The AperFix® Tibial 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

The Cayenne Medical AperFix® Tibial Implant with Inserter is a non-absorbable internal fixation device intended to provide tendon to bone fixation in arthroscopic or open procedures during Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), and Medial Patellofemoral Ligament (MPFL) reconstruction. It includes a screw and a twopart screw sheath. AperFix Tibial Implants are available in diameters of 8, 9, 10 and 11 mm with a standard length of 30 mm. Each device is intended for single use and is provided with a sterile inserter.

AI/ML Overview

The provided 510(k) summary for the AperFix® Tibial Implant with Inserter (K083607) focuses on establishing substantial equivalence to predicate devices through mechanical testing. It does not contain information about clinical studies with human participants, expert review, or detailed ground truth establishment as would be typical for AI-based medical devices or diagnostic tools.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics (especially those related to human reader interaction or AI standalone performance) are not applicable or not present in this document.

Here's a breakdown of the available information based on the prompt's categories:

Acceptance Criteria and Reported Device Performance

The document states: "Mechanical testing was performed on the AperFix Tibial Implant. It was shown that pull-out strength is significantly higher than that of a predicate device."

This implies that the acceptance criterion for the mechanical testing was likely a demonstration of superior or at least equivalent (non-inferior) pull-out strength compared to a predicate device. The device "met" this criterion by showing significantly higher strength.

Acceptance Criteria	Reported Device Performance
Demonstration of superior or equivalent pull-out strength compared to a predicate device	Pull-out strength is significantly higher than that of a predicate device.

Study Details (Limitations due to document content)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document only mentions "Mechanical testing was performed" but does not specify the number of samples tested or the origin of any data (as it's mechanical testing, 'country of origin' isn't really applicable in the same way clinical data would be).
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 / Not provided. For mechanical testing, the "ground truth" is typically established by the physical testing methodology itself and validated against engineering standards, not by human expert assessment in the way clinical diagnostic accuracy is.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication methods are relevant for human expert assessments of clinical data, not for mechanical testing of device properties.
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 implant device, not a diagnostic or AI-assisted interpretation product. Therefore, an MRMC study related to human reader performance with AI assistance is not relevant and was not performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not have an algorithm component.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the mechanical testing would be the measured physical properties (pull-out strength) under controlled laboratory conditions, validated against established engineering principles and possibly compared to a predicate device's known performance. It's not based on expert consensus, pathology, or outcomes data.
The sample size for the training set
- Not applicable / Not provided. There is no "training set" as this is not a machine learning or AI-driven device.
How the ground truth for the training set was established
- Not applicable / Not provided. As there's no training set, this question is not relevant.

In summary, the 510(k) provided focuses on demonstrating substantial equivalence through a comparison of a key mechanical property (pull-out strength) with a predicate device. It does not involve AI, clinical studies, or expert review in the manner described by the prompt's more granular questions.

Summary

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510(k) Summary

AperFix® Tibial Implant with Inserter

K083607

510(k) Summary

FEB - 5 2009

Cayenne Medical, Inc. AperFix Tibial 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:

Screw, fixation, bone

Trade/Proprietary Name: AperFix® Tibial 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

Revised Page 17 of 220

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DEVICE DESCRIPTION

The AperFix Tibial Implant with Inserter will be supplied sterile. Sterilization is accomplished by means of Co60 gamma irradiation at a dose of 25-40 kGy.

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

EQUIVALENCE TO MARKETED PRODUCT

Cavenne Medical. Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the AperFix Tibial 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.

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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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black, set against a white background.

Public Health Service

Cayenne Medical, Inc. % Kereshmeh Shahriari 16597 N. 92nd Street, Suite 101 Scottsdale, Arizona 85260

Re: K083607

Trade/Device Name: AperFix® Tibial 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 Kereshmeh 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, 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.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Page 2 - 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 N. Milliman

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): K083607

Device Name: AperFix® Tibial Implant with Inserter

Indications for Use:

The AperFix Tibial 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. Comment (

Prescription Use(Part 21 CFR 801 Subpart D)	X
	AND/OR
Over-The-Counter Use(21 CFR 801 Subpart C)	_________________

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

(Division Sign-Off)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative,
and Neurological Devices

510(k) Number	1083.607
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Revised Page 15 of 220

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.