(88 days)
Use of the Modular Radial Head Implants 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:
- joint destruction and/or subluxation visible on x-ray; and/or
- 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 Modular Radial Head is manufactured from Cobalt Chrome (ASTM F 1537) . The stem is designed to be a two-piece modular design that is assembled at the time of implantation. The proximal portion of the head is concave and has rounded contours. The head and stem are available in standard sizes and +2 and +4 configurations.
The information provided describes a medical device submission (K991915) for a "Modular Radial Head" prosthesis. However, the provided text does not contain specific acceptance criteria, details of a clinical study, or performance metrics beyond a statement about mechanical test data.
Therefore, I cannot fulfill most of your request based on the given input. The document focuses on the regulatory submission process, intended use, and the FDA's determination of substantial equivalence.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not provided. The document states, "Mechanical test data demonstrated that it meets the requirements cited in the FDA Guidance Documents," but it does not specify what those requirements (acceptance criteria) were or what the specific test results were.
- Reported Device Performance: Not provided. Only a general statement about meeting requirements is present.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size (Test Set): Not provided. The document refers to "mechanical test data" but gives no details about the size or nature of any test set (e.g., number of implant samples, number of patients).
- Data Provenance: Not provided. There is no mention of country of origin or whether any data was retrospective or prospective. Given it's "mechanical test data," it's likely bench testing, not patient data in the typical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. The "ground truth" concept usually applies to studies involving human interpretation or clinical outcomes. This document only mentions "mechanical test data," which typically relies on established engineering standards and measurements, not expert consensus on interpretations.
4. Adjudication method for the test set:
- Not applicable / Not provided. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert opinions, which is not relevant to mechanical testing.
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:
- No. This is a medical device for orthopedic joint replacement, not an AI-assisted diagnostic tool. An MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not provided (but implied by "mechanical test data"): For mechanical testing of an implant, the "ground truth" would typically be defined by engineering specifications, material properties, and performance benchmarks (e.g., load-bearing capacity, fatigue life) measured objectively. The document does not specify these.
8. The sample size for the training set:
- Not applicable / Not provided. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. This is not an AI/machine learning device.
In summary, the provided text is a regulatory clearance letter and a summary of the device's intended use and design. It confirms that "Mechanical test data demonstrated that it meets the requirements cited in the FDA Guidance Documents" but does not detail the specific criteria, the study methodology, or the results of those mechanical tests.
§ 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.