The LifeCell Tissue Matrix (LTM) Surgical Mesh is intended for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Indications for use also include the repair of body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.

The device 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 sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.

LTM is intended for single patient, one time use only.

Device Description

The LTM is a surgical mesh that is derived from porcine skin. The LTM device consists of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and thicknesses, and packaged in double pouch configuration.

AI/ML Overview

The provided text describes a 510(k) summary for the LTM Surgical Mesh. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study design with specific performance metrics as one would find for a novel device or software.

Here's a breakdown of the information requested, based on the provided text:

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

Acceptance Criteria	Reported Device Performance
Biocompatibility: Device is suitable for contact with living tissue without causing adverse reactions.	The data indicate that the device is biocompatible.
Viral Inactivation: Manufacturing process effectively inactivates viral components that may be present in the starting material.	The manufacturing process is capable of inactivating any viral components that may come with the starting material.
Biomechanical Strength & Suture Retention: The material possesses sufficient strength and suture retention for its intended use (reinforcement of soft tissue in tendon repair and body wall defects).	The biomechanical data show that the LTM matrix possesses sufficient strength and suture retention for the intended use.
Substantial Equivalence: LTM Surgical Mesh is as safe and effective as legally marketed predicate devices.	LTM is substantially equivalent to LifeCell Corp.'s LTM Surgical Mesh (K070560) and Pegasus Biologics, Inc.'s OrthADAPT™ (K071065).

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

The document does not specify a "test set" in the context of a dataset for an AI device. Instead, it refers to different types of testing:

Biocompatibility testing: Not specified.
Animal testing: Not specified.
Viral inactivation testing: Not specified.
Biomechanical testing: Not specified.

The text does not mention the country of origin of data or whether it was retrospective or prospective, as these are details commonly associated with clinical studies for AI/software devices. The studies mentioned here are performance and safety tests for a biological medical device.

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

This information is not applicable and is not provided. The ground truth for this device's performance is established through laboratory and animal testing, not expert interpretation of data points.

4. Adjudication method for the test set

This information is not applicable and is not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human readers or expert panels for diagnostic tasks, which is not the nature of the testing described here for a surgical mesh.

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 such study was conducted or mentioned. This type of study is relevant for AI-powered diagnostic or assistive devices, not for a surgical mesh.

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

This concept is not applicable to the LTM Surgical Mesh, which is a physical device, not an algorithm.

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

The "ground truth" for this device's performance is based on:

Biocompatibility standards: Likely established through standardized in-vitro and in-vivo tests.
Viral inactivation protocols: Based on validated methods to demonstrate removal or inactivation of viruses.
Biomechanical engineering principles: Measured properties like tensile strength and suture retention, compared against established requirements for the intended application.

8. The sample size for the training set

This information is not applicable as the LTM Surgical Mesh is a physical product, not an AI/software device that requires a training set.

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

This information is not applicable.

Summary

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K080353
Page 1/2

510(K) SUMMARY

ﭘﻮ

LifeCell Corporation's LTM Surgical Mesh

APR - 3 2008

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

LifeCell Corporation One Millennium Way Branchburg, NJ 08876 (908) 947-1115 Phone: (908) 947-1095 Facsimile:

Lorraine T. Montemurro, R.N., R.A.C. Contact Person: February 08, 2008 Date Prepared:

Name of Device and Name/Address of Sponsor

LTM Surgical Mesh

LifeCell Corporation One Millennium Way Branchburg, NJ 08876

Common or Usual Name

Surgical Mesh

Classification Name

Surgical Mesh

Classification

Class II

Product Code

FTM

Predicate Devices

LifeCell Corporation's LTM Surgical Mesh (K070560) Pegasus Biologics, Inc.'s OrthADAPT™ (K071065)

Intended Use / Indications for Use

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K080353
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LTM is intended for single patient, one time use only.

Technological Characteristics

Performance Data

The LTM has undergone extensive biocompatibility testing, animal testing, viral inactivation testing, and biomechanical testing. The data indicate that the device is biocompatible and that the manufacturing process is capable of inactivating any viral components that may come with the starting material. The biomechanical data show that the LTM matrix possesses sufficient strength and suture retention for the intended use.

Substantial Equivalence

LTM is substantially equivalent to the legally marketed predicate devices, LifeCell Corp.'s LTM Surgical Mesh (K070560) and Pegasus Biologics, Inc.'s OrthADAPT™ (K071065) surgical mesh devices. LTM has the same intended uses and the same or similar indications, technological characteristics, and principles of operation as these predicate devices. Performance data demonstrate that LTM functions equivalently to the predicate devices. Thus, LTM is substantially equivalent.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

LifeCell Corporation % Ms. Lorraine T. Montemurro, R.N., R.A.C. Manager, Regulatory Affairs One Millennium Way Branchburg, New Jersey 08876-3876

APR - 3 2008

Re: K080353

Trade/Device Name: LTM Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: February 8, 2008 Received: February 11, 2008

Dear Ms. Montemurro:

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 r ou may yours is 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 he 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 or any 1 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. Sharon Alexander

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 the reporting 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 M. Mulhausen

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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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: LTM Surgical Mesh

Indications for Use:

LTM is intended for single patient, one time use only.

Prescription Use X (Part 21 C.F.R. 801 Subpart D)

AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. Boyle for mxm

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

510(k) Number K080353

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.