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The device is designed for press-fitting into the human femurs for total hip replacement. This hip is indicated for patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprosthesis and/or total hip components in the affected extremity; patients with acute femoral neck fractures.

The device is identical to the predicate hip of Zimmer LFIC Hip Prosthesis, Zimmer Inc., , P.O. Box 708, Warsaw, Indiana 46581-0708, (K952776). It is intended for pressfit use into the intramedullary canal for pathological or degenerative conditions involving the femur and/or acetabulum. These stems are made of Tivanium Ti-6A1-4V Alloy and anatomic in shape.

Lateral Flare Internal Collar (LFIC), (proportional sizes). These stems are made of Tivanium Ti-6A1-4V Alloy and anatomic in shape.

The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Lateral Flare Internal Collar (LFIC)," an internal hip prosthesis. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with AI/ML device performance or clinical studies with quantifiable metrics.

The FDA 510(k) clearance process primarily establishes "substantial equivalence" to a predicate device. This often involves demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as a legally marketed predicate device. While testing (e.g., mechanical, biocompatibility) is usually performed for such devices, the level of detail regarding specific performance metrics and studies is not typically included in the summary provided in the 510(k) clearance letter itself.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be stated based on the provided text:

• Device Name: Lateral Flare Internal Collar (LFIC)

• Intended Use: The device is designed for press-fitting into the human femurs for total hip replacement. It is indicated for patients suffering from severe hip pain and disability due to various conditions such as rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprosthesis and/or total hip components in the affected extremity; and patients with acute femoral neck fractures.

The document explicitly states: "The device is identical to the predicate hip of Zimmer LFIC Hip Prosthesis, Zimmer Inc., P.O. Box 708, Warsaw, Indiana 46581-0708, (K952776). It is intended for pressfit use into the intramedullary canal for pathological or degenerative conditions involving the femur and/or acetabulum. These stems are made of Tivanium Ti-6A1-4V Alloy and anatomic in shape."

Based on the provided text, I cannot answer the following points as they are not present in the document:

1. A table of acceptance criteria and the reported device performance.
2. Sample sized used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance. (This is a traditional medical device, not an AI/ML device).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done. (This is a traditional medical device, not an AI/ML device).
7. The type of ground truth used.
8. The sample size for the training set. (This is a traditional medical device, not an AI/ML device).
9. How the ground truth for the training set was established. (This is a traditional medical device, not an AI/ML device).

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