Permacol™ 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. It is specifically indicated for use in the following types of soft tissue repair procedures: abdominal, inquinal, diaphragmatic, femoral, scrotal, . umbilical, and incisional hernias; . colon, rectal, urethral, and vaginal prolapse: muscle flap reinforcement; . . reconstruction of the pelvic floor; sacrocolposuspension; and . . urethral sling.

Device Description

Permacol™ is a sterile, tough. off-white. moist. flexible, fibrous flat sheet solely comprised of acellular crosslinked porcine dermal collagen and elastin

AI/ML Overview

The prompt requests information on acceptance criteria and study details for a device, but the provided text describes a surgical mesh (Permacol™) and its 510(k) premarket notification. This type of medical device submission typically focuses on demonstrating substantial equivalence to existing predicate devices rather than establishing specific quantitative acceptance criteria or conducting studies as would be done for a novel diagnostic algorithm.

Therefore, many of the requested data points (such as sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and training set details) are not applicable or available in this type of submission. The provided text outlines biocompatibility testing and clinical experience used to support substantial equivalence and safety/effectiveness, but not a controlled clinical trial with specific numerical outcome measures against acceptance criteria in the way a diagnostic AI would have.

However, I can extract the information that is present and explain where the requested details are not provided.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance for Permacol™ Porcine Collagen Surgical Mesh

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (as implied by FDA submission)	Permacol™ Porcine Collagen Surgical Mesh Performance
Biocompatibility	The product passed all standard biocompatibility tests: Hemolysis, Cytotoxicity (elution method), Acute Systemic Toxicity, Implantation/Subchronic Toxicity, Genotoxicity (Ames Mutagenesis, Bone Marrow Micronucleus, Mouse Lymphoma Mutagenesis), Sensitization (Magnusson and Kligman), Pyrogenicity.
Histological Evaluation	Histological evaluation after 6 months implantation in rats demonstrated the material is safe and well tolerated.
Clinical Safety & Tolerance	"Clinical experience in several hundred patients in Europe also has demonstrated that Permacol™ is safe and well tolerated."
Clinical Outcomes (Effectiveness)	Case histories for 60 patients showed "successful clinical outcomes were achieved in nearly all cases."
Adverse Effects	"No product-related adverse effects were noted in any of the procedures."
Ease of Handling	Case histories for 60 patients demonstrated Permacol™ is "easy to handle."
Substantial Equivalence (Overall)	"Permacol™ is substantially equivalent to the predicate devices in terms of its intended use, specific indications, and performance." Minor technological differences "do not raise any new concerns of either safety or effectiveness."

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

Sample Size for Human Clinical Experience: "several hundred patients in Europe" for general clinical safety and tolerance.
Sample Size for Detailed Case Histories: 60 patients for detailed evaluation of handling and clinical outcomes.
Data Provenance: Clinical experience in Europe (specifically mentioned). The studies referenced appear to be retrospective collections of "case histories" rather than a prospective, randomized controlled trial.
Animal Study Sample Size: Not explicitly stated, but mentioned as "implantation in rats."

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

Not Applicable / Not provided: This type of information is typically associated with diagnostic device evaluations, especially those involving expert interpretation of medical images or data. For a surgical mesh, "ground truth" would be established through direct clinical observation of patient outcomes and histological analysis, not through expert consensus on diagnostic interpretations. The document references "clinical experience" and "histological evaluation" which implies medical professionals (surgeons, pathologists) were involved, but the specific number or qualifications are not detailed as they would be for a diagnostic study.

4. Adjudication method for the test set

Not Applicable / Not provided: Adjudication methods (e.g., 2+1, 3+1) are typically used in diagnostic studies where multiple readers interpret data and discrepancies need to be resolved. This is not relevant for the type of clinical experience and biocompatibility testing described 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: An MRMC comparative effectiveness study, especially concerning AI assistance, is not relevant to a surgical mesh like Permacol™. This device is not an AI-powered diagnostic tool.

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

Not Applicable: Permacol™ is a physical surgical mesh, not an algorithm. Standalone algorithm performance is not relevant.

7. The type of ground truth used

Biocompatibility Studies: Laboratory test results (e.g., cell viability, hemolytic index, mutagenicity assays) and histological findings from animal implantation.
Clinical Experience: Direct observation of patient safety (adverse events), tolerance, and surgical outcomes (e.g., successful repair, ease of handling). These would be derived from clinical records and surgeon's assessments.

8. The sample size for the training set

Not Applicable: Permacol™ is a manufactured device, not an AI model that requires a "training set."

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

Not Applicable: As there is no AI model or training set, this question is not relevant.

Summary

{0}------------------------------------------------

Permacol™ Porcine Collagen Surgical Mesh 510(k) Premarket Notification Submission

FEB 1 7 2000

510(k) Summary

Sponsor: Tissue Science Laboratories, PLC Grevholme House Victoria Road Aldershot Hants GU11 1SJ United Kingdom

Contact Person:

Dr. Allison F. Wren The Wren Group 7124 La Jolla Blvd La Jolla CA 92037 Tel: (619) 454-6260 Fax: (619) 454-2508 E-mail: TheWrenGrp@aol.com

Howard M. Holstein, Esq. Hogan & Hartson, LLP 555 Thirteenth Street, N.W. Washington, DC 20004 Tel: (202) 637-5813 Fax: (202) 637-5910 E-mail: hmholstein@hhlaw.com

Submission July 31, 1999 Date:
Device Name: Permacol™
Classification: Polymeric Surgical Mesh

Predicate Devices:

GraftPatch® Rapi-Seal™ Patch Biosynthetic Surgical Mesh Peri-Guard® family of products Glycar Tissue Repair Patch

{1}------------------------------------------------

Permacol™ Porcine Collagen Surgical Mesh 510(k) Premarket Notification Submission

Device Description: Permacol™ is a sterile, tough. off-white. moist. flexible, fibrous flat sheet solely comprised of acellular crosslinked porcine dermal collagen and elastin Intended Use: Permacol™ 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. It is specifically indicated for use in the following types of soft tissue repair procedures: abdominal, inquinal, diaphragmatic, femoral, scrotal, . umbilical, and incisional hernias; . colon, rectal, urethral, and vaginal prolapse: muscle flap reinforcement; . . reconstruction of the pelvic floor; sacrocolposuspension; and . . urethral sling. Substantial Equivalence: Permacol™ is substantially equivalent to the predicate devices in terms of its intended use, specific indications, and performance. There are minor differences in the technological characteristics, but laboratory and animal testing as well as clinical experience have shown that these do not raise any new concerns of either safety or effectiveness. Safetv Evaluation: Standard biocompatibility testing was performed according to the FDA-modified matrix recommended in FDA memorandum #G95-1. The product passed all of the following tests: Hemolysis Cytotoxicity - elution method Acute Systemic Toxicity Implantation/Subchronic Toxicity Genotoxicity - Ames Mutagenesis Genotoxicity - Bone Marrow Micronucleus Genotoxicity - Mouse Lymphoma Mutagenesis Sensitization-Magnusson and Kligman Pyrogenicity

{2}------------------------------------------------

	Permacol™ Porcine Collagen Surgical Mesh510(k) Premarket Notification Submission
	In addition to standard biocompatibility testing, a histologicalevaluation of the material after implantation in rats for 6months demonstrated that Permacol™ is safe and welltolerated.
ClinicalEvaluation:	Clinical experience in several hundred patients in Europealso has demonstrated that Permacol™ is safe and welltolerated. Case histories for 60 patients undergoing avariety of soft tissue repair procedures demonstrate thatPermacol™ is easy to handle, and successful clinicaloutcomes were achieved in nearly all cases. Noproduct-related adverse effects were noted in any of theprocedures.
ConclusionsDrawn:	Permacol™ is biocompatible, safe and effective for its

intended use.

\\DC - 59177/1 - 0790126.01

The Wren Group on Behalf of Tissue Science Laboratories, PLC Aldershot, UK

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles three overlapping lines that form a shape similar to a bird in flight or a stylized human figure.

Public Health Service

FEB 1 7 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tissue Science Laboratories, PLC c/o Mr. Howard M. Holstein, Esq. Hogan & Hartson, LLP 555 Thirteenth Street, N.W. Washington, D.C. 20004

K992556 Re: Trade Name: Permacol™ Regulatory Class: II Product Code: FTL Dated: December 22, 1999 Received: December 22, 1999

Dear Mr. Holstein:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{4}------------------------------------------------

Page 2 - Mr. Howard M. Holstein, Esq.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Neil K.R. Ogden

ದ್ದಾಗಿ Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

510(k) Number (if known):	K992556
Device Name:	Permacol™

Indications for Use:

Permacol™ 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. It is specifically indicated for the repair of abdominal, inguinal, diaphragmatic, femoral, scrotal, umbilical and incisional hernias; colon, rectal, urethral and vaginal prolapse; muscle flap reinforcement; reconstruction of the pelvic floor and procedures such as sacrocolposuspension and urethral sling.

	NRO for JZD
(Division Sign-Off
Division of General Devices
510(k) Number	K992556

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
Use
(Per 21 CFR 801.109)

Over-The-Counter

(Optional Format 1 - 2.96) (Form prepared by The Wren Group)

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.