Mentor ObTape Trans-obturator Tape is an implantable, suburethral, support tape indicated for the surgical treatment of all types of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Device Description

ObTape is made from non-woven polypropylene fibers. This structure gives the ObTape resistance to traction, tissue colonization and facilitates positioning during surgery. Disposable and re-usable Introducer Needles necessary for the implantation are also available with the device.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Mentor ObTape Trans-obturator Tape and Introducers). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and a detailed performance evaluation in the way an AI/software device would.

Therefore, many of the requested categories for a study proving device acceptance against specific criteria are not applicable or cannot be extracted from this document, as it describes a physical surgical mesh and its introducers.

Here's an attempt to answer the questions based on the available information:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

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

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Material Properties	Adherence to established EDANA standards for Tear Strength	Complies with established EDANA standards for Tear Strength
	Adherence to established EDANA standards for Tensile Strength	Complies with established EDANA standards for Tensile Strength
	Adherence to established EDANA standards for Elongation	Complies with established EDANA standards for Elongation
Biocompatibility	Compliance with USP, ISO 10993, or EN standards for Cytotoxicity	Complies with established USP, ISO 10993 or EN standards for Cytotoxicity
	Compliance with USP, ISO 10993, or EN standards for Genotoxicity	Complies with established USP, ISO 10993 or EN standards for Genotoxicity
	Compliance with USP, ISO 10993, or EN standards for Hemolysis	Complies with established USP, ISO 10993 or EN standards for Hemolysis
	Compliance with USP, ISO 10993, or EN standards for Implantation	Complies with established USP, ISO 10993 or EN standards for Implantation
	Compliance with USP, ISO 10993, or EN standards for Pyrogenicity	Complies with established USP, ISO 10993 or EN standards for Pyrogenicity
	Compliance with USP, ISO 10993, or EN standards for Intracutaneous Reactivity	Complies with established USP, ISO 10993 or EN standards for Intracutaneous Reactivity
	Compliance with USP, ISO 10993, or EN standards for Sensitization	Complies with established USP, ISO 10993 or EN standards for Sensitization
	Compliance with USP, ISO 10993, or EN standards for Systemic Toxicity	Complies with established USP, ISO 10993 or EN standards for Systemic Toxicity

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

This information is not provided in the 510(k) summary. The document describes tests against established standards for materials and biocompatibility, but it does not detail the specific sample sizes used for these tests, nor the data provenance in terms of country of origin or whether the tests were retrospective/prospective. This type of detail is typically part of the underlying test reports, not the summary.

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)

This is not applicable to the type of device and testing described. The "ground truth" for this device is determined by physical and biological testing against recognized industry standards (EDANA, USP, ISO, EN), not by expert interpretation of clinical data in the same way an AI device would require.

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

This is not applicable to the type of testing described. Adjudication methods are typically used when interpreting subjective data (like medical images), which is not the case for mechanical properties or biocompatibility testing. The compliance is determined by objective measurements against predefined thresholds within the standards.

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

This is not applicable. An MRMC study is relevant for evaluating the clinical performance of diagnostic or assistive AI technologies. This submission is for a surgical implant (mesh), not an AI-powered diagnostic tool.

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

This is not applicable. The device is a physical surgical implant, not an algorithm.

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

The "ground truth" is based on established industry and regulatory standards for material properties and biocompatibility.

For mechanical testing: The ground truth for compliance is whether the measured Tear Strength, Tensile Strength, and Elongation meet the specified values within the EDANA standards.
For biocompatibility: The ground truth for compliance is whether the results of tests for Cytotoxicity, Genotoxicity, Hemolysis, Implantation, Pyrogenicity, Intracutaneous Reactivity, Sensitization, and Systemic Toxicity adhere to the requirements of USP, ISO 10993, or EN standards.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

This is not applicable. As there is no training set for a physical device, this question is irrelevant.

Summary

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JUL 1 7 2003

K031767$\rho_{1/2}$

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92

The assigned 510(k) number is: ---------------------------------------------------------------

Contact Person:	Donna A. CrawfordDirector, Corporate Regulatory AffairsMentor Corporation201 Mentor DriveSanta Barbara, CA 93111
Telephone:	805-879-6304
FAX:	805-879-6015
Date Prepared:	June 6, 2003

Device Name and Classification

Proprietary Name:	Mentor ObTape Trans-obturator Tape and Introducers
Common Name:	Pubourethral Support Sling
Classification Name:	Surgical Mesh, polymeric
Class:	Class II
Product Code:	OTN
CFR #:	§878.3300

Device Description

Similar to Johnson and Johnson's Tension Free Vaginal Tape (TVT) System cleared under 510(k) No: K974098 and American Medical Systems' Sparc Sling System cleared under 510(k) K013355, ObTape will be manufactured from polypropylene material.

Substantial Equivalence Claim

The Mentor ObTape Trans-obturator Tape is substantially equivalent in material, function, performance and design to the urethral support tape products manufactured and marketed by Johnson & Johnson, 510(k) No: K974098 and American Medical Systems, 510(k) K013355.

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K031767${P{2/2}}$

Indications for Use

Summary of Testing

All mechanical testing specifications comply with established EDANA standards for Tear Strength, Tensile Strength, and Elongation.

All biocompatibility testing comply with established USP, ISO 10993 or EN standards for Cytotoxicity, Genotoxicity, Hemolysis, Implantation, Pyrogenicity, Intracutaneous, Sensitization, and Systemic Toxicity.

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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 or bird symbol, with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Donna Crawford Director, Corporate Regulatory Affairs Mentor Corporation 201 Mentor Drive SANTA BARBARA CA 93111

SEP 2 8 2012

Re: K031767 Trade/Device Name: Mentor ObTape Trans-obturator Tape and Introducers Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: June 6, 2003 Received: June 10, 2003

Dear Ms. Crawford:

This letter corrects our substantially equivalent letter of July 17, 2003,

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 (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 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

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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Perkins

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K 021767

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Mentor ObTape Trans-obturator Tape and Introducers

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over the Counter Use

(Per CFR 801.109)

(Optimal Format 1-2-96)

Miriam C. Provost

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

510(k) Number K031767

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.