I-STOP® Trans Obturator Male / Female Sling is intended to be used as a sub-urethral sling implant for the treatment of male stress urinary incontinence post-prostatectomy. And for females: for the treatment of urinary stress incontinence due to intrinsic sphincter deficiency and/or intrinsic sphincter deficiency.

Device Description

I-STOP® Trans Obturator Male / Female Sling is a sterile, single use kit consisting of one sling of knitted monofilament polypropylene, two stainless two polycarbonate handles and two stainless steel needles molded with polycarbonate handles.

AI/ML Overview

This 510(k) summary does not contain the detailed information necessary to complete all sections of your request. The document describes a medical device, the I-STOP® Trans Obturator Male / Female Sling, and states that it underwent "Mechanical tests, biocompatibility tests in compliance with ISO 10993 and chemical tests" as well as "Three studies on this surgical technique and three anatomical studies." However, it does not provide specific acceptance criteria, performance metrics, sample sizes for test or training sets, ground truth establishment methods, or details about expert involvement in a way that aligns with your request for AI/algorithm performance studies.

Therefore, I cannot generate the requested table and fully answer all questions as the provided text is primarily a 510(k) notification for a surgical mesh device, not a study evaluating an AI/algorithm's performance.

Here's what can be extracted and what cannot:

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

Cannot be provided. The document discusses compatibility with ISO 10993 for biocompatibility and mentions "mechanical tests" and "chemical tests," but it does not specify acceptance criteria for these tests nor does it report detailed performance results against such criteria in a quantifiable manner. It also mentions "clinical tests" and "anatomical studies," but again, no specific acceptance criteria or performance results are detailed.

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

Cannot be provided. The document states "Three studies on this surgical technique and three anatomical studies," but provides no details on sample sizes, study design (retrospective/prospective), or data provenance for these 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)

Cannot be provided. This information is typically relevant for studies involving subjective assessments or interpretation (like imaging studies) where human experts establish ground truth. As this is a surgical mesh device, the "ground truth" would likely relate to objective clinical outcomes or mechanical properties, not expert interpretation in the way relevant for AI performance studies. The document does not discuss expert involvement in establishing ground truth for any tests.

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

Cannot be provided. Not applicable given the nature of the device and the lack of AI-specific performance evaluation.

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

Cannot be provided. This document is for a physical surgical device, not an AI or imaging-based diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant or described.

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

Cannot be provided. Not applicable, as this is not an algorithm or AI device.

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

Cannot be provided. The document does not specify the ground truth used for its "clinical tests" or "anatomical studies." For a surgical mesh, ground truth for clinical studies would typically be patient outcomes (e.g., continence rates, complication rates) or histological analysis (for biocompatibility).

8. The sample size for the training set

Cannot be provided. The concept of a "training set" applies to machine learning and AI algorithms. This device is a physical surgical implant.

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

Cannot be provided. Not applicable, as this is not an AI/algorithm device.

Summary

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510(k) Summary

NOW - 7 2006

Submitter's name: CL Médical Address: 28 avenue Général de Gaulle Pre Center II F - 69110 Sainte Foy Les Lyon - FRANCE + 33.(0)4.78.59.54.93 Tel: + 33.(0)4.78.59.89.78 Fax: Contact person: Mr. Vincent GORIA . October 2nd, 2006 Date of summary preparation: . Device common name: Surgical mesh, Sling, Urethral Sling . I-STOP® Trans Obturator Male / Female Sling . Device trade name: Surgical mesh, polymeric (21 CFR 878.3300) Device classification name: .
Product code: .

. Regulatory status:

Predicate Device: .
FTL Class II I-STOP K051533 AMS Male Transobturator Sling System K053371

Device description: .

. Indications for Use:

Comparison to predicate device: .

This is exactly the same device than I-STOP (K051533) with the same knitted sling and the same needles and handles. The device is similar to the AMS Male Transobturator Sling System (K053371).

. Summary of testing:

Mechanical tests. biocompatibility tests in compliance with ISO 10993 and chemical tests.

. Summary of clinical tests:

Three studies on this surgical technique and three anatomical studies.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with stylized wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CL Medical % Mr. Vincent GORIA CEO 28 avenue Général de Gaulle Pré Center II 69110 Sainte Foy Les Lyon France

Re: K063079

Trade/Device Name: I-STOP Trans Obturator Malc/Female Sling Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: October 2, 2006 Received: October 10, 2006

Dear Mr. GORIA:

We have reviewed your Scction 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.

NOV - 7 2006

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

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Page 2 – Mr. Vincent GORIA

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. 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 yours

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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K063079

Indications for Use

510(k) Number (if known):	K063079
Device Name:	I-STOP Trans Obturator Male / Female Sling
Indications for Use:	I-STOP® Trans Obturator Male / Female Sling is intended to be used as a sub-urethral sling implant for the treatment of male stress urinary incontinence post-prostatectomy. And for females: for the treatment of urinary stress incontinence due to intrinsic sphincter deficiency and/or intrinsic sphincter deficiency.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

PDP

(Division Sign-Of Division of General, Restorative, and Neurological Devices

510(k) Number 1663079

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.