(157 days)
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:
- A table of acceptance criteria and the reported device performance: No acceptance criteria or performance results from a clinical study are provided.
- Sample size used for the test set and the data provenance: No test set from a clinical study is mentioned.
- 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.
- Adjudication method for the test set: Not applicable as there is no clinical test set.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an algorithm.
- The type of ground truth used: Not applicable as there is no clinical study with ground truth.
- The sample size for the training set: Not applicable as there is no training set for an algorithm.
- 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."
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.