The Herniamesh T-sling is a dual-component pubourethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Device Description

Pre-shaped Duel-component mesh Polypropylene and bioabsorbable polymer

AI/ML Overview

The provided text describes a Premarket Notification for the Herniamesh T-Sling, focusing on establishing substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a study proving device performance against those criteria in the context of diagnostic accuracy.

However, from the provided text, we can extract the "acceptance criteria" as the functional requirements and characteristics of surgical meshes that the Herniamesh T-Sling must meet or exceed to be considered substantially equivalent to predicate devices. The "study" refers to the performance data obtained through various tests.

Here's an attempt to structure the information based on your request, acknowledging that the document is a 510(k) submission, not a study report demonstrating diagnostic accuracy:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly defined by the properties of the predicate devices (Ethicon TVT and Injectx Inc BioSling™). The study demonstrates that the Herniamesh T-Sling's performance "meets or exceeds" these requirements.

Feature	Acceptance Criteria (Predicate Devices - Ethicon TVT ranges or description)	Reported Device Performance (Herniamesh T-Sling)
Burst Strength (10² Kpa)	55 ± 3 (Ethicon TVT) / Substantially Equivalent (Injectx Inc BioSling™)	28.4
Suture Retention (N)	warp 52 ± 9, weft 51 ± 7, 45° 57 ± 3 (Ethicon TVT) / Substantially Equivalent (Injectx Inc BioSling™)	warp 43, weft 55, 45° 52
Pore Size	Substantially Equivalent, Porosity 87% (Ethicon TVT) / Substantially Equivalent (Injectx Inc BioSling™)	797.4μ & 228.3μ, Porosity 62.4%
Tensile Strength	warp 23 ± 6, weft 15 ± 5, 45° 14 ± 5 (Ethicon TVT) / Substantially Equivalent (Injectx Inc BioSling™)	warp 31.1, weft 33.1, 45° 29.7
Tissue Ingrowth	Complete tissue incorporation of implant (Ethicon TVT) / Not Tested (Injectx Inc BioSling™)	Complete tissue incorporation of implant

Note on Burst Strength & Suture Retention: While the Herniamesh T-Sling's specific values for Burst Strength appear lower than the Ethicon TVT's reported value, and its Suture Retention warp value is lower, the document explicitly states: "the technological differences meet or exceed the functional requirements of surgical meshes compared to the predicate devices" and "The physical and mechanical characteristics of the Hermiamesh T-Sling meet or exceed those of the predicate devices." This suggests that the listed predicate values might not represent a strict lower bound for substantial equivalence, or there are other considerations not fully detailed in this excerpt that support the "meets or exceeds" claim. This highlights a common aspect of 510(k) submissions where the "acceptance criteria" are not always hard numerical thresholds for superiority but rather for safe and effective equivalence.

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

Sample Size: Not explicitly stated as a number of devices/cases for each test, but implied to be sufficient for mechanical, biocompatibility, and in vivo testing for the Herniamesh T-Sling. For the predicate device data (Ethicon TVT), the Burst Strength and Suture Retention values are presented with standard deviations (e.g., 55 ± 3, 52 ± 9), indicating multiple measurements were taken, likely from a sample of devices.
Data Provenance:
- Herniamesh T-Sling: Performance data comes from "mechanical testing, scanning electron microscopy, biocompatibility and in vivo safety and effectiveness testing" conducted on the Herniamesh T-Sling. The location of these tests is not specified, but the applicant is "Herniamesh USA, Inc."
- Ethicon TVT (Predicate): Values for Prolene TVT were taken from the textbook: Prostheses and Abdominal Wall Hemias by Dr. Robert Bendavid (pages 197, 200). This indicates retrospective data collection from published literature.
- Injectx Inc BioSling™ (Predicate): Described as "Substantially Equivalent" for most mechanical properties, indicating a comparison against its own predicate or established benchmarks, but no specific values are given. "Not Tested" for Tissue Ingrowth for this predicate.

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

This information is not applicable to this type of submission. This document describes the characterization of a medical device (surgical mesh) through physical, mechanical, and biological testing, not a diagnostic algorithm where expert ground truth is typically established (e.g., for image interpretation).
The "ground truth" for the test set here refers to the actual measured physical and biological properties of the device and its predicates, established through standard scientific methods and measurements.

4. Adjudication method for the test set:

This information is not applicable. Adjudication methods (like 2+1 or 3+1) are used in studies involving human interpretation or subjective assessments, often with multiple readers, to resolve discrepancies and establish a consensus ground truth. This is not relevant for the objective mechanical and biological 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:

This information is not applicable. This document is a 510(k) submission for a surgical mesh, not an AI-based diagnostic device. Therefore, no MRMC study involving human readers or AI assistance was conducted or reported.

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

This information is not applicable. The device is a surgical mesh, not an algorithm. Therefore, no standalone algorithm performance study was performed.

7. The type of ground truth used:

The "ground truth" for the Herniamesh T-Sling and the predicate devices is based on objective measurements and observations from:
- Mechanical Testing: Burst Strength, Suture Retention, Tensile Strength.
- Microscopy: Pore Size (from scanning electron microscopy).
- Biocompatibility Testing: Used to assess biological interaction/safety.
- In Vivo Testing: To assess safety and effectiveness in a living organism, including "Complete tissue incorporation of implant" (which could be verified by histological examination of explanted tissue).

8. The sample size for the training set:

This information is not applicable. This document focuses on demonstrating the performance of a physical medical device (surgical mesh) through testing, not on training a machine learning algorithm.

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

This information is not applicable. As there is no machine learning model involved, there is no training set or associated ground truth establishment process.

Summary

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Premarket Notification for Herniamesh T-Sling

Summary of Safety and Effectiveness

The Hermiamesh T-Sling is substantially equivalent to the TVT (Tension-free Vaginal The neimanteer. I warketed by Ethicon Inc. and the BioSling™ - Bioabsorbable Polymer Sling & Surgical Mesh ourrently marketed by Prosury Inc. / Injectx Inc. The 510 (K) "Substantial Equivalence" Decision-Making Process (detailed)" decision tree was utilized to make a determination of substantial equivalence (see Exhibit 1). The answers to the following questions lead to a determination of substantial. equivalence.

Does the new device have the same indication statement?

Yes, the Hermiamesh T-Sling has the same intended use as the legally marketed predicate devices listed above. All are pubourethral slings for the treatment of stress uninary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphinder deficiency. Therefore, the Herniamesh T-Sling has the same intended use as the predicate devices and is considered to be "substantially equivalent."

Does the new device have same technological characteristics, e.g. design, materials, indication etc?

No, the Hermiamesh T-Sling has different technological characteristics. However, the technological differences meet or exceed the functional requirements of surgical meshes compared to the predicate devices. Please refer to Table of Similarities and Differences / Substantial Equivalence to Predicate Devices.

Could the new technological characteristics affect safety and effectiveness?

Yes, the new technological characteristics could affect safety and effectiveness. The differences in safety and effectiveness meet or exceed the reguirements of surpical mesthes compared to predicate devices.

Do the new characteristics raise new types of safety or effectiveness questions?

No, the safety and effectiveness questions are not new and include issues such as materials, pore size, tensile strength, siture retertion, and biocompatibility. Sufficient data has been provided in this premarket notification to address any new safety and efficacy questions, Additionally, there are a variety of other meshes ourrently on the market with different. characteristics compared to the Hermiamesh T-Sling or the predicate devices.

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Summary of Safety and Effectiveness (continued)

Do accepted scientific methods exist for assessing the effects of the new characteristics?

Yes. The effects of the new characteristics of the Herniamesh T-Sling can be assessed by r ess. The encour a the now a mestes. These include mechanical testing, scanning electron microscopy, biocompatibility and in vivo safety and effectiveness testing.

Are performance data available to assess the effects of the new characteristics?

Yes. These tests include mechanical testing, scanning electron microscopy, biocompatibility testing and in vivo testing.

Do performance data demonstrate equivalence?

Yes. The physical and mechanical characteristics of the Hermiamesh T-Sling meet or exceed those of the predicate devices. Please refer to Table of Similarities and Differences / Substantial Equivalence to Predicate Devices.

Based on this information the Hemiamesh T-Sling is determined to be substantially equivalent to the predicate devices.

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Table of Similarities and Differences / Substantial Equivalence to Predicate Devices (Continued)

Feature	Herniamesh T-Sling	Ethicon TVT	Injectx Inc BioSling™
BurstStrength	28.4 (10² Kpa)	55 ± 3 (10² Kpa)	SubstantiallyEquivalent
SutureRetention (N)	warp 43weft 5545° 52	warp 52 ± 9weft 51 ± 745° 57 ± 3	SubstantiallyEquivalent
Pore Size	797.4μ & 228.3μPorosity 62.4%	Substantially EquivalentPorosity 87%	SubstantiallyEquivalent
TensileStrength	warp 31.1weft 33.145° 29.7	warp 23 ± 6weft 15 ± 545° 14 ± 5	SubstantiallyEquivalent
Tissue Ingrowth	Complete tissue incorporationof implant	Complete tissueincorporation of implant	Not Tested

Note: Values for Prolene TVT were taken from the textbook: Prostheses and Abdominal Wall Hemias by Dr. Robert Bendavid (pages 197,200)

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Feature	Herniamesh T-Sling	Ethicon TVT	Injectx Inc BioSling™
510(k) No.	To be determined	K974098	K010533
Classification	Class II: Polymeric SurgicalMesh	Class II: PolymericSurgical Mesh	Class II: PolymericSurgical Mesh
Indication	Pubourethral sling fortreatment of stress urinaryincontinence (SUI) resultingfrom urethral hypermobilityand/or intrinsic sphincterdeficiency	Pubourethral sling fortreatment of stress urinaryincontinence (SUI)resulting from urethralhypermobility and/orintrinsic sphincterdeficiency	Pubourethral sling fortreatment of stress urinaryincontinence (SUI)resulting from urethralhypermobility and/orintrinsic sphincterdeficiency
Product Design	Pre-shapedDuel-component meshPolypropylene andbioabsorbable polymer	Pre-shapedPolypropylenemesh	Pre-shapedbioabsorbable polymerand Surgical mesh
Materials	Polypropylene &Polydioxanone(Bioabsorbable Polymer)	Polypropylene	Bioabsorbable polyesterPolymer
Sterilization	Eto	Eto	Eto
Packaging	Tyvek pouch with outer heatsealed foil pouch	PVC tray with Tyvek back	Substantially Equivalent
Size	2cm x 15cm	1.1cm x 45cm	Substantially Equivalent

Table of Similarities and Differences / Substantial Equivalence to Predicate Devices

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.

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

Herniamesh USA, Inc. % Ms. Lorena Trabucco 8 Orange Drive JERICHO NY 11753

SEP 2 8 2012

Re: K020652 Trade/Device Name: T-Sling Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAH Dated: February 21, 2002 Received: February 28, 2002

Dear Ms. Trabucco:

This letter corrects our substantially equivalent letter of May 15, 2002.

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 (OS) 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/ResourcesforYou/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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Premarket Notification for Herniamesh T-Sling

Attachment # 1

Indications for Use Form

510(k) Number: K020652

Device Name: T-Sling

Indications For Use:

The Herniamesh T-sling is a dual-component pubourethral sling for the treatment of stress r ice recimatinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_V (per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Miriam C. Provost

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

K020652 510(k) Number .

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.