The Arthrex BioComposite GraftBolt is intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone during cruciate ligament reconstruction procedures.

Device Description

The Arthrex BioComposite GraftBolt consists of a pre-packaged mating sheath and a screw pair offered in various sizes.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Arthrex BioComposite GraftBolt) and not a study report about AI/ML device performance. Therefore, most of the requested information (acceptance criteria for AI, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable to this document.

However, I can extract the relevant information regarding the device acceptance criteria and the type of study performed to demonstrate substantial equivalence, based on the provided text.

Here's the closest interpretation of your request using the given document:

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

Acceptance Criteria	Reported Device Performance
No explicit numerical acceptance criteria for ultimate load strength were stated in this summary. The general acceptance criterion is that the device "meets or exceeds the minimum acceptance criteria" established for the predicate devices.	The submitted degradation and biomechanical testing data "demonstrates that the ultimate load strength of the proposed devices meets or exceeds the minimum acceptance criteria."

Note: The document states that "Any differences between the BioComposite GraftBolt and the predicate devices are considered minor and do not raise questions concerning safety and effectiveness" and that "The submitted degradation and biomechanical testing data demonstrates that the ultimate load strength of the proposed devices meets or exceeds the minimum acceptance criteria." It does not, however, specify the numerical values of these minimum acceptance criteria or the exact reported ultimate load strength of the proposed device.

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

This information is not applicable as the document describes a submission for a physical medical device (bone fixation screw), not an AI/ML device. The "test set" in this context would refer to the samples of the device used for biomechanical and degradation testing, but the sample size is not specified.

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 information is not applicable as the document is about a physical medical device. Ground truth as typically understood for AI/ML devices is irrelevant here.

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

This information is 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

This information is not applicable as the document is about a physical medical device, not an AI-assisted diagnostic tool involving human readers.

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

This information is not applicable as the document is about a physical medical device, not an AI algorithm.

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

This information is not applicable as the document is about a physical medical device. The "ground truth" for a physical device is its physical and mechanical properties, which are measured through standardized tests.

8. The sample size for the training set

This information is not applicable.

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

This information is not applicable.

Summary of the study conducted (as per the document):

The "study" referenced in this 510(k) submission is a series of degradation and biomechanical testing conducted on the Arthrex BioComposite GraftBolt. This testing was performed to demonstrate that the proposed device's ultimate load strength meets or exceeds the minimum acceptance criteria and to support its substantial equivalence to predicate devices (Arthrex Tibial GraftBolt, Arthrex BioComposite Transfix, and Arthrex BioComposite Interference Screws). The primary focus of the submission is to show that the new device, a line-extension using an existing biocomposite material, is equivalent in terms of safety and effectiveness to previously cleared devices.

Summary

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K 12.0540 (1/2)

Special 510(k): Arthrex BioComposite GraftBolt, February 17, 2012

MAR 2 0 2012

Arthrex SPECIAL 510(K); ARTHREX BIOCOMPOSITE GRAFTBOLT

510(k) Summary of Safety and Effectiveness 2

Date Summary Prepared	February 15, 2012
Manufacturer/Distributor/Sponsor	Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA
510(k) Contact	Courtney SmithManager, Regulatory AffairsArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 1720Fax: 239/598.5508Email: courtney.smith@arthrex.com
Trade Name	Arthrex BioComposite GraftBolt
Common Name	Screw, Fixation, Bone
Product Code -ClassificationName	HWC - Screw, fixation, boneMAI - Fastener, fixation, biodegradable
CFR	21 CFR 888.3030: Single/multiple component metallic bonefixation appliances & accessories
Predicate Device	K093912, K103060: Arthrex Tibial GraftBoltK112040: Arthrex BioComposite TransfixK071177: Arthrex BioComposite Interference Screws
Purpose of Submission	This special 510(k) premarket notification is submitted toobtain clearance for the BioComposite GraftBolt, which is aline-extension of the Arthrex Tibial GraftBolt (K093912,K103060).
Device Description and IntendedUse	The Arthrex BioComposite GraftBolt consists of a pre-packaged mating sheath and a screw pair offered in varioussizes.The Arthrex BioComposite GraftBolt is intended to be usedfor fixation of tissue including ligament or tendon to bone andbone tendon bone during cruciate ligament reconstructionprocedures.
Substantial EquivalenceSummary	The Arthrex BioComposite GraftBolt is substantiallyequivalent to the Arthrex Tibial GraftBolt (K093912,K103060) in which the basic features, and intended uses arethe same. The biocomposite material is the same materialused in the Arthrex BioComposite Transfix (K112040) and
BioComposite Interference Screws (K071177).	Any differences between the BioComposite GraftBolt andthe predicate devices are considered minor and do not raisequestions concerning safety and effectiveness.The submitted degradation and biomechanical testing datademonstrates that the ultimate load strength of the proposeddevices meets or exceeds the minimum acceptance criteria.Based on the indication for use, technological characteristicsand the comparison to the predicate devices, Arthrex, Inc. hadetermined that the Arthrex BioComposite GraftBolt issubstantially equivalent to currently marketed predicatedevices.

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. . . .

Comments of the country

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Special 510(k): Arthrex BioComposite GraftBolt, February 17, 2012

Arthrait SPECIAL 510(K): ARTHREX BIOCOMPOSITE GRAFTBOLT .

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

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

Arthrex, Incorporated % Ms. Courtney Smith Manager, Regulatory Affairs 1370 Creekside Boulevard -Naples, Florida 34108

MAR 2 0 2012

Re: K120540

Trade/Device Name: Arthrex BioComposite GraftBolt Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories

Regulatory Class: Class II Product Code: MAI, HWC Dated: March 6, 2012 Received: March 8, 2012

Dear Ms. Smith:

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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Courtney Smith

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for At. B. A.

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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Special 510(k): Arthrex BioComposite GraftBolt, February 17, 2012

Arthrex SPECIAL 510(K): ARTHREX BIOCOMPOSITE GRAFTBOLT

Indications for Use Form

Indications for Use

510(k) Number:

Device Name:

Arthrex BioComposite GraftBolt

Indications For Use:

The Arthrex BioComposite GraftBolt is intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone during cruciate ligament reconstruction procedures.

AND/OR Over-The-Counter Use Prescription Use V (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

PAGE 1 of 1

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

510(k) Number ________________________________________________________________________________________________________________________________________________________________

10 of 241

K 120540(11)

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.