(81 days)
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.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Design Characteristics: Similar design, materials, sizes, fixation, constraint. | The Avanta Product (Finger Joint Prosthesis) is compared to the Sutter Finger Joint Prosthesis across various items (Product Name, Use, Fixation, Constraint, Material, Sizes, Indications for use). All listed characteristics between the Avanta Product and the Sutter Biomedical predicate device are identical. |
| Intended Use: Identical indications for use. | Identical: "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." This matches the predicate device's indications precisely. |
| Functional Equivalence: Demonstrated through relevant testing. | "Flexion testing was performed on the Avanta Product to demonstrate substantial equivalence to the predicate device." No specific results or quantitative acceptance criteria for this testing are provided, only that it was performed to support equivalence. |
| Material Equivalence: Industry standard materials, no new materials introduced. | Identical: Both devices use Silicone and are described as using "industry standard materials. No new materials are introduced in either product." |
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.
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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.
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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.
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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.
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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.
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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.
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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.
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that would have a training set.
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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.