The ConMed Linvatec CrossFT™ BC Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

Device Description

The ConMed Linvatec CrossFT™ BC Suture Anchor is a device that is used to assist the surgeon in reattaching soft tissue to bone. The device includes anchors, manufactured of 96L/4D PLA co-polymer + β-TCP and two (2), or three (3) Hi-Fi® sutures manufactured of polyethylene and polypropylene. The device is bioabsorbable and is available in sizes between 4.5mm to 6.5mm diameter and 17mm lengths. A disposable driver is included to implant the suture anchor.

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to complete all sections of your request. The document is a 510(k) summary and FDA clearance letter for a medical device (suture anchor), which primarily focuses on substantial equivalence to predicate devices rather than a detailed study proving performance against specific acceptance criteria.

Here's what I can extract and what is missing based on the provided text:

Acceptance Criteria and Study Information for ConMed Linvatec CrossFT™ BC Suture Anchor

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was measured)	Reported Device Performance (What did the device achieve)
Fixation strength	Verified and validated (specific quantitative results not provided)
Cyclic loading	Verified and validated (specific quantitative results not provided)
Insertion torque	Verified and validated (specific quantitative results not provided)
Material degradation	Verified and validated (specific quantitative results not provided)
Packaging/transportation qualification	Verified and validated (specific quantitative results not provided)

The document states "The verification and validation testing of the ConMed Linvatec CrossFT™ BC Suture Anchor includes fixation strength, cyclic loading, insertion torque, material degradation and packaging/transportation qualification." However, it does not provide the specific quantitative acceptance criteria (e.g., minimum pull-out strength in Newtons, maximum displacement under cyclic loading) nor the numerical results obtained by the device for these tests.

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

Sample Size: Not specified in the provided text.
Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

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

This information is typically relevant for studies involving human interpretation (e.g., image analysis, clinical assessments). For a mechanical device like a suture anchor undergoing physical and material testing, the "ground truth" is established through standardized engineering and material science testing methods and reference standards. The document does not mention the use of human experts in this context.

4. Adjudication method for the test set

Not applicable in the context of purely physical/mechanical device testing as described.

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 for surgical implantation, not an AI or diagnostic imaging device that involves human readers.

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

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

7. The type of ground truth used

For the mentioned tests (fixation strength, cyclic loading, insertion torque, material degradation, packaging/transportation qualification), the ground truth would be established by:

Standardized Test Methods: Adherence to recognized ASTM, ISO, or other industry standards for mechanical testing of orthopedic implants and materials.
Material Specifications: Compliance with established specifications for the raw materials (PLA co-polymer + β-TCP) and components (sutures).
Predicate Device Performance: Comparison to the established performance characteristics of the predicate devices, as the basis for substantial equivalence.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning algorithm.

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

Not applicable. This is a physical medical device, not a machine learning algorithm.

Summary of Missing Information & Why:

The provided document is a 510(k) summary, which is a premarket notification to the FDA. Its primary purpose is to demonstrate "substantial equivalence" to legally marketed predicate devices, not to provide a detailed technical report of the device's performance against specific, quantitative acceptance criteria. While it states that "verification and validation testing" was performed, it does not disclose the specific numerical results of these tests or the exact acceptance criteria used. These details would typically be found in the full design history file or specific test reports, which are not part of the publicly available 510(k) summary. For mechanical devices, the "ground truth" is typically derived from engineering standards and material properties, rather than expert consensus or pathology in the clinical sense.

Summary

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K101100 p.1 of 2

AUG 2 6 2010

510(k) SUMMARY ConMed Linvatec CrossFT™ BC Suture Anchor

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, ConMed Linvatec is hereby submitting the 510(k) Summary of Safety and Effectiveness for the 510(k) Number 101100 .

A. Submitter

ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294

B. Company Contact

John Cusack Regulatory Affairs Manager (727) 319-5562 Telephone (727) 399-5264 FAX

C. Device Name

Trade Name:	ConMed Linvatec CrossFT™ BC Suture Anchor
Common Name:	Bioabsorbable suture anchor
Classification Name:	Single/multiple component metallic bone fixation appliances and accessories.
Proposed Class/Device:	Class II
Product Code:	MAI
Regulation:	21 CFR Part 888.3030

D. Predicate/Legally Marketed Devices

Device Name:	ConMed Linvatec Soft Tissue to Bone System
Company Name:	ConMed Linvatec
510(k) #:	K091549
Device Name:	ConMed Linvatec Bio Mini-Revo
Company Name:	ConMed Linvatec
510(k) #:	K053561
Device Name:	ConMed Linvatec Matryx Interference Screw
Company Name:	ConMed Linvatec
510(k) #:	K052080

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E. Device Description

F. Intended Use/ Indications

G. Contraindications

The ConMed Linvatec CrossFT™ BC Suture Anchor is contraindicated for the following orthopedic procedures:

ACL (Anterior Cruciate Ligament), PCL (Posterior Cruciate Ligament), foot, and hand procedures

H. Substantial Equivalence

The ConMed Linvatec CrossFT™ BC Suture Anchor is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the ConMed Linvatec CrossFT PEEK Suture Anchor (K091549 - Soft Tissue to Bone System), ConMed Linvatec Bio Mini-Revo Suture Anchor (K053561), and ConMed Linvatec Matryx Interference Screw (K052080). The verification and validation testing of the ConMed Linvatec CrossFT™ BC Suture Anchor includes fixation strength, cyclic loading, insertion torque, material degradation and packaging/transportation qualification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and is positioned around the upper half of the logo.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

ConMed Linvatec c/o Mr. John Cusack Regulatory Affairs Manager 11311 Concept Boulevard Largo, Florida 33773

AUG 26 2010

Re: K101100

Trade/Device Name: CrossFT BC Suture Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories. Regulatory Class: Class II Product Code: MAI Dated: August 6, 2010 Received: August 9, 2010

Dear Mr. Cusack:

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. 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 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

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Page 2 - Mr. John Cusack

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.

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" (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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Свойво Виенно

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

Enclosure

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K101100

Indications for Use

510(k) Number (if known):

Device Name:

ConMed Linvatec CrossFT™ BC Suture Anchor

Indications for Use:

The ConMed Linvatec CrossFT™ BC Suture Anchor is intended to reattach soft , tissue to bone in orthopedic surgical procedures. The system may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendon, or joint capsules to the The suture anchor system thereby stabilizes the damaged soft tissue, in bone. conjunction with appropriate postoperative immobilization, throughout the healing period.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shuta for mxm
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101100

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.