The DePuy DuPont Finger Joint Prosthesis is indicated for cementless replacement of the metacarpophalangeal (MCP) joints of the finger where disabled by rheumatoid, degenerative or traumatic arthritis.

Device Description

The DePuy DuPont Orthopaedics (DDO) Finger Joint Prosthesis is a flexible, one-piece, hinged silicone elastomer implant designed to be implanted across the metacarpophalangeal (MCP) joint. The proximal and distal stems of the prosthesis form a 30° angle which mimics the approximate position of the joint when the hand is relaxed.

AI/ML Overview

This document (K970544) describes a 510(k) premarket notification for the DePuy DuPont Orthopaedics Finger Joint Prosthesis, which is a flexible, one-piece, hinged silicone elastomer implant. This submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to meet specific acceptance criteria for performance. Therefore, many of the requested categories related to clinical study design and performance metrics are not applicable in the context of this document.

Here's the information as it can be extracted from the provided text:

Acceptance Criteria and Device Performance (Not Applicable - Substantial Equivalence Submission)

The document does not detail specific acceptance criteria or report device performance against such criteria in the way a clinical study would. Instead, it relies on demonstrating substantial equivalence to pre-existing devices. The "performance" mentioned is comparative, focusing on flexural fatigue testing.

Acceptance Criteria	Reported Device Performance
Not specified directly as acceptance criteria for regulatory approval.	See "Basis of Substantial Equivalence" below.

Basis of Substantial Equivalence (instead of acceptance criteria):

The DDO Finger Joint Prosthesis is considered substantially equivalent to the Dow Corning Wright Swanson Finger Joint Implant and the Sutter Avanta MCP Joint Prosthesis based on:

Intended Use: All are intended to replace the MCP joint due to rheumatoid, degenerative, or traumatic arthritis.
Material: All are manufactured from silicone elastomer.
Design: All have a hinge design.
Flexural Fatigue Testing: "Flexural fatigue testing shows that the DDO Finger Joint implants sustain the same or less damage than the Swanson or Sutter implants when cycled through a total of 90° of flexion/extension for 10 million cycles."

1. A table of acceptance criteria and the reported device performance
As noted above, this document focuses on demonstrating substantial equivalence, not on meeting specific quantitative acceptance criteria of the type that would typically be reported in a table for device performance against predefined thresholds in a clinical study. The performance described is in comparison to predicate devices, specifically:

Performance Metric	DDO Finger Joint Prosthesis Performance (Relative to Predicate Devices)
Flexural Fatigue (Damage)	Sustains "the same or less damage" than the Swanson or Sutter implants when cycled through 90° flexion/extension for 10 million cycles.

This implicitly suggests that "sustaining the same or less damage" than the predicate devices under these conditions serves as an acceptable "performance."

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. The document mentions "Flexural fatigue testing" but does not detail the sample size (number of implants tested), the specific test set used, or any human-subject data. This appears to be bench testing.

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. This is not a study involving human-subject data or medical diagnosis where expert ground truth would be established.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving adjudication of clinical cases or data.

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 is not a study involving AI or human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for the flexural fatigue testing would be the physical measurement of damage or failure based on engineering standards, not medical ground truth.

8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of device submission.

9. How the ground truth for the training set was established
Not applicable. See above.

Summary

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5970544

SUMMARY OF SAFETY AND EFFECTIVENESS SEP 1 2 1997

NAME OF FIRM:	DePuy Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988
510(k) CONTACT:	Cheryl HastingsManager, Clinical Affairs
TRADE NAME:	DePuy DuPont OrthopaedicsFinger Joint Prosthesis
COMMON NAME:	Finger Joint Prosthesis
CLASSIFICATION:	888.3230 Finger joint, polymer, constrainedprosthesis
DEVICE PRODUCT CODE:	87 KYJ
SUBSTANTIALLYEQUIVALENT DEVICES:	Sutter Avanta MCP Joint ProsthesisDow Corning Wright Swanson Finger JointImplant

DEVICE DESCRIPTION AND INTENDED USE:

The DDO Finger Joint Prosthesis is indicated for cementless replacement of the metacarpophalangeal (MCP) joints of the finger where disabled by rheumatoid, degenerative or traumatic arthritis.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The DDO Finger Joint Prosthesis is substantially equivalent to both the Dow Corning Wright Swanson Finger Joint Implant and the Sutter Avanta MCP Joint Prosthesis in that all of these implants are intended to replace the MCP joint when it is damaged due to rheumatoid, degenerative or traumatic arthritis. All of these implants are manufactured from silicone elastomer and all have a hinge design. The Swanson and Sutter implants are both designed as "straight" hinges while the DDO implant incorporates a 30° angle. Flexural fatigue testing shows that the DDO Finger Joint implants sustain the same or less damage than the Swanson or Sutter implants when cycled through a total of 90° of flexion/extension for 10 million cycles.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings and a head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 1997

Ms. Cheryl Hastings Manager, Clinical Affairs DePuy, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

K970544 Re: Trade Name: DePuy DuPont Orthopaedics Finger Joint Prosthesis Requlatory Class: II Product Code: KYJ Dated: June 13, 1997 Received: June 16, 1997

Dear Ms. Hastings:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Cheryl Hastings

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D.,

Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K970544

Device Name DePuy DuPont Finger Joint Prosthesis

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation

Signature

(Division Sign-Off) Division of General Restorative Dev 510(k) Number

Prescription Use

)

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

Regulation Number and Section

§ 888.3230 Finger joint polymer constrained prosthesis.

(a)
Identification. A finger joint polymer constrained prosthesis is a device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint. This generic type of device includes prostheses that consist of a single flexible across-the-joint component made from either a silicone elastomer or a combination pf polypropylene and polyester material. The flexible across-the-joint component may be covered with a silicone rubber sleeve.(b)
Classification. Class II.