The AperFix™ Interference Screw is intended for use with bone-patellar tendon-bone (BPTB) grafts to provide fixation during arthroscopic or open ACL reconstruction procedures.

Device Description

The Cayenne Medical AperFix™ Interference Screw is intended for the bone-patellar tendonbone (BPTB) reconstruction of the anterior cruciate ligament (ACL). During an ACL reconstruction procedure, BPTB grafts are fixed to the femur and tibia utilizing the AperFix™ Interference Screw. BPTB grafts are typically harvested from the patient's ipsilateral leg, but cadaveric grafts are also acceptable. The AperFix™ Interference Screw is packaged STERILE. The AperFix™ Interference Screw provides interference fixation of the BPTB graft within the femoral and tibial tunnels.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the AperFix Interference Screw. It describes the device, its intended use, and its equivalence to marketed products. However, it does not contain information regarding studies to prove the device meets specific acceptance criteria in the format requested, particularly for an AI/ML device.

The document states: "Mechanical testing was performed on the AperFix Interference Screw. It was shown that pullout strength is significantly higher than that of a predicate interference screw." This is the extent of performance data provided.

Therefore, many of the requested fields cannot be populated from the provided text.

Here's a response based on the available information:

Based on the provided 510(k) Premarket Notification for the AperFix™ Interference Screw, the following information regarding acceptance criteria and performance studies can be extracted or deduced:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Mechanical pullout strength	Significantly higher pullout strength than a predicate interference screw.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in the provided text.
Data Provenance: Not specified, but generally, mechanical testing for such devices is conducted in a laboratory setting. This is a physical device, not an AI/ML system, so concepts like "country of origin of data" in the AI/ML context are not directly applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a mechanical implant, not an AI/ML diagnostic or predictive tool that requires expert-established ground truth from medical images or clinical data.

4. Adjudication method for the test set

Not applicable. This device is a mechanical implant. The "adjudication method" concept is typically relevant to subjective expert reviews for AI/ML performance.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. This type of study (MRMC for human readers with/without AI assistance) is specific to AI/ML diagnostic or screening devices and is not relevant for a mechanical implant.

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

Not applicable. The AperFix™ Interference Screw is a physical medical device (an implant), not an algorithm or software requiring standalone performance evaluation in the context of AI/ML.

7. The type of ground truth used

For mechanical testing, the "ground truth" would be the direct physical measurements of the device's properties (e.g., force required for pullout). There is no "expert consensus, pathology, or outcomes data" ground truth in the AI/ML sense.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML model that undergoes "training."

9. How the ground truth for the training set was established

Not applicable. As this is not an AI/ML model, there is no "training set" or establishment of ground truth for such a set.

Summary

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510(k) Premarket Notification

K073426 (pg 1 of 2)
AperFix

perFix™ Interference Screw

510(k) Summary

Cayenne Medical, Inc. AperFix Interference Screw

ADMINISTRATIVE INFORMATION

Manufacturer Name: Cayenne Medical, Inc. 16597 N. 92nd St., Suite 101 Scottsdale, AZ 85260 Telephone (480) 502-3661 FAX (480) 502-3670 Kereshmeh Shahriari Official Contact: 16597 N. 92nd St., Suite 101 Scottsdale, A7. 85260 kshahriari@cayennemedical.com Telephone (480) 502-3661 FAX (480) 502-3670

DEVICE NAME

Classification Names:	Screw, fixation, bone
Trade/Proprietary Name:	AperFix™ Interference Screw
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.

FEB 19 2008

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INTENDED USE

The AperFix™ Interference Screw is intended for use with bone-patellar tendon-bone (BPTB) grafts to provide fixation during arthroscopic or open ACL reconstruction procedures.

DEVICE DESCRIPTION

The AperFix Interference Screw will be supplied sterilization will be accomplished by means of Co60 gamma irradiation at a dose of 25-40 kGy.

Mechanical testing was performed on the AperFix Interference Screw. It was shown that pullout strength is significantly higher than that of a predicate interference screw.

EQUIVALENCE TO MARKETED PRODUCT

Cavenne Medical, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the AperFix™ Interference Screw is substantially equivalent in indications and design principles to predicate devices, cach of which has been determined by FDA to be substantially equivalent to preamendment devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

FEB 19 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cayenne Medical, Incorporated % Ms. Kereshmeh Shahriari Directory of Quality Assurance & Regulatory Affairs 16597 North 92nd Street, Suite 101 Scottsdale, Arizona 85260

Re: K073426 Trade/Device Name: AperFix 1M Interference Screw

Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: December 4, 2007 Received: December 5, 2007

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, 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

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Page 2 - Ms. Kereshmeh Shahriari

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. 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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

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

510(k) Number (if known): _ |4073426

Device Name: AperFix™ Interference Screw

Indications for Use:

The AperFix™ Interference Screw is intended for use with bone patellar tendon bone (BPTB) grafts to provide fixation during arthroscopic or open ACL reconstruction procedures.

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)

Mark A. Millkum

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

510(k) Number

Revised Page 15 of 186

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.