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Indications for the HipLOC™ Compression Hip Screw include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures.

The HipLOC™ Compression Hip Screw is designed as an internal fixation device to provide alignment and strong stabilization for fractures of the proximal femur.

The provided text is a 510(k) summary for the HipLOC™ Compression Hip Screw, an internal fracture fixation device. The document states that no clinical testing was performed as a basis for substantial equivalence. Therefore, it does not contain the information required to answer the prompt regarding acceptance criteria and a study proving the device meets those criteria.

The document focuses on demonstrating substantial equivalence to predicate devices (Biomet® Compression Hip Screw System, K781389; DHS® System, Synthes, K981757) based on technological characteristics and non-clinical laboratory testing.

Specifically, the following sections cannot be fulfilled based on the provided text:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or performance results from a clinical study are provided.
2. Sample size used for the test set and the data provenance: No test set from a clinical study is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth from a clinical study is mentioned.
4. Adjudication method for the test set: Not applicable as there is no clinical test set.
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 as this is not an AI/imaging device and no clinical study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an algorithm.
7. The type of ground truth used: Not applicable as there is no clinical study with ground truth.
8. The sample size for the training set: Not applicable as there is no training set for an algorithm.
9. How the ground truth for the training set was established: Not applicable as there is no training set for an algorithm.

The document explicitly states under "Non-Clinical Testing": "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." And under "Clinical Testing": "None provided as a basis for substantial equivalence."

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