LTM-BPS 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 which require the use of reinforcing or bridging material to obtain the desired surgical outcome. The implant is intended for reinforcement of soft tissues in plastic and reconstructive surgery.

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

Device Description

The LTM-BPS is a surgical mesh that is derived from porcine skin. The LTM-BPS 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 document is a 510(k) premarket notification for a medical device called "LTM-BPS Surgical Mesh." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through a traditional acceptance criteria study. Therefore, the information requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not typically found in a 510(k) summary for this type of device.

Instead, the document highlights biocompatibility, viral inactivation, and biomechanical testing to support the safety and technological characteristics of the device.

Here's a breakdown of why specific information is missing and what is provided:

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

This information is not explicitly provided in the 510(k) summary. For device approvals based on substantial equivalence, the "acceptance criteria" are implicitly met if the device demonstrates equivalent performance characteristics (e.g., strength, biocompatibility) to predicate devices.
The document states: "The biomechanical data show that the LTM-BPS matrix possesses sufficient strength and suture retention for the intended use." This is an overall statement of performance but does not list specific numerical criteria or outcomes.

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

Not applicable for a 510(k) demonstrating substantial equivalence through non-clinical testing. The "test set" would refer to samples used for biocompatibility, animal, viral inactivation, and biomechanical testing. The exact number of samples for each of these tests is not quantified in the summary.
The document states: "The LTM-BPS has undergone extensive biocompatibility testing, animal testing, viral inactivation testing and biomechanical testing." This indicates the types of tests performed.

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 as typically understood in a clinical study (e.g., disease presence/absence based on expert review) is not established here. The assessment of test results (e.g., biocompatibility) would be performed by qualified laboratory personnel following established protocols.

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

Not applicable. Adjudication methods are relevant for studies involving human interpretation or multi-reader scenarios, which is not the case for the testing described.

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. This device is a surgical mesh, not an AI-powered diagnostic tool, and therefore MRMC studies are not relevant.

6. 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.

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

Not applicable in the traditional sense of a clinical study. For the non-clinical tests conducted, the "ground truth" would be established by validated testing methodologies and standards (e.g., ISO standards for biocompatibility).

8. The sample size for the training set:

Not applicable. No training set is used as this is not an AI/machine learning device.

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

Not applicable. No training set is used.

Summary

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K082176
pg 192

NOV 1 4 2008

510(K) SUMMARY

LifeCell Corporation's LTM-BPS Surgical Mesh

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

LifeCell Corporation One Millennium Way Branchburg, NJ 08869 (908) 947-1115 Phone: (908) 947-1095 Facsimile:

Lorraine T. Montemurro, R.N., R.A.C. Contact Person: Date Prepared: October 23, 2008

Name of Device and Name/Address of Sponsor

LTM-BPS Surgical Mesh

LifeCell Corporation One Millennium Way Branchburg, NJ 08876

Common or Usual Name

Surgical Mesh

Classification Name

Surgical Mesh

Predicate Devices

LTM Surgical Mesh (K070560)

PelviSoft™ (K031332)

Permacol® (K013625)

Intended Use / Indications for Use

LTM-BPS 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 which wouldred blass of reinforcing or bridging material to obtain the desired surgical outcome. The implant is intended for reinforcement of soft tissues in plastic and reconstructive surgery.

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

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K082176
pg 2n2

Technological Characteristics

Performance Data

The LTM-BPS 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-BPS matrix possesses sufficient strength and suture retention for the intended use.

Substantial Equivalence

LTM-BPS is substantially equivalent to legally marketed predicate devices, such as the LTM Surgical Mesh (K070560), PelviSoft™ (K031332) and Permacol® Implant (K013625) surgical mesh devices. LTM-BPS 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-BPS functions equivalently to the predicate devices. Thus, LTM-BPS is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. 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 Senior Regulatory Affairs Manager One Millennium Way Branchburg, New Jersey 08876-3876

NOV 1 4 2008

Re: K082176 Trade/Device Name: LTM-BPS Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: October 23, 2008 Received: October 29, 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 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 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 Compliation 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 a its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark M. Milliman

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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1682176

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: LTM-BPS Surgical Mesh

Indications for Use:

LTM-BPS 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)

Nil K.E.Olsen for mxm

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

510(k) Number K082176

11:47

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.