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Synthes (USA) LCP Proximal Femur Hook Plate is intended for fractures of the femur including: fractures of the trochanteric region, trochanteric simple, cervicotrochanteric, trochanterodiaphyseal, multifragmentary pertrochanteric, intertrochanteric, intertrochanteric reversed, or transverse or with additional fracture of medial cortex. Fractures of the proximal end of the femur combined with ispsilateral shaft fractures, metastatic fracture of the proximal femur and osteotomies of the proximal femur.

The LCP Proximal Femur Hook Plates are contoured to match the anatomy of the proximal femur with a limited contact low profile design. The plate has dynamic compression holes combined with conical shaped threaded screw holes, which accept 4.5 mm cortex, 4.5 mm shaft screws, 4.0 mm or 5.0 mm locking screws, 5.0mm cannulated screws, and 7.3 mm cannulated locking & cannulated conical screws. The plates are available in a various lengths.

The provided text is a 510(k) summary for the Synthes (USA) LCP Proximal Femur Hook Plates. This document details the regulatory pathway for a medical device by demonstrating its substantial equivalence to a legally marketed predicate device.

Crucially, a 510(k) submission for this type of device (metallic bone fixation appliances) typically relies on demonstrating substantial equivalence in design, materials, and intended use to an existing predicate device, rather than on new clinical performance studies with specific accuracy metrics and ground truth evaluations like those for diagnostic AI devices.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, and comparative effectiveness studies is not applicable to this 510(k) submission.

Here's an analysis based on the available information:

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

• Not applicable. This submission doesn't present performance metrics like those for diagnostic AI devices (e.g., sensitivity, specificity, AUC). The "acceptance criteria" for a 510(k) for this type of implantable device are based on demonstrating substantial equivalence to a predicate device in terms of design, materials, and intended use, often supported by mechanical testing rather than clinical performance-based metrics. The document states: "Comparative information presented supports substantial equivalence."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. There is no "test set" in the context of clinical performance data described. Substantial equivalence is typically demonstrated through engineering analyses, bench testing, and comparison of design specifications to the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. Ground truth establishment by experts for a test set is not part of this type of 510(k) submission.

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

• Not applicable. No adjudication method for a test set 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

• Not applicable. This device is a bone fixation plate, not an AI diagnostic tool. MRMC studies are not relevant here.

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

• Not applicable. This device is a physical implant, not an algorithm.

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

• Not applicable. "Ground truth" in the diagnostic AI sense is not relevant for this device's 510(k) submission. The "ground truth" equivalent would be established engineering standards, material properties, and clinical performance data of the predicate device that the new device is compared against.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. Not an AI/machine learning device.

Summary relevant to this 510(k):

The Synthes (USA) LCP Proximal Femur Hook Plates gained market clearance through a 510(k) submission by demonstrating substantial equivalence to the Synthes (USA) LCP Proximal Femur Plates (predicate device). This means the FDA concluded that the new device is as safe and effective as the predicate device already on the market, based on a comparison of intended use, technological characteristics (design, materials), and performance (often mechanical testing for implants) without necessarily requiring new clinical trials or performance studies against specific accuracy metrics. The key information is the comparison to the predicate device, not new performance data against a specific acceptance criterion table.

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