The Extremity Medical Trapezium Prosthesis is indicated for use in degenerative or posttraumatic (e.g. following an old Bennett fracture) disabilities of the thumb basal joint with:

Localized pain and palpable crepitation at the base of the thumb on the "grind test" (circumduction with axial compression of the thumb)
Decreased motion, pinch, and grip strength
X-ray evidence of arthritic changes of the trapeziometacarpal, trapezioscaphoid, trapeziotrapezoid, and trapezium-second metacarpal joints, singly or in combination.
Associated unstable, stiff, or painful distal joints of thumb or swan neck deformity

Device Description

The EXTREMITY MEDICAL Trapezium Prosthesis

AI/ML Overview

The provided text is a 510(k) summary for the EXTREMITY MEDICAL Trapezium Prosthesis. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is not applicable or not present in this type of regulatory submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as performance metrics. The core "acceptance criteria" for K092548 is demonstrating substantial equivalence to predicate devices in terms of indications for use, materials, design, and principles of operation.
Reported Device Performance: No specific performance metrics (e.g., success rates, complication rates, functional outcomes) are reported for the EXTREMITY MEDICAL Trapezium Prosthesis itself. The study's "performance" is its argument for substantial equivalence.

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

Sample Size: Not applicable. This document is a regulatory submission for substantial equivalence, not a clinical study reporting on patient outcomes with a specific test set.
Data Provenance: Not applicable for a test set of the device itself. The data provenance for the predicate devices would be from their original studies or regulatory submissions, which are not detailed here.

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

Not applicable. There is no "test set" in the context of clinical performance evaluation described here, nor is there a ground truth established by experts for performance data of this specific device.

4. Adjudication method for the test set:

Not applicable. See point 3.

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. This is a medical implant, not an AI diagnostic tool. MRMC studies and "human readers improve with AI" are not relevant to this device.

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

No. This is a medical implant, not an algorithm.

7. The type of ground truth used:

The "ground truth" for this submission is the established safety and effectiveness of the predicate devices. The new device aims to demonstrate it is substantially equivalent to these already-approved devices, rather than establishing de novo safety and effectiveness through clinical trials with a primary ground truth (like pathology or outcomes data for a novel treatment).

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an algorithm being developed.

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

Not applicable. See point 8.

Summary of what the document does provide regarding the "study" for acceptance:

Study Type: This is a predator-based 510(k) submission, not a clinical or performance study of the subject device. The "study" here refers to the process of comparing the new device against legally marketed predicate devices.
Acceptance Criteria (Implicit for 510k): The device is "accepted" (cleared for market) if it is found to be "substantially equivalent" to legally marketed predicate devices. This means it must have:
- The same intended use as the predicate device.
- The same technological characteristics as the predicate device; OR
- Different technological characteristics from the predicate device that do not raise different questions of safety and effectiveness; AND
- The information submitted to FDA, including appropriate scientific data, demonstrates that the device is as safe and effective as the legally marketed device.
Device Performance (as presented): The document states: "The EXTREMITY MEDICAL Trapezium Prosthesis is substantially equivalent to its predicate devices. This conclusion is based upon the fact that this device is substantially equivalent in terms of indications for use, materials, design and principles of operation." No specific performance data (e.g., clinical outcomes, wear rates, complication rates) for the EXTREMITY MEDICAL Trapezium Prosthesis are presented. Performance is inferred from equivalence to the predicates.
Predicate Devices Used for Comparison:
- Wright Medical, Metallic CMC Spherical Implant K960534
- Wright Medical, Orthosphere Ceramic Spherical Implant, K030319
- Wright Medical, Swanson Titanium Carpal Scaphoid Implant, K864490
- Wright Medical, Swanson Titanium Carpal Lunate Implant, K864491
- Wright Medical, TIE-IN Trapezium, K033529
- Wright Medical, Trapezium Implant, K781756
- Ascension Orthopedics, PyroSphere, K042690
- Ascension Orthopedics, PyroCarbon Lunate, K080997

Summary

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K092548 1/2

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DEC 1 5 2009

510(k) Summary of Safety and Effectiveness:

EXTREMITY MEDICAL Implant System

Submitter:	EXTREMITY MEDICAL LLC
	300 Interpace Parkway
	Suite 410
	Parsippany, NJ 07054
Contact Person	Jamy Gannoe
	President
	Phone: 973-588-8980
	Email: jgannoe@extremitymedical.com
Date Prepared	August 18, 2009
Trade Name	EXTREMITY MEDICAL Trapezium Prosthesis
Classification Nameand Number	21 CFR 888.3770
Product Code	KYI
Predicate Devices	Wright Medical, Metallic CMC Spherical Implant K960534
	Wright Medical, Orthosphere Ceramic Spherical Implant,
	K030319
	Wright Medical, Swanson Titanium Carpal Scaphoid Implant,
	K864490
	Wright Medical, Swanson Titanium Carpal Lunate Implant,
	K864491
	Wright Medical, TIE-IN Trapezium, K033529
	Wright Medical, Trapezium Implant, K781756
	Ascension Orthopedics, PyroSphere, K042690
	Ascension Orthopedics, PyroCarbon Lunate, K080997
Device Description	The EXTREMITY MEDICAL Trapezium Prosthesis
Indications for use	The Extremity Medical Trapezium Prosthesis is indicated foruse in degenerative or post-traumatic (e.g. following an oldBennett fracture) disabilities of the thumb basal joint with:- Localized pain and palpable crepitation at the base of thethumb on the "grind test" (circumduction with axialcompression of the thumb)- Decreased motion, pinch, and grip strength- X-ray evidence of arthritic changes of the trapeziometacarpal,trapezioscaphoid, trapeziotrapezoid, and trapezium-secondmetacarpal joints, singly or in combination.- Associated unstable, stiff, or painful distal joints of thumb orswan neck deformity
Statement ofTechnologicalComparison	The EXTREMITY MEDICAL Trapezium Prosthesis and itspredicate devices have a similar design, and are made of thesimilar materials.
Conclusion	The EXTREMITY MEDICAL Trapezium Prosthesis issubstantially equivalent to its predicate devices. Thisconclusion is based upon the fact that this device is substantiallyequivalent in terms of indications for use, materials, design andprinciples of operation.

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2/2 K042548

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above three wavy lines.

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

DEC 1 5 2009

EXTREMITY MEDICAL LLC % Mr. Jamy Gannoe 300 Interpace Parkway Suite 410 Parsippany, NJ 07054

Re: K092548

Trade/Device Name: Extremity Medical Trapezium Prosthesis Regulation Number: 21 CFR 888.3770 Regulation Name: Wrist joint carpal trapezium polymer prosthesis Regulatory Class: II Product Code: K.YI Dated: November 19, 2009 Received: November 23, 2009

Dear Mr. Gannoe:

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.

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 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.

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Page 2 – Mr. Jamy Gannoe

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Jonita Js

Image /page/3/Picture/5 description: This image contains a handwritten symbol that appears to be a combination of a lowercase letter 'g' and a superscript 'n'. The 'g' is written in a cursive style, with a loop at the top and a tail extending downwards. The 'n' is smaller and positioned above and to the right of the 'g', indicating it may be a superscript or an abbreviation. The symbol is presented in black against a white background.

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): KO925 48

EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS Device Name: Indications for Use:

The Extremity Medical Trapezium Prosthesis is indicated for use in degenerative or posttraumatic (e.g. following an old Bennett fracture) disabilities of the thumb basal joint with:

Localized pain and palpable crepitation at the base of the thumb on the "grind test" -(circumduction with axial compression of the thumb)
-Decreased motion, pinch, and grip strength
X-ray evidence of arthritic changes of the trapeziometacarpal, trapezioscaphoid, trapeziotrapezoid, and trapezium-second metacarpal joints, singly or in combination.
Associated unstable, stiff, or painful distal joints of thumb or swan neck deformity

Over-the-counter Prescription Use X_ AND/OR (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anita for MXM
Division Signoff

hopedic. iroical estorative Devi

510(k) Number K092578

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.