LTM Surgical Mesh (LTM) is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use include the repair of hernias and /or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.

LTM is intended for single patient 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) premarket notification for the LTM Surgical Mesh. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving direct clinical efficacy through a detailed study with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the kind of detailed information about acceptance criteria and a study proving device performance as typically expected for an AI/device performance study.

Here's a breakdown of why this information is not present and what is stated instead:

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

Not Applicable in this context. The 510(k) summary focuses on demonstrating substantial equivalence, not on meeting specific, quantifiable acceptance criteria for a novel performance characteristic.
What is reported: "The biomechanical data show that the LTM matrix possesses sufficient strength and suture retention for the intended use." This is a general statement, not a table of specific criteria and results.

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

Not discussed. There is no mention of a "test set" in the context of clinical or performance data for software or AI. The performance data mentioned refers to lab-based biocompatibility, animal testing, viral inactivation, and biomechanical testing.

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. Ground truth in the context of expert consensus is not a component of this submission. The device is a surgical mesh, not a diagnostic tool requiring expert interpretation for performance validation.

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

Not Applicable. Adjudication methods are relevant for studies where human interpretation of results (e.g., medical images) is involved to establish ground truth or resolve discrepancies. This is not the case 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:

Not Applicable. MRMC studies and the concept of "human readers improving with AI" are specific to AI-powered diagnostic or assistive devices. The LTM Surgical Mesh is a physical implant.

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

Not Applicable. This refers to AI algorithm performance, which is not relevant to a surgical mesh.

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

Not Applicable in the typical sense. For the performance data cited (biocompatibility, animal testing, viral inactivation, biomechanical testing), the "ground truth" would be established by scientific and laboratory standards, validated assays, and accepted engineering principles for material strength. It's not a diagnostic "ground truth" as you'd define for an AI system.

8. The sample size for the training set:

Not Applicable. There is no "training set" as this device is not an AI/machine learning algorithm.

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

Not Applicable. As there's no training set, there's no ground truth to establish for it.

Summary of Device Performance as Stated in the 510(k) Document:

The LTM Surgical Mesh's performance is demonstrated through:

Extensive biocompatibility testing: Indicates the device is safe for biological interaction.
Animal testing: Used to assess in-vivo performance and safety.
Viral inactivation testing: Proves the manufacturing process effectively eliminates viral components from the porcine source material.
Biomechanical testing: Shows the LTM matrix has "sufficient strength and suture retention for the intended use."

The entire submission hinges on demonstrating substantial equivalence to existing predicate devices (Permacol® Implant and Surgisis®) based on:

Same intended uses and similar indications.
Same or similar technological characteristics (derived from porcine skin, terminally sterilized sheet of processed dermal matrix).
Similar principles of operation.

The statement explicitly says: "Performance data demonstrate that LTM functions equivalently to the predicate devices. Thus, LTM is substantially equivalent." This is the core "proof" in a 510(k) for this type of device, rather than meeting specific, numerical acceptance criteria for novel performance claims.

Summary

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K070560

510(K) SUMMARY

JUN 1 1 2007

LifeCell Corporation's LTM Surgical Mesh

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

LifeCell Corporation
One Millennium Way
Branchburg, NJ 08869
Phone:	(908) 947-1115
Facsimile:	(908) 947-1095
Contact Person:	Lorraine T. Montemurro, R.N., R.A.C.
Date Prepared:	June 6, 2007

Name of Device and Name/Address of Sponsor

LTM Surgical Mesh

LifeCell Corporation One Millennium Way Branchburg, NJ 08869

Common or Usual Name

Surgical Mesh

Classification Name

Surgical Mesh

Predicate Devices

Permacol® Implant (K050355)

Surgisis® (K034039)

Intended Use / Indications for Use

LTM is intended for single patient use only.

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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 legally marketed predicate devices, such as the Permacol@ Implant (K050355) and Surgisis® (K034039) 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JUN 1 1 2007

Re: K070560

Trade/Device Name: LTM Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: May 7, 2007 Received: May 8, 2007

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 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. Lorraine T. Montemurro, R.N., RAC

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 Iogally 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 (2) Cregulation over), pro "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 analy 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 vours.

P.R. DSDh

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 Surgical Mesh is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use include the repair of hernias and /or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.

LTM is intended for single patient use only.

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

AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sigmeral, Restorative, and Neurological De

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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.