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510(k) Data Aggregation
(251 days)
ARTELON SPACER CMC-1
The Artimplant Artelon® Spacer CMC-I The Artelon™ Spacer CMC-I is intended to be implanted into the first carpometacarpal joint as an interpositional spacer between the trapezium and first metacarpal.
The device is intended to be used in thumb disabilities because of osteoarthritis.
The Artelon™ Spacer CMC-I is a one-piece device intended to be implanted into the CMC-I joint and serve as an interpositional spacer between the trapezium bone and the first metacarpal bone.
It is composed of Artelon™, a polycaprolactone based poly(urethane urea), in multifilament form.
The Artelon™ Spacer CMC-I will be offered sterile.
This submission describes a 510(k) premarket notification for the Artelon™ Spacer CMC-I, a wrist joint carpal trapezium polymer prosthesis. The document focuses on demonstrating substantial equivalence to a predicate device, the Avanta Orthopedics TRL Trapezium Soft Skeletal Implant (K964381).
Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies, while noting the limitations of the provided text in addressing all requested points for a typical AI/ML device study:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly define specific, quantitative acceptance criteria for the Artelon™ Spacer CMC-I. Instead, it relies on demonstrating substantial equivalence to an existing predicate device. The performance is assessed through various tests and comparisons.
| Acceptance Criteria (Implicit from Substantial Equivalence) | Reported Device Performance |
|---|---|
| Safety Profile Equivalent to Predicate Device | "collection of tests has been conducted and successfully completed including safety and biocompatibility studies" |
| "presents no new concerns about safety and effectiveness." | |
| Mechanical Performance Equivalent to Predicate Device | "tensile and compression tests" have been successfully completed. |
| "comparison of the design and materials of the Artelon™ Spacer CMC-I to the predicate Avanta TRL Trapezium Implant" supports equivalence. | |
| Clinical Efficacy Equivalent to Predicate Device | "clinical evaluation in accordance to Artimplant's Quality System based on ISO 13485 and 21 CFR Part 820" |
| "device has the same indications as the predicate device" | |
| Labeling Consistency | "the labeling of the device is consistent with current medical practice." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "clinical evaluation" but does not provide details on the sample size or data provenance (country of origin, retrospective/prospective nature) for any specific clinical test set. The focus is on technical and clinical performance in general to establish substantial equivalence.
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)
This information is not provided in the document. Given that this is a medical device (implant) and not an AI/ML diagnostic tool, the concept of "ground truth" established by experts in the context of an AI/ML study is not directly applicable here. The "ground truth" for a medical implant would be its safety and effectiveness in patients, assessed through clinical trials and post-market surveillance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided and is not relevant for this type of medical device submission. Adjudication methods are typically used in studies involving subjective assessments, especially in AI/ML performance evaluation where multiple human readers might disagree.
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
An MRMC study is not mentioned, and it is not applicable to this medical implant device. MRMC studies are designed to evaluate the impact of a diagnostic aid (like AI) on human reader performance, which is not the purpose of this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation (as understood for an AI algorithm) was not done, and it is not applicable to this medical implant device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this medical implant, the "ground truth" for its performance would implicitly be:
- Biocompatibility test results: Demonstrating no adverse biological reactions.
- Mechanical test results: Verifying structural integrity and performance under stress.
- Clinical outcomes data: Assessed through the "clinical evaluation," likely involving patient follow-ups to determine pain relief, improved function, absence of complications, etc. However, specific details of this "clinical evaluation" and its outcomes are not provided.
8. The sample size for the training set
This is not applicable as the Artelon™ Spacer CMC-I is a physical medical implant, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
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