The AFX® 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

The AFX Femoral Implant with Inserter is a non-absorbable internal fixation device used in arthroscopic or open cruciate ligament reconstruction to anchor tendon grafts (such as the hamstring tendon) within a surgically created femoral tunnel to enable tissue ingrowth with the resultant formation of a permanent bony attachment.

AI/ML Overview

The provided texts describe a medical device, the AFX Femoral Implant with Inserter, and its clearance process with the FDA. However, the document does NOT contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in the way typically associated with diagnostic algorithms or AI models.

This document is a 510(k) summary for a device modification, not a new diagnostic device. The substantial equivalence is demonstrated through non-clinical testing (mechanical, biocompatibility, sterilization, pyrogenicity, and shelf-life) compared to a predicate device, and not through clinical performance metrics against a predefined acceptance criterion.

Therefore, many of the requested items (e.g., sample sizes for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance) are not applicable or not present in this document because the device is a medical implant, not a diagnostic tool requiring such evaluations.

Here’s a breakdown based on the information available in the document:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria for clinical performance that would typically be seen for a diagnostic device. Instead, it relies on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Acceptance Criteria (Implied from Non-Clinical Testing)	Reported Device Performance
Mechanical Testing:
- Meet predetermined specifications	Met specifications
- Ultimate pull-out strength comparable to predicate	Was comparable to predicate
Biocompatibility:
- Substantial equivalence to predicate	Demonstrated
Sterilization:
- Substantial equivalence to predicate	Demonstrated
Pyrogenicity:
- Substantial equivalence to predicate	Demonstrated
Shelf-Life:
- Substantial equivalence to predicate	Demonstrated

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable, as this is a medical implant cleared via non-clinical testing for a device modification, not a diagnostic algorithm with a clinical test set. The document refers to "testing" which is mechanical and other non-clinical evaluations, not human-patient-based test sets.

3. 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. Ground truth for diagnostic performance is not relevant for this type of device clearance which relies on non-clinical engineering and materials testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

5. 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 not a diagnostic device or an AI-assisted tool.

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

Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is based on engineering and material standards, and benchmarked against the predicate device's established performance in non-clinical tests (e.g., mechanical strength, biocompatibility).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device.

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

Not applicable.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The document describes Non-Clinical Testing conducted to demonstrate that the modified AFX® Femoral Implant with Inserter is substantially equivalent to its predicate device (AFX® Femoral Implant with Inserter, K161033).

Type of Study: Non-clinical (bench testing) and other non-human evaluations (biocompatibility, sterilization, pyrogenicity, shelf-life).
Purpose: To demonstrate that revisions to the implant (combining wedge and deployment screw, rounding the screw top, increasing length) and the inserter (adding red indicator, locking mechanism) do not raise new questions of safety or efficacy and that the modified device performs comparably to the predicate.
Methods:
- Mechanical Testing: Included cyclic and pull-out tests on the subject device. The results were assessed against "predetermined specifications" and compared to the "ultimate pull-out strength" of the predicate device.
- Biocompatibility: Evaluated for substantial equivalence to the predicate device.
- Sterilization: Evaluated for substantial equivalence to the predicate device.
- Pyrogenicity: Evaluated for substantial equivalence to the predicate device.
- Shelf-Life: Evaluated for substantial equivalence to the predicate device.
Results: The non-clinical testing demonstrated that the functionality and safety of the subject AFX femoral implant are adequate for its intended use. Mechanical testing met predetermined specifications, and ultimate pull-out strength was comparable to the predicate device. Biocompatibility, sterilization, pyrogenicity, and shelf-life also demonstrated substantial equivalence.
Conclusion: The testing concluded that the modified device is substantially equivalent to the predicate device, given "Any differences in the technological characteristics between the subject and predicate device do not raise new issues of safety or efficacy."

Clinical Testing: The document explicitly states: "Clinical testing was not used to establish substantial equivalence to predicate device." This means no human subject studies were conducted or relied upon for this specific 510(k) clearance.

Summary

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Cayenne Medical Shima Hashemian QA/RA Associate Director 16597 N 92nd Street Scottsdale, Arizona 85260

Re: K192428

Trade/Device Name: AFX® Femoral Implant with Inserter Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: September 3, 2019 Received: September 5, 2019

Dear Ms. Hashemian:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laurence D. Coyne, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Device Name:

AFX® Femoral Implant with Inserter

Indications for Use:

The AFX 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 801 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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51 0(k) Number: K 192428 Date received: September 5, 2019 Special 510(k): Device Modification

510(k) Summary

Cayenne Medical, Inc. Special 510(k): Device Modification

AFX® Femoral Implant with Inserter

ADMINISTRATIVE INFORMATION

Date of summary:

Manufacturer Name:	Cayenne Medical, Inc. 16597 N. 92nd St., Suite 101 Scottsdale, AZ 85260 Telephone +1 (480) 502-3661 Fax +1 (480) 502-3670
Official Contact:	Shima Hashemian 16597 N. 92nd St., Suite 101 Scottsdale, AZ 85260 shashemian@cayennemedical.com Telephone (480) 458-2196 FAX (480) 502-3670

Device Name

Classification Name:	Smooth or threaded metallic bone fixation fastener
Trade/Proprietary Name:	AFX® Femoral Implant with Inserter
Common Name:	Bone screw
Predicate device:	AFX® Femoral Implant with Inserter (K161033)

Device Classification

FDA has classified bone fixation fasteners as Class II devices (21 CFR 888.3040). The product code for Fastener, Fixation, Nondegradable, and Soft Tissue is MBI. These devices are reviewed by Orthopedic Joint Devices Branch.

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INTENDED USE

DEVICE DESCRIPTION AND COMPARISON WITH PREDICATE DEVICE

The predicate device implant, AFX Femoral Implant with Inserter, was changed to combine two components, wedge and deployment screw, while rounding the top of the deployment screw to allow for easier insertion into the bone. The integration of the wedge with the deployment screw reduces the total number of components in the subject implant. The overall length of the subject implant has also been increased from 24mm to 25mm due to rounding the top of the deployment screw.

The predicate device inserter was also modified to add a red indicator section to clearly indicate when the device is in drive mode and a locking mechanism as a safety feature to prevent the device from being deployed while in load mode. The mechanism within the implant that deploys the implant in both subject and predicate devices is identical.

NON-CLINICAL TESTING

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence is included. The results of performance testing and mechanical testing demonstrated that functionality and safety of the subject AFX femoral implant are adequate for its intended use and determination of substantial equivalence to the predicate device. Mechanical testing, cyclic and pull-out, were performed on the subject device and the test results met the predetermined specifications. Testing also showed that the AFX femoral implant ultimate pull-out strength was comparable to that of the predicate device. The results of assessment of biocompatibility, sterilization, pyrogenicity, and shelf-life also demonstrated substantial equivalence to the predicate device.

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CLINICAL TESTING

Clinical testing was not used to establish substantial equivalence to predicate device.

EQUIVALENCE TO MARKETED PRODUCT

The modified AFX Femoral Implant with Inserter device has the following similarities to the unmodified predicate device:

· has the same intended use,
· uses the same operating principle,
· incorporates the same basic design,
· incorporates the same polymeric materials, and
· is packaged using the same materials and processes.

In summary, the AFX Femoral Implant with Inserter described in this submission is, in our opinion, substantially equivalent to the predicate device. The data included in this submission demonstrates substantial equivalence to the predicate device listed above. Any differences in the technological characteristics between the subject and predicate device do not raise new issues of safety or efficacy.

Regulation Number and Section

N/A