sample sizes for these engineering tests, nor does it refer to patient data or its provenance.
• Number of Experts and Qualifications (3), Adjudication Method (4): These concepts are for establishing ground truth in AI/diagnostic studies, typically involving interpretation of medical images or clinical data by experts. They are not applicable to the evaluation of a surgical anchor.
• MRMC Comparative Effectiveness Study (5): This is a study design for evaluating the impact of an AI system on human reader performance. It is not relevant to a surgical implant device.
• Standalone Performance (6): "Standalone performance" refers to an algorithm's performance without human intervention. This is not applicable to a physical surgical implant.
• Type of Ground Truth Used (7): Ground truth in the context of this document would be the results of engineering tests (e.g., a measured pull-out strength). It's not clinical "outcomes data" or "expert consensus" in the diagnostic sense.
• Training Set Sample Size (8), How Ground Truth for Training Set was Established (9): These are concepts related to machine learning models. This document is about a physical medical device, not an AI or machine learning algorithm.

In summary, the provided document is a regulatory submission for a physical medical device (a surgical anchor), not an AI-powered diagnostic tool. Hence, the questions posed about AI acceptance criteria, study methodologies (MRMC, standalone performance), and ground truth establishment for AI training/test sets are entirely outside the scope and content of this document.

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