(30 days)
Use of the Modular Radial Head Implant may be considered for :
- . Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- a. joint destruction and/or subluxation visible on x-ray; and/or
- b. resistance to conservative treatment.
- Primary replacement after fracture of the radial head. .
- Symptomatic sequelae after radial head resection. .
- Revision following failed radial head arthroplasty. .
The EVOLVE® Modular Radial Head Implant System is being extended to include additional size stems and heads. The design features of these additional sizes are identical to the previously submitted and cleared stems and heads under 510(k); K991915- EVOLVE® Modular Radial Head.
This document describes a 510(k) submission for the EVOLVE® Modular Radial Head, specifically for an extension to include additional size stems and heads. The submission asserts substantial equivalence to a previously cleared device (K991915).
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain explicit acceptance criteria or a study that directly reports the performance of the EVOLVE® Modular Radial Head against such criteria. Instead, the submission relies on demonstrating substantial equivalence to a previously cleared device.
The "acceptance criteria" in this context are implicitly met if the new sizes are shown to be substantially equivalent to the predicate device in terms of design features, intended use, operating principles, and materials, with adequate support from materials data and testing results.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use | The intended use of the extended EVOLVE® Modular Radial Head is identical to the predicate device (K991915). This includes replacement for degenerative/post-traumatic disabilities, primary replacement after radial head fracture, symptomatic sequelae after radial head resection, and revision following failed radial head arthroplasty. |
| Type of Interface | Substantially equivalent to the predicate device (K991915). |
| Operating Principles | Substantially equivalent to the predicate device (K991915). |
| Shelf Life | Substantially equivalent to the predicate device (K991915). |
| Design Features (for new sizes) | The design features of the additional sizes are identical to the previously submitted and cleared stems and heads under 510(k) K991915. |
| Materials Data and Testing Results | Safety and effectiveness are "adequately supported by the substantial equivalent information, materials data, and testing results provided within this Premarket Notification." (Specific details of these tests are not provided in this summary). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the traditional sense of a clinical trial or performance study involving patients. The evaluation is based on engineering principles and comparison to a predicate device. Therefore, no information is available regarding:
- Sample size used for a test set.
- Data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this type of regulatory submission. There was no "ground truth" to establish through expert consensus as it's not a diagnostic or AI-based device requiring such validation. The regulatory review is performed by FDA personnel based on submitted technical documentation.
4. Adjudication Method for the Test Set
This is not applicable as there was no test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation, often with AI assistance, to assess the impact of AI on reader performance. The EVOLVE® Modular Radial Head is an implantable orthopedic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No, a standalone performance study was not done. This is also relevant for AI/diagnostic algorithms. The device itself is a physical implant; it does not have an "algorithm-only" performance to evaluate in this context.
7. The Type of Ground Truth Used
As this is a mechanical medical device and the submission focuses on substantial equivalence based on engineering and materials data, the concept of "ground truth" (expert consensus, pathology, outcomes data) as it applies to diagnostic or prognostic devices is not directly relevant or used in the provided summary. The "ground truth" for demonstrating safety and effectiveness for a mechanical device is typically established through:
- Design specifications and analysis: Ensuring the design meets engineering requirements.
- Material properties: Verifying materials meet established standards.
- Mechanical testing: Bench testing for strength, fatigue, wear, etc. (Though specific results are not detailed in this summary, they are mentioned as being provided).
- Clinical history of the predicate device: The safety and effectiveness of the predicate device (K991915) serves as the primary "ground truth" indirectly, as the new device is demonstrated to be identical or substantially equivalent.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of an AI/machine learning model for this physical medical device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set.
§ 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.
(a)
Identification. An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.(b)
Classification. Class II.