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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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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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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 the repair of both inguinal and ventral hernias. The Rebound HRD™ is 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 HRDTM conforms to the anatomy while providing stability; eliminating the need for anchoring. The super-elastic, multi-strand, Nitinol frame allows the device to be folded into the supplied 10mm 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 text does not contain acceptance criteria for a device performance study, nor does it describe a study that directly proves the device meets specific performance acceptance criteria.

Instead, this document is a 510(k) summary for a medical device (REBOUND HRD™ hernia mesh device) seeking substantial equivalence to predicate devices. The summary outlines the device's description, indications for use, and a summary of testing conducted to support its safety and substantial equivalence, but not a study designed to meet specific performance "acceptance criteria" in the way a clinical trial or performance study report would.

Here's a breakdown of the requested information based on what is available and what is not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes several types of testing (biocompatibility, mechanical, in-vivo animal testing, MRI compatibility) but does not specify sample sizes for any of these tests. It also does not mention a "test set" in the context of human clinical data or imaging data. The testing described appears to be primarily bench testing and animal studies, not human clinical trials. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in the context of human data.

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

Not Applicable. The document does not describe a study involving expert assessment of a "test set" to establish ground truth for a diagnostic or AI device. The testing mentioned (biocompatibility, mechanical, animal) involves laboratory measurements and observations by technical and scientific personnel, not expert interpretation of clinical cases.

4. Adjudication Method for the Test Set

Not Applicable. As there is no described test set requiring expert interpretation and ground truth establishment, no adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not describe an MRMC comparative effectiveness study. This type of study is typically performed for diagnostic imaging devices to evaluate the impact of an AI algorithm on human reader performance. The Rebound HRD™ is a hernia mesh device, not an imaging or diagnostic AI device.

6. Standalone (Algorithm Only) Performance Study

No. The Rebound HRD™ is a physical medical device (hernia mesh), not an algorithm or AI system. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied in AI/diagnostic studies (e.g., pathology, outcomes data) is not directly applicable to the testing described for this physical device. The "truth" for the various engineering and biological tests performed would be established by:

• Biocompatibility: Standardized assays and histological examination, comparing against established norms for biocompatible materials.
• Mechanical Testing: Measured physical properties (weld strength, burst strength, fatigue life) against design specifications or engineering standards.
• Animal Testing: Direct observation during implantation, gross pathology, and histology of explanted tissue. This provides "actual" biological response.
• MRI Compatibility: Measurements of susceptibility artifacts, heating, and other parameters in an MRI environment according to standards.

8. Sample Size for the Training Set

Not Applicable. The Rebound HRD™ is a physical medical device; it does not involve an AI algorithm or a "training set" in the computational sense.

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

Not Applicable. As there is no training set mentioned, this question is not relevant to the provided text.

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