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The Exeter Ceramic Femoral Heads are intended to be used with modular femoral components in primary and secondary cementless total hip replacement procedures. These devices are intended to articulate with a polyethylene cup or a metal backed polyethylene cup component to reconstruct painful and/or severely disabled hip joints resulting from osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, avascular necrosis, subcapital fracture, or a revision of a failed femoral prosthesis. The Exeter Ceramic Femoral Heads are intended to be used with the femoral components of the previously released Exeter hip stems - and Exeter II Total Hip System (K891454).

This device is a modular femoral head component which is affixed to a femoral stem component and articulates with a polyethylene acetabular cup or a metal backed polyethylene acetabular cup to reconstruct painful and/or severely disabled hip joints resulting from osteoarthritis, theumatoid arthritis, post-traumatic arthritis, avascular necrosis, subcapital fracture or a revision of a failed femoral prosthesis. The Exeter Ceramic Femoral Heads described in this submission are a modification of a previously cleared Zirconia head (K972381) and Orthinox® head (K891454). The modification is a slight change in the taper angle of the device.

Here's an analysis of the provided text regarding the Exeter Ceramic Femoral Heads, structured to address your specific questions about acceptance criteria and the supporting study:

The provided 510(k) summary for the Exeter Ceramic Femoral Heads does not describe a study involving human subjects or AI. Instead, it focuses on the mechanical performance and substantial equivalence to previously cleared devices. Therefore, many of your questions related to clinical studies, human readers, ground truth, and training sets will not be directly applicable to this specific submission.

Here's the information extracted and interpreted based on the document:

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: Not explicitly stated as a number (e.g., "N=X heads"). The document says "All heads tested for ultimate compression strength," implying that all units intended for testing met the criteria, but the exact count of heads tested is not provided.
• Data Provenance: Not applicable in the context of human data. This was a laboratory mechanical test.

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

Not applicable. "Ground truth" in this context refers to the specified mechanical performance requirement (46 kN), which is based on an FDA guidance document, not expert consensus on human data.

4. Adjudication method for the test set

Not applicable. The "test set" here refers to the ceramic femoral heads subjected to mechanical testing. The assessment was against a single, objective numerical standard (46 kN), not a subjective assessment requiring 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

No. This document describes a medical device (femoral head for hip replacement), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI assistance are not relevant.

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

No. This is not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's acceptance was the regulatory standard for ultimate compression strength for ceramic ball hip systems, specifically: "46 kN as specified in the FDA Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems."

8. The sample size for the training set

Not applicable. There is no AI model or "training set" involved in the development of this mechanical device.

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

Not applicable. See point 8.

Summary of the K993889 Submission Focus:

The K993889 submission is a 510(k) premarket notification for a Class II medical device. Its primary purpose is to demonstrate substantial equivalence to existing, legally marketed predicate devices. This demonstration heavily relies on:

• Equivalence in intended use, materials, design, operational principles, and relative indications and contraindications.
• Performance data from mechanical testing to ensure the device meets established safety and performance standards for its type (in this case, ultimate compression strength).

The specific modification described is a "slight change in the taper angle." The mechanical testing (ultimate compression strength) confirms that this modification, and the device as a whole, maintains the required structural integrity as per FDA guidance.

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