(337 days)
The SURGIMESH®XD mesh is recommended for reinforcement of hernia defects. The hernia repair is for an inguinal hernia. The SURGIMESH®XD implant is indicated for use via an extraperitoneal approach either by open or laparoscopic surgery.
The SURGIMESH®XD consists of non-absorbable synthetic mesh, made of polypropylene. The SURGIMESH®XD has a 3D shape to fit the inguinal anatomy. In addition, two translucent windows are incorporated into the SURGIMESH®XD implant to allow proper positioning of the implant. The two windows allow the surgeon to place the implant in the correct anatomical location using the Cooper's ligament and the spermatic cord as anatomical guides in repairing a hernia defect. SURGIMESH®XD mesh is supplied sterile.
The provided text describes a 510(k) premarket notification for a surgical mesh device, SURGIMESH®XD. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a comprehensive study proving the device meets those criteria.
Therefore, much of the requested information regarding specific acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for a study proving the device meets acceptance criteria cannot be extracted directly from this document. The document describes pre-clinical testing for safety and materials, which are typical for substantial equivalence claims.
Here's a breakdown of what can and cannot be extracted:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Device is biocompatible per ISO 10993-1 standards. |
| Sterility | Device is sterile per ISO 10993-7, ISO 1137-1, ISO 14937, and USP 28 standards. |
| Product Packaging | Device packaging has appropriate sealing characteristics per ISO 11607. |
| Device Structure & Material Characterization (Mechanical/Material Characteristics) | SURGIMESH®XD specifications (ISO 5084, ISO 3801, ISO 9073-3, ISO 9073-4, ISO 9073-7, ISO 13934-1 and ISO 13938-1) are substantially similar to identified predicate device specifications. |
| Functionality | In all instances of preclinical testing, the SURGIMESH®XD functioned as intended. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The text refers to "preclinical testing" but does not specify sample sizes for these tests or the data provenance.
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 information is not provided. The document describes physical and material testing, not diagnostic or interpretive tasks that would require human expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided, as the testing described doesn't involve human interpretation requiring adjudication.
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:
An MRMC study was not conducted or described. This document pertains to a medical device (surgical mesh) that does not incorporate AI or require human interpretive reading in the way an AI-powered diagnostic tool would.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
A "standalone" performance in the context of an algorithm is not applicable here, as the device is a physical surgical mesh and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance tests mentioned would be the defined standards themselves (e.g., ISO standards for biocompatibility or sterility, or the physical characteristics of the predicate devices for material characterization). For functionality, it would be the expected function of the device under test conditions.
8. The sample size for the training set:
This information is not applicable/not provided. The device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable/not provided. The device is not an AI algorithm that requires a training set.
§ 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.