(22 days)
The S-Bone Hip Tool™ is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture.
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This document is a 510(k) summary for a medical device called the "S-Bone Hip Tool™", a bone plate. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about performance studies with acceptance criteria or ground truth establishment typically associated with AI/ML devices. Therefore, I cannot provide the requested information.
The document does not contain the following information:
- Acceptance criteria and reported device performance: This document is a regulatory submission for a bone fixation device, not an AI/ML algorithm. It doesn't present performance metrics like sensitivity, specificity, or F1-score with acceptance criteria, which are common for AI/ML device evaluations.
- Sample size and data provenance for a test set: This information is not relevant to a 510(k) submission for a bone plate, where evaluation typically involves mechanical testing or clinical use data for the device itself rather than a test set for an algorithm.
- Number and qualifications of experts for ground truth: Not applicable for this type of device submission.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: This device is a physical bone plate, not an algorithm.
- Type of ground truth used: Not applicable as it's not an AI/ML device.
- Sample size for the training set: Not applicable.
- How ground truth for the training set was established: Not applicable.
Since the provided document is for a physical medical device (bone plate) and not an AI/ML powered device, the questions related to AI/ML evaluation metrics and study design are not applicable. The purpose of this 510(k) submission is to demonstrate substantial equivalence to a predicate device, which is typically done through comparison of indications for use, technological characteristics, and performance data from mechanical testing or clinical experience without the need for detailed ground truth establishment methods for an algorithm.
§ 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.