Proxy Biomedical VITAMESH™ surgical mesh is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing.

Device Description

The VITAMESH TM is a non-absorbable, synthetic mesh, constructed of knitted filaments of Polyproylene. The VITAMESH™ is supplied sterile and provided in sheet form to be cut to size and sutured by the surgeon to meet the patient's needs. The mesh is approximately 0.010" thick, and exhibits high burst strength and tensibe strength The VITAMESH™ is knitted by a process which provides for elasticity in both digetions. Use of VITAMESH™ allows a fibroblastic response through the interstices of the implant, forming a strong fibrous wall.

AI/ML Overview

The provided text describes a 510(k) submission for a surgical mesh device, VITAMESH™, and not a diagnostic AI device. Therefore, the questions related to acceptance criteria, study details, sample sizes, ground truth, experts, and MRMC studies, which are standard for AI/ML device evaluations, are not directly applicable to this document.

However, I can extract the information relevant to the device's performance assessment and substantial equivalence claim as presented in the document.

Here's a summary based on the provided text, adapted to the context of a medical device submission rather than an AI/ML diagnostic:

Acceptance Criteria and Study for VITAMESH™ Surgical Mesh

VITAMESH™ is a non-absorbable, synthetic surgical mesh made of knitted polypropylene filaments. Its acceptance criteria and proof of meeting them are based on demonstrating substantial equivalence to predicate devices through bench testing and biocompatibility assessments, rather than diagnostic performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Tests	Reported Device Performance
Mechanical Properties	High Burst Strength	Demonstrated high burst strength (stated as substantially equivalent).
	Tensile Strength	Demonstrated high tensile strength (stated as substantially equivalent).
	Elasticity in both directions	Knitted by a process providing elasticity in both directions.
Material Characterization	Thickness	Approximately 0.010" thick.
	Substantially equivalent to predicate mechanics and materials	Bench test data demonstrate mechanical and material characterization values are substantially equivalent to predicate devices (Bard PTFE Mesh, Mersilene Mesh, Bard Mesh).
Biocompatibility	Non-toxic	Biocompatibility test results show the material is non-toxic.
	Non-sensitizing to biological tissues	Biocompatibility test results show the material is non-sensitizing to biological tissues.
	Consistent with intended use	Biocompatibility results are consistent with the intended use.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated in terms of a numerical count of devices or test samples. The document refers to "Bench test data" and "biocompatibility test results" generally.
Data Provenance: Not explicitly stated, but assumed to be laboratory testing conducted by or for Proxy Biomedical, Ltd. No information about country of origin, retrospective or prospective nature of data collection, as these are not relevant for bench testing of medical devices in this context.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This question is not applicable as the evaluation is not based on interpreting diagnostic images or clinical scenarios requiring expert ground truth in the traditional sense. The "ground truth" here is the established scientific and engineering principles for material and mechanical performance, and biological response to materials.

4. Adjudication Method for the Test Set

This question is not applicable as there is no human interpretation or adjudication of diagnostic outputs involved. The "adjudication" is through standardized test methods and comparison to predicate device specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for evaluating diagnostic devices (often imaging-based) where human readers interpret cases, and an AI's impact on their performance is assessed. This is not relevant for a surgical mesh device's pre-market submission for mechanical and biocompatibility properties.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. VITAMESH™ is a physical surgical implant, not an algorithm or AI device. Its performance is inherent in its physical properties, not in a standalone algorithm's output.

7. The Type of Ground Truth Used

The "ground truth" for VITAMESH™'s evaluation is primarily based on:
- Validated laboratory test methods: For mechanical properties (burst strength, tensile strength, elasticity) and material characterization.
- Established biocompatibility standards: For assessing non-toxicity and non-sensitizing properties to biological tissues, likely following ISO 10993 standards.
- Predicate device specifications: The performance of legally marketed predicate devices (Bard PTFE Mesh, Mersilene Mesh, Bard Mesh) serves as a benchmark for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

This question is not applicable. This device is not an AI/ML algorithm that requires a "training set." The polypropylene material and knitting process are engineered and manufactured, not "trained."

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no training set for a physical surgical mesh device.

Summary

{0}------------------------------------------------

MAR 2 8 2006

K060520
Page 1 of 1

SECTION 1 510(k) Summary

SUBMITTED FOR:

Company Name:	Proxy Biomedical, Ltd.
Address:	Unit 6D, Mervue Business Park
	Galway, IRELAND
	Contact Person: Peter Mulrooney, Quality Assurance Manager
	Tel: +353 (0)91 709161 Fax: +353 (0)91 709162
Submitted by:	Elaine Duncan, M.S.M.E., RAC
	President, Paladin Medical, Inc.
	PO Box 560
	Stillwater, MN 55082
	715-549-6035
	715-549-5380
CONTACT PERSON:	Elaine Duncan
DATE PREPARED:	Feb 11, 2006
TRADE NAME:	VITAMESH™
COMMON NAME:	Surgical Mesh
REGULATORY CLASS:	This device is class II
DEVICE PANEL AND PRODUCT CODE:	General and Plastic Surgery21 CFR 878.330 FTI

SUBSTANTIALLY EQUIVALENT TO: VITAMESH™ is substantially equivalent to the Bard PTFE Mesh. (Davol Inc.),Mersilene Mesh (Ethicon, Inc.), and the Bard Mesh (C.R. Bard, Inc.) a polypropylene mesh.

DESCRIPTION of the DEVICE:

INDICATIONS FOR USE:

SUMMARY of TESTING:

Bench test data demonstrate that VITAMESH™ has mechanical and material characterization values that are substantially equivalent to the predicate devices. The biocompatibility test results show that the material used in the design and manufacture of the device is non-toxic and nonsensitizing to biological tissues consistent with their intended use.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 8 2006

Proxy Biomedical, Ltd. c/o Paladin Medical, Inc. Ms. Elaine Duncan, M.S.M.E., RAC President P.O. Box 560 Stillwater, Minnesota 55082

Re: K060520

Trade/Device Name: VITAMESH™ MacroPorous PP Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: February 23, 2006 Received: February 27, 2006

Dear Ms. Duncan:

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 docs 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

{2}------------------------------------------------

Page 2 - Ms. Elaine Duncan, M.S.M.E., RAC

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Hubert Lemmer MD

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

Enclosure

{3}------------------------------------------------

Indications for Use

KO60520 510(k) Number (if known):

Device Name: VITAMESH™ MacroPorous PP Surgical Mesh

Indications For 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)

Hubert Lemons

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

510(k) Number K060520

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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.