The Ascension® CMC 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 is an uncemented prosthesis designed for press fit use only.

Device Description

The Ascension® CMC is intended for use as a hemi joint replacement for the base of the first metacarpal of the carpometacarpal (CMC) joint. The Ascension CMC is a one component prosthesis having a saddle configuration articular surface which bears against the mating saddle articular surface of the trapczium. The saddle design allows for flexion-extension joint motion and abduction-adduction motion. It is designed to be a press fit device. Each device is comprised of a pyrocarbon layer encasing a machined graphite substrate. The graphite substrate material is impregnated with a small amount (I atomic percent) of tungsten. This small amount of tungsten renders the graphite substrate radiopaque. The device is provided sterile in packaging containing a single device.

AI/ML Overview

The provided text describes a 510(k) Premarket Notification for the Ascension® CMC device, a wrist joint carpal trapezium polymer prosthesis. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria. Therefore, most of the requested information regarding study design, sample sizes, expert involvement, and ground truth establishment is not available in the provided text.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Material Biocompatibility	Demonstrated through in vitro material biocompatibility tests to be substantially equivalent to the predicate device.
Performance (Mechanical/Functional)	Demonstrated through performance tests on Ascension CMC devices to be substantially equivalent to the predicate device.
Pre-clinical Safety	Demonstrated through pre-clinical animal tests to be substantially equivalent to the predicate device.
(Other specific quantifiable acceptance criteria, e.g., range of motion, wear resistance, implant stability, fatigue life, etc.)	Not specified in the provided text.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only mentions "Performance tests conducted on Ascension CMC devices," "in vitro material biocompatibility tests," and "pre-clinical animal tests."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable/Not specified, as no human-expert-driven ground truth establishment for a diagnostic/AI device is described. The "ground truth" here refers to the results of the performance, biocompatibility, and animal tests.

4. Adjudication Method for the Test Set

Not applicable/Not specified, as no human-expert-driven adjudication process for a diagnostic/AI device is described.

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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is a prosthesis, not an AI or diagnostic imaging device that would typically involve human readers.

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

Not applicable. This device is a medical implant (prosthesis), not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" implicitly used for demonstrating substantial equivalence are the results of specific engineering performance tests, in vitro material tests, and pre-clinical animal studies. These tests are presumed to provide definitive data on the device's characteristics and safety.

8. The Sample Size for the Training Set

Not applicable/Not specified. There is no mention of a "training set" for an algorithm, as this is a medical device (prosthesis).

9. How the Ground Truth for the Training Set was Established

Not applicable/Not specified. There is no mention of a "training set" or its ground truth establishment for an algorithm.

Summary of the Study type based on the provided text:

The study described is a demonstration of substantial equivalence to a predicate device (Ascension® PHS, K041451) through:

Performance tests on Ascension CMC devices.
In vitro material biocompatibility tests.
Pre-clinical animal tests.

The goal of these "tests" or "studies" was to show that the Ascension® CMC performs as intended and is as safe and effective as the previously cleared predicate device, rather than to meet specific, quantifiable acceptance criteria that are typically established for novel diagnostic or AI-powered devices. The success criterion here is the FDA's determination of "substantial equivalence."

Summary

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510(k) Premarket Notification Device: Ascension® CMC

061451

510(k) SUMMARY

AUG 1 1 2006 SUBMITTER NAME: Ascension Orthopedics, Inc. 8700 Cameron Road. C-100 Austin, TX 78754-3832 510(k) CONTACT: Glen Neally Ph: (512) 836-5001 TRADE NAME: Ascension® CMC COMMON NAME: prosthesis, wrist, carpal trapezium CLASSIFICATION: 21 CFR §888.3770 Wrist joint carpal trapezium polymer prosthesis PRODUCT CODE: KYI PANEL: Orthopedic Devices PREDICATE DEVICE: Ascension® PHS, (K041451)

DEVICE DESCRIPTION:

INTENDED USE:

The Ascension® CMC is intended to replace the proximal end of the first metacarpal in cases of theumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture defonomianon or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion. This is an uncemented prosthesis designed for press fit use only.

BASIS OF SUBSTANTIAL EQUIVALENCE:

Performance tests conducted on Ascension CMC devices, in vitro material biocompatibility tests, and pre-clinical animal tests demonstrate that the Ascension CMC is substantially equivalent to the predicate device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA", which is arranged in a circular pattern around the left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 1 2006

Ascension Orthopedics, Inc. % Mr. Glen Neally VP of QA/RA/CA 8700 Cameron Road, Suite 100 Austin, Texas 78754

Re: K061451

Trade/Device Name: Ascension® CMC Regulation Number: 21 CFR 888.3770 Regulation Name: Wrist joint carpal trapezium polymer prosthesis Regulatory Class: Class II Product Code: KYI Dated: May 22, 2006 Received: May 25, 2006

Dear Mr. Neally:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became ine device is substantially equivalent (for the indications ferenced above and nave determined ly marketed predicate devices marketed in interstate for use stated in the encreate) ve togging to the Medical Device Amendments, or to conninesee prof to may 20, 1978, in excordance with the provisions of the Federal Food, Drug, devices that have been receised in avere approval of a premarket approval application (PMA). and Cosmette Act (1101) that as nevice, subject to the general controls provisions of the Act. The Tourmaly, therefore, mains of the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 rr your device to such additional controls. Existing major regulations affecting your device can may oc subject to back additions, 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 I Toast of advised that I Drivedantly that your device complies with other requirements of the Act that I DA has made a associations administered by other Federal agencies. You must of any I oderal buttores and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Far 6075, abounding (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 production of to begin marketing your device as described in your Section 510(k)

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Page 2 - Mr. Glen Neally

premarket notification. The FDA finding of substantial equivalence of your device to a legally premaince nevice 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Barbara Buehrig

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

06145

510(K) Number:

Ascension® CMC Device Name:

The Ascension® CMC is intended to replace the proximal end of the first Indications for Use: 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 is an uncemented prosthesis designed for press fit use only.

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aulian Dvelum for mym

Restorative, and Neurological Devices

510(k) Number K061451

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.