(248 days)
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
| Acceptance Criteria (Not Specified in Document) | Reported Device Performance (Summary of Testing) |
|---|---|
| (No specific quantitative or qualitative acceptance criteria were provided for device performance in the document.) | - Biocompatibility: Confirmed that processing and additional materials do not alter the excellent biocompatibility of the basic mesh. |
| - Weld Testing: Performed. (No specific results or acceptance criteria given). | |
| - Burst Strength Testing (on assembly): Performed. (No specific results or acceptance criteria given). | |
| - Deployment: Device successfully deployed through a cannula. (No specific success rate or criteria given). | |
| - Fatigue Testing: Performed. (No specific results or acceptance criteria given). | |
| - MRI Compatibility: Confirmed MRI compatibility. (No specific details of compatibility criteria or results given). | |
| - Animal Testing (In-vivo): Demonstrated the device will stay in place, will stay together when implanted, can be detected via X-ray, and has tissue response typical for this type of implant. (No specific quantitative acceptance criteria or detailed results given). | |
| - Instructions for Use: Evaluated. (No specific evaluation method or criteria given). |
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.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.