The WMT Collagen Dermal Matrix is intended to reinforce soft tissue where weakness exists, specifically, for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, and other tendons. The WMT Collagen Dermal Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear, and suture or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.

Device Description

The WMT Collagen Dermal Matrix is a sterile, non-perforated processed porcine collagen dermal matrix.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "WMT Collagen Dermal Matrix," a surgical mesh. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through clinical trials or standalone performance studies like those for AI/ML-based medical devices.

Therefore, the requested information, which is relevant to AI/ML device evaluations, is largely not applicable or not explicitly detailed in this document for the WMT Collagen Dermal Matrix. The document primarily focuses on a comparison to predicate devices through bench testing of mechanical properties.

Here's an assessment based on the available information:

A table of acceptance criteria and the reported device performance
- Not applicable in the context of this 510(k) submission as requested for AI/ML devices. The document states that "Mechanical testing characterized the suitability of the subject device, WMT Collagen Dermal Matrix, in orthopedic applications, and compared the test results of both OrthADAPT™ FX and RESTORE® predicate devices." However, specific numerical acceptance criteria (e.g., sensitivity, specificity, F1-score thresholds) and detailed performance metrics against those criteria are not provided. The bench testing would have compared mechanical properties but these are not quantified in the summary.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. This device is a surgical mesh, and its evaluation primarily involved bench testing (mechanical characterization) rather than a test set of patient data. The document does not describe patient data or clinical trials with test sets.
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 test set requiring expert ground truth establishment is described for this device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring adjudication is described for this device.
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/ML diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical surgical mesh, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not explicitly defined in typical AI/ML terms. For a surgical mesh, the "ground truth" for mechanical testing would be established by standardized testing methods and material properties, rather than expert consensus on a diagnostic outcome or pathology. The document indicates "bench testing comparing predicate devices and the subject device," implying that the performance of the device was compared directly against the mechanical properties of the predicate devices.
The sample size for the training set
- Not applicable. This device is a surgical mesh and does not involve a training set as an AI/ML algorithm would.
How the ground truth for the training set was established
- Not applicable. No training set is involved for this device.

Summary for the WMT Collagen Dermal Matrix (K073219):

The 510(k) submission for the WMT Collagen Dermal Matrix demonstrates substantial equivalence to predicate devices primarily through bench testing of mechanical properties. The report states: "Mechanical testing characterized the suitability of the subject device, WMT Collagen Dermal Matrix, in orthopedic applications, and compared the test results of both OrthADAPT™ FX and RESTORE® predicate devices, surgical meshes which are currently indicated for orthopedic applications."

The acceptance criteria are implicitly that the mechanical properties of the WMT Collagen Dermal Matrix are comparable to or within acceptable ranges of the predicate devices. However, specific numerical acceptance thresholds and the detailed results of the mechanical testing that "proves the device meets the acceptance criteria" are not provided in this summary document. The "study" mentioned is "new bench testing comparing predicate devices and the subject device." This testing would have involved engineering and material science standards rather than clinical or AI/ML evaluation metrics.

Summary

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K073219
1/1

ನ. 510(k) Summary Statement

Submitter:	American Medical Systems (AMS)10070 Bren Road WestMinnetonka, MN 55343Phone: 952.933.6139FAX: 952.930.5785
Contact Person:	Mona InmanAPR 10 200
Device Common Name:	Surgical Mesh
Device Trade Name:	WMT Collagen Dermal Matrix
Device Classification Name:	Surgical Mesh (FTM)
Predicate Devices:	AMS Collagen Dermal Matrix, marketed as "InteXenLP" (K050445),RESTORE Soft Tissue Implant (K071016),OrthADAPT FX (K071065)

Device Description

The WMT Collagen Dermal Matrix is a sterile, non-perforated processed porcine collagen dermal matrix.

Indications for Use

Comparison to Predicate Devices

The three predicate devices are biological-derived surgical mesh used in tissue repair and tissue reinforcement. Mechanical testing characterized the suitability of the subject device, WMT Collagen Dermal Matrix, in orthopedic applications, and compared the test results of both OrthADAPT™ FX and RESTORE® predicate devices, surgical meshes which are currently indicated for orthopedic applications. All predicate surgical mcshes are provided sterile and are indicated for single use.

Supporting Information

Substantial equivalency was supported by information from previously cleared devices, and new bench testing comparing predicate devices and the subject device.

WMT Collagen Dermal Matrix 510(k) Notification

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with outstretched wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 0 2008

K073219 Re:

% Ms. Mona Inman 10700 Bren Road West

American Medical Systems

Minnetonka, Minnesota 55343

Trade/Device Name: WMT Collagen Dermal Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTM Dated: April 1, 2008 Received: April 2, 2008

Dear Ms. Inman:

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 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.

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Page 2 – Ms. Mona Inman

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,

Mark N Millerson

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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KO73219

INDICATIONS FOR USE

510(k) Number (if known):

Device Name: WMT Collagen Dermal Matrix

Indications For Use:

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

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)

Nish R.P. Qalla for nam
Sign-Off

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

510(k) Number K073219

WMT Collagen Dermal Matrix 510(k) Notification

Page 16 of 76

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.