The Ascension® PyroSphere™ CMC/TMT is intended to replace the joint between the first metacarpal and the trapezium 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.

The Ascension® PyroSphere™ CMC/TMT is also intended for use in the 4th /5th tarsometatarsal (TMT) joint involvement where degenerative or post-traumatic arthritis presents:

. decreased motion
. arthritic changes and/or subluxation
. unstable, stiff, or painful joints
degenerative joint disease of the midfoot associated with gout or pseudogout .

Device Description

The Ascension Ascension® PyroSphere™ CMC/TMT is a single-use, spherical, interpositional prosthesis intended for use in the carpometacarpal (CMC) basal thumb joint or the the 4" /5th tarsometatarsal (TMT) joint involvement. It articulates against recesses prepared in the base of the first metacarpal and the trapezium or the tarsometatarsal joint.

AI/ML Overview

The provided text is a 510(k) summary for the Ascension® PyroSphere™ CMC/TMT, a pyrocarbon spherical implant. This document is a regulatory submission for medical device approval and focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study that establishes acceptance criteria and proves the device meets them in the way a clinical performance study would for an AI/software device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not applicable or available within the provided text.

The document describes the device, its intended use, and states that its basis for substantial equivalence is a comparison of design features and performance tests. However, it does not detail these performance tests in a way that aligns with the questions posed for an AI/software device's validation study.

Here's a breakdown of why each requested point cannot be addressed from the given text:

A table of acceptance criteria and the reported device performance: This document does not describe specific acceptance criteria (e.g., sensitivity, specificity, F1-score) or reported device performance metrics in the context of an AI/software evaluation. It discusses the device's intended use and design, but not performance in a measurable way relevant to AI.
Sample size used for the test set and the data provenance: Not applicable. There is no mention of a "test set" in the context of evaluating an algorithm. The document pertains to a physical implant.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment with experts is relevant for diagnostic or AI imaging products. This is a physical implant.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used to resolve discrepancies in expert-generated ground truth for AI/software evaluations.
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. MRMC studies are used to assess the impact of AI on human readers' performance in diagnostic tasks. This device is a physical implant, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This refers to the performance of an AI algorithm on its own.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI/software algorithm evaluation. "Ground truth" for a physical implant would relate to its physical properties, biocompatibility, and clinical outcomes, but not in the way requested for an AI/software device.
The sample size for the training set: Not applicable. This device is a physical implant and does not involve AI training.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a physical medical implant (Ascension® PyroSphere™ CMC/TMT) and its regulatory submission for substantial equivalence, not the validation study of an AI/software device. Therefore, the requested information cannot be extracted from the text.

Summary

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510(k) SUMMARY

SUBMITTER NAME:	Ascension Orthopedics, Inc.87200 Cameron Road, C-100Austin, TX 78754-3832
CONTACT:	Glen NeallyPhone: (512) 836-5001 ext 1513Fax: (512) 836-6933
DATE OF SUMMARY:	28 February 2006
TRADE NAME:	Ascension® PyroSphere®
COMMON NAME:	pyrocarbon spherical implant
CLASSIFICATION:	21 CFR §888.3730
PRODUCT CODE:	KWD
PANEL:	Orthopedic

K060560

MAY - 5 2005

PREDICATE DEVICES:

Orthosphere Ceramic Spherical Implant (K030319) Ascension® PyroSphere® (K042690)

DEVICE DESCRIPTION:

INTENDED USE:

The Ascension® PyroSphere™ CMC/TMT) is intended to replace the joint between the first metacarpal and the trapezium 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.

The Ascension® PyroSphere™ CMC/TMT is also intended for use in the 4th /5th

tarsometatarsal (TMT) joint involvement where degenerative or post-traumatic arthritis presents:

. decreased motion
. arthritic changes and/or subluxation
. unstable, stiff, or painful joints
degenerative joint disease of the midfoot associated with gout or pseudogout .

BASIS OF SUBSTANTIAL EQUIVALENCE:

A comparison of the design features as well as performance tests demonstrate that the Ascension® PyroSphere™ CMC/TMT is substantially equivalent to the predicate device.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a snake winding around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY -5 2006

Ascension Orthopedics, Inc. Mr. Glen Neally Vice President of QA/RA/CA 8700 Cameron Road, Suite C-100 Austin, Texas 78754-3832

Re: K060560

Trade/Device Name: Ascension® PyroSphere™ CMC/TMT Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: Class II Product Code: KWD Dated: February 28, 2006 Received: March 2, 2006

Dear Mr. Neally:

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

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Page 2 - Mr. Glen Neally

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. 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 its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html .

Sincerely yours.

Herbert Leonard co

for

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: K060560

Ascension® PyroSphere™ CMC/TMT Device Name:

Indications for Use:

The Ascension® PyroSphere™ CMC/TMT is also intended for use in the 4th /5th tarsometatarsal (TMT) joint involvement where degenerative or post-traumatic arthritis

presents:
. decreased motion
. arthritic changes and/or subluxation
unstable, stiff, or painful joints .
degenerative joint disease of the midfoot associated with gout or pseudogout .

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)

Herbert Lerner

Division of General, Restorative and Neurological Devices

510(k) Number K060560

Regulation Number and Section

§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.

(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.