LTM-RC 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. The implant is intended for the reinforcement of soft tissues repaired by sutures or suture anchors, during rotator cuff surgery. Indications for use also 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.

The device is not intended to replace normal body structure or provide the full mechanical strength to repair the rotator cuff. Sutures used to repair the tear, and the sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the rotator cuff repair.

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

Device Description

The LTM-RC is a surgical mesh that is derived from porcine skin. The LTM-RC 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 the 510(k) summary for the LifeCell Tissue Matrix-Rotator Cuff (LTM-RC) Surgical Mesh. This is a medical device application, and as such, the "acceptance criteria" and "device performance" are typically framed in terms of substantial equivalence to predicate devices rather than meeting specific numerical performance targets like AI algorithms. The "study" here refers to the testing conducted to demonstrate this substantial equivalence.

Here's an analysis based on the provided document:

1. Acceptance Criteria and Reported Device Performance

For medical devices seeking 510(k) clearance, the "acceptance criteria" is essentially demonstrating substantial equivalence to a legally marketed predicate device. This means the new device has the same intended use, similar technological characteristics, and functions equivalently.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: Device is safe for use in the human body.	"The data indicate that the device is biocompatible."
Viral Inactivation: Manufacturing process inactivates viruses.	"The manufacturing process is capable of inactivating any viral components."
Biomechanical Strength: Sufficient strength and suture retention for intended use.	"The biomechanical data show that the LTM-RC matrix possesses sufficient strength and suture retention for the intended use."
Equivalence to Predicate Devices: Same intended uses, similar indications, technological characteristics, and principles of operation.	"LTM-RC is substantially equivalent... LTM-RC 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-RC functions equivalently to the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

The document states that the LTM-RC underwent "extensive biocompatibility testing, animal testing, viral inactivation testing, and biomechanical testing."

Sample Size for Test Set: The specific sample sizes for these tests (e.g., number of animals, number of specimens for biomechanical testing) are not detailed in the provided 510(k) summary. This level of detail is typically found in the full technical documentation submitted to the FDA, not in the summary.
Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given that LifeCell Corporation is based in Branchburg, NJ, USA, it is highly probable that the testing was conducted in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This device is a surgical mesh, not an AI diagnostic tool that relies on expert interpretation of images. Therefore, the concept of "experts used to establish ground truth" as it applies to medical imaging is not applicable here. The ground truth for the performance tests (biocompatibility, biomechanical strength) would be established by standardized testing protocols and analytical methods, not by human interpretation in the same way.

4. Adjudication Method for the Test Set

Again, as this is a physical medical device and not an AI diagnostic, an "adjudication method" (like 2+1 or 3+1 for discordant reads) is not applicable. The outcome of physical and biological tests is determined by objective measurements and scientific analysis, not by subjective expert consensus on ambiguous cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving human interpretation, sometimes aided by AI) to assess human reader performance with and without assistance. The LTM-RC is a surgical mesh; its effectiveness is evaluated through its physical and biological properties and its ability to reinforce tissue, not through diagnostic interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study (algorithm only) was not done. This concept applies to AI algorithms and is not relevant for a physical surgical mesh product.

7. The Type of Ground Truth Used

The "ground truth" for the LTM-RC testing would be defined by validated scientific measurements and established standards in different fields:

Biocompatibility: Established through standardized in vitro and in vivo tests (e.g., cytotoxicity assays, sensitization tests, implantation studies), with comparison to known safe materials.
Viral Inactivation: Determined by analytical methods to detect viral particles or infer inactivation rates based on validated processes.
Biomechanical Strength: Measured using material testing equipment (e.g., tensile testers) according to established engineering standards, providing objective quantifiable data like ultimate tensile strength or suture retention strength.
Substantial Equivalence: Achieved by comparing the device's characteristics and performance to those of the predicate devices.

8. The Sample Size for the Training Set

This concept is not applicable to a physical surgical mesh. A "training set" refers to data used to train machine learning models. The LTM-RC is a manufactured product; it doesn't have a "training set" in the AI sense.

9. How the Ground Truth for the Training Set Was Established

As the concept of a "training set" is not applicable, the establishment of ground truth for a training set is also not applicable.

Summary

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K071986 page1/2

III. 510(K) SUMMARY

LifeCell Tissue Matrix-Rotator Cuff (LTM-RC) Surgical Mesh

007 1 9 2007

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

LifeCell CorporationOne 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:	July 19, 2007

Name of Device and Name/Address of Sponsor

LTM-RC 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)

Permacol® Implant (K050355)

Permacol® (K021056)

Intended Use / Indications for Use

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The device is not intended to replace normal body structure or provide the full
mechanical strength to repair the rotator cuff. Sutures used to repair the tear, and the sutures or
bone anchors used to attach the tissue to the bone, provide biomechanical strength for the rotator
cuff repair.

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

Technological Characteristics

Performance Data

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

Substantial Equivalence

LTM-RC is substantially equivalent to legally marketed predicate devices, such as the LTM Surgical Mesh (K070560) and Permacol® Implant (K050355) surgical mesh devices. LTM-RC 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-RC functions equivalently to the predicate devices. Thus, LTM-RC is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 9 2007

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

Re: K071986

Trade/Device Name: LifeCell Tissue Matrix-Rotator Cuff (LTM-RC) Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: September 24, 2007 Received: September 26, 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 - Lorraine T. Montemurro, R.N, R.A.C.

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "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 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 your

For
Mark N. Melkerson
DEB
D.R
1.19.07

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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II. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K071986

Device Name: LifeCell Tissue Matrix-Rotator Cuff (LTM-RC) Surgical Mesh

Indications for Use:

LTM-RC 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. The implant is intended for the reinforcement of soft tissues repaired by sutures or suture anchors during rotator cuff repair surgery. Indications for use also 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.

The device is not intended to replace normal body structure or provide full mechanical strength to repair the rotator cuff. Sutures used to repair the tear and the sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the rotator cuff repair.

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

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

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

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE) Sion Sign-Division of General, Restorative, Page _________________________________________________________________________________________________________________________________________________________________________ of and Neurological Devices

510(k) Number L01194

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.