Artelon® CMC Spacer Arthro intended to be implanted into first carpometacarpal joint (CMC-I) as an interpositional spacer between the trapezial bone and the first metacarpal bone. The device is intended to be used in thumb disabilities caused by osteoarthritis.

Device Description

ARTELON CMC Spacer Arthro is a woven textile device made of ARTELON fibres. ARTELON is a biocompatible, degradable material made of polycaprolactone-based polyurethaneurea. ARTELON CMC Spacer Arthro is designed to act as an interposition part in the joint. The purpose of the vertical portion is to separate the surfaces of the arthritic joint from each other. The purpose of the horizontal portion of ARTELON CMC Spacer Arthro is to fixate the device. ARTELON CMC Spacer Arthro is a single-use device packaged in double sterile barriers. The ARTELON CMC Spacer Arthro wings are fixed in place using commercially available suture anchors (non-absorbable, diameter approximately 2 mm) in combination with two double-armed class I nonabsorbable USP size 1 sutures.

AI/ML Overview

The provided text is a 510(k) summary for the ARTELON CMC Spacer Arthro. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain a study that demonstrates the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or accuracy.

Instead, the submission relies on bench testing to demonstrate performance and substantial equivalence to a previously cleared device.

Therefore, many of the requested details about acceptance criteria and study design for measuring device performance cannot be extracted from this document because such a study was not performed or reported in this summary.

Here's a breakdown of the information that can be extracted or inferred based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly defined in terms of specific performance metrics for clinical outcome (e.g., success rate, pain reduction, range of motion improvement).	"The new product met the same release specifications as the previously cleared device." "Performance bench testing was utilized needed to demonstrate Substantial Equivalence." Demonstrated substantial equivalence to a predicate device (ARTELON CMC Spacer, K040070) based on dimensions, materials, basic design, and intended use.

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

Test Set Sample Size: Not applicable. No clinical "test set" in the context of a performance study (e.g., measuring disease detection accuracy) was conducted for this 510(k) submission. Performance was assessed via bench testing and comparison to a predicate device.
Data Provenance: Not applicable for a clinical performance study. The submission describes bench testing which would typically be conducted in a laboratory setting.

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

Not applicable. No ground truth establishment by experts for a clinical performance study was reported.

4. Adjudication Method for the Test Set

Not applicable. No clinical performance study requiring adjudication was reported.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done. The document does not describe any human-in-the-loop performance evaluation or comparison with AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

No, a standalone (algorithm only) performance study of this nature was not done. The device is a physical implant, not an algorithm. Performance was assessed through engineering bench tests and comparison to a predicate device.

7. Type of Ground Truth Used

For demonstrating equivalence: The "ground truth" was the performance and characteristics of the predicate device (ARTELON CMC Spacer, K040070), along with compliance to recognized standards (ISO 10993, ISO 14971, etc.) through bench testing.
For clinical outcomes: Not applicable, as detailed clinical outcomes data from a specific study for this device's 510(k) submission are not provided.

8. Sample Size for the Training Set

Not applicable. This device is a physical implant, not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is a physical implant, not an AI/ML algorithm.

Summary of the 510(k) Approach:

The 510(k) submission for the ARTELON CMC Spacer Arthro focused on demonstrating substantial equivalence to a previously cleared device (ARTELON CMC Spacer, K040070). This involved:

Bench Testing: Ensuring the new device met the same "release specifications" as the predicate device and complied with relevant ISO and AAMI standards for biocompatibility, sterilization, packaging, and risk management.
Comparison of Features: Highlighting the similarity in dimensions, materials, basic design, and intended use between the new device and the predicate.

This type of submission typically does not include de novo clinical studies with specific performance metrics like sensitivity or specificity, or studies involving human readers or AI algorithms for diagnostic purposes. The "acceptance criteria" here are primarily around meeting engineering specifications and demonstrating equivalency to a device already deemed safe and effective by the FDA.

Summary

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Artimplant AB: Artelon CMC Spacer Arthro- K061954

510(k) SUMMARY

Summary of Safety and Effectiveness

In accordance with 21 CFR 807.92, the following information constitutes Artimplant AB's summary for the ARTELON CMC Spacer Arthro.

SUBMITTER'S NAME Artimplant AB ADDRESS: Hulda Mellgrens gata 5. SE-421 32 Västra Frölunda. Sweden CONTACT PERSON: Ajrulla Zuta TELEPHONE NUMBER: +46 31 7465600 FAX NUMBER: DATE OF SUBMISSION: July 10, 2006

1. Identification of device

Proprietary Name: ARTELON CMC Spacer Arthro Common Name: Prosthesis, wrist, carpal trapezium Classification Status: Class II per Regulation §888.3770 Product Code: KYI, wrist joint carpal trapezium polymer prosthesis

2. Equivalent device

ARTELON CMC Spacer, K040070, 09/21/2004.

3. Description of the Device

ARTELON CMC Spacer Arthro is a woven textile device made of ARTELON fibres. ARTELON is a biocompatible, degradable material made of polycaprolactone-based polyurethaneurea.

ARTELON CMC Spacer Arthro is designed to act as an interposition part in the joint. The purpose of the vertical portion is to separate the surfaces of the arthritic joint from each other. The purpose of the horizontal portion of ARTELON CMC Spacer Arthro is to fixate the device.

ARTELON CMC Spacer Arthro is a single-use device packaged in double sterile barriers. The ARTELON CMC Spacer Arthro wings are fixed in place using commercially available suture anchors (non-absorbable, diameter approximately 2 mm) in combination with two double-armed class I nonabsorbable USP size 1 sutures.

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4. Intended Use

The ARTELON CMC Spacer Arthro is intended to be implanted into the first carpometacarpal joint (CMC-I) as an interpositional spacer between the trapezial bone and the first metacarpal bone.

The device is intended to be used in thumb disabilities caused by osteoarthritis. This is the same intended use as previously cleared for the ARTELON CMC Spacer, K040070.

5. Discussion of Performance Testing

Performance bench testing was utilized needed to demonstrate Substantial Equivalence. The new product met the same release specifications as the previously cleared device. This fact, in conjunction with a comparison of dimensions, materials, basic design, and intended use demonstrated Substantial Equivalence.

A collection of tests have been performed in accordance with:

ISO 10993 standards
ISO 14971
ISO 11137 ●
. ISO 11607
ISO 11737-1 .
AAMI TIR27:2001 .
EN868-1 �

6. Conclusion

The ARTELON CMC Spacer Arthro described in the submission is substantially equivalent to the predicate device, and presents no new concerns about safety and effectiveness. Additionally, the devices have identical indication to the predicate device, and the labeling is consistent both with FDA guidance as well as current medical practice.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Artimplant AB c/o Ms. Terry Sheridan Powell Senior Project Manager M Squared Associates, Inc. 719 A Street, NE Washington, DC 20002

JUN - 1 2007

Re: K061954

Trade Name: ARTELON CMC Spacer Arthro Regulation Number: 21 CFR 888.3770 Regulation Name: Wrist joint carpal trapezium polymer prosthesis Regulatory Class: Class II Product Code: KYI Dated: April 24, 2007 Received: May 4, 2007

Dear Ms. Powell:

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 such 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); 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.

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Page 2 - Ms. Terry Sherdan Powell

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Milburn

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

510(K) Number (if known): K061954

Device Name: Artelon® CMC Spacer Arthro

Indications for Use:

Prescription Use X AND/OR

(Part 21 CFR 801 Subpart D)

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, Q gvice Evaluation (ODE) ttice of sion Sign-Off) (Division of General, Restorative, and Neurological Devi-

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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.