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REBOUND HRD® V 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 V (Hernia Repair Device) is a self-expanding nitinol framed surgical mesh designed for placement directly over the hernia defect so that there is at least 4 cm of circumferential overlap of the hernia defect by the device. The REBOUND HRD V conforms to the anatomy while providing stability. The super-elastic multi-stranded nitinol frame allows the device to be folded into a loading cannula (supplied in the product package) and inserted laparoscopically through an appropriately sized access port. It may also be placed via an open incisional approach. The REBOUND HRD V is supplied sterile and is designed as a single use device. It is manufactured in three sizes to accommodate different hernia types, anatomies and surgeon preference.

The provided text is a 510(k) summary for the REBOUND HRD® V surgical mesh. This document does not contain the detailed technical study information typically found in a device's design verification and validation reports. Therefore, I cannot fully answer your request.

Here's what I can extract and what is missing based on the provided text:

Acceptance Criteria and Reported Device Performance (Missing)

The document states: "Design verification and validation activities were performed as identified during risk analysis." However, it does not explicitly list the acceptance criteria for these activities or the reported device performance metrics against those criteria. It only concludes that the device is substantially equivalent to the predicate.

Missing Information/Cannot Answer based on provided text:

• A table of acceptance criteria and the reported device performance: This information is not present. The document summarizes the device's characteristics and its equivalence to a predicate, but doesn't detail performance metrics.
• Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not mentioned in the provided text.
• 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 mentioned. This type of information would be relevant for devices that rely on expert review for ground truth, which this surgical mesh does not appear to.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as this is not a diagnostic device relying on expert adjudication of results.
• 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: Not applicable. This is a medical device (surgical mesh), not an AI-powered diagnostic tool.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (surgical mesh), not an AI algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. For a surgical mesh, ground truth for performance would typically involve biomechanical testing, animal studies, or clinical outcomes (which are implied but not detailed).
• The sample size for the training set: Not applicable as this is not an AI/machine learning device.
• How the ground truth for the training set was established: Not applicable as this is not an AI/machine learning device.

What the document does indicate:

• Device Type: Surgical mesh (REBOUND HRD® V)
• Intended Use: 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.
• Predicate Device: REBOUND HRDTM (K063671, K080393)
• Conclusion for Equivalence: The REBOUND HRD V is substantially equivalent to the predicate in regards to indications for use, basic operating principle, materials, sterilization, packaging, and shelf-life.
• Study Type Implied: Design verification and validation activities were performed according to design control requirements and risk analysis. These would typically include bench testing for mechanical properties, biocompatibility, sterility, and possibly animal studies, but the specifics are not provided.
• Data Provenance (Implicit): The studies would have been conducted by Minnesota Medical Development, Inc. or contractors. The country of origin of data is not specified, but the applicant is based in the USA. The studies would be considered prospective for the device development, but the clinical implications are evaluated against existing predicate devices.

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