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Avanta Orthopaedics Finger Joint Prosthesis is intended for replacement of the Metacarpophalangeal joint of the hand which has been damaged by rheumatoid, osteo or post traumatic arthritis.

The finger joint prosthesis like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the MCP joint of the hand.

The provided text describes a 510(k) premarket notification for the Avanta Orthopaedics Finger Joint Prosthesis, which aims to demonstrate substantial equivalence to a predicate device, the Sutter Finger Joint Prosthesis. The information is primarily focused on comparing the new device to the predicate device in terms of design characteristics, materials, and indications for use.

Here's an analysis of the requested information based on the provided text:

Acceptance Criteria and Device Performance

The provided document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device. The performance is assessed through a comparison of key characteristics and a specific test.

Study Details

The provided text describes the basis for a 510(k) submission, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than a comprehensive de novo clinical study with detailed performance metrics against quantitative acceptance criteria.

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

   • Sample Size: Not specified. The document mentions "Flexion testing was performed on the Avanta Product" but provides no details on the number of samples tested or the methodology.
   • Data Provenance: Not specified. It cannot be determined if the data is retrospective or prospective, or the country of origin.

2. 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/Not specified. The study described is a bench test ("Flexion testing") for demonstrating mechanical equivalence, not a clinical trial requiring expert ground truth for diagnostic accuracy.

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

   • Not applicable. This is not a study involving human interpretation or clinical outcomes requiring adjudication.

4. 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:

   • No. This is not a study involving AI assistance or human readers.

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

   • No. This is not an algorithm or AI device. The "Flexion testing" could be considered a form of standalone mechanical performance assessment, but not in the context of an algorithm.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • Not explicitly stated in terms of "ground truth" for a diagnostic or clinical outcome. The "ground truth" for the flexion testing would likely be the objective measurements of the device's mechanical properties and its comparison to the predicate device's known mechanical properties or performance standards.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that would have a training set.

8. How the ground truth for the training set was established:

   • Not applicable. See above.

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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.

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:

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.

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