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The Partnership Calcar Femoral Components consist of a series of Titanium femoral stems with Titanium plasma spray coating that are intended to be used with Howmedica V40™ femoral heads, Howmedica Unipolar and Bipolar components, and Howmedica acetabular components in primary and revision total hip arthroplasty. These femoral stems are designed to be press fit into the proximal femur. They do not achieve fixation by biological ingrowth.

The Partnership Calcar Femoral Components consist of a family of Titanium femoral stems with Titanium plasma spray coating. The stems are intended to be used with Howmedica V40™ femoral heads, Howmedica Unipolar and Bipolar components, and Howmedica acetabular components in primary and revision total hip arthroplasty. These femoral stems are designed to be press fit into the proximal femur. They do not achieve fixation by biological ingrowth. These femoral components are manufactured from Titanium alloy, Ti-6Al-4V, which meets the requirements of ASTM specification F 136. The Titanium plasma spray coating is CP titanium, which conforms to ASTM specification F 1580.

This document is a 510(k) summary for a medical device called "Partnership Calcar Femoral Components." It describes the device, its intended use, and its substantial equivalence to other legally marketed devices. However, it does not contain a study proving the device meets specific acceptance criteria in the manner requested (e.g., performance metrics, sample sizes, expert ground truth).

Instead, the document states: "Testing has demonstrated that the fatigue load carrying capacity of the Partnership Calcar Femoral stems exceeds the minimum ISO load requirements." This indicates that a mechanical performance test was conducted, and the acceptance criterion was "exceeds the minimum ISO load requirements" for fatigue load carrying capacity.

Therefore, most of the requested information regarding sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for a diagnostic or AI-driven device is not applicable to this document, as it pertains to a mechanical medical implant, not a diagnostic or AI device.

Here's how we can extract what is present:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified (refers to "Testing" in general, not a specific number of components or a clinical study).
• Data Provenance: Not specified (implied to be laboratory testing of the device itself).

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

• Not Applicable. This is a mechanical device, not one requiring expert interpretation for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not Applicable. Mechanical testing typically relies on predefined test procedures and measurements against standards, not expert adjudication.

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:

• Not Applicable. This is a mechanical implant, not an AI or diagnostic device that would involve human readers.

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

• Not Applicable. This is a mechanical implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For the fatigue test, the "ground truth" or standard is the minimum ISO load requirements for hip prostheses. This is a technical standard, not a clinical ground truth.

8. The sample size for the training set:

• Not Applicable. This is a mechanical device, not an AI model requiring a training set.

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

• Not Applicable. No training set is involved.

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