The Stablyx CMC Arthroplasty Implant System is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis or post fracture deformation or bone loss which present as either painful, unstable thumb or a thumb with limited range of motion. The implant is intended for uncemented, press fit use.

Device Description

The Stablyx CMC Arthroplasty System is a hemi monoblock prosthesis for replacement of the first metacarpal carpometacarpal (CMC) ioint. The single piece prosthesis has a highly polished. saddle shaped (toroidal) articular surface which mirrors the normal anatomy of the base of the first metacarpal. The saddle surface of the Stablyx CMC prosthesis articulates aqainst the saddle surface of the trapezium, allowing for flexion-extension, abduction-adduction and opposition motions. The prosthesis is available in fixe sizes, and is made of Cobalt Chrome (CoCr) with a Titanium Plasma Spray (TPS) coated stem which may assist in biological fixation. The stem is intended to press fit into the medullary canal. Each prosthesis is packaged and provided sterile. The Stablyx CMC Arthroplasty System is comprised of: Multiple sized hemi joint prosthesis System specific instrumentation

AI/ML Overview

The provided text is a Fragment of a 510(k) Pre-market Notification for a medical device called the "Stablyx CMC Arthroplasty Implant System". This document is primarily focused on demonstrating substantial equivalence to a predicate device, as required by the FDA.

Based on the information provided, it is not possible to answer the detailed questions regarding acceptance criteria and a study proving the device meets those criteria. The document states:

"Engineering analysis and testing demonstrated that the Stablyx CMC Arthroplasty System is substantially equivalent to the predicate device currently marketed."
"Characterization testing, including gravimetric testing and analysis established equivalency."
"Therefore, the subject device is as safe and effective as legally marketed predicate devices."

This indicates that comparisons were made to a predicate device (Stablyx CMC Arthroplasty Implant System (K111068)) to establish substantial equivalence. However, the document does not provide:

A table of acceptance criteria with reported device performance.
Details about a sample size used for a test set or data provenance in a clinical study.
Information about experts establishing ground truth.
An adjudication method.
A multi-reader multi-case (MRMC) comparative effectiveness study.
Details of a standalone performance study.
The type of ground truth used.
Sample size for a training set or how its ground truth was established, as these are typically associated with machine learning or AI device development, which is not indicated here.

The "Performance Testing" section vaguely refers to "Engineering analysis and testing" and "Characterization testing, including gravimetric testing and analysis" to establish equivalency. This likely refers to bench testing (e.g., mechanical properties, wear resistance, dimensional analysis) to ensure the new device performs similarly to the predicate device and meets relevant performance standards for orthopedic implants.

In summary, the provided FDA 510(k) document is a regulatory submission focused on substantial equivalence based on engineering and characterization testing, not on clinical study data with acceptance criteria as typically defined for performance studies of AI/ML-driven devices or devices requiring extensive human reader involvement.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Skeletal Dynamics, LLC Ana Escagedo President 8905 SW 87 Avenue, Suite 201 Miami, Florida 33176

Re: K180744

Trade/Device Name: Stablyx CMC Arthroplasty Implant System Regulation Number: 21 CFR 888.3770 Regulation Name: Wrist Joint Carpal Trapezium Polymer Prosthesis Regulatory Class: Class II Product Code: KYI Dated: March 20, 2018 Received: March 22, 2018

Dear Ana Escagedo:

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

April 11, 2018

{1}------------------------------------------------

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K180744

Device Name Stablyx CMC Arthroplasty Implant System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for Skeletal Dynamics. The logo consists of a stylized green and blue graphic to the left of the company name. The company name, "skeletal dynamics", is written in a sans-serif font, with "skeletal" on the top line and "dynamics" on the bottom line.

510(k) Summary of Safety and Effectiveness Skeletal Dynamics Stablyx CMC Arthroplasty Implant System

March 20, 2018

Submitter:

Skeletal Dynamics, LLC 8905 SW 87 Avenue Suite 201 Miami, FL 33176 Tel: (305) 596-7585 Fax: (305) 596-7591 Contact: Ana M. Escagedo, Vice President Email: aescagedo@skeletaldynamics.com

Establishment Registration Number: 3006742481

Name and Classification:

Name	Stablyx CMC Arthroplasty Implant System
Common Name	Prosthesis, wrist, carpal trapezium
Classification	21 CFR §888.3770
Product Code	KYI
Class	Class II

Predicate Devices:

Stablyx CMC Arthroplasty Implant System (K111068)

Description of the Device:

The prosthesis is available in fixe sizes, and is made of Cobalt Chrome (CoCr) with a Titanium Plasma Spray (TPS) coated stem which may assist in biological fixation. The stem is intended to press fit into the medullary canal. Each prosthesis is packaged and provided sterile.

The Stablyx CMC Arthroplasty System is comprised of:

Multiple sized hemi joint prosthesis ●
System specific instrumentation o

Intended Use:

The Stablyx CMC Arthroplasty Implant System is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture

{4}------------------------------------------------

K180744 PAGE 2 OF 2

deformation or bone loss which present as either a painful, unstable thumb or a thumb with limited range of motion. The implant is intended for uncemented, press fit use.

Technoloqical Characteristics:

The substantial equivalence of the Stablyx CMC Arthroplasty Implant System to the predicate device is demonstrated by similarities in intended use, indications for use, materials, design (fundamental scientific technology), performance, sterility and packaging, and does not present any new issues of safety or effectiveness.

Performance Testing:

Engineering analysis and testing demonstrated that the Stablyx CMC Arthroplasty System is substantially equivalent to the predicate device currently marketed. Characterization testing, including gravimetric testing and analysis established equivalency. Therefore, the subject device is as safe and effective as legally marketed predicate devices.

Conclusion:

The Skeletal Dynamics Stablyx CMC Arthroplasty System is substantially equivalent to the predicate device identified in this premarket notification.

Regulation Number and Section

§ 888.3770 Wrist joint carpal trapezium polymer prosthesis.

(a)
Identification. A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.(b)
Classification. Class II.