Modified PROLENE mesh is intended for the repair of hernia and other fascial deficiencies that require the addition of a reinforcing or bridging material, to obtain the desired surgical result. Modified PROLENE mesh has the same intended use as the preamendment predicate device PROLENE mesh. Modified PROLENE mesh is intended for the repair of hernia and other fascial deficiencies that require the addition of a reinforcing or bridging material.

Device Description

Modified PROLENE mesh is constructed of knitted filaments of extruded polypropylene identical in composition to that used in PROLENE suture nonabsorbable surgical sutures, U.S.P. (ETHICON, INC.). The mesh is approximately 0.027 inches thick. This material, when used as a suture, has been reported to be nonreactive and to retain its strength indefinitely in clinical use.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Modified PROLENE polypropylene mesh nonabsorbable synthetic surgical mesh). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and device performance metrics in the way a diagnostic AI would.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or cannot be extracted from this document, as it's not a study designed to evaluate an AI diagnostic device.

Here's an analysis based on the provided text, addressing the applicable points:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated as specific numerical acceptance criteria. The overarching "acceptance criterion" is proving substantial equivalence to the predicate device.	Burst strength testing was conducted to compare the predicate device and the modified device. (No specific numerical results or comparison thresholds 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 specified. The document mentions "burst strength testing was conducted" but does not detail the number of samples used in this testing for either the predicate or the modified device.
Data Provenance: Not applicable/specified. This is a physical device test, not data from patients or a specific geographic region. The testing would have been performed by the manufacturer, ETHICON, Inc.

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 summary describes testing of a physical medical device (surgical mesh), not an AI diagnostic system requiring expert interpretation or ground truth establishment based on clinical observations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. See point 3.

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

No. This is a physical device, not an AI diagnostic tool. MRMC studies are not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the burst strength testing would be the measured physical properties of the material itself, as determined by standardized laboratory methods for mechanical testing.

8. The sample size for the training set

Not applicable. This is a physical device test, not an AI training process.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary of Device and Equivalence Claim (from the document):

Device Name: Modified PROLENE* polypropylene mesh nonabsorbable synthetic surgical mesh
Predicate Device Name: PROLENE* polypropylene mesh nonabsorbable synthetic surgical mesh
Intended Use: Repair of hernia and other fascial deficiencies that require the addition of a reinforcing or bridging material.
Technological Characteristics: The modified device has the same technological characteristics (chemistry, material, composition) as the predicate device. The only differences are additional sizes and a pre-cut keyhole shape for convenience.
Performance Data (Study): Burst strength testing was conducted comparing the predicate and modified devices.
Conclusion: Based on the information, the modified device is substantially equivalent to the Predicate Device under the Federal Food, Drug, and Cosmetic Act.

Summary

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K96253c

AUG - 9 1996

SECTION 7 SUMMARY OF SAFETY AND EFFECTIVENESS

Information supporting claims of substantial equivalence, as 510(k) Summary of Safety and Effectiveness defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "... 510(k) Summaries and 510(k) Statements ... " (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency. NEW DEVICE NAME: Modified PROLENE* polypropylene mesh nonabsorbable synthetic surgical mesh PREDICATE DEVICE NAME: PROLENE* polypropylene mesh nonabsorbable synthetic surgical mesh 510(k) SUMMARY Device Description Modified PROLENE mesh is constructed of knitted filaments of extruded polypropylene identical in composition to that used in PROLENE suture nonabsorbable surgical sutures, U.S.P. (ETHICON, INC.). The mesh is approximately 0.027 inches thick. This material, when used as a suture, has been reported to be nonreactive and to retain its strength indefinitely in clinical use. Modified PROLENE mesh is intended for the repair of hernia Intended Use and other fascial deficiencies that require the addition of a reinforcing or bridging material, to obtain the desired surgical result. Continued on next page

Modified PROLENE polypropylene mesh nonabsorbable synthetic surgical mesh ETHICON, Inc.

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SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

	510(k) SUMMARY, Continued
Intended Use (continued)	Modified PROLENE mesh has the same intended use as thepreamendment predicate device PROLENE mesh.
Indications Statement	Modified PROLENE mesh is intended for the repair of herniaand other fascial deficiencies that require the addition of areinforcing or bridging material.
TechnologicalCharacteristics	The modified device has the same technological characteristicsas the predicate device. There is no change in chemistry,material or composition.When compared to the predicate device, Modified PROLENEmesh differs in the additional sizes that are being supplied and akey hole shape which is being provided precut as a convenienceto the surgeon.
Performance Data	Burst strength testing was conducted to compare the predicatedevice and the modified device.
Conclusions	Based on the 510(k) summaries and 510(k) statements (21 CFR807) and the information provided herein, we conclude that themodified device is substantially equivalent to the PredicateDevice under the Federal Food, Drug, and Cosmetic Act.
	Continued on next page

Modified PROLENE polypropylene mesh nonabsorbable synthetic surgical mesh ETHICON, Inc.

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SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

Contact

John D. Paulson, Ph.D. 1 Vice President, Regulatory Affairs ETHICON, Inc. Rt. #22, West Somerville, NJ 08876-0151

Date

June 25, 1996

Modified PROLENE polypropylene mesh nonabsorbable synthetic surgical mesh ETHICON, Inc.

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.