(212 days)
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.
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.
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.
§ 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.