(265 days)
Indications for the SIGN Hip Construct (SHC) include all peritrochanteric fractures of the hip with proper soft tissue management. This does not include femoral neck fractures and may include subtrochanteric fractures.
The SIGN Hip Construct (SHC) is composed of a Fin Nail Flat (Intramedullary Nail, a Rod Plate, a Rod Connector, an Interlocking Screw, two Compression Screws, a Unicortical Screw and a set of surgical instruments. Each implant component is made from stainless steel, per requirements in ASTM F138.
The provided document is a 510(k) summary for the SIGN Hip Construct (SHC). It describes a medical device, specifically a metallic bone fixation appliance, and its submission for regulatory clearance.
This document describes mechanical testing for the device, not a study involving human subjects or AI. Therefore, most of the requested information (related to AI, human readers, experts, ground truth methodologies, etc.) is not applicable.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sufficient strength for static loading modes | Demonstrated sufficient strength |
| Sufficient strength for dynamic compressive loading modes | Demonstrated sufficient strength |
| Sufficient strength for torsional loading modes | Demonstrated sufficient strength |
| Resistance to subsidence | Demonstrated resistance to subsidence |
| Resistance to expulsion | Demonstrated resistance to expulsion |
The document states: "Mechanical testing was performed on the SHC implant and the results demonstrated sufficient strength for static and dynamic compressive and torsional loading modes and resistance to subsidence and expulsion. The results did not raise any issues on the safety or effectiveness of the device."
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the mechanical testing. It also does not provide details on "data provenance" as this typically refers to patient data, which is not relevant for this type of mechanical engineering study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was a mechanical engineering study, not a study requiring expert consensus for ground truth on clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was a mechanical engineering study, not a study requiring adjudication of expert interpretations.
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
No, an MRMC study was not done. The device is a physical orthopedic implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a physical orthopedic implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this mechanical study would be established engineering standards and specifications for orthopedic implants (e.g., ASTM standards for material strength, fatigue testing protocols). The reported results indicate that the device met these intrinsic engineering performance metrics.
8. The sample size for the training set
Not applicable. This was a mechanical engineering study; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable.
§ 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.