This document, a 510(k) premarket notification from the FDA, pertains to a medical device (KATOR Suture Anchor) and does not describe or contain information about a study proving that a device meets acceptance criteria for an AI/Software as a Medical Device (SaMD) product.

Instead, this document is a Traditional 510(k) approval for a physical medical device (suture anchor). The "tests" mentioned are nonclinical (mechanical) tests to ensure the device's physical performance, not diagnostic performance of an AI algorithm.

Therefore, I cannot provide the requested information for an AI/SaMD product based on this document. The document lists:

Device Name: KATOR Suture Anchor
Regulation Name: Smooth or threaded metallic bone fixation fastener
Regulatory Class: Class II (physical device)
Product Code: MBI (physical device)
Predicate Device: Arthrex Corkscrew FT (K061665) - also a physical device.

The "Nonclinical Testing" section states:
"The device performance was characterized through the following tests:

Static and Dynamic Performance
Suture Knot Strength"

These are mechanical tests, not performance studies for a diagnostic AI.

To answer your request about acceptance criteria and a study for an AI/SaMD, I would need a document that describes the clinical performance evaluation of an AI or software device, typically involving a test set, ground truth establishment, and statistical analysis of diagnostic metrics. This document does not contain that information.

Summary

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

November 4, 2015

KATOR, LLC Mr. Robert Hov Director of Research 124 South 600 West, Suite 100 Logan, Utah 84321

Re: K152236

Trade/Device Name: KATOR Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: August 7, 2015 Received: August 10, 2015

Dear Mr. Hoy:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known)

K152236

Device Name KATOR Suture Anchor

Indications for Use (Describe)

The KATOR Suture Anchor is intended for fixation of suture to bone in rotator cuff repairs and Achilles tendon repairs.

Type of Use ( Select one or both, as applicable )
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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5. 510(k) Summary

Device Trade Name:	KATOR Suture Anchor
Manufacturer:	KATOR LLC124 South 600 West, Suite 100Logan, UT 84321
Contact:	Mr. Robert HoyDirector of ResearchPhone: (614) 448-6358Fax: (435) 213-4878bob@surgicalfrontiers.com
Prepared by:	Musculoskeletal Clinical Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Phone: (202) 552-5800Fax: (202) 552-5798
Date Prepared:	August 7, 2015
Common Name:	Fastener, Fixation, Soft Tissue
Classification:	21 CFR 888.3040
Class:	II
Product Code:	MBI

Indications for Use:

The KATOR Suture Anchor is intended for fixation of suture to bone in rotator cuff repairs and Achilles tendon repairs.

Device Description:

The KATOR Suture Anchor is a device which is preloaded with suture and is designed to attach soft tissues to bone.

Predicate Device:

The Arthrex Corkscrew FT (K061665) serves as the predicate device.

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Technological Characteristics Comparison:

The KATOR Suture Anchor and its predicate device are similar in size and shape. Both devices are generally cylindrical and have features on their outer diameter for engaging bone tunnel walls via an interference fit. In addition, both devices are designed to be deployed in conjunction with suture. The KATOR Suture Anchor and predicate device are both manufactured from polyetheretherketone (PEEK). There are no substantial differences in technological characteristics between the two devices and as such the KATOR Suture Anchor introduces no new issues of safety or effectiveness.

Nonclinical Testing:

All necessary testing has been performed for the worst-case KATOR Suture Anchor to assure substantial equivalence to the predicate device and demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. Clinical data were not needed to support the safety and effectiveness of the subject device.

The device performance was characterized through the following tests:

Static and Dynamic Performance ●
o Suture Knot Strength

Conclusion:

The KATOR Suture Anchor is substantially equivalent to the Arthrex Corkscrew FT (K061665) with respect to its indications for use, design, and function. Side-by-side performance testing demonstrates the substantial equivalence of the KATOR Suture Anchor to the Corkscrew FT.

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.