(242 days)
The Surgical Mesh System is intended to be implanted to reinforce soft tissue where weakness exists. The device is intended for one-time use.
The NuVasive Surgical Mesh System consists of a series of specialized shapes of surgical mesh made from commercially available polyester suture fibers. All sizes incorporate regions of reinforced holes to assist secure anchoring of the mesh to tissue. Thoodpoines are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
Here's an analysis of the provided text regarding the NuVasive Surgical Mesh System, focusing on the absence of information related to acceptance criteria and performance studies in the context of medical device performance evaluation.
Based on the provided 510(k) summary for the NuVasive Surgical Mesh System (K053215), there is no information available regarding acceptance criteria or a study proving the device meets specific acceptance criteria in terms of clinical performance metrics.
The document is a 510(k) premarket notification, which primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving efficacy or determining specific performance statistics against predefined acceptance criteria through clinical studies.
Here's a breakdown of why many of your requested points cannot be answered from this document:
-
A table of acceptance criteria and the reported device performance: Not applicable. The 510(k) process for this device did not require the establishment of specific performance acceptance criteria beyond demonstrating substantial equivalence in design, materials, and mechanical properties to the predicate. No clinical performance metrics (like sensitivity, specificity, accuracy, etc.) are reported.
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for clinical performance. The document mentions "Mechanical testing was presented" in "Summary of Non-Clinical Tests," but details about sample sizes, specific tests, or results are not included in this summary. These tests would be related to material properties and structural integrity, not clinical outcomes.
-
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. No clinical ground truth was established or used for performance evaluation in a clinical study as described in this 510(k) summary.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical adjudications were performed as there was no clinical study evaluating performance against ground truth.
-
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 device is a surgical mesh; it does not involve image interpretation or AI assistance for human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical mesh; it is not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No clinical ground truth was used for performance evaluation in a clinical study as described.
-
The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
-
How the ground truth for the training set was established: Not applicable, as it's not an AI/ML algorithm.
Summary of Information from the Provided Text about Device Performance and Equivalence:
The provided document asserts substantial equivalence based on:
- Design: Stated as "substantially equivalent, if not identical."
- Materials of Composition: Made from "commercially available polyester suture fibers," asserting equivalence here too.
- Indications for Use: "to reinforce soft tissue where weakness exists," which aligns with predicate devices.
- Mechanical Testing: A "Summary of Non-Clinical Tests" states "Mechanical testing was presented." However, no specific acceptance criteria or results from this testing are included in the summary.
- No Clinical Tests: The "Summary of Clinical Tests" explicitly states "(Not Applicable)." This indicates that no clinical studies were conducted or provided as part of this 510(k) submission to demonstrate performance against specific clinical acceptance criteria.
Conclusion:
The NuVasive Surgical Mesh System (K053215) gained 510(k) clearance by demonstrating substantial equivalence to existing legally marketed predicate devices through a comparison of design, materials, indications for use, and non-clinical (mechanical) testing. The summary explicitly states that clinical tests were "Not Applicable," meaning there was no study performed to establish specific clinical performance metrics against predefined acceptance criteria for this particular device under this submission.
§ 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.