(84 days)
NovaSilk Mesh is indicated for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy, laparoscopic, or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.
NovaSilk Mesh is an implantable, permanent, non-resorbable, synthetic support mesh manufactured from knitted, monofilament polypropylene. It is square in shape, measuring 150mm x 150mm, and 0.25mm thick.
Here's an analysis of the provided text regarding the NovaSilk Mesh device, specifically addressing the acceptance criteria and study information:
Based on the provided K122968 510(k) summary, the device is NovaSilk Mesh, and this submission is for a "Traditional 510(k) with Narrowed Indications." This type of submission relies heavily on demonstrating substantial equivalence to a previously cleared predicate device, rather than new extensive clinical trials for performance. Therefore, many of the typical "acceptance criteria" and "study" details you'd find for a new, novel AI or diagnostic device will not be present.
Acceptance Criteria and Reported Device Performance
The provided documentation does not define specific quantitative "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) or numerical efficacy targets that the NovaSilk Mesh needs to meet. This is characteristic of a 510(k) submission for a surgical mesh, where the primary focus is on demonstrating substantial equivalence to a predicate device.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the 510(k) process):
| Acceptance Criteria (Inferred from 510(k) process for substantial equivalence) | Reported Device Performance |
|---|---|
| Technological Characteristics: | |
| - Identical materials (knitted monofilament polypropylene) | "identical to NovaSilk Mesh (K053414, predicate device)" |
| - Identical design (square, 150mm x 150mm, 0.25mm thick) | "identical to NovaSilk Mesh (K053414, predicate device)" |
| - Identical fundamental scientific technology | "The fundamental scientific technology has not changed from the predicate device to the subject device." |
| - Similar materials to another predicate (Vertessa K120327) | "NovaSilk Mesh (subject device) also has similar materials... as Vertessa (K120327, predicate device)." |
| Indications for Use: | |
| - Indications for use either identical or narrower than predicate | "NovaSilk Mesh (subject device) has narrower indications for use than NovaSilk Mesh (K053414, predicate device)." |
| - Similar indications for use to another predicate (Vertessa K120327) | "NovaSilk Mesh (subject device) also has similar...indications for use as Vertessa (K120327, predicate device)." |
| Performance Testing: | |
| - Design verification, biocompatibility, sterilization, and shelf life | "Design verification, biocompatibility, sterilization, and shelf life testing completed on the predicate Novasilk Mesh confirm the subject device meets the established design specifications and is substantially equivalent to the predicate." |
Study Details:
Given that this is a 510(k) for substantial equivalence of a surgical mesh, the "study" is primarily a non-clinical comparison and verification of physical and material properties against predicate devices. There is no mention of a clinical study or performance study in the context of diagnostic accuracy, AI performance, or human reader improvement, as these types of studies are generally not required for this class and type of device in a 510(k).
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of a clinical performance study as might be expected for an AI device. The testing refers to non-clinical bench testing.
- Data Provenance: Not specified, but the testing was likely conducted in a lab setting by the manufacturer or contracted labs. Retrospective/prospective terms do not apply here.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the sense of clinical annotations by experts, is not established for this type of device submission. The "ground truth" for the non-clinical testing is compliance with established engineering and safety standards.
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Adjudication method for the test set:
- Not applicable. There is no expert adjudication process for this type of non-clinical testing.
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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 MRMC study was done. This is not an AI device or a diagnostic device where human reader performance would be a relevant metric.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
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The type of ground truth used:
- For the non-clinical performance data mentioned ("Design verification, biocompatibility, sterilization, and shelf life testing"), the "ground truth" is adherence to established industry standards, regulatory guidelines (e.g., ISO standards for biocompatibility), and internal design specifications for surgical meshes.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable.
Summary of Approach:
The provided document describes a 510(k) submission for a surgical mesh device. The regulatory strategy is based on demonstrating substantial equivalence to previously cleared predicate devices (NovaSilk Mesh K053414 and Vertessa K120327). This involves showing that the subject device has identical or similar technological characteristics (materials, design, fundamental scientific technology) and identical or narrower indications for use compared to the predicates.
The "performance data summary" refers to non-clinical testing (design verification, biocompatibility, sterilization, and shelf life testing) that was previously completed on the predicate NovaSilk Mesh, which then supports the substantial equivalence claim for the new NovaSilk Mesh (subject device) because the subject device is technologically identical. No new clinical performance data or studies defining specific acceptance criteria in terms of clinical outcomes or reader performance are presented in this 510(k) summary.
§ 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.