The CoLS® PEEK is designed for the fixation of tendons graft to the femur and tibia during orthopedic surgical procedures for Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) reconstructions.

Device Description

The CoLS® PEEK is a screw made out of PEEK (Poly-Ether-Ketone) and used with the tape of TLS® fixation system agreed by FDA K080974. To standardize CoLS® range, the TLS® tape will be called CoLS® tape. The difference between CoLS® screw made out of PEEK and TLS® screw made out of titanium is only the raw material. The CoLS® PEEK is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the CoLS® PEEK device, based only on the provided text:

Important Note: The provided document is a 510(k) Premarket Notification summary for a medical device. This type of submission aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving enhanced effectiveness or an "effect size" as typically seen in AI/ML performance studies. Therefore, many of the requested categories related to AI/ML performance (e.g., human reader improvement with AI, multi-reader multi-case studies, training set details) are not applicable to this traditional medical device submission.

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Acceptance Criteria (from document)	Reported Device Performance (from document)
Substantial Equivalence	To be substantially equivalent to predicate devices (TLS Fixation System K080974 and BIOSURE® SYNC Smith & Nephew PEEK Interference Screws K083226) in terms of material, ranges of sizes, intended use, performances, safety and effectiveness.	The CoLS® PEEK was determined to have performances substantially equivalent to those of the selected predicate devices.
Material	Made out of PEEK.	Made out of PEEK (Poly-Ether-Ketone).
Sizes	Available in similar ranges of sizes to predicate devices.	Available in similar ranges of sizes.
Intended Use	Fixation of tendons graft to the femur and tibia during orthopedic surgical procedures for Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) reconstructions.	Designed for the fixation of tendons graft to the femur and tibia during orthopedic surgical procedures for Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) reconstructions.
Performance Standard Testing	Tested according to ASTM F543-07.	Testing was completed according to ASTM F543-07.
Specific Performance Test	Insertion torque test (as per ASTM F543-07).	The insertion torque test was performed.
Safety and Effectiveness	Risks to health addressed through specified materials, processing controls, quality assurance, and compliance to Medical Device Good Manufacturing Practices Regulations.	Conclusion states substantial equivalence in safety and effectiveness.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the performance testing.
- Data Provenance: Not explicitly stated, but the manufacturer is based in France (Fournitures Hospitalières industrie, Quimper, France). The testing was for a physical device, not patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a physical device performance test (insertion torque), not an assessment of diagnostic performance requiring expert interpretation.
Adjudication method for the test set:
- Not applicable. This is a physical device performance test adhering to a standard (ASTM F543-07). Adjudication methods like 2+1 or 3+1 are typically for clinical or imaging studies where expert consensus is needed.
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:
- No, a MRMC comparative effectiveness study was not done. This device is a fixation screw, not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device. The device's "performance" refers to its mechanical properties.
The type of ground truth used:
- The "ground truth" for the device's performance was the standardized method and results defined by ASTM F543-07 for insertion torque testing. The predicate devices' performance in similar tests would have served as a benchmark for substantial equivalence.
The sample size for the training set:
- Not applicable. This is a traditional medical device, not an AI/ML device that requires a "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML model.

Summary

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Fournitures Hospitalières industrie

CoLS® PEEK Traditional 510(k) Premarket Notification

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: November 24th 2011

The assigned 510(k) number is:

Fournitures Hospitalières industrie 5-1. Applicant: 6 Rue Nobel, Z.I. de Kernévez 29000 QUIMPER - FRANCE Tel: (+33) 2.98.55.68.95 Fax: (+33) 2.98.53.42.13
Franck HUNT, General Manager 5-2. Company Contact: Tel: (+33) 2.98.55.68.95
5-3. Product :
- CoLS® PEEK Trade name:
- Common name: Fixation screw

Classification: Fixation screw:

Product code: HWC : screw, fixation, bone Regulation: 21 CFR 888.3040 Class: II

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5-4. Predicate/ Legally Marketed Devices :

Information on devices to which substantial equivalence is claimed:

Manufacturer:	Fournitures Hospitalières Industrie
Device Trade Name:	TLS Fixation System
510 (K):	K080974
Manufacturer:	Smith & Nephew, Inc.
Device Trade Name:	BIOSURE® SYNC Smith & Nephew PEEKInterference Screws
510 (K):	K083226

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Fournitures Hospitalières industrie

5-5. Device Description:

The difference between CoLS® screw made out of PEEK and TLS® screw made out of titanium is only the raw material.

The CoLS® PEEK is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.

5-6. Indications for Use/ Intended Use:

As stated in the Indications for Use section and on the product related labeling (instructions for use and commercial documents):

5-7. Comparison of Technological Characteristics:

The CoLS® PEEK and the above selected predicate devices have the same intended use and substantial similar indications for use and share the following similarities:

they are made out of the same material: PEEK, -
they are available in similar ranges of sizes, -

5-8. Performances:

The CoLS® PEEK was tested according to ASTM F543-07. The test performed in ASTM F543 was the insertion torque test. After the testing was completed, it was determined that the CoLS® PEEK performances were substantially equivalent to those of the selected predicate devices.

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

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Kr13591

CoLS® PEEK Traditional 510(k) Premarket Notification

5-9. Conclusion:

Following the examination of all the above mentioned information, we believe that the CoLS® PEEK is substantially equivalent to the selected predicate devices in terms of material, ranges of sizes, intended use, performances, safety and effectiveness.

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Image /page/3/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Fournitures Hospitalières Industrie % Mr. Franck Hunt General Manager 6 Rue Nobel, Z.I. de Kernèvez 29000 Quimper France

DEC 2 2 2011

Re: K113591

Trade/Device Name: CoLS® PEEK Regulation Number: 21 CFR 888.3040 . Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: November 24, 2011 Received: December 5, 2011

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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 (reporting of medical

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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/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" (21CFR 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,

for Delle

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

Enclosure

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4. Indications for Use

510(k) Number (if known): _ K // 359 l

Device Name:

CoLS® PEEK

This device is composed of fixation screw made out of PEEK.

Indications for Use: The CoLS® PEEK is designed for the fixation of tendons graft to the femur and tibia during orthopedic surgical 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)

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Concurence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1

(Division Sign-Off) Division of Surgical, Orthopedic. and Restorative Devices

510(k) Number	K113591
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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.