The First Choice® Partial Ulnar Head implant is intended for partial replacement of the distal ulna for rheumatoid, degenerative, or post-traumatic arthritis presenting with pain and weakness localized to the distal radioulnar joint and not improved by conservative treatment.

The First Choice Partial Ulnar Head implant is intended for press-fit use.

Device Description

The First Choice Partial Ulnar Head implant is a onepiece hemi-arthroplasty device intended to replace the articulating surface of the distal ulnar head. It is constructed from cobalt chromium alloy and replaces the ulnar head while retaining the ulnar neck and styloid. The distal head is polished to a mirror finish for articulation within the distal radioulnar joint and the proximal stem has a roughened grit-blasted surface for uncemented press-fit fixation in the ulnar medullary canal. The First Choice Partial Ulnar Head implant is available in 12 sizes.

AI/ML Overview

Here's an analysis of the provided text regarding the "First Choice Partial Ulnar Head Implant" and how it addresses the requested information about acceptance criteria and supporting studies:

This document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than explicitly defining and meeting new acceptance criteria through a clinical study. Therefore, many of the requested categories related to independent clinical studies with specific performance metrics will not be directly applicable or present in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Non-Clinical Performance:	Non-Clinical Performance:
Substantial equivalence in terms of strength and function to the predicate device (Ascension® Modular Ulnar Head (MUH); K052137).	Demonstrated via: - Ulnar Head Biomechanics testing. - DRUJ Stem Bend Strength testing. (Specific quantitative acceptance thresholds for these tests are not provided in this summary, but the implicit acceptance criterion is that the results fall within limits demonstrating equivalence to the predicate.)
Clinical Performance:	Clinical Performance:
Not necessary to support substantial equivalence.	Clinical performance data were not necessary to support substantial equivalence.

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

Sample Size for Test Set: Not applicable. No clinical test set. The non-clinical tests were conducted on prototypes of the new device and, by inference, compared to design specifications or performance characteristics of the predicate device. The document does not specify the number of units tested.
Data Provenance: Not applicable. The testing described is non-clinical (biomechanical), likely conducted in a lab setting by the manufacturer, Ascension Orthopedics.

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

Not applicable. There was no clinical test set requiring expert-established ground truth. The "ground truth" for the non-clinical tests would be the established engineering and biomechanical principles and potentially the performance data of the predicate device.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

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 device is a physical orthopedic implant, not an AI or imaging-based diagnostic tool. Therefore, MRMC studies and AI-assisted reading are irrelevant.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

Non-Clinical: The implicit "ground truth" for the non-clinical performance data (Ulnar Head Biomechanics and DRUJ Stem Bend Strength) is the established engineering and biomechanical performance characteristics considered acceptable for the device's function, and, critically, the performance of the predicate device (Ascension® Modular Ulnar Head, K052137). The goal was to prove substantial equivalence, meaning the new device performs at least as well as the legally marketed predicate.
Clinical: Not applicable, as clinical data was deemed unnecessary for this 510(k) submission.

8. The Sample Size for the Training Set

Not applicable. This is not an AI or machine learning device that requires a training set.

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

Not applicable. As noted above, this is not an AI or machine learning device.

Explanation of the Study and Why it Meets "Acceptance Criteria"

The "study" in this context is the non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device, not an efficacy or safety study to meet specific, pre-defined acceptance criteria for a novel device.

Device: First Choice Partial Ulnar Head Implant
Purpose of the "Study" (Non-Clinical Testing): To demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device (Ascension® Modular Ulnar Head, K052137) in terms of intended use, technological characteristics, and performance (strength and function).
Acceptance Criteria (Implicit): The primary acceptance criterion for this 510(k) submission is that the First Choice Partial Ulnar Head Implant's performance, as measured by the non-clinical tests, is comparable to, or as safe and effective as, the predicate device. This ensures the new device does not raise new questions of safety or effectiveness.
Tests Performed:
- Ulnar Head Biomechanics: Likely assessed mechanical properties related to joint articulation and stress distribution.
- DRUJ Stem Bend Strength: Assessed the structural integrity and resistance to bending of the stem portion of the implant, which is fixed into the ulna.
Outcome: The document states, "Performance data demonstrates that the subject device design is substantially equivalent to the predicate in terms of strength and function." This statement is the conclusion that the device has met the implicit acceptance criterion for substantial equivalence based on the non-clinical testing.
Why Clinical Data Wasn't Needed: For many 510(k) submissions, if the new device is sufficiently similar to a predicate, and non-clinical data can bridge any differences, clinical data is not required by the FDA. This was the case here, as noted: "Clinical performance data were not necessary to support substantial equivalence."

In summary, for medical devices cleared through the 510(k) pathway, the "acceptance criteria" are usually tied to demonstrating substantial equivalence to an already legally marketed device, often through non-clinical testing, rather than through a new clinical trial establishing standalone efficacy and safety metrics.

Summary

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Image /page/0/Picture/0 description: The image shows the word "INTEGRA" in all capital letters. Below the word "INTEGRA" is the phrase "LIMIT UNCERTAINTY" in smaller letters. To the right of the word "INTEGRA" are three black squares of different sizes stacked on top of each other.

APR - 9 2012

Summary of Safety and Effectiveness

Sponsor:

Contact Person:

Date:

Trade Name:

Common Name:

Product Code:

Classification:

Panel:

Predicate Device:

Device Description:

Intended Use:

Ascension Orthopedics 8700 Cameron Road Austin, TX 78754-3832

Bradley W. Strasser Senior Analyst, Regulatory Affairs 512-836-5001 ext. 1541

06 April 2012

First Choice® Partial Ulnar Head Implant

Ulnar Head Prosthesis

KXE - Prosthesis, Wrist, Hemi-, Ulnar

21 CFR §888.3810 – Wrist joint ulnar (hemi-wrist) polymer prosthesis

Orthopedic

Ascension® Modular Ulnar Head (MUH); K052137, cleared 03 November 2005; manufactured by Ascension Orthopedics, Inc.

The First Choice Partial Ulnar Head implant is intended for partial replacement of the distal ulna for rheumatoid, degenerative, or post-traumatic arthritis presenting with pain and weakness localized to the

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Non-Clinical Performance Data:

Clinical Performance Data:

Clinical Performance Data.

•

distal radioulnar joint and not improved by conservative treatment.

The First Choice Partial Ulnar Head implant is intended for press-fit use.

The First Choice Partial Ulnar Head implant is similar to the First Choice Modular Ulnar Head implant in terms of intended use and fundamental scientific technology. Performance data demonstrates that the subject device design is substantially equivalent to the predicate in terms of strength and function.

The following non-clinical tests and analyses were conducted to support substantial equivalence of the First Choice Partial Ulnar Head implant to the predicate Modular Ulnar Head implant:

Ulnar Head Biomechanics .
DRUJ Stem Bend Strength .

Clinical performance data were not necessary to support substantial equivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: This image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Mail Center - WO66-G609, Silver Spring, MD 20993-0002. The text is black and the background is white.

APR - 9 2012

Ascension Orthopedics % Mr. Bradley W. Strasser 8700 Cameron Road Suite 100 Austin, TX 78754-3832

Re: K112481

Trade/Device Name: First Choice Partial Ulnar Head Implant Regulation Number: 21 CFR 888.3810 Regulation Name: Wrist joint ulnar (hemi-wrist) polymer prosthesis Regulatory Class: II Product Code: KXE Dated: March 2, 2012 Received: March 5, 2012

Dear Mr. Strasser:

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 (reporting of medical

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Page 2 - Mr. Bradley W. Strasser

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.

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.

Fon Ponto
Def Di

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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510(k) Number (if known): K112481

Device Name:

First Choice® Partial Ulnar Head Implant

Indications for Use:

The First Choice Partial Ulnar Head implant is intended for press-fit use.

X 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 OF NEEDED)

Copeut reple of CPRA, Office of Device Evaluation (ODE)
(Division Sign-Oft)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112481

Regulation Number and Section

§ 888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.

(a)
Identification. A wrist joint ulnar (hemi-wrist) polymer prosthesis is a mushroom-shaped device made of a medical grade silicone elastomer or ultra-high molecular weight polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide an articular surface for the radius and carpus.(b)
Classification. Class II.