The Artimplant Artelon® Spacer CMC-I The Artelon™ Spacer CMC-I is intended to be implanted into the first carpometacarpal joint as an interpositional spacer between the trapezium and first metacarpal.

The device is intended to be used in thumb disabilities because of osteoarthritis.

Device Description

The Artelon™ Spacer CMC-I is a one-piece device intended to be implanted into the CMC-I joint and serve as an interpositional spacer between the trapezium bone and the first metacarpal bone.

It is composed of Artelon™, a polycaprolactone based poly(urethane urea), in multifilament form.

The Artelon™ Spacer CMC-I will be offered sterile.

AI/ML Overview

This submission describes a 510(k) premarket notification for the Artelon™ Spacer CMC-I, a wrist joint carpal trapezium polymer prosthesis. The document focuses on demonstrating substantial equivalence to a predicate device, the Avanta Orthopedics TRL Trapezium Soft Skeletal Implant (K964381).

Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies, while noting the limitations of the provided text in addressing all requested points for a typical AI/ML device study:

1. A table of acceptance criteria and the reported device performance

The provided text does not explicitly define specific, quantitative acceptance criteria for the Artelon™ Spacer CMC-I. Instead, it relies on demonstrating substantial equivalence to an existing predicate device. The performance is assessed through various tests and comparisons.

Acceptance Criteria (Implicit from Substantial Equivalence)	Reported Device Performance
Safety Profile Equivalent to Predicate Device	"collection of tests has been conducted and successfully completed including safety and biocompatibility studies" "presents no new concerns about safety and effectiveness."
Mechanical Performance Equivalent to Predicate Device	"tensile and compression tests" have been successfully completed. "comparison of the design and materials of the Artelon™ Spacer CMC-I to the predicate Avanta TRL Trapezium Implant" supports equivalence.
Clinical Efficacy Equivalent to Predicate Device	"clinical evaluation in accordance to Artimplant's Quality System based on ISO 13485 and 21 CFR Part 820" "device has the same indications as the predicate device"
Labeling Consistency	"the labeling of the device is consistent with current medical practice."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions "clinical evaluation" but does not provide details on the sample size or data provenance (country of origin, retrospective/prospective nature) for any specific clinical test set. The focus is on technical and clinical performance in general to establish substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided in the document. Given that this is a medical device (implant) and not an AI/ML diagnostic tool, the concept of "ground truth" established by experts in the context of an AI/ML study is not directly applicable here. The "ground truth" for a medical implant would be its safety and effectiveness in patients, assessed through clinical trials and post-market surveillance.

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

This information is not provided and is not relevant for this type of medical device submission. Adjudication methods are typically used in studies involving subjective assessments, especially in AI/ML performance evaluation where multiple human readers might disagree.

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

An MRMC study is not mentioned, and it is not applicable to this medical implant device. MRMC studies are designed to evaluate the impact of a diagnostic aid (like AI) on human reader performance, which is not the purpose of this submission.

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

A standalone performance evaluation (as understood for an AI algorithm) was not done, and it is not applicable to this medical implant device.

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

For this medical implant, the "ground truth" for its performance would implicitly be:

Biocompatibility test results: Demonstrating no adverse biological reactions.
Mechanical test results: Verifying structural integrity and performance under stress.
Clinical outcomes data: Assessed through the "clinical evaluation," likely involving patient follow-ups to determine pain relief, improved function, absence of complications, etc. However, specific details of this "clinical evaluation" and its outcomes are not provided.

8. The sample size for the training set

This is not applicable as the Artelon™ Spacer CMC-I is a physical medical implant, not an AI/ML algorithm that requires a training set.

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

This is not applicable for the same reason as point 8.

Summary

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510(K) SUMMARY

SEP 2 1 2004

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In accordance with 21 CFR 807.92, the following information constitutes the Artimplant AB's summary for the Artelon™ Spacer CMC-I

SUBMITTER'S NAME:	Artimplant AB
ADDRESS:	Hulda Mellgrens gata 5, SE-421 32 Västra Frölunda,Sweden
CONTACT PERSON:	Britt Novén
TELEPHONE NUMBER:	+46 31 7465699 or +46 705 280255
FAX NUMBER:	+46 31 7465660
DATE OF SUBMISSION:	January 5, 2004

1. Identification of device

Proprietary Name: Artelon™ Spacer CMC-I Common Name: Prosthesis, wrist, carpal trapezium Classification Status: Class II per regulations §888.3770 Product Codes: KYI - Wrist joint carpal trapezium polymer prosthesis

2. Equivalent devices

The Artimplant Artelon™ Spacer CMC-I is substantially equivalent to the Avanta Orthopedics TRL Trapezium Soft Skeletal Implant (K964381)

3. Description of the Device

The Artelon™ Spacer CMC-I is a one-piece device intended to be implanted into the CMC-I joint and serve as an interpositional spacer between the trapezium bone and the first metacarpal bone.

It is composed of Artelon™, a polycaprolactone based poly(urethane urea), in multifilament form.

The Artelon™ Spacer CMC-I will be offered sterile.

4. Intended use

The Artelon™ Spacer CMC-I is intended to be implanted into the CMC-I joint as an interpositional spacer between the trapezium bone and the first metacarpal bone.

The device is intended to be used in thumb disabilities because of osteoarthritis.

న. Predicate device

Substantial Equivalence: The Artimplant Artelon™ Spacer CMC-I is substantially equivalent to the Avanta Orthopedics TRL Trapezium Soft Skeletal Implant (K964381).

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K040070

6. Discussion of performance testing

A collection of tests has been conducted and successfully completed including safety and biocompatibility studies, tensile and compression tests and clinical evaluation in accordance to Artimplant's Quality System based on ISO 13485 and 21 CFR Part 820.

7. Discussion of Substantial Equivalence

Based on extensive technical and clinical performance testing and a comparison of the design and materials of the Artelon™ Spacer CMC-I to the predicate Avanta TRL Trapezium Implant, the Artelon™ Spacer CMC-I is substantially equivalent to the Avanta TRL Trapezium Implant (K964381) and presents no new concerns about safety and effectiveness. Additionally, the device has the same indications as the predicate device, and the labeling of the device is consistent with current medical practice.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.

Public Health Service

SEP 2 1 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Artimplant AB C/o Ms. Marie Marlow President and CEO M Squared Associates, Inc. 719 A Street. NE Washington, DC 20002

Re: K040070

Trade/Device Name: Artimplant AB, Artelon™ Spacer CMC-I Regulation Number: 21 CFR 888.3770 Regulation Name: Wrist joint carpal trapezium polymer prosthesis Regulatory Class: II Product Code: KYI Dated: June 22, 2004 Received: June 23, 2004

Dear Ms. Marlow:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bected. o re(x) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to connineres prof to may 20, 2019, in accordance with the provisions of the Federal Food, Drug, the rices mat nave been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The rou may, morelore, mans 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 such additional controls. Existing major regulations affecting your device can may be subject to bach 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dri has made a assist regulations administered by other Federal agencies. You must or uny I ederal battler and states and states and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OF N Fart 007), accems (21 (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 - Ms. Marie Marlow

This letter will allow you to begin marketing your device as described in your Section 510(k) Find lotter with and wy of substantial equivalence of your device of your device to a legally promatics notificate device 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 if you attence of Compliance at (301) 594-4639. 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 may be obtained from the Oiner general mill Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Mikkelsen

Celia M. Witten, PhD, MD 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

510(k) Number (if known): K040070

Artimplant AB, Artelon™ Spacer CMC-1 Device Name:

Indications for Use:

The device is intended to be used in thumb disabilities because of osteoarthritis.

Prescription Use (Part 21 CFR 801 Subpart

AND/OR

Over-The-Counter Use
(21 CFR 801 Subpart C) Nb

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Mulkerson

Division of General, Restorative, and Neurological Devices

510(k) Number K040070

Page 1 of 1

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.