The AperFix® Femoral Implant with Inserter is intended for use in tenodesis procedures with soft tissue grafts, utilizing cither 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

The Cayenne Medical AperFix® Femoral Implant with Inserter is a non-absorbable internal fixation device intended to provide tendon to bone fixation in arthroscopic or open procedures such as Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Collateral Ligament (MCL), Lateral Collatcral Ligament (LCL), and Medial Patellofemoral Ligament (MPFL) reconstruction. It includes a body, wedge, two deployable arms, and compression pads. AperFix Femoral Implants are available in diameters of 9, 10 and 11 mm with two different lengths of 29 mm and 35 mm. Each device is intended for single use and is pre-loaded on a sterile inserter.

AI/ML Overview

The AperFix® Femoral Implant with Inserter is a medical device and the provided text describes its 510(k) summary for FDA approval. For medical devices, "acceptance criteria" and "device performance" are typically related to regulatory requirements for safety and effectiveness, often demonstrated through bench testing and comparison to predicate devices, rather than clinical study metrics like sensitivity or specificity.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Material Properties/Design: Substantial equivalence in design principles to predicate devices.	The device is found substantially equivalent in indications and design principles to predicate devices.
Sterilization: Device must be sterile.	Sterilization is accomplished by means of Co gamma irradiation at a dose of 25-40 kGy.
Mechanical Strength: Adequate pull-out strength for its intended use in tenodesis procedures.	Mechanical testing was performed on the AperFix Femoral Implant. It was shown that pull-out strength is significantly higher than that of a predicate device.
Intended Use Compatibility: Suitable for use in tenodesis procedures with soft tissue grafts for ACL, PCL, MCL, LCL, and MPFL reconstruction.	The device is intended for use in the specified tenodesis procedures.
Biocompatibility: (Implied by equivalence to predicate devices, though not explicitly stated as a test in the excerpt).	The device is found substantially equivalent to predicate devices, implying similar biocompatibility if the predicates are biocompatible.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify a sample size for a "test set" in the context of clinical trials or performance studies involving human subjects for device performance metrics like sensitivity/specificity. The performance data mentioned relates to mechanical testing.

Sample Size for Mechanical Testing: Not explicitly stated. The text only says "Mechanical testing was performed."
Data Provenance: The mechanical testing was conducted as part of the regulatory submission by Cayenne Medical, Inc. The exact location or nature (e.g., in-house lab, third-party lab) is not specified, but it would be considered retrospective in the context of generating data for a premarket submission. No country of origin for patients or images is relevant here as it's mechanical testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the provided text describes a medical device (an implant), not an AI/imaging algorithm requiring expert interpretation of a "test set" for ground truth establishment. The "ground truth" for this device's performance would be the direct measurements from mechanical tests.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human experts in diagnostic tasks, which is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This information is not applicable. An MRMC study compares the performance of human readers, typically in diagnostic imaging, with and without the assistance of an AI tool. The AperFix® Femoral Implant is a physical implant, not a diagnostic AI tool, so this type of study would not be performed for its approval.

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

This information is not applicable. This question refers to the performance of an algorithm in isolation, which is relevant for AI-powered diagnostic tools. The AperFix® Femoral Implant is a physical device that functions in-vivo as an implant.

7. The Type of Ground Truth Used

For the AperFix® Femoral Implant, the "ground truth" for its performance is established through:

Direct Mechanical Measurement: For attributes like pull-out strength.
Material Science Principles: For the properties of the implant materials.
Biological Equivalence: Implied by substantial equivalence to predicate devices which have established biocompatibility and clinical safety.

8. The Sample Size for the Training Set

This information is not applicable. "Training set" refers to data used to train an AI model. The AperFix® Femoral Implant is a physical medical device, not an AI model, and therefore does not have a "training set."

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reason as point 8.

Summary

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K083612 (pg. 1

510(k) Summary

AperFix® Femoral Implant with Inserter

510(k) Summary

Cayenne Medical, Inc. AperFix Femoral Implant with Inserter

ADMINISTRATIVE INFORMATION

Manufacturer Name:

Cayenne Medical, Inc. 16597 N. 92nd St., Suite 101 Scottsdale, AZ 85260 Telephone (480) 520-3661 FAX (480) 520-3670

Official Contact:

Kereshmeh Shahriari

DEVICE NAME

Classification Names:

Trade/Proprietary Name:

Screw, fixation, bone

AperFix® Femoral Implant with Inserter

Common Name:

Bone screw

DEVICE CLASSIFICATION

FDA has classified bone screws as Class II devices (21 CFR 888.3040). The product code for screw, fixation, bone is HWC. These devices are reviewed by the Orthopedic Joint Devices Branch

INTENDED USE

The AperFix® 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.

Revised Page 17 of 316

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510(k) Summary

AperFix® Femoral Implant with Inserter

DEVICE DESCRIPTION

The AperFix Femoral Implant with Inserter will be supplied sterile. Sterilization is accomplished by means of Co gamma irradiation at a dose of 25-40 kGy.

Mechanical testing was performed on the AperFix Femoral Implant. It was shown that pull-out strength is significantly higher than that of a predicate device.

EQUIVALENCE TO MARKETED PRODUCT

Cayenne Medical, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the AperFix Femoral Implant with Inserter is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices.

Page 18 of 316

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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 stylized eagle with three wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle. The eagle is black, and the text is also black.

Public Health Service

MAR - 4 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cayenne Medical, Inc. % Ms. Kereshmeh Shahriari 16597 N. 92md St. Suite 101 Scottsdale, Arizona 85260

Re: K083612

Trade/Device Name: AperFix® Femoral Implant with Inserter Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: December 3, 2008 Received: December 5, 2008

Dear Ms. Shahriari:

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. Ilsting 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. Kereshmeh Shahriari

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 yours,

Mark H. Milburn

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

510(k) Number (if known):

Device Name: AperFix® Femoral Implant with Inserter

Indications for Use:

The AperFix Femoral Implant with Inserter is intended for use in tenodesis procedures with soft tissue grafts, utilizing cither 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)

Over-The-Counter Use AND/OR (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)

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
Revised Page 15 of 316
510(k) Number/14083617

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.