(52 days)
Trochanteric reattachment whenever the trochanter is osteotomized in any of the procedures listed below.
- Primary total hip arthroplasty
- Revision total hip arthroplasty
- Any procedure using anterolateral or lateral approaches
The Cabling System Trochanteric Hook is made of Ti-6Al-4V. The trochanteric hook is used in conjunction with 2.0mm diameter cobalt chrome cables and cobalt chrome clamps from the Smith & Nephew Orthopaedics Cabling System (K031162). The trochanteric hook features one hook to attach to the trochanter and one hole to allow a cable to be routed through the device. The cable is routed through the hole in the device and around the femur. The cable will be tensioned and secured with a clamp. The hook is designed to prevent proximal migration of the trochanter. The device is intended for single use.
The provided document describes a 510(k) premarket notification for a medical device, the Cabling System Trochanteric Hook. It focuses on establishing substantial equivalence to previously marketed predicate devices rather than proving performance against specific acceptance criteria through a clinical study or performance testing.
Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth cannot be extracted from this document, as it is not the purpose of a 510(k) summary to provide such details.
However, I can provide the limited information available:
1. A table of acceptance criteria and the reported device performance:
This document does not specify quantitative acceptance criteria or report specific device performance metrics. The entire submission is built on the premise of substantial equivalence to predicate devices.
2. Sample size used for the test set and the data provenance:
Not applicable. This 510(k) submission does not describe a clinical or performance testing study involving a "test set" in the context of device performance evaluation. It relies on a comparison to predicate devices, which means prior data and established use were considered.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. As no new testing study is described, there is no "test set" and no experts establishing ground truth for performance.
4. Adjudication method for the test set:
Not applicable. No test set requiring adjudication 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 mechanical surgical hook, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical surgical implant, not an algorithm.
7. The type of ground truth used:
Not applicable in the context of a new performance study. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices to which the new device is compared for substantial equivalence.
8. The sample size for the training set:
Not applicable. This document does not describe a training set for an algorithm or a device.
9. How the ground truth for the training set was established:
Not applicable.
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.