The KFx APPIANFx PEEK Femoral Implant with Inserter is intended for use in tenodesis procedures with soft tissue grafts. utilizing either arthroscopic or open techniques during Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), and Medial Patellofemoral Ligament (MPFL) reconstruction.

Device Description

KFx APPIANFx PEEK Femoral Implant with Inserter consists of a two body anchor fixation device comprised of a body with deployable arms and a wedge and a disposable suture loop preloaded in a delivery (insertion) handle. Technologically it is similar in design, materials and mode of operation to the KFx PEEK Bone Anchor with Pre-Attached Sutures and Delivery Handle.

AI/ML Overview

The provided 510(k) summary describes a medical device, the KFx APPIANFx PEEK Femoral Implant with Inserter, and its substantial equivalence to a predicate device. This type of submission generally relies on non-clinical performance testing rather than clinical studies involving patient data and ground truth established by experts.

Therefore, many of the requested categories related to clinical study design, expert evaluation, and ground truth are not applicable in this context.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Reported Device Performance (from text)
Biocompatibility	The materials used are biocompatible and identical to the materials used in the predicate device. The same materials are used in a myriad of legally marketed orthopedic devices.
Functional Performance	Non-clinical test data, which includes cycle testing and pullout strength, 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.
Sterility	Devices are provided "STERILE"; sterilization is by Ethylene Oxide (EO) gas and provides a sterility assurance level of 10-6.
Substantial Equivalence	Concluded to be substantially equivalent to the currently marketed predicate device (KFx PEEK Bone Anchor with Pre-Attached Sutures and Delivery Handle) based on similar design, materials, and mode of operation.
Intended Use	Intended for use in tenodesis procedures with soft tissue grafts, utilizing either arthroscopic or open techniques during ACL, PCL, MCL, LCL, and MPFL reconstruction. Performance data supports safe and effective use as indicated.
Device Dimensions	Available in 8 and 9 mm diameters and are 27 mm long pre-deployment. (This is a specification rather than a performance criterion, but it's a key physical characteristic that would be tested).
Single Use	Each device is intended for single use. (An acceptance criterion would involve verifying it's designed for and performs as a single-use device).
Pre-loaded	Device is pre-loaded on a sterile inserter. (An acceptance criterion would verify proper pre-loading).

Study Details

Sample size used for the test set and the data provenance:
- The document mentions "non-clinical test data, which includes cycle testing and pullout strength." It does not specify the sample size for these engineering tests.
- Data provenance is not applicable as this refers to non-clinical laboratory testing, not human-derived data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission relies on engineering testing and comparison to a predicate device, not clinical ground truth established by medical experts for patient data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This applies to expert review of clinical data, which was not part of this submission.
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 (implant) and not an AI/imaging diagnostic device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a medical device (implant) and not an AI/imaging diagnostic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" for this device's performance is established through engineering specifications and non-clinical mechanical testing results (e.g., strength measurements meeting defined thresholds, sterility levels, material composition verification), and comparison to the predicate device's known performance.
The sample size for the training set:
- Not applicable. This refers to non-clinical engineering tests, not machine learning model training.
How the ground truth for the training set was established:
- Not applicable. This refers to non-clinical engineering tests, not machine learning model training.

Summary

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MAY 2 0 2010

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

KIDI JEZ (1/2)

APPLICANT INFORMATION

A.	Company Name:	KFx Medical, Corporation
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 HirotaOA/RA

DEVICE IDENTIFICATION

A.	Trade Name:	KFx APPIANFx PEEK Femoral Implant withInserter
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
	DATE SUMMARY PREPARED	April 25, 2010

IDENTIFICATION OF MODIFIED DEVICE

The KFx APPIANFx PEEK Femoral Implant with Inserter is substantially equivalent to the KFx PEEK Bone Anchor with Pre-Attached Sutures and Delivery Handle.

DEVICE DESCRIPTION

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APPIANFx PEEK Femoral Implants are available in 8 and 9 mm diameters and are 27 mm long pre-deployment. Each device is intended for single use and is pre-loaded on a sterile inserter. The device may be used in both arthroscopic and open procedures.

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

INTENDED USE

The KFx APPIANFx PEEK Femoral Implant with Inserter is intended for use in tenodesis procedures with soft tissue grafts, utilizing either arthroscopic or open techniques during Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), and Medial Patellofemoral Ligament (MPFL) reconstruction.

BIOCOMPATIBILITY AND PERFORMANCE DATA

The materials used in the KFx APPIANFx PEEK Femoral Implant with Inserter are biocompatible and identical to the materials used in the predicate device. The same materials are used in a myriad of legally marketed orthopedic devices.

Non-clinical test data, which includes cycle testing and pullout strength, 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 documentation provided demonstrates that the KFx APPIANFx PEEK Femoral Implant with Inserter is substantially equivalent to the currently marketed predicate device and is safe and effective when used as indicated.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, composed of three curved lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The logo is simple, clean, and easily recognizable.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

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

MAY 2 0 2010

Re: K101175

Trade/Device Name: KFx APPIANFx PEEK Femoral Implant with Inserter Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: April 25, 2010 Received: April 27, 2010

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 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 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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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,

C. Fintan Bucchino

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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SECTION 1.6 Indications for Use.

510(k) Number (if known): 《 | 0 | | 7-5

Device Name: KFx APPIANFx PEEK Femoral Implant with Inserter

Indications For Use: The KFx APPIANFx PEEK Femoral Implant with Inserter is intended for use in tenodesis procedures with soft tissue grafts. utilizing either arthroscopic or open techniques during Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), and Medial Patellofemoral Ligament (MPFL) reconstruction.

Prescription Use X (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)

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(D)vision Sign Aco

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

510(k) Number K101175

Page 1 of 1

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.