The intended use of the KFx Suture Lock Tissue Fixation System is for the fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow. Specifically:
Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tenodesis, deltoid repairs.
Foot and Ankle: Hallux valgus repairs, medial or lateral instability repairs/reconstructions, Achilles repairs/reconstructions, mid-foot reconstructions, metatarsal ligament repair.
Knee: Medial collateral ligament repairs, lateral ligament repairs, posterior oblique ligament repairs, lliotibial band tenodesis, patellar tendon repairs.
Hand, Wrist and Elbow: Scapholunate ligament reconstructions, ulnar or radial collateral ligament reconstructions, tennis elbow repair, biceps tendon reattachment.

Device Description

The KFx Tissue Fixation System consists of a Nail Bone Anchor with two suture leads pre-loaded in a single use insertion handle and a Bone Screw Anchor (also pre-loaded in a single use delivery handle) used to capture the sutures, eliminating the need to tie suture knots. The KFx Tissue Fixation System also includes re-usable surgical instruments for the implantation of the Nail Bone and Bone Screw Anchors.
Devices are provided "STERILE"; sterilization is by Ethylene Oxide (EO) gas and provides a sterility assurance level of 10-6.

AI/ML Overview

The provided text describes the KFx Suture Lock Nail Bone Anchor, a medical device for tissue fixation. It refers to "Bench test results" that "indicate that the device is safe and satisfies functional performance requirements" and concludes that the device is "substantially equivalent" to a previously cleared predicate device.

However, the document does not provide specific acceptance criteria or detailed results of a study in a tabular format as requested. It states that the device is substantially equivalent to a previously cleared device (K072063). The "Biocompatibility and Performance Data" section provides a high-level summary of the study findings, but lacks the granular details needed to fill out all the requested information about a specific study proving it meets acceptance criteria.

Therefore, much of the requested information cannot be extracted directly from the provided text.

Here is what can be inferred or stated based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Specific criteria not explicitly stated in the document.	"Bench test results indicate that the device is safe and satisfies functional performance requirements when used as indicated and do not raise new issues of safety or effectiveness."
Substantial equivalence to predicate device (K072063) in design, technology, construction, and mechanical performance.	"The test results demonstrate that the modified KFx Suture Lock Nail Bone Anchor is substantially equivalent to the currently marketed predicate device."
Biocompatibility	"The materials used in the KFx Suture Lock Nail Bone Anchor are biocompatible. The same materials are used in a myriad of legally marketed orthopedic devices."

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample size: Not specified.
- Data provenance: Not specified (bench tests are typically conducted in a controlled lab environment, not on human data in the context of this device). The document refers to "bench test results."
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):
- Not applicable as this is a mechanical device evaluated through bench testing, not image analysis or clinical expert review.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable; this would typically be relevant for studies involving human interpretation or clinical endpoints.
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 MRMC study was done, as this is a mechanical bone anchor device, not an AI or imaging diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable; this is a physical medical device, not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" (or basis for evaluation) appears to be derived from established engineering and biocompatibility standards for medical devices and comparison to a predicate device. For mechanical performance, this would involve quantitative measurements against specified thresholds, but these thresholds are not provided.
The sample size for the training set:
- Not applicable, as this is not a machine learning model.
How the ground truth for the training set was established:
- Not applicable, as this is not a machine learning model.

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

JUL - 3 2008

APPLICANT INFORMATION		K081598 (pg 1/2)
A.	Company Name:	KFx Medical, Inc
B.	Company Address:	5845 Avenida EncinasSuite 128Carlsbad, CA 92008
C.	Company Phone:	(760) 444-8844
D.	Company Facsimile:	(760) 602-9252
E.	Contact Person:	Gayle HirotaQA/RA

DEVICE IDENTIFICATION

A.	Trade Name:	KFx Suture Lock Nail Bone Anchor
B.	Common Name:	Bone Anchor
C.	Classification Name:	Fastener, Fixation, Nondegradable, Soft Tissue
D.	Product Code:	MBI
E.	Device Panel:	Orthopedic
F.	Device Class:	Class II

IDENTIFICATION OF MODIFIED DEVICE

The KFx Suture Lock Nail Bone Anchor is similar in basic design and intended use to the KFx Medical Suture Lock Nail Bone Anchor component of the KFx Tissue Fixation System, cleared under 510(k) K072063.

DEVICE DESCRIPTION

Devices are provided "STERILE"; sterilization is by Ethylene Oxide (EO) gas and provides a sterility assurance level of 10-6.

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KOBIS988pg 212)

INTENDED USE

The intended use of the KFx Suture Lock Tissue Fixation System is for the fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow.

Specifically:

Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tenodesis, deltoid repairs.

Foot and Ankle: Hallux valgus repairs, medial or lateral instability repairs/reconstructions, Achilles repairs/reconstructions, mid-foot reconstructions, metatarsal ligament repair.

Knee: Medial collateral ligament repairs, lateral ligament repairs, posterior oblique ligament repairs, lliotibial band tenodesis, patellar tendon repairs.

Hand, Wrist and Elbow: Scapholunate ligament reconstructions, ulnar or radial collateral ligament reconstructions, tennis elbow repair, biceps tendon reattachment.

EQUIVALENT DEVICE

The KFx Suture Lock Nail Bone Anchor is similar in basic design, technology, construction and mechanical performance to the Suture Lock Nail Bone Anchor included in the KFx Tissue Fixation System previously cleared under 510(k) K072063. Intended use is identical. Device modification includes use of an additional biocompatible material.

BIOCOMPATIBILITY AND PERFORMANCE DATA

The materials used in the KFx Suture Lock Nail Bone Anchor are biocompatible. The same materials are used in a myriad of legally marketed orthopedic devices.

Bench test results indicate that the device is safe and satisfies functional performance requirements when used as indicated and do not raise new issues of safety or effectiveness.

CONCLUSIONS DRAWN FROM STUDIES

The test results demonstrate that the modified KFx Suture Lock Nail Bone Anchor is substantially equivalent to the currently marketed predicate device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its wing, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

KFx Medical % Ms. Gayle Hirota 5845 Avenida Encinas , Suite 128 Carlsbad, CA 92008

JUL - 8 2008

Re: K081598

Trade/Device Name: KFx Suture Lock Nail Bone Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: June 5, 2008 Received: June 6, 2008

Dear Ms. Hirota:

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. Gayle Hirota

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Mark M Millman

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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Indications for Use SECTION 1.6

510(k) Number (if known):

KFx Suture Lock Nail Bone Anchor (component of the KFx Tissue Device Name: Fixation System and Accessories)

The KFx Tissue Fixation System (comprised of the KFx Suture Indications For Use: Lock Bone Screw Anchor and KFx Suture Lock Nail Bone Anchor) and Accessories are intended for the fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow. Specifically:
Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromioclavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tenodesis, deltoid repairs

Foot and Ankle: Hallux valgus repairs, medial or lateral instability repairs/reconstructions, Achilles repairs/reconstructions, mid-foot reconstructions, metatarsal ligament repair.

Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, lliotibial band tenodesis, patellar tendon repair.

Hand/Wrist/Elbow: Scapholunate ligament reconstructions, ulnar or radial collateral ligament reconstructions, tennis elbow repair, biceps tendon reattachment.

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH. Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorativest and Neurological Devices

510(k) Number

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.