Reinforced Absorbable Synthetic Surgical Mesh is indicated for use in the surgical repair of damaged or ruptured soft tissue where reinforcing or bridging materials are needed. This device is intended for one-time use.

Device Description

The reinforced absorbable synthetic surgical mesh is a foam encased mesh. The foam component is a biocompatible elastomeric polymer that is bioabsorbable. This elastomer exhibits a high percent elongation, while possessing good tensile strength and good recovery characteristics. It has been found to be non-antigenic, non-pyrogenic, and elicits a slight, but typical, tissue reaction during absorption. Therapeutically, the foam component provides wound support as well as increases the opportunity for bridging to occur due to its porosity. The mesh component is a woven polydioxanone mesh that is used to provide wound support during the healing process. It has been found to be non-antigenic, non-pyrogenic, and also elicits a slight, but typical, tissue reaction during absorption. Therapeutically, the mesh component retains strength for a period of time long enough to permit sufficient healing, preventing wound dehiscence.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the "Reinforced Absorbable Synthetic Surgical Mesh." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving efficacy or meeting specific performance acceptance criteria through a standalone study. Therefore, much of the information requested in the prompt, such as detailed acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods for AI performance, is not applicable or available in this document.

Here's an analysis based on the provided text, addressing the prompt's points where possible:

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

As this is a 510(k) submission, the "acceptance criteria" are primarily related to demonstrating substantial equivalence to predicate devices, not specific performance metrics against a pre-defined standard in the way an AI algorithm might be evaluated. The "reported device performance" is framed in terms of similarity to the predicate devices.

Acceptance Criteria (based on 510(k) process for substantial equivalence)	Reported Device Performance
Similar Indications for Use	Same as predicate devices
Similar overall function and performance in reinforcing soft tissue wound strength	Performs in a similar manner to PDS™ Mesh (K844228) and AFB (K014183)
Similar absorption characteristics	Similar to predicate devices
Similar degradation characteristics	Similar to predicate devices
Similar burst strength	Similar to predicate devices
Biocompatibility	Biocompatibility testing for predicate devices (AFB and PDS™ Mesh) is deemed sufficient and applicable; no additional new testing performed.

2. Sample size used for the test set and the data provenance

Sample size for test set: Not applicable. No "test set" in the context of evaluating an AI algorithm or a new clinical performance study was conducted. The assessment relies on existing data from predicate devices.
Data provenance: The data provenance is from pre-existing 510(k) submissions for the predicate devices: PDS™ Mesh (K844228) and AFB (Absorbable Foam Buttress) (K014183). This is essentially retrospective review of prior regulatory submissions for similar devices. The country of origin of the original predicate device data is not specified in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No "test set" requiring expert-established ground truth was used for this 510(k) submission. The FDA's review process itself involves regulatory experts.

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

Not applicable. No test set requiring expert adjudication was part of this submission. The "adjudication" in a 510(k) lies with the FDA's regulatory review.

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 device is a surgical mesh, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is entirely irrelevant to this submission.

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.)

The "ground truth" for this 510(k) submission is the regulatory acceptance and established performance of the predicate devices (PDSTM Mesh K844228 and AFB K014183) based on their own prior documentation regarding indications, materials, and functional characteristics. The submission argues that the new device meets the 'ground truth' of being substantially equivalent to these already-marketed devices.

8. The sample size for the training set

Not applicable. No "training set" in the context of AI development was used.

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

Not applicable. No "training set" was used.

Summary

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K023328

SUMMARY OF SAFETY AND EFFECTIVENESS

DEC 1 2 2002 GENERAL INFORMATION Center for Biomaterials and Advanced A. Submitted By: Technologies, Medical Devices Group, a division of Ethicon, Inc. Route 22 West, P.O. Box 151 Somerville, NJ 08876 (908) 218-2041 Tel: (908) 218-3679 Fax: Contact Person: David A. Dalessandro At address above Reinforced Absorbable Synthetic Surgical B. Device Trade Name: Mesh Surgical Mesh Common Name: Classification Name: Mesh, Surgical, Polymeric FTL, 21 CFR 878.3300 C. Predicate Device(s): Manufacturer Product Name 510(k) No. PDSTM (polydioxanone) Mesh Ethicon, Inc. K844228

J&J Corporate AFB (Absorbable Foam K014183 Biomaterials Center Buttress)

D. Device Description:

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Accordingly, no or minimal undesirable side effects occur during the healing process.

Indications for Use: E.
Reinforced Absorbable Synthetic Surgical Mesh is indicated for use in the surgical repair of damaged or ruptured soft tissue where reinforcing or bridging materials are needed. This device is intended for one-time use.
F. Technological Comparison:
The reinforced absorbable synthetic surgical mesh and PDSTM Mesh (K844228) have similar indications for use and overall function and perform in a similar manner with respect to reinforcement of soft tissue wound strength. The reinforced absorbable synthetic surgical mesh has similar absorption, degradation, and burst strength to the predicate device.

The foam component of the reinforced absorbable synthetic surgical mesh functions and performs in the same manner as AFB (Absorbable Foam Buttress) (K014183).

II. TESTING

The biocompatibility testing for AFB and PDS™ Mesh are sufficient and applicable to the reinforced absorbable synthetic surgical mesh. Accordingly, no additional biocompatibility or animal testing on the reinforced absorbable synthetic surgical mesh was performed.

III. CONCLUSIONS

In summary, Center for Biomaterials and Advanced Technologies, Medical Devices Group, a division of Ethicon, Inc. has demonstrated that the intended use for the reinforced absorbable synthetic surgical mesh is the same as the original devices. The technological characteristics have been described in sufficient detail to demonstrate that they are the same as the original devices. Therefore, this premarket notification has demonstrated substantial equivalence as defined and understood in the Federal Food, Drug, & Cosmetic Act and its amendments.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Center for Biomaterials and Advanced Technologies Melissa Mahall c/o Bio-Reg Associates 11800 Baltimore Avenue, Suite 105

Beltsville. Maryland 20705

Re: K023328

Trade/Device Name: Reinforced Absorbable Synthetic Surgical Mesh Regulation Number: 878.3300 Regulation Name: Polymeric Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: October 2, 2002 Received: October 4, 2002

Dear Ms. Mahall:

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 forth in the

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Page 2 – Ms. Melissa Mahall

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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., MD 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 STATEMENT

510(k) Number (if known):

KOZ3328

Device Name:

Reinforced Absorbable Synthetic Surgical Mesh

Sponsor Name:

Center for Biomaterials and Advanced Technologies, Medical Devices Group, a division of Ethicon, Inc.

Indications for Use:

Do Not Write Below This Line - Continue on Another Page if Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Over-The-Counter Use

风

Miriam C. Provost

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K023328

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.