(70 days)
The ExploR™ Modular Radial Head Replacement Device is intended 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
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 device is intended for single use with or without bone cement.
The ExploR™ Modular Radial Head Replacement Device is a two-piece cobalt alloy prosthesis consisting of a stem and a head. The tapered stem is cemented into the intramedullary canal of the radius. The enlarged head has a highly polished concave surface to articulate with the natural bone of the humerus. The proximal portion of the sterns are roughened by a titanium Bond Coat coating. The components connect via a dove-tail joint secured by a locking screw. The device is available in four head diameters, 18mm, 20mm, 22mm with head heights that vary from 8 to 20mm. Stems are available in six diameters with varying lengths.
This looks like a 510(k) premarket notification document for a medical device. Based on the provided text, the device is the ExploR™ Modular Radial Head Replacement Device.
Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Composition | Two-piece cobalt alloy |
| Design Characteristics | Stem and head (tapered stem, enlarged polished concave head) |
| Sizing | Four head diameters (18, 20, 22mm); varying head heights (8-20mm); six stem diameters with varying lengths |
| Intended Use | Replacement of radial head for: |
- Degenerative/post-traumatic disabilities (pain, crepitation, decreased motion, joint destruction/subluxation on X-ray, resistance to conservative treatment)
- Primary replacement after radial head fracture
- Symptomatic sequelae after radial head resection
- Revision following failed radial head arthroplasty |
| Safety and Effectiveness | Demonstrated through substantial equivalence to predicate devices (K040611, K984290, K002644, K991915) based on technological characteristics (materials, design, sizing, indications) and non-clinical testing. |
| Biocompatibility | Implied to be acceptable as it uses materials similar to legally marketed predicate devices. |
| Mechanical Integrity | Engineering analysis and mechanical testing were provided. |
Study Proving Device Meets Acceptance Criteria:
The document explicitly states: "Clinical Testing: None provided as a basis of substantial equivalence."
This indicates that clinical studies were not performed to demonstrate the device meets acceptance criteria in the traditional sense of a clinical trial proving safety and efficacy. Instead, the basis for market clearance (substantial equivalence) relies on non-clinical data and comparison to predicate devices.
Given the lack of clinical testing, the following information points related to clinical studies (test sets, ground truth, expert involvement, MRMC, standalone performance, training sets) are not applicable in this case.
Therefore, for the specific questions you asked about a study proving the device meets acceptance criteria:
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A table of acceptance criteria and the reported device performance: (Provided above) The acceptance criteria are largely implied by the description and intended use of the device, and its similarity to predicate devices. The reported performance refers to its physical characteristics and functionality as designed.
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Sample size used for the test set and the data provenance: Not applicable. No clinical test set was used for substantial equivalence.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert ground truth was performed for substantial equivalence.
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Adjudication method for the test set: Not applicable.
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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: Not applicable. This device is a physical implant, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
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The sample size for the training set: Not applicable. No machine learning training set was used.
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How the ground truth for the training set was established: Not applicable.
In summary:
This 510(k) submission successfully achieved market clearance based on non-clinical testing (engineering analysis and mechanical testing) and the demonstration of substantial equivalence to existing, legally marketed predicate devices. "Substantial equivalence" here means that the new device has the same intended use and technological characteristics as the predicate devices, or if there are differences, those differences do not raise new questions of safety or effectiveness. No clinical studies were required or provided.
§ 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.