MOTIFMESH™ Soft Tissue Patch is intended to assist in the repair and/or reinforcement of hemia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing.

Device Description

MOTIFMESH™ Soft Tissue Patch is a nonabsorbable, inert, sterile, macro porous surgical soft tissue patch Produced from polytetrafluoroethylene. The MotifMesh TM Soft Tissue Patch is designed to facilitate the reinforcement and repair of damaged or ruptured soft tissue structures. The implant has a structure characterized by closed cell openings in a high strength film. The construction allows the soft tissue patch to be stretched in both directions, to accommodate and reinforce tissue defects. The soft tissue patch measures 0.006''+/. 001" in thickness and exhibits high burst strength and tensile strength. Use of MOTIFMESH™ Soft Tissue Patch 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) summary for the MOTIFMESH™ Soft Tissue Patch. The submission focuses on demonstrating substantial equivalence to predicate devices based on mechanical characterization and biocompatibility testing. The document does not contain specific acceptance criteria, reported device performance metrics in a structured table, details on sample sizes for test sets, data provenance, ground truth establishment for a test set, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), or a standalone algorithm performance study. It also doesn't specify a training set or how its ground truth was established.

Therefore, many of the requested fields cannot be filled based on the provided text.

Here's a breakdown of what can be extracted and what information is missing:

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

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical characterization values substantially equivalent to predicate devices (Bard PTFE Mesh, Mersilene Mesh, Bard Mesh)	"Bench test data reveal the applicant device has mechanical characterisation values, which are substantially equivalent to the predicate devices."
Material non-toxic to biological tissues	"The biocompatibility test results show that the material used in the design and manufacture of the device are non-toxic..."
Material non-sensitizing to biological tissues	"...and non-sensitizing to biological tissues consistent with their intended use."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size (Test Set): Not specified.
Data Provenance: Not specified (likely from internal lab testing at Proxy Biomedical, Ltd. in Ireland, but not explicitly stated).
Retrospective or Prospective: Not specified.

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 as this is a medical device for physical repair, not an image analysis or diagnostic device requiring expert interpretation of a test set. Ground truth relates to mechanical properties and biocompatibility.

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

Not applicable for the type of testing described (mechanical and biocompatibility).

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 not a diagnostic device or an AI-assisted device. The study described is a bench test and biocompatibility study for a surgical mesh.

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

No. This is not an algorithm or AI device.

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

For mechanical characterization: Benchmark values of predicate devices (Bard PTFE Mesh, Mersilene Mesh, Bard Mesh).
For biocompatibility: Established biocompatibility standards and testing methodologies (e.g., ISO 10993 series, though not explicitly mentioned, implied by "non-toxic and non-sensitizing"). The "ground truth" would be the successful passing of these tests according to predefined criteria for toxicity and sensitization.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set. The "training" here would be for the manufacturing process to consistently produce the device.

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

Not applicable due to the nature of the device (surgical mesh, not an AI/ML device).

Summary

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510(k) Summary K05 0678

SUBMITTED FOR:

Company Name: Address:

Proxy Biomedical, Ltd.

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: DATE PREPARED: TRADE NAME: COMMON NAME:

Elaine Duncan March 14, 2005 MOTIFMESHTM Soft Tissue Patch Surgical Mesh

SUBSTANTIALLY EQUIVALENT TO: MOTIFMESH™ Soft Tissue Patch is substantially equivalent to the Bard PTFE Mesh. (Davol Inc.), Mersilene Mesh (Ethicon) and the Bard Mesh (Davol Inc.), a polypropylene mesh.

DESCRIPTION of the DEVICE:

INDICATIONS FOR USE:

SUMMARY of TESTING:

Bench test data reveal the applicant device has mechanical characterisation values, which are substantially equivalent to the predicate devices. The biocompatibility test results show that the material used in the design and manufacture of the device are non-toxic and non-sensitizing to biological tissues consistent with their intended use.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design.

MAY 2 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050678

K050678
Trade/Device Name: MOTIFMESH™ Soft Tissue Patch Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: March 14, 2005 Received: March 16, 2005

Dear Ms. Duncan:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section > I o(x) premainer is substantially equivalent (for the indications
referenced above and have determined the device is subserverketed in interst referenced above and nave delemined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate device. Amendments for use stated in the enclosure) to regally manced to career and cal Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Registions of the Federal F commerce prior to May 28, 1970, the chaculture with the provisions of the Federal Food. Drug, devices that have been reclassified in accordance what as provisions of the Act . The and Cosmetic Act (Act) that do not require approval or a provisions of the Act. The Act. The Act. The You may, therefore, market the device, subject to the gentlal registration, listing of
general controls provisions of the Act include requirements for any provisionaling and general controls provisions of the Act mende requirements as and the submit misbranding and adulteration.

, I

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (See and C) mich and (opregulations affecting your device
it may be subject to such additional controls. Existing major regulation FDA it may be subject to such additional controls: Existing major vegan to 898. In addition, FDA
can be found in the Code of Federal Regulations, Title 21, Peris 800 to Registe can be found in the Code of Federal Regalations, The C-77 in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualite of a substantity of the requirements of the Act
that FDA has made a determination that your device addression . You must that FDA has made a determination hial your de reas by other Federal agencies. You must
or any Federal statutes and regulations administered by registration and listin or any Federal statutes and regulations administers of other was included to: registration and listing (21 l
comply with all the Act's requirements, including, but not assess comply with all the Act s requirements, mendams, our not turing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); end 800); end familicable, the electro CFR Part 807); labeling (21 CFR 1 at 601); good manage (200); and if applicable, the clectronic
forth in the quality systems (QS) regulation (21 CFR 1000-1050 forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-

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

This letter will allow you to begin marketing your device as described in your Section 510(k)
The same of the support of aling of a list of the spivalence of your device to a This letter will allow you to begin hiaketing your active as usesnese of your device to a legally
premarket notification. The FDA finding of substantial equivales of tyour premarket notification. The FDA Iniding of Subscantal organ 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
rs the real and the many of 10, 276, 0115 - Alancelone note the regulation If you desire specific advice for your de not our our our our our one note the regulation entitled, contact the Office of Compliance at (240) 270 - 1 (21CFR Part 807.97). You may obtain
"Misbranding by reference to premarket notification the Division of Small "Misbranding by reference to prematics nonification (ne Act from the Division of Small
other general information on your responsibilities under the Act from pumber (800) 638– other general information on your responsion.com its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance findex html Manufacturers, International and Consumer 713.555ant of the loved in and 10 minuters html.
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/

Sincerely yours,

Miriam C. Provost

Miriam C. Provost, Ph.D. -Acting 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

05067 8

510(k) Number (if known):

MOTIFMESH™ Soft Tissue Patch

Device Name:

Indications For Use:

MOTIFMESH™ Soft Tissue Patch is intended to assist in the repair and/or reinforcement of a nonabsorbable implant MOTIFMESH™ Soft Tissue Patch is intended to assist in the Icpar and of reason of a nonabsorbable implant
hemia and other fascial defects requiring the additional support of a nerma and after wound healing.

Prescription Use __ × (Part 21 CFR 801 Subpart D)

الد م

AND/OR

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

(Fart F ST WEET PAGE OW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

estorative

K050678

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.