The Ascension® PyroHemiSphere™ is intended to replace the proximal end of the first metacarpal 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.

Device Description

The Ascension PyroHemiSphere (PHS) is single-use, uncemented, onc-component prosthesis for the basal thumb joint. It is fabricated from a thick pyrocarbon layer encasing a graphite core that is impregnated with one-atomic percent tungsten so it is radiopaque. The device is available in five sizes and is provided sterile in packaging containing a single component.

AI/ML Overview

This document is a 510(k) summary for a medical device called the Ascension PyroHemiSphere, a carpometacarpal (CMC) implant. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a study. Therefore, the requested information cannot be fully extracted as it pertains to AI/algorithm performance and clinical study methodology typically found in reports for such devices, not a 510(k) summary for a physical implant.

However, based on the provided text, here's an attempt to address the points where applicable, noting that many crucial details are not present in the given document:

1. Table of acceptance criteria and the reported device performance

This document describes a physical implant, not an AI or algorithmic device. It relies on demonstrating "substantial equivalence" of design features and performance tests to predicate devices rather than meeting predefined acceptance criteria for a specific outcome measure like accuracy or sensitivity. The document does not provide a table of acceptance criteria or specific performance metrics from a study in the context typically seen for AI/algorithm performance.

If "performance" refers to mechanical properties, the document states: "A comparison of the design features as well as performance tests demonstrate that the Ascension PyroHemiSphere is substantially equivalent to the predicate device." However, the results of these performance tests (e.g., tensile strength, wear, durability) and their acceptance criteria are not detailed in this summary.

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

Not applicable. This is for a physical orthopedic implant. There is no "test set" in the context of data for an algorithm. The 510(k) summary does not describe any clinical study involving human subjects or data sets for performance evaluation in this manner.

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)

Not applicable. As this is a physical implant, there's no "ground truth" to be established by experts in the context of data interpretation for an algorithm.

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

Not applicable. There is no "test set" or adjudication method mentioned for a clinical study related to data interpretation.

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 document does not describe a study involving human readers or AI assistance.

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

Not applicable. This is for a physical orthopedic implant, not an algorithm.

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

Not applicable. There is no "ground truth" in the context of data interpretation mentioned in this document. For a physical implant, "ground truth" might refer to clinical outcomes, but no such study is detailed here.

8. The sample size for the training set

Not applicable. This is for a physical orthopedic implant and does not involve a "training set" for an algorithm.

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

Not applicable. As above, this document does not refer to an algorithm or a training set.

Summary of what is available regarding "acceptance criteria" and "study":

The document states that "A comparison of the design features as well as performance tests demonstrate that the Ascension PyroHemiSphere is substantially equivalent to the predicate device." This implies that the 'acceptance criteria' were met by demonstrating equivalence in design and performance to existing, legally marketed devices (K864488, K960659, K964472). The "study" mentioned is likely a series of engineering or pre-clinical bench tests (e.g., mechanical testing, material compatibility) rather than a clinical trial with human subjects. The details of these tests, specific parameters measured, and the numerical results are not provided in this 510(k) summary. The primary "proof" of meeting criteria for this type of device in a 510(k) submission is the demonstration of substantial equivalence, not necessarily a new clinical trial proving independent efficacy against pre-defined performance metrics.

Summary

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AUG 2 5 2004	510(k) SUMMARY	page 1
SUBMITTER NAME:	Ascension Orthopedics, Inc.8200 Cameron Road, C-140Austin, TX 78754-3832	K04145
CONTACT:	Peter StrzepaPhone: (512) 836-5001Fax: (512) 836-6933
DATE OF SUMMARY:	28 May 2004
TRADE NAME:	Ascension® PyroHemiSphereTM
COMMON NAME:	carpometacarpal (CMC) implant
CLASSIFICATION:	21 CFR §888.3770
PRODUCT CODE:	87 KYI
PANEL:	Orthopedic and Rehabilitation Devices

PREDICATE DEVICE:

Swanson Titanium Basal Thumb (K864488) Ceramic Zirconia Spherical CMC Implant (K960659) Biopro Cobalt Trapeziometacarpal Replacement (K964472)

DEVICE DESCRIPTION:

INTENDED USE:

The Ascension® PyroHemiSphere™ is intended to replace the proximal end of the first mctacarpal 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.

BASIS OF SUBSTANTIAL EQUIVALENCE:

A comparison of the design features as well as performance tests demonstrate that the Ascension PyroHemiSphere is substantially equivalent to the predicate device.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 5 2004

Mr. Peter Strzepa Vice President Science and Technology Ascension Orthopedics, Inc. 8200 Cameron Road, Suite C-140 Austin, Texas 78754

Re: K041451

Trade/Device Name: Ascension PyroHemiSphere Regulation Numbers: 21 CFR 888.3770 Regulation Name: Wrist joint carpal trapezium polymer prosthesis Regulatory Class: II Product Code: KYI Dated: May 28, 2004 Received: June 1, 2004

Dear Mr. Strzepa:

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 (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.

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Page 2 -- Mr. Peter Strzepa

Page 2 - Mr. Peter Strzepa

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. 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/dsma/dsmamain.html

Sincerely yours,

L. Mark A. Milkins

Celia M. Witten, Ph.D., M.D. 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

Kodines I 510(K) Number:

Ascension® PyroHemiSphere Device Name:

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milkers

I. Restorative, Division of Ge and Neurological Devices

510(k) I

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.