(449 days)
OviTex PRS (Long-Term Resorbable) is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one time use.
OviTex PRS (Long-Term Resorbable) is a surqical mesh manufactured by layering sheets of ovine forestomach matrix to create multi-layer configurations of devices sewn together with resorbable Poly(lactic-co-glycolic Acid) ("PLGA") suture for use in plastic and reconstructive surgery. The 2-8 ply devices are available in surface areas up to 434 cm² in various shapes.
This document is a 510(k) Premarket Notification from the FDA for the OviTex PRS (Long-Term Resorbable) surgical mesh. While it discusses the device's characteristics and its comparison to a predicate device, it does not contain information about the acceptance criteria and study that proves the device meets specific performance criteria in the way typically expected for an AI/ML medical device.
The document indicates that substantial equivalence was not based on an assessment of clinical performance data. Instead, it relies on preclinical, mechanical, and biocompatibility testing to demonstrate substantial equivalence to a predicate device.
Therefore, many of the requested points cannot be answered from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document states: "New bench testing included mechanical strength, suture retention, endotoxin, and compliance testing. Results of the testing confirms that the proposed device meets all product specifications." However, it does not provide the specific acceptance criteria (e.g., tensile strength > X N, suture retention > Y N) or the quantitative reported device performance for these tests.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Bench Testing (Mechanical, Suture Retention, Endotoxin, Compliance): The sample sizes for these tests are not provided. Data provenance is not specified beyond "Preclinical testing."
- Biocompatibility Assessment: Not specified.
- Implantation Study: Not specified.
3. 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)
This is not applicable to the type of studies described (mechanical, biocompatibility, implantation) for a surgical mesh. These studies do not typically involve experts establishing ground truth in the way an AI/ML diagnostic device would for image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for the types of studies described.
5. 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, an MRMC study was not done. This device is a surgical mesh, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Bench Testing: Engineering specifications and standardized test methods.
- Biocompatibility: ISO 10993 standards and toxicological risk assessment.
- Implantation Study: Histopathological evaluation of tissue response compared to the predicate, as per ISO 10993-6. This could be considered a form of "pathology" ground truth. The study concluded that the subject device was "classified as a non-irritant" and had "advanced to complete resorption by 78 weeks."
8. The sample size for the training set
Not applicable. This device does not use an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary Table (Limited Information Available from Document):
| Criterion | Information from Document |
|---|---|
| Acceptance Criteria & Device Performance | Acceptance Criteria: "product specifications" (details not provided). |
| Reported Performance: "Results of the testing confirms that the proposed device meets all product specifications." (Quantitative results not provided.) | |
| Study Type to Prove Acceptance | Preclinical bench testing (mechanical strength, suture retention, endotoxin, compliance), biocompatibility assessment (ISO 10993-1, E&L, TRA in accordance with ISO 10993-18), and an implantation study (ISO 10993-6). Substantial equivalence was not based on clinical data. |
| Test Set Sample Size | Not specified for any of the studies. |
| Data Provenance (Test Set) | Not detailed beyond "Preclinical testing." |
| Number of Experts (Ground Truth) | Not applicable for mechanical, biocompatibility, or implantation studies in the context of "ground truth" for a diagnostic device. |
| Qualifications of Experts | Not applicable. |
| Adjudication Method (Test Set) | Not applicable. |
| MRMC Comparative Effectiveness Study | No. |
| AI vs. Without AI Assistance Effect Size | Not applicable. |
| Standalone Performance (Algorithm Only) | Not applicable. |
| Type of Ground Truth Used | Engineering specifications, standardized test methods, ISO 10993 standards (biocompatibility, toxicological risk assessment), and histopathological evaluation (implantation study). |
| Training Set Sample Size | Not applicable. |
| How Ground Truth for Training Set Established | Not applicable. |
§ 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.