Search Results

The Capitello-Condylar Total Elbow Prosthesis is indicated for arthroplasty of the elbow in patients suffering from rheumatoid arthritis with intractable elbow pain, limited motion, and radiographically identifiable destruction, with relative preservation of bony stock. It is also indicated for use in certain older posttraumatic or osteoarthritic patients where a relatively low activity level is anticipated. This device is intended for cemented use.

The Captiello-Condylar Total Elbow Prosthesis is an elbow replacement which relies on existing soft tissue structures such as the medial collateral ligament and triceps tendon for support and stability. The Humeral component is composed of cobalt-chromium-molybdenum (Co-Cr-Mo) alloy and has an intramedullary stem for fixation. The Ulnar component is composed of Co-Cr-Mo, with an articulating surface of ultra-high molecular weight polyethylene (UHMWPE). The device is designed to rely on soft tissue structures to support and absorb the forces which would otherwise be transmitted to the prosthesis, cement, or bone. The device is intended for use with bone cement.

The provided text describes a 510(k) submission for the Capitello-Condylar Total Elbow Prosthesis. Under a 510(k) submission, the primary goal is to demonstrate "substantial equivalence" to a predicate (already legally marketed) device, rather than proving efficacy through clinical trials with specific acceptance criteria in the same way a device seeking de novo authorization or PMA does. Therefore, the device does not have explicit acceptance criteria or a study designed to meet them in the traditional sense.

Instead, the "acceptance criteria" for a 510(k) are met by demonstrating that the new device is as safe and effective as a predicate device. This is primarily done through comparison of design, materials, manufacturing, function, and sometimes, performance testing.

Here's an analysis of the provided text in relation to your questions:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable in the context of clinical testing for establishing efficacy or safety against pre-defined clinical acceptance criteria. The "test set" here refers to the materials testing.
• Data Provenance: The device testing summary mentions "extensive evaluation testing" of the calcium stearate-free UHMWPE. This likely refers to in vitro mechanical and material property testing, not in vivo clinical data from patients. No information is provided regarding the specific origin of these test results (e.g., country of origin). It's typically conducted in a laboratory setting.
• Retrospective or Prospective: Not applicable as there are no clinical studies described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. The "test set" refers to material and mechanical property testing, where the "ground truth" is typically established by engineering standards, specifications, and laboratory measurements, not by expert clinical consensus.

4. Adjudication method for the test set

• Not applicable. No clinical test set or adjudication process is described.

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 device is a passive implantable prosthesis (an elbow replacement), not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This device is a passive implantable prosthesis.

7. The type of ground truth used

• For material properties: Engineering specifications, material standards, and benchmark performance of the predicate device's materials.
• For design/function: Comparison against the design and known function of the legally marketed predicate device, likely supported by engineering analysis.

8. The sample size for the training set

• Not applicable. This device is a passive implantable prosthesis. There is no training set as would be used for machine learning algorithms.

9. How the ground truth for the training set was established

• Not applicable. There is no training set. The "ground truth" for the device's substantial equivalence largely relies on comparing its characteristics to the well-established "truth" (safety and effectiveness) of the predicate device.

Ask a specific question about this device