TRULENE MESH, NONABSORBABLE POLYPROPYLENE SURGICAL MESH IS INDICATED FOR USE IN HERNIA REPAIR AND OTHER FASCIAL DEFICIENCIES THAT REQUIRE THE ADDITION OF A REINFORCING OR BRIDGING MATERIAL TO OBTAIN THE DESIRED SURGICAL RESULT.

Device Description

Trulene Mesh is Nonabsorbable Polypropylene Surgical Mesh, produced by knitting filaments of extruded undyed Monofilament Polypropylene, a synthetic linear Poly olefin.

AI/ML Overview

The provided document describes a medical device called "TRULENE MESH" and its equivalence to predicate devices. It does not contain information about an AI/ML device, nor does it address the specific criteria typically associated with testing and validation of AI/ML diagnostic tools (e.g., ground truth establishment, expert qualifications, adjudication methods, or MRMC studies).

Therefore, I cannot provide details for most of your questions based on the provided text. The document focuses on demonstrating substantial equivalence based on material composition, design, intended use, and physical properties compared to existing devices.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comparison table against predicate devices for various physical and material properties. The 'acceptance criteria' are implicitly that the TRULENE MESH performs "Same" or "approximately the same" as the predicate devices, and meets or exceeds requirements.

Comparison Item	TRULENE MESH Performance	Acceptance Criteria (Implied)
Raw Material used	Same	Same as predicate
U.S.P. Size of the Polypropylene thread (5-0)	Same	Same as predicate
Diameter of the raw material (0.1 to 0.149 mm)	Same	Same as predicate
Knot Pull Tensile Strength of raw material (NLT 0.5 Kgf)	NLT 0.5 Kgf	Same as predicate
Linear Tensile Strength of raw material (0.75 +/- 0.05 Kgf)	0.75 +/- 0.05 Kgf	Same as predicate
Intended Use	Same	Same as predicate
Supplied for single use only	Same	Same as predicate
Sterilized by E.O. method	Same	Same as predicate
Packaging and Labeling	Same	Same as predicate
Thickness of the Trulene Mesh	0.44 - 0.46 mm	Approximately the same
Density of the Trulene Mesh	95 Gram per Sq. Meter	Approximately the same
Pore Size of the Trulene Mesh	22 to 23 Pores per inch	Approximately the same
Tensile Strength of Trulene Mesh	14.0 to 16.0 Kgf	Approximately the same
Burst Strength of Trulene Mesh	12.0 to 13.0 Kg/S.Cm	Approximately the same
Tear resistance of Trulene Mesh	5.0 to 6.5 Kgf	Approximately the same
Suture Pull out Strength	6.25 to 7.5 Kgf	Approximately the same
Biologically compatible (as per ISO-10993)	Same	Same as predicate

2. Sample size used for the test set and the data provenance: Not applicable. This is a medical device (surgical mesh), not a diagnostic AI/ML system. Testing refers to physical property measurements, not evaluation on a 'test set' of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device performance relies on established physical and material testing standards and comparison to legally marketed predicate devices.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

Summary of the Study Proving Acceptance Criteria (from the document):

The study demonstrates substantial equivalence of the TRULENE MESH to predicate devices (United States Surgicals' Nonabsorbable Polypropylene Surgical Mesh K905655 and MPathy Medical Devices Ltd's Minimesh K041632) by:

Material Equivalence: Stating it is composed of the "same material" (undyed Monofilament Nonabsorbable polypropylene).
Design Equivalence: Stating it has a "similar knit design" and is manufactured in a "manner typical of the industry and equivalent to that to produce the predicate devices."
Performance Testing: Performing comparative testing for parameters such as:
- Thickness
- Density
- Pore Size
- Burst Strength
- Tensile Strength
- Tear Resistance
- Cleanliness
- Sterility requirements
- Biological compatibility (as per ISO-10993 standards)
Conclusion: The testing "demonstrates that 'TRULENE' Polypropylene Nonabsorbable surgical suture meets or exceeds the requirements and are equivalent in terms of the above mentioned predicate devices."

The study is essentially a set of comparative physical and material property tests to show the new device is functionally identical or superior to existing, legally marketed devices.

Summary

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510 (k) SUMMARY OF INFORMATIONS, AS REQUIRED BY 21 CFR 807,92 REGARDING PERFORMANCE, SAFETY AND EFFECTIVENESS UPON WHICH AN EQUIVALENCE DETERMINATION CAN BE MADE.

A. APPLICANT INFORMATION

Name of the Manufacturer	: SUTURES INDIA PVT.LTD.
Address	: 472 D, 13 th Cross, 4 th Phase,Peenya Industrial Area,Bangalore 560058, India.
Phone NumberFax Number	: 91-80-41868000 to 8030 (30 lines): 91-80-41171056
E.MailWeb Address	: sutures@suturesin.com: www.suturesin.com
B. OFFICIAL CORRESPONDENT: L.G.ChandrasekharManaging Director
C. DEVICE NAME

Trade Name	: TRULENE MESH
Common Name	: Nonabsorbable Polypropylene Surgical Mesh
Classification Name	: Mesh Surgical Polymeric

D. PREDICATE DEVICES:

(1) Device Name: Nonabsorbable Polypropylene Surgical Mesh 510(k) Number: K 905655
Manufacturer: United States Surgicals, A Division of Tyco Health,

150, Glover Ave, Norwalk CT 06856

(2) Device Name (Proprietary): Minimesh
Generic / Common Name: Polymeric Surgical Mesh

510 (k) Number : K 041632

Manufacturer: Mpathy Medical Devices Ltd,

150, Aran Hill road, Fairfield, CT 06824 1712

E. REGULATION NUMBER: 878.3300 PRODUCT CODE: FTL

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K060018

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E. DESCRIPTION OF THE DEVICE:

Trulene Mesh is Nonabsorbable Polypropylene Surgical Mesh, produced by knitting

filaments of extruded undyed Monofilament Polypropylene, a synthetic linear Poly

olefin.

F. INTENDED USE OF THE DEVICE:

Trulene mesh may be used for the repair of hernia and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

COMPARISON TABLE SUTURES INDIA'S "TRULENE MESH" NONABSORBABLE SURGICAL MESH (POLYPROPYLENE) TO PREDICATE DEVICES

Comparison items	SuturesIndia	United StatesSurgicals.	MPathySurgical
Raw Material used:Undyed Monofilament Nonabsorbablepolypropylene, flexible thread prepared fromlong-chain polyolefin polymer known asPolypropylene .	Same	Same	Same
U.S.P. Size of the Polypropylene threadDiameter of the raw material (Metric Size)	5-00.1 to0.149 mm	Same	Same
Knot Pull Tensile Strength of raw material	NLT 0.5Kgf	Same	Same
Linear Tensile Strength of raw material	0.75 +/0.05 Kgf	Same	Same
Trulene mesh may be used for the repair ofhernia and other fascial deficiencies thatrequire the addition of a reinforcing orbridging material to obtain the desiredsurgical result.	Same	Same	Same
Comparison items	SuturesIndia	Ethicon	U.S.Surgicals
Trulene Polypropylene NonabsorbableSurgical Mesh is supplied for single use only	Same	Same	Same
Trulene Polypropylene NonabsorbableSurgical Mesh is sterilized by E.O. method	Same	Same	Same
TrulenePolypropyleneNonabsorbableSurgical Mesh is packed in the same orequivalent manner, and has the same orequivalent labeling claims as the predicatedevices including indications,warnings.cautions and precautions	Same	Same	Same
Thickness of the Trulene Mesh is	0.44 -0.46 mm	approximatelythe same	approximatelythe same
Density of the Trulene Mesh is	95 GramperSq. Meter	approximatelythe same	approximatelythe same
Pore Size of the Trulene Mesh:	22 to 23Pores perinch	approximatelythe same	approximatelythe same
Tensile Strength of Trulene Mesh:	14.0 to16.0 Kgf	approximatelythe same	approximatelythe same
Burst Strength of Trulene Mesh:	12.0 to13.0Kg/S.Cm	approximatelythe same	approximatelythe same
Tear resistance of Trulene Mesh	5.0 to 6.5Kgf	approximatelythe same	approximatelythe same
Suture Pull out Strength	6.25 to7.5 Kgf	approximatelythe same	approximatelythe same
Trulene Polypropylene NonabsorbableSurgical Mesh is biologically compatiblewhen tested as per ISO-10993 standards	Same	Same	Same

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CONCLUSION

Trulene Polypropylene Nonabsorbable surgical Mesh is composed of the same material, as are the predicate devices and has similar knit design, as do the predicate devices. The mesh is manufactured in a manner typical of the industry and equivalent to abat to produce the predicate devices.

Testing of Trulene Mesh and the substantially equivalent devices for the parameters, viz, Thickness, Density, Pore Size, Burst Strength, Tensile Strength, Tear Resistance, cleanliness, Sterility requirements demonstrates that "TRULENE" Polypropylede Nonabsorbable surgical suture meets or exceeds the requirements and are equivalent in terms of the above mentioned predicate devices.

L.G.Chandrasekhar Managing Director

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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 is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES U.S.A." arranged around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 26 2006

Sutures India Pvt. Ltd. % L.G. Chandrasekhar Managing Director 472-D, 13th Cross, 4th Phase Peenya Industria Area Bangalore - 560 058 India

Re: K060018

Trade/Device Name: TRULENE MESH Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: June 14, 2006 Received: June 19, 2006

Dear L.G. Chandrasekhar:

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither 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 vour 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 – L.G. Chandrasekhar

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, permitts 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/cdrl/industry/support/index.html.

Sincerely yours,

Halen Lemmer
Mark N. Muller

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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KOGOOIS

INDICATIONS FOR USE

510(K) No. : K 060018

: TRULENE MESH DEVICE NAME NONABSORBABLE POLYPROPYLENE SURGICAL MESH

INDICATIONS FOR USE:

Prescription Use(Part 21 CFR 801 Subpart D)	✓	AND / OR	Over -The - Counter Use(21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, Page 1 of 1
and Neurological Devices

510(k) Number	K060018
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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.