The Skeletal Dynamics Stablyx CMC Arthroplasty Implant Set is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb or a thumb with limited range of motion. This 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) joint. 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 against the saddle surface of the trapezium, allowing for flexionextension, abduction-adduction and opposition motions.

The prosthesis is available in five 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 ioint prosthesis .
System specific instrumentation .

AI/ML Overview

The provided document is a 510(k) summary for the Skeletal Dynamics Stablyx CMC Arthroplasty Implant Set. It describes a medical device, and 510(k) submissions typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed studies with specific acceptance criteria, sample sizes, and ground truth methodologies that would be common for AI/Software as a Medical Device (SaMD) clearances.

Therefore, much of the requested information regarding acceptance criteria and study particulars for device performance in the context of an AI/SaMD product is not applicable to this traditional medical implant submission.

However, I can extract information related to the demonstration of "performance" as it pertains to showing substantial equivalence.

Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) for this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for substantial equivalence)	Reported Device Performance (supporting substantial equivalence)
Intended Use: Device intended for specific CMC joint replacement cases.	"The Skeletal Dynamics Stablyx CMC Arthrodesis Implant Set is substantially equivalent to the predicate devices identified in this premarket notification."
Indications for Use: Matches predicate devices.	Intended Use: "intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion."
Materials: Similar to predicate devices.	"Similarities in intended use, indications for use, materials, design (fundamental scientific technology), performance, sterility and packaging." Device made of Cobalt Chrome (CoCr) with a Titanium Plasma Spray (TPS) coated stem.
Design (fundamental scientific technology): Similar to predicate devices.	"Hemi monoblock prosthesis for replacement of the first metacarpal carpometacarpal (CMC) joint. ... highly polished, saddle shaped (toroidal) articular surface which mirrors the normal anatomy of the base of the first metacarpal."
Performance (general biomechanical/functional): Consistent with predicate devices.	"Engineering analysis and cadaveric testing demonstrated that the Stablyx CMC Arthrodesis Implant Set is substantially equivalent to devices currently marketed."
Sterility & Packaging: Similar to predicate devices.	"Similarities in intended use, indications for use, materials, design (fundamental scientific technology), performance, sterility and packaging." (Device is packaged and provided sterile).
No new issues of safety or effectiveness.	"does not present any new issues of safety or effectiveness."

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

Sample Size: Not specified in terms of a "test set" as understood for AI/SaMD. The document mentions "cadaveric testing," but the number of cadavers or specific samples tested is not provided.
Data Provenance: "Cadaveric testing" implies human cadaveric tissue. The country of origin is not specified. The study is implicitly prospective as it involves testing of the new device.

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

Not Applicable (N/A): This type of information (experts for ground truth) is not relevant for a 510(k) submission for a mechanical implant. The assessment of "performance" is based on engineering analyses and biomechanical testing, compared against established standards or predicate device performance. There isn't a "ground truth" establishment in the sense of expert labeling for an AI algorithm.

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

Not Applicable (N/A): Adjudication methods are typically for consensus building among experts on image or data interpretations, which is not relevant for this device submission.

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

No: An MRMC comparative effectiveness study is not relevant for this type of medical implant. These studies are typically conducted for AI-powered diagnostic or assistive tools to evaluate their impact on human reader performance.

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

Not Applicable (N/A): This refers to AI algorithm performance. This device is a physical implant, not an algorithm.

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

Not Applicable (N/A) / Different Context: The concept of "ground truth" in this context would likely refer to established biomechanical principles, engineering standards, and the known performance characteristics of predicate devices. The "performance testing" referenced "engineering analysis and cadaveric testing" which would generate data amenable to such comparisons, rather than a "ground truth" derived from expert consensus on clinical data.

8. The sample size for the training set

Not Applicable (N/A): This refers to AI model training data. This device is a physical implant, not an AI model.

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

Not Applicable (N/A): This refers to AI model training data. This device is a physical implant, not an AI model.

Summary

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DEC 3 0 2011

Image /page/0/Picture/2 description: The image shows the logo for Skeletal Dynamics. The logo consists of a stylized four-petal flower-like symbol on the left, followed by the words "skeletal dynamics" on the right. The word "skeletal" is on the first line, and the word "dynamics" is on the second line.

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

April 14, 2011

Submitter:

Skeletal Dynamics, LLC 8905 SW 87 Avenue Suite 102 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

Trade Name, Common Name. Classification:

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

Predicate Devices:

Ascension, PyroCarbon Saddle CMC (K061451) BioPro Modular Thumb Implant (K052596)

Description of the Device:

The Stablyx CMC Arthroplasty System is comprised of:

Multiple sized hemi ioint prosthesis .
System specific instrumentation .

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Intended Use:

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

Summary of Technological Characteristics / Substantial Equivalence:

The substantial equivalence of the Skeletal Dynamics Stablyx CMC Arthrodesis Implant Set to the predicate devices 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 cadaveric testing demonstrated that the Stablyx CMC Arthrodesis Implant Set is substantially equivalent to devices currently marketed. Therefore, the subject device is as safe and effective as legally marketed predicate devices.

Conclusion:

The Skeletal Dynamics Stablyx CMC Arthrodesis Implant Set is substantially equivalent to the predicate devices identified in this premarket notification.

KIIIDPA

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

DEC 3 0 2011

Skeletal Dynamics, Inc. % Ms. Ana Escagedo 8905 SW 87th Avenue Suite 201 Miami, Florida 33176

Re: K111068

Trade/Device Name: Stablyx CMC Arthroplasty System Regulation Number: 21 CFR 888.3770 Regulation Name: Wrist joint carpal trapezium polymer prosthesis Regulatory Class: II Product Code: KYI Dated: December 10, 2011 Received: December 12, 2011

Dear Ms. 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

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Page 2 - Ms. Ana Escagedo

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark M. Millman

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative 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: Stablyx CMC Arthroplasty Implant Set

Indications For Use:

Prescription Use × (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)

M. Thuner

Sign-Oft) (Divis . >f Surgical, Orthopedic, Divisi . and Nesprative Devices

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K11068 510(k) Number.

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.