The TLS® Fixation System is designed for the fixation of tendons graft to the femur and tibia during orthopaedic surgical procedures for Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) reconstructions.

Device Description

The TLS® Fixation System is composed of the following elements:

The TLS® screw, used for the fixation of the TLS® tape to the bone. -
The TLS®+ tendon fixation tape kit, for the ACL and PCL reconstruction, to which the tendon graft is attached.
This kit is composed of:
= 1 non-absorbable tape : implantable,
· 2 passing wires: non implantable, to be used to pass the tape and the attached graft through the bone tunnel,
· 1 tape support: non implantable, to be used for the preparation of the graft.

AI/ML Overview

This document describes the TLS® Fixation System and its substantial equivalence to predicate devices, focusing on the mechanical properties rather than AI/ML performance. Therefore, many of the requested criteria related to AI/ML studies are not applicable.

Here's an analysis based on the provided text:

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

Acceptance Criteria (Implicit)	Reported Device Performance
Equivalent strength to predicate device (EndoButton™) based on: - Tensile Strength - Stiffness - Cyclic Fatigue Testing	"The TLS® Fixation System was tested against the EndoButton to determine if it was equivalent in strength. Tensile Strength, Stiffness and Cyclic Fatigue Testing were examined. After the testing was completed, it was determined that the TLS® Fixation System is as strong as the currently marketed EndoButton™."
Substantial equivalence in: - Materials - Intended Use - Performances - Safety - Effectiveness	"The TLS® Fixation System ... are substantially equivalent to the selected predicate devices in terms of materials, intended use, performances, safety and effectiveness." (Based on comparison tables for TLS® tape vs. ENDOBUTTON™ CL/TENOLIG®, and TLS® screw vs. Rci™ screw, which show similar characteristics).
Addresses risks to health	"Risk to health have been addressed through the specified materials, processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations."

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

The document mentions "Tensile Strength, Stiffness and Cyclic Fatigue Testing" but does not specify the sample size for these tests. The provenance of the data is from F.H. Industrie (Fournitures Hospitalières Industrie), located in Quimper, France. The study appears to be prospective testing conducted by the manufacturer.

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 product is a medical device (fixation system for ACL/PCL reconstruction), not an AI/ML diagnostic tool. Therefore, there are no "experts used to establish the ground truth" in the context of image interpretation or similar AI applications. The "ground truth" for this device relates to its mechanical performance, which is established through physical testing and comparison to predicate devices, not expert consensus on medical images.

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

Not applicable. This is not an AI/ML study involving human readers' assessments that would require an adjudication method.

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. This is a medical device, not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

Not applicable. This is a medical device, not an AI algorithm.

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

The "ground truth" for this medical device is established through:

Mechanical Testing: Tensile strength, stiffness, and cyclic fatigue testing results comparing the TLS® Fixation System directly against the predicate device (EndoButton™).
Predicate Device Characteristics: The established safety and effectiveness of the legally marketed predicate devices (EndoButton™ Continuous Loop, Tenolig®, and RCi™ screw) served as the benchmark for substantial equivalence comparisons in terms of materials, indications for use, and performance characteristics.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI/ML system that utilizes a training set.

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

Not applicable. There is no training set for this type of medical device.

Summary

{0}------------------------------------------------

JUL - 1 2008

5. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance to the requirements of SDMA 1990 and 21 CFR 807.92.

Date prepared : February 25th 2008

The assigned 510(k) number is: K080774

5-1. SUBMITTER :

Fournitures Hospitalières Industrie 6 Rue Nobel, Z.I. de Kernévez 29000 QUIMPER - FRANCE Tel: (+33) 2.98.55.68.95 Fax: (+33) 2.98.53.42.13

5-2. COMPANY CONTACT :

Franck HUNT, General Manager Tel: (+33) 2.98.55.68.95

5-3. DEVICE NAME :

Trade name : TLS® Fixation System Common name : Fixation screw and Non absorbable surgical suture Classification name : - Non absorbable surgical suture (Poly[ethylene terephtalate]): Regulation: 21 CFR 878.5000 / Procode: GAT - Fixation screw: Regulation: 21 CFR 888.3040 / Procode: HWC

5-4. PREDICATE/ LEGALLY MARKETED DEVICES :

> Non-absorbable suture :

Manufacturer :	Smith & Nephew
Device Trade Name :	EndoButton™ Continuous Loop
510 (K) :	K980155
Date cleared :	04/01/1998

Manufacturer :	F.H INDUSTRIE
Device Trade Name :	Tenolig®
510 (K) :	K060367
Date cleared :	09/08/2006

{1}------------------------------------------------

> Fixation screw:

Manufacturer :	Smith & Nephew
Device Trade Name :	RCiTM screw
510 (K) :	K992945
Date cleared :	11/18/1999

5-5. DEVICE DESCRIPTION:

The TLS® Fixation System is composed of the following elements:

The TLS® screw, used for the fixation of the TLS® tape to the bone. -
The TLS®+ tendon fixation tape kit, for the ACL and PCL reconstruction, to which the tendon graft is attached.

This kit is composed of:

= 1 non-absorbable tape : implantable,
· 2 passing wires: non implantable, to be used to pass the tape and the attached graft through the bone tunnel,
· 1 tape support: non implantable, to be used for the preparation of the graft.

The following table details our fixation screws and our non-absorbable surgical suture:

Products		Materials	Sizes	To beimplanted
TLS® Screw		Titaniumalloy	Ø10Length 20,25mm	Yes
TLS®+ tendon fixation tapekit	Tape	Poly[ethyleneterephtalate]	Length: 60cm,Width: 6 cm	Yes
	Passingwires	Poly[ethyleneterephtalate]	Length: 50 cm,Ø 0.7mm	No
	Tapesupport	Anodizedaluminium	-	No

5-6. INDICATIONS FOR USE/ INTENDED USE:

5-7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

The TLS® screws and the TLS®+ tendon fixation tape have the same intended use and substantial similar indications for use as the predicate devices selected. The products are all made of the same material (titanium alloy and polyethylene terephtalate), are available in similar diameters and lengths, with similar designs.

{2}------------------------------------------------

5-8. PERFORMANCES:

The TLS® Fixation System was tested against the EndoButton to determine if it was equivalent in strength. Tensile Strength, Stiffness and Cyclic Fatigue Testing were examined. After the testing was completed, it was determined that the TLS® Fixation System is as strong as the currently marketed EndoButton™.

Risk to health have been addressed through the specified materials, processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations.

5-9. SUBSTANTIAL EQUIVALENCE:

The substantial equivalence of our products when compared to the selected predicate devices has been established following manufacturers' commercial documents and 510(k) submission's information available on FDA's website.

Characteristics	TLS® tape	ENDOBUTTON™ CL	TENOLIG®
Manufacturer	F.H. industrie	Smith & Nephew	F.H. industrie
510(k) number	Pending	K980155	K060367
Indications for Use	Used for ACL and PCLreconstruction	Used for ACL and PCLreconstruction	Indicated for surgicalrepair of Achille tendonruptures by percutaneousapproach
Material	Polyethylene terephtalate	Polyethylene terephtalate	Polyethylene terephtalate
Lengths	60 cm	10 to 80 cm	36 cm
Diameter	6 mm	6 to 12 mm	0,85mm
Sterilization	Gamma irradiation	Gamma irradiation	Gamma irradiation
Single Use	Yes	Yes	Yes

Tables of Substantial Equivalence

Characteristics	TLS® screw	Rci™ screw
Manufacturer	F.H. industrie	Smith & Nephew
510(k) number	Pending	K992945
Indications for Use	Graft fixation for ACL andPCL reconstruction	Graft fixation for ACL andPCL reconstruction
Material	Titanium alloy	Titanium alloy
Lengths	20 to 25 mm	25 to 50 mm
Diameter	10 mm	6 to 12 mm
Sterilization	Gamma irradiation	Gamma irradiation
Single Use	Yes	Yes

5-10. CONCLUSION:

Following the examination of all the above mentioned information, we can then conclude that the TLS® Fixation System composed of the TLS® screw and the TLS®+ tendon fixation tape are substantially equivalent to the selected predicate devices in terms of materials, intended use, performances, safety and effectiveness.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Fournitures Hospitalieres Industrie % Mr. Franck Hunt General Manager ZI de Kernevez 6 rue Nobel 29000 Quimper France

JUL - 1 2008

Re: K080974 Trade/Device Name: TLS® Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI, JDR Dated: February 25, 2008 Received: April 4, 2008

Dear Mr. Hunt:

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, 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.

{4}------------------------------------------------

Page 2 - Mr. Franck Hunt

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Mullean

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

Enclosure

{5}------------------------------------------------

4. Indications for Use

510(k) Number (if known):

Device Name :

TLS® Fixation System

KO80974

This product is composed of the following elements:

The TLS® screw, ー
The TLS+® tendon fixation system -(1 tape , 2 passing wires, 1 tape support)

Indications for Use:

The TLS® Fixation System is designed for the fixation of tendons graft to the femur and tibia during orthopaedic procedures for Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) reconstructions.

Prescription Use:	Yes (Part 21 CFR 801 Subpart D)
	AND/OR
Over the counter Use:	No (21 CFR 801 Subpart C)

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

(Division Sign-Off)

Division of General

Concurrence of CDRH, Office of Device Evaluation (ODE) Page of

and Neurological

510(k) Number: K080974

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.