SURGIS Staple Line Reinforcement II is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. The device may be used for buttressing and reinforcing staple lines during lung resection, (e.g., wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomy/pneumectomy, pneumoreduction) and other incisions and excisions of the lung and bronchus. The device can be used for the reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding, and for reinforcement of staple lines during small bowel, mesentery, colon, and colorectal procedures. The device may be used with anastomotic staplers or non-anastomotic staplers. The device is supplied sterile and is intended for one-time use.

Device Description

SURGIS® Staple Line Reinforcement II is manufactured from porcine small intestinal submucosa (SIS) and is nominally supplied in strip sizes (unfolded) of 1.0 x 10.8 cm to 1.2 x 19.8 cm. The device is surface treated to allow it to temporarily adhere to the stapler arms, is packaged in a lyophilized (dried) state, and supplied sterile in a sealed double pouch system.

AI/ML Overview

The provided text describes the 510(k) Premarket Notification for the SURGISIS® Staple Line Reinforcement II device. It includes information about the device's intended use, predicate devices, and a summary of testing for substantial equivalence. However, it does not contain the specific details required to complete your request for acceptance criteria and a study proving those criteria are met.

Here's why and what information is missing:

Acceptance Criteria and Reported Device Performance: The document states "Outcomes show the device to be biocompatible, manufacturing processes to adequately disinfect the material, and mechanical characteristics to be sufficient." This is a general statement, not a table of specific acceptance criteria (e.g., tensile strength > X MPa, burst pressure > Y mmHg) and the corresponding numerical results obtained from testing.
Sample Size (Test Set), Data Provenance: This information is not present. The document mentions "extensive biocompatibility testing, viral inactivation testing, and mechanical testing," but does not detail the sample sizes for these tests or the origin of any data (human or animal, retrospective/prospective).
Number of Experts, Qualifications, Adjudication Method: These points are relevant to studies involving human interpretation or consensus, which are not described here. The tests mentioned are laboratory-based (biocompatibility, viral inactivation, mechanical), not studies requiring human expert adjudication.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This type of study would compare human performance with and without AI assistance. The SURGISIS® Staple Line Reinforcement II is a physical medical device (surgical mesh), not an AI algorithm. Therefore, an MRMC study is not applicable.
Standalone (Algorithm Only) Performance: As above, this device is a physical product, not an algorithm.
Type of Ground Truth Used: For physical device testing, "ground truth" typically refers to established standards and methods for measuring material properties. The document doesn't specify these, beyond general statements about "biocompatibility testing," "viral inactivation testing," and "mechanical testing." It doesn't mention expert consensus, pathology, or outcomes data in the context of establishing a benchmark for performance.
Sample Size for Training Set & How Ground Truth for Training Set was Established: These points are relevant to machine learning or AI development, which is not applicable to this physical device.

In summary, the provided text describes a 510(k) submission for a physical surgical mesh. The "studies" mentioned are laboratory tests designed to demonstrate that the device is substantially equivalent to predicate devices based on its material properties and safety. It does not involve AI, human expert review, or clinical trials in the way your questions imply.

Therefore, I cannot populate the table and answer the specific questions based only on the provided text. The document is a regulatory summary focusing on substantial equivalence, not a detailed scientific study report with specific performance metrics against defined acceptance criteria.

Summary

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KOS2048 1/2
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510(k) Premarket Notification: SURGIS® Staple Line Reinforcement II

9. 510(K) SUMMARY

Submitted By:	Mark Bleyer, PresidentCook Biotech Incorporated1425 Innovation PlaceWest Lafayette, IN 47906Tel: (765) 497-3355Fax: (765) 497-2361April 22, 2005
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Names of Device:

Trade Name:	SURGISIS® Staple Line Reinforcement II
Common/Usual Name:	Surgical Mesh, Staple Line Bolster
Proposed Classification:	Surgical Mesh 21 CFR 878.3300 (79FTM) Class II

Intended Use:

Predicate Devices:

SURGIS® Staple Line Reinforcement II is similar to predicate devices, including the SURGIS Staple Line Reinforcement (K022044) and SURGISIS® Soft Tissue Graft (K980431) manufactured by Cook Biotech Incorporated, Peri-Strips® Staple Line Reinforcement (K040119) manufactured by Synovis Surgical Innovations, and Gore Seamguard® Bioabsorbable Staple Line Reinforcement Material (K032865) manufactured by W.L. Gore & Associates.

Device Description:

Substantial Equivalence:

SURGIS Staple Line Reinforcement II is similar with respect to intended use, materials and technological characteristics to the above predicate devices in terms of 510(k) substantial equivalence as shown through bench and biocompatibility testing.

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K0510484/2

510(k) Premarket Notification: SURGISIS® Staple Line Reinforcement II

Discussion of Tests and Test Results:

The material comprising the SURGIS® Staple Line Reinforcement II was subjected to extensive biocompatibility testing, viral inactivation testing, and mechanical testing. Outcomes show the device to be biocompatible, manufacturing processes to adequately disinfect the material, and mechanical characteristics to be sufficient.

Conclusions Drawn from the Tests:

Outcomes from the evaluation of SURGISIS Staple Line Reinforcement II provide evidence of its suitability for use in soft tissue reconstruction and substantial equivalency to predicate devices in terms of intended use and technological characteristics.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract image of an eagle with three stripes representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 2005

Mr. Mark Bleyer President Cook Biotech Incorporated 1425 Innovation Place West Lafayette, Indiana 47906

Re: K051048

Trade/Device Name: SURGISIS® Staple Line Reinforcement II Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: August 23, 2005 Received: August 24, 2005

Dear Mr. Bleyer:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use battler to May 28, 1976, the enactment date of the Medical Device Amendments, or to conimer of provision to rial as a cordance 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 r ou mayy are so 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- Mr. Mark Bleyer

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anon-you've ough finding of substantial equivalence of your device to a legally premaince notification. The start 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 rryou don't specific darroliance 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 other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Fairbairn Buelud
for

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

Enclosure

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K0510Yf

Indications for Use

510(k) Number (if known):

Device Name: SURGISIS® Staple Line Reinforcement II

Indications for Use:

Surgisls® Staple Line Reinforcement II is intended for use as a prosthesis Surgical repair of soft tissue deficiencies using surgical staplers. for the Surgical repair of Solt tions and reinforcing staple lines during The device may be used for battlessing and and the ctomy, bullectomy, lung resection (c.g., weage rocomy, pneumonectomy/pneumectomy, bronemal reseouoli, ooginentions and excisions of the lung and pheumoreduction) and other the reinforcement of the gastric staple line during the bariatic surgical procedures of gastric bypall bound Staple line during the banainforcement of staple lines during small bowel, gastric banding, and for rollifered more . The device may be used with mesentery, colon, and ocronemastomotic staplers. The device is supplied sterile and is intended for one-time 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)

borbau buemts

Division of General, Restorative, and Neurological Devices

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

510(k) Number K051048

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.