(138 days)
Endoform Reconstructive Template – Non-Absorbable is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists.
Endoform Reconstructive Template – Non-Absorbable is indicated for use in the repair of hernias and/or abdominal wall defects that require the use of reinforcing or bridging material to obtain the desired surgical outcome.
Endoform Reconstructive Template - Non-Absorbable is a surgical mesh manufactured by layering sheets of ovine forestomach matrix to create multi-layer configurations of devices laminated with non-resorbable polypropylene (PP) suture material in a variety of sizes for use in soft tissue reconstruction. Devices up to 400 cm² are available in thicknesses from 1- through 10- ply, and larger devices up to 1000cm2 are available in 4-, 6-, and 8-ply presentations.
This document describes the Endoform Reconstructive Template - Non-Absorbable, a surgical mesh. The submission (K181935) is a 510(k) premarket notification for a line extension to increase the maximum device size.
Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Specifications) | Reported Device Performance |
|---|---|
| Material composition | Remains the same as predicate |
| Biocompatibility | Remains the same as predicate |
| Sterilization | Remains the same as predicate |
| Packaging materials and processes | Remains the same as predicate |
| Mechanical Strength | Meets all product specifications for the intended use |
| Endotoxin levels | Meets all product specifications for the intended use |
| Dimensional verification | Meets all product specifications for the intended use |
| Performance (general) | Performance specifications have not changed and are met |
The document states that the performance specifications for the device have not changed and that the device meets these specifications. The specific quantitative values of these specifications are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size for test set: Not explicitly stated. The document refers to "Bench testing and validation" and "results of verification and validation testing" without providing specific sample numbers for each test.
- Data provenance: Not explicitly stated, but the company is Aroa Biosurgery Ltd. located in New Zealand. These would be non-clinical, laboratory-based tests.
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)
Not applicable. This device is a surgical mesh, and the testing described is non-clinical (bench testing) for physical properties, not a clinical study involving radiologists or medical image interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically for clinical studies involving multiple reviewers/experts, which is not the case here.
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. This is not an AI/software device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (surgical mesh), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance data, the "ground truth" would be established by:
- Engineering specifications and standards for mechanical strength and dimensional properties.
- Validated laboratory assays for endotoxin levels and biocompatibility (as carried over from the predicate device).
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of physical device testing.
9. How the ground truth for the training set was established
Not applicable. There is no 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.