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.

AI/ML Overview

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.

Summary

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JUL 1 7 2006

Image /page/0/Picture/1 description: The image shows the text "NuVasive®, Incorporated". The text is in a serif font and is black. The registered trademark symbol is next to the word NuVasive.

510(k) Premarket Notification Surgical Mesh System <053215

5. 510(K) SUMMARY

In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided:

A. Submitted by

Laetitia Cousin Director of Regulatory Affairs and Quality Assurance NuVasive, Incorporated 4545 Towne Centre Court San Diego, CA 92121 Telephone: (858) 909-1868 Date Prepared: July 6, 2006.

B. Device Name
Trade or Proprietary Name: Common or Usual Name: Classification Name:

NuVasive Surgical Mesh System Surgical Mesh Surgical Mesh (21 CFR Part 878.3300; Surgical Mesh, Class II, Product Code FTL.)

C. Predicate Devices

The subject device is substantially equivalent to similar previously cleared devices.

D. Device Description

E. Intended Use

The Surgical Mesh System is intended to be implanted to reinforce soft tissue where weakness exists. The device is intended for one-time use.

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F. Comparison to Predicate Devices

As was established in this submission, the subject device is substantially equivalent to other devices cleared by the agency for commercial distribution in the United States.

Engineering drawings, labeling, and mechanical testing have demonstrated that the subject device is substantially equivalent, if not identical, to its predicate devices in terms of design, materials of composition, indications for use, and such other characteristics as may be associated with the manufacture of any medical device.

G. Summary of Non-Clinical Tests

Mechanical testing was presented.

H. Summary of Clinical Tests

(Not Applicable).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is positioned around the upper half of the circular logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 2006

NuVasive. Inc. % Ms. Letitia Cousin Director, Regulatory Affairs and Quality Assurance 4545 Towne Centre Court San Diego, California 92121

Re: K053215

Trade/Device Name: NuVasive Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: June 16, 2006 Received: June 19, 2006

Dear Ms. Cousin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 – Ms. Letitia Cousin

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Barbara Buchup

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K053215

Device Name: NuVasive Surgical Mesh

Indications For Use:

The Surgical Mesh System is intended to be implanted to reinforce soft tissue where weakness exists. The device is intended for one-time use.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aubare Buchamp for mcan
(Division Sign-Off)

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Division of General, Restorative and Neurological Devices

510(k) Number K053215

Regulation Number and Section

§ 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.