The provided documents do not detail specific quantitative acceptance criteria or a dedicated study proving the device meets those criteria in a typical AI/software-as-a-medical-device (SaMD) context. Instead, this 510(k) submission focuses on demonstrating substantial equivalence to predicate devices, which is a common regulatory pathway for many medical devices that are not SaMDs.

Therefore, many of the requested points related to AI performance, ground truth, expert adjudication, and sample sizes for training/test sets are not applicable to this submission.

Here's a breakdown based on the information available:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Safety	Met specifications, does not raise new issues of safety. Materials are biocompatible, identical to predicate devices and commonly used in similar medical devices.
Effectiveness	Met specifications, does not raise new issues of effectiveness. Intended use, design, and technology characteristics are substantially equivalent to existing FDA-cleared suturing devices.
Biocompatibility	Materials are biocompatible, identical to those in identified predicates and commonly used in similar medical devices.

Study Proving Acceptance Criteria:
The study that proves the device meets the acceptance criteria is described as "physical bench testing." The results of this testing were used to demonstrate that the KFx Knotless Fixation System meets its specifications and does not raise new issues of safety or effectiveness.

Detailed Information (as applicable)

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. "Physical bench testing" does not typically refer to patient data or a test set in the same way an AI model would have one. It refers to a series of mechanical or functional tests on the device itself.
- Data Provenance: Not applicable in the context of patient data. The tests were performed on the device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a physical device, not an AI/SaMD. "Ground truth" in this context would likely refer to engineering specifications or industry standards against which the bench tests were measured, not expert-labeled data.
Adjudication method for the test set:
- Not applicable.
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. This is a physical medical device, not an AI system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not an AI algorithm.
The type of ground truth used:
- For the physical tests, the "ground truth" would be the pre-defined engineering specifications and performance standards for bone anchors and fixation systems (e.g., tensile strength, fixation strength, design tolerances). The document only broadly states the device "meets its specifications."
The sample size for the training set:
- Not applicable. This is a physical device, not an AI model requiring a training set.
How the ground truth for the training set was established:
- Not applicable. This is a physical device.

Summary from the provided documents:

The KFx Knotless Fixation System gained clearance based on a 510(k) pathway, which relies on demonstrating substantial equivalence to already legally marketed predicate devices. The primary evidence presented for safety and effectiveness is:

Physical bench testing to show the device "meets its specifications" and prevents new safety/effectiveness concerns.
Biocompatibility assessment by confirming the use of materials identical to those in predicate devices and commonly used in similar medical devices.
Comparison of intended use, design, and technology to predicate devices.

The document does not contain the type of detailed statistical study, expert consensus, or performance metrics that would be relevant for an AI/SaMD device's acceptance criteria and validation.

Summary

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KFx Knotless Fixation System

K061294 (pg. 1 of 2)
510(k) Notification

510(k) Summary

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. Date Prepared: September x, 2005

510(k) number:

JUL 1 9 2006

Applicant Information:

KFx Medical 5145 Avenida Encinas Suite C Carlsbad, CA 92008

Contact Person

Malcolm Heaven Phone Number: (619) 270-8475 Fax Number: (760) 602 9252

Device Information:

Trade Name:	KFx Knotless Fixation System and Targeting Grasper
Classification:	Class II
Classification Name:	Bone Anchor; Grasper

Physical Description:

The KFx Knotless Fixation System consists of

. KFx Nail Bone Anchor with two suture leads, mounted to a single use handle
KFx Suture Lock Bone Screw Anchor mounted to a single use handle .
Optional KFx Targeting Grasper. .

Intended Use:

The KFx Knotless Fixation System is intended for the fixation of soft tissue to bone during rotator cuff repair.

Equivalent Device:

The KFx Knotless Fixation System is substantially equivalent to existing suturing devices cleared by the Food and Drug Administration. The Linvatec Super Revo Herculine Suture Anchor (K041713), the Opus Medical Magnum Anchor with Inserter (K041440, K042914), and the Arthrex FASTak Suture Anchor (K960516) devices are examples of substantially equivalent devices with the same intended use, design and technology characteristics requested by KFx Medical. Inc. The intended use of the KFx Knotless Fixation System is substantially equivalent to the intended use of the suturing devices listed above.

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Test Results:

Performance

Results of physical bench testing demonstrate that the KFx Knotless Fixation System meets its specifications and does not raise new issues of safety or effectiveness.

8061294

Biocompatibility

The materials used in the KFx Knotless Fixation System are biocompatible. The same materials are used in the identified predicates and are also commonly used in similar medical devices.

Summary:

Based on the intended use, product, performance and biocompatibility information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 9 2006

KFx Medical c/o Ms. Beth Bierman Morgan Lewis 1111 Pennsylvania Ave., NW Washington, DC 20004

Re: K061294

Trade/Device Name: KFx Knotless Fixation System and Targeting Grasper Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: May 8, 2006 Received: May 9, 2006

Dear Ms. Bierman:

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.

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Page 2 - Ms. Beth Bierman

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to begin maining of substantial equivalence of your device to a legally promatics motificated. 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 If you dosire of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Aubrey Buettner

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

Enclosure

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KFx Knotless Fixation System

Indications for Use

510(k) Number (if known): _ ҚО61294

Device Name: KFx Knotless Fixation System, Optional KFx Targeting Grasper

Indications for Use:

The KFx Knotless Fixation System and Accessory Targeting Grasper are intended for the fixation of soft tissue to bone during rotator cuff repair.

ﮯ Prescription Use (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)
Division Sign-Off

Division of General, Restorative, and Neurological Devices

Page of of

510(k) Number K061294

KFx Medical

CONFIDENTIAL

Page 10

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.