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REBOUND HRD™ is intended to assist in the repair and/or reinforcement of hernia or other soft tissue defects where weakness exists and where the support of a nonabsorbable material is preferred.

The REBOUND HRD™ (Hernia Repair Device) is a self-expanding nitinol framed surgical mesh designed for placement between the fascia and fully closed peritoneum so that it covers the direct and indirect space with at least a 15mm margin beyond the edges of the hernia defect. The REBOUND HRD™ conforms to the anatomy while providing stability; eliminating the need for anchoring. The superelastic multi-stranded nitinol frame allows the device to be folded into a loading cannula (supplied in the product package) and inserted laparoscopically through a 10-12mm access port. It may also be placed via an open incision approach using the same dissection and positioning methods described for the laparoscopic technique. The REBOUND HRD™ is supplied sterile and is designed as a single use device. It is manufactured in several shapes to accommodate different hernia types, anatomies and surgeon preference.

The provided document is a 510(k) summary for the REBOUND HRD™ (Hernia Repair Device), which is a surgical mesh. This type of document is filed and reviewed by the FDA to determine if a new medical device is "substantially equivalent" to an existing legally marketed device (predicate device).

Critically, a 510(k) summary (like the one provided) does not typically contain detailed information about specific acceptance criteria or an analytical study proving that the device meets those criteria, as you would find for a device making novel claims or undergoing a Pre-Market Approval (PMA) process. The focus of a 510(k) is to demonstrate substantial equivalence to a predicate device based on similar technological characteristics, materials, and intended use.

Therefore, many of the specific questions regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment cannot be answered from the provided text. The document states: "Design verification and validation activities were performed as identified during risk analysis. REBOUND HRD™ is substantially equivalent to the REBOUND HRD™ (K063671) in regards to the indications for use, the basic operating principle, materials, sterilization, packaging and shelf-life." This general statement implies that such activities were done, but it does not describe them.

Based on the information available in the provided text, here's what can be inferred or directly stated:

Acceptance Criteria and Device Performance:

Since this is a 510(k) submission, the primary "acceptance criterion" from the FDA's perspective is substantial equivalence to a predicate device. This means the new device is as safe and effective as a legally marketed device. Specific performance metrics are generally not detailed in the summary itself, but rather referenced as being similar to the predicate.

Study Information (Based on limitations of a 510(k) summary):

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not provided in the document. A 510(k) summary typically doesn't include details of specific clinical or analytical studies unless they were conducted to a demonstrate a specific performance characteristic not covered by the predicate. The document merely states "Design verification and validation activities were performed as identified during risk analysis."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not provided in the document. This level of detail is characteristic of clinical efficacy or diagnostic studies, which are generally not the primary focus of a 510(k) summary for a "substantially equivalent" surgical mesh.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not provided in the document. See point 2.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This is not applicable to the REBOUND HRD™ device. This device is a surgical mesh, not an AI-powered diagnostic or assistive tool. An MRMC study is used for evaluating human reader performance with medical images.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No. This is not applicable to the REBOUND HRD™ device. As noted above, this is a surgical mesh.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not provided in the document. The basis for "ground truth" (if any specific outcome data was collected beyond comparison to the predicate) would likely be clinical outcomes, surgical success rates, or anatomical integrity assessments, but these are not detailed.

7. The sample size for the training set:

   • Not applicable / Not provided. Surgical meshes are not "trained" in the way AI algorithms are. If the question refers to design verification/validation testing, those sample sizes are not disclosed here.

8. How the ground truth for the training set was established:

   • Not applicable / Not provided. See point 7.

In summary, the provided document is a regulatory filing focused on establishing substantial equivalence for a surgical mesh, not a detailed scientific study report with specific performance metrics and study designs that would answer most of your questions. The "study" proving the device meets acceptance criteria is primarily an analysis demonstrating its similarities to the predicate device (REBOUND HRD™ K063671) in terms of materials, operating principles, and intended use, along with successful completion of internal design verification and validation activities, the specifics of which are not disclosed in this summary.

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