The Kensey Nash Bioresorbable Surgical Mesh is to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. Tissue attachment to the bioresorbable surgical mesh is minimized in case of direct contact with the viscera.

Device Description

The Kensey Nash Bioresorbable Mesh is a biodegradable surgical mesh for trauma and reconstructive surgical procedures involving soft tissues. The Kensey Nash Bioresorbable Mesh is available in various sizes and thickness for use in maintaining the relative position of healing tissues. The implants maintain the stability of soft tissues during the healing period and minimize the attachment of the device. The Kensey Nash Bioresorbable Mesh material is subsequently reabsorbed by the body once the soft tissues have healed. The implants are not intended for use where permanent implants are required.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Kensey Nash Bioresorbable Surgical Mesh". It's a submission to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices, and therefore does not require a PMA (Premarket Approval) application.

Medical devices cleared through the 510(k) pathway do not typically involve the type of acceptance criteria and clinical study designs seen in AI/software as a medical device (SaMD) or drug approval processes. Instead, the focus is on demonstrating "substantial equivalence" to a predicate device. This means showing that the new device has the same intended use and technological characteristics as a legally marketed device, or, if there are differences, that those differences do not raise different questions of safety and effectiveness.

Therefore, the requested information (acceptance criteria, specific study details like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is generally not applicable to a 510(k) submission for a physical medical device like a surgical mesh. These questions are more relevant to performance studies for diagnostic devices, AI algorithms, or clinical trials for drug products.

However, I can extract information related to the demonstration of "substantial equivalence" as it functions similarly to meeting "acceptance criteria" for physical devices. The "study" in this context is the comparison to predicate devices, supported by in vitro and in vivo testing.

Here's an attempt to adapt your request to the provided document, focusing on "substantial equivalence" as the "acceptance criteria":

Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria

The "acceptance criteria" for the Kensey Nash Bioresorbable Surgical Mesh are met by demonstrating substantial equivalence to legally marketed predicate devices. This demonstration involves showing that the new device has the same intended use and substantially equivalent technological characteristics (design, materials, mechanical performance) to the predicates, and that any differences do not raise new questions of safety or effectiveness.

The "study" proving this substantial equivalence primarily involved comparative analysis with predicate devices, supported by in vitro and in vivo testing.

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

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (as demonstrated in the submission)
Intended Use: Identical to predicate devices.	The Kensey Nash Bioresorbable Surgical Mesh shares identical indications for use principles with the predicate devices (MacroPore Surgi-Wrap (TS) and MacroPore Surgi-Wrap MAST). Both are indicated for temporary wound support, reinforcing soft tissues, and repair of hernia/fascial defects, minimizing tissue attachment to viscera.
Design Principles: Substantially equivalent to predicates.	Physical designs are substantially equivalent, consisting of thin, semi-rigid, bioresorbable sheets manufactured by the same process. Both allow for contouring when heated (e.g., Kensey Nash device and Surgi-Wrap predicate are fully contourable at ~55°C).
Materials: Identical or substantially equivalent.	Made from the identical bioresorbable PLA raw material: amorphous biodegradable copolymer 70:30 poly (L-lactide-co, DL-lactide).
Physical Characteristics (Thickness, Shapes, Sizes): Substantially equivalent to predicates.	Thickness: Thinnest device (0.02mm) is identical to the Surgi-Wrap predicate. Sizes: Rectangular sheets ranging from 25mm x 25mm to 500mm, with thickness ranges from 0.02mm to 1.0mm, substantially equivalent to predicates. Both can be cut to specific shapes/sizes by the end user.
Mechanical Characteristics: Substantially equivalent.	Mechanical characteristics are substantially equivalent to the predicate devices with respect to mechanical strength. (Specific quantitative comparisons are not detailed in this excerpt but are implied to be part of the full submission). In vitro testing showed inherent viscosity remained appropriate when heated. Aging and mechanical testing for adequacy for indications.
Safety and Efficacy: Demonstrated via testing.	In Vitro Testing: Confirmed material integrity and stability when heated (relevant for surgical preparation). Aging and mechanical testing supported adequacy for indications. In Vivo Testing: Animal studies shown to demonstrate the device material is safe and efficacious for the indications for use.
Biocompatibility/Resorption: Consistent with predicates.	Material degrades and resorbs in vivo by hydrolysis and is metabolized by the body into CO2 and H3O, consistent with the known behavior of the identical raw material also used in predicates.

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

In Vitro Testing: The document mentions "Testing has shown inherent viscosity remains within an appropriate range over 120 minutes when heated to 60°C in saline" and "Aging and mechanical testing shows that the device material is adequate."
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified; likely internal lab testing by Kensey Nash Corporation.
- Retrospective/Prospective: These are typically controlled, prospective laboratory studies.
In Vivo Testing: The document states "The animal studies have shown that the device material is safe and efficacious for the indications for use."
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified; generally conducted in research institutions or CROs, often within the US or compliant with international standards.
- Retrospective/Prospective: These are typically prospective animal studies.

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 in the context of this 510(k) submission for a physical surgical mesh. This type of expert ground truth establishment is primarily for diagnostic devices or AI algorithms. The assessment of substantial equivalence relies on engineering and biological comparative analysis, and animal study results.

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

Not applicable. Adjudication methods are typically for subjective assessments, especially in clinical trials or for diagnostic image interpretation. The tests conducted here (inherent viscosity, mechanical testing, animal studies) rely on objective measurements and observations, which do not require interpretive adjudication in the same manner.

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 are for evaluating the performance of diagnostic imaging devices or AI tools, often involving human readers interpreting cases. This device is a surgical implant, not an imaging or diagnostic tool.

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 or software. Its performance is inherent to its material properties and design, not an algorithm's output.

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

For the comparative analysis to predicate devices, the "ground truth" for substantial equivalence is derived from:
- Predicate Device Specifications: The established indications, design, materials, and mechanical properties of the legally marketed predicate devices (MacroPore Surgi-Wrap and MacroPore Surgi-Wrap MAST).
- Objective Measurements: Results from in vitro (e.g., inherent viscosity, mechanical strength) and in vivo (e.g., safety, efficacy, tissue response in animal models) testing of the Kensey Nash Bioresorbable Surgical Mesh, which are then compared to the expected performance of or actual data from the predicate devices (if available/required for comparison).

8. The sample size for the training set

Not applicable. This device is a physical product, not an AI algorithm that requires a "training set."

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

Not applicable, as there is no "training set" for a physical medical device.

Summary

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

ADMINISTRATIVE INFORMATION

Manufacturer Name:	Kensey Nash Corporation735 Pennsylvania DriveExton, PA 19341
Official Contact:	Cindy R. Varughese, RACRegulatory Affairs SpecialistKensey Nash CorporationTelephone: (484)-713-2174Fax: (484)-713-2903	DEC 3 1 2007
Date Prepared:	December 20, 2007
DEVICE NAME
Classification Name:	Surgical Mesh
Trade/Proprietary Name:	Kensey Nash Bioresorbable Surgical Mesh

EST ABLISHMENT REGISTRATION NUMBER 2530154

DEVICE CLASSIFICATION AND PRODUCT CODE

As shown in 21CFR 878.3300, Surgical Meshes are polymeric screens intended to be implanted to reinforce soft tissues. These devices are classified as Class II. Surgical Meshes have been assigned Product Code FTL.

INTENDED USE

DEVICE DESCRIPTION

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

Material

The Kensey Nash Bioresorbable Mesh is made from the amorphous biodegradable copolymer 70:30 poly (L-lactide-co, DL-lactide). This copolymer degrades and resorbs in vivo by hydrolysis and is metabolized by the body into CO2 and H3O.

In Vitro Testing

The Kensey Nash Bioresorbable Surgical Mesh is intended to be heated in the surgical suite to temperatures above the material's glass transition temperature to facilitate shaping to anatomic structures. Testing has shown that inherent viscosity remains within an appropriate range over 120 minutes when heated to 60℃ in saline. The relatively brief exposure anticipated during the surgical preparation of Kensey Nash Bioresorbable Surgical Mesh is not expected to have a significant effect on its mechanical properties. Aging and mechanical testing shows that the device material is adequate for the indications for use and substantially equivalent to the predicate devices.

In Vivo Testing

The animal studies have shown that the device material is safe and efficacious for the indications for use.

EQUIVALENCE TO MARKETED PRODUCT

The Kensey Nash Bioresorbable Surgical Mesh shares indications and design principles with the following predicate devices which have been determined by FDA to be substantially equivalent to pre-amendment devices: MacroPore Surgi-Wrap (TS) and the MacroPore Surgi-Wrap MAST; Class II medical devices that were cleared for marketing in the United States under K012025 and K031955, respectively.

Indications For Use

The Kensey Nash Bioresorbable Surgical Mesh shares identical indications for use principles with the predicate devices, as both the Kensey Nash Bioresorbable Surgical Mesh and the predicate devices are indicated for the same surgical procedures.

Design and Materials

The physical designs of Kensey Nash Bioresorbable Surgical Mesh and the predicate devices (MacroPore Surgi-Wrap and the MacroPore Surgi-Wrap MAST) are substantially equivalent. consisting of thin, semi-rigid, bioresorbable sheets manufactured by the same process and fabricated from the identical bioresorbable PLA raw material. The Kensey Nash Bioresorbable Surgical Mesh and the predicates also share design features of allowing for contouring. The device and the MacroPore Surgi-Wrap predicate are fully contourable when heated to approximately 55°C. The thickness of the predicate devices and the Kensey Nash Bioresorbable Surgical Mesh are substantially equivalent, as the thinnest device thickness is identical to the Surgi-Wrap predicate (0.02mm). The shapes and sizes of the predicate devices and the Kensey Nash Bioresorbable Surgical Mesh are also substantially equivalent, as they are rectangular sheets provided in size ranges from 25mm x 25mm to 500mm with thickness ranges from 0.02mm to 1.0mm. The mechanical characteristics of the device are substantially equivalent to the predicate devices with respect to mechanical strength. In addition to physical characteristics, both the predicate devices and the Kensey Nash Bioresorbable Surgical Mesh can be cut to specific shapes and sizes by the end user.

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

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three overlapping, curved lines extending from its head, resembling feathers or wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 3 1 2007

Kensey Nash Corporation % Ms. Cindy Varughese, RAC Regulatory Affairs Specialist 735 Pennsylvania Drive Exton, Pennsylvania 19341

Re: K071695

Trade/Device Name: Kensey Nash Bioresorbable Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: December 21, 2007 Received: December 26, 2007

Dear Ms. Varughese:

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.

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

Page 2 - Ms. Cindy Varughese, 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 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 N. Millhusan

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

Enclosure

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

Indications for Use

510(k) Number : K071695

Device Name: Kensey Nash Bioresorbable Surgical Mesh

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

LAUREN D. O'CONNOR FOR MARK MELKERSON

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

KO71695 510(k) Number_

Page 1 of 1

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.