(27 days)
To treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.
Synthes LCP Dynamic Helical Hip System is a plate and screw system that consists of a straight plate with an angled barrel that accepts a helical blade. Synthes Helical blades, ranging in lengths from 135 mm to 150 mm are to be added to this system
The provided document is a 510(k) summary for the Synthes LCP® Dynamic Helical Hip System, Additional Helix Blades. This document focuses on the substantial equivalence of a medical device to a legally marketed predicate device, rather than providing details on a study proving the device meets specific acceptance criteria in terms of performance metrics.
Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be fully retrieved from this document. The 510(k) process primarily assesses whether a new device is as safe and effective as an already marketed device, often through engineering analysis and comparison of materials, design, and indications for use.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not available. The document states that "Documentation is provided which demonstrates that the Synthes LCP Dynamic Helical Hip System, additional Helix Blades is substantially equivalent to other legally marketed Synthes devices." This implies that the 'acceptance criteria' are met by demonstrating similarity to the predicate device, not by achieving quantitative performance thresholds through a clinical study described here.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available. No clinical or performance study involving a "test set" is described in this 510(k) summary.
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 available. As no test set study is detailed, there's no information on experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available.
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 available. This device is a surgical implant (hip system), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not available. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not available.
8. The sample size for the training set
- Not available.
9. How the ground truth for the training set was established
- Not available.
Summary based on the provided document:
The 510(k) summary focuses on demonstrating that the "Synthes LCP® Dynamic Helical Hip System, Additional Helix Blades" is substantially equivalent to its predicate device, the "Synthes LCP® Dynamic Helical Hip System." The key elements for this determination are:
- Indications for Use: Both devices are intended "to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed."
- Material: Both are made of Stainless Steel.
- Description: The new device adds specific helical blade lengths (135mm to 150mm) to the existing plate and screw system.
The "study" in this context is the documentation provided to the FDA demonstrating this substantial equivalence, which primarily relies on engineering comparisons, material properties, and intended use, rather than a clinical performance study with defined acceptance criteria and performance metrics.
§ 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.