Search Results

The Modular Radial Head Replacement Device is intended for:

1. Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, creptation, 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
2. Primary replacement after fracture of the radial head
3. Symptomatic sequelae after radial head resection
4. Revision following failed radial head arthroplasty
   The device is intended for single use with bone cement.

The Modular Radial Head Replacement Device is a two-piece prosthesis consisting of a stem (Ti-6Al-4V) and a head (Co-Cr-Mo). The tapered stem is cemented into the intramedullary canal of the radius. The head has a highly polished concave surface to articulate with the natural bone of the humerus and ulna. The proximal portion of the stems are roughened with a Bond Coat surface. The components connect via a dove-tail joint secured by a locking screw. The device is available in three diameters, 18mm, 20mm and 22mm with head heights that vary from 8 to 20mm. Stems are available in six diameters with varying lengths.

The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) premarket notification for a medical device (Modular Radial Head Replacement Device).

Here's what the document indicates:

• Non-Clinical Testing and Clinical Testing: The document explicitly states "none provided as a basis of substantial equivalence." This means no new testing was submitted to demonstrate the device's performance against specific acceptance criteria.
• Substantial Equivalence: The FDA's letter confirms that the device is "substantially equivalent" to legally marketed predicate devices. This regulatory pathway relies on demonstrating that the new device is as safe and effective as a legally marketed device that is already on the market, rather than requiring new performance studies against predefined acceptance criteria.

Therefore, since no study was conducted or reported in this document to demonstrate performance against acceptance criteria, most of the requested information cannot be extracted.

Ask a specific question about this device

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.

Ask a specific question about this device