(180 days)
Angimesh Pre: "Repair of inguinal hernia defects."
Folded Mesh: "Repair of inguinal hernia defects."
Repol Plug Basic: "Repair of inguinal hernia defects."
Repol Plug Cap: "Repair of inguinal hernia defects."
Repol Plug Flower: "Repair of inguinal hernia defects."
Repol Angimesh: "To reinforce soft tissue where weakness exists, i.e., repair of hernias."
Wings Mesh: "Use in all kind of hernia repair requiring reinforcement with nonabsorbable support material."
Monofilament polypropylene mesh, available in various weights, rigidity, shapes and sizes, to allow an easy use in surgical techniques.
The document provided describes a 510(k) premarket notification for a surgical mesh, focusing on its substantial equivalence to a predicate device, rather than providing detailed performance studies against specific acceptance criteria. Therefore, most of the requested information cannot be extracted from the given text.
Here is what can be inferred or directly stated from the document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated. The core of a 510(k) submission, as implied by this document, is to demonstrate substantial equivalence to a legally marketed predicate device, rather than meeting pre-defined performance acceptance criteria a new device would need to meet.
- Reported Device Performance: Not reported in terms of specific performance metrics. The document states: "The determination of substantial equivalence is not based on an assessment of performance data."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. The 510(k) states that substantial equivalence is not based on an assessment of performance data. This implies there was no specific "test set" in the context of device performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. No performance studies or test sets are described.
4. Adjudication method for the test set
- Not applicable/Not provided. No test sets requiring adjudication are 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
- Not applicable/Not provided. This document describes a surgical mesh, not an AI-assisted diagnostic or therapeutic device. No MRMC studies are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. New performance data or ground truth establishment relevant to specific performance metrics is not mentioned as part of the substantial equivalence determination for this device. The basis for ground truth in this submission is likely the established safety and effectiveness of the predicate device.
8. The sample size for the training set
- Not applicable/Not provided. No training sets for algorithms are relevant to this medical device submission.
9. How the ground truth for the training set was established
- Not applicable/Not provided. No training sets for algorithms are relevant to this medical device submission.
Summary based on the provided document:
The provided 510(k) notification focuses on establishing substantial equivalence for a surgical mesh by comparing its intended use, target population, contact type, and technological characteristics (materials, sterility, general shape) to a predicate device (SURGICAL MESH "BARD MESH" produced by DAVOL INC.). The crucial statement, "The determination of substantial equivalence is not based on an assessment of performance data," makes it clear that the submission did not include new performance studies or data against specific acceptance criteria for the device itself. Therefore, the detailed information requested regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment, which are typical for studies demonstrating device performance, is explicitly stated as not being the basis for this particular 510(k) clearance.
§ 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.