(181 days)
The Smith & Nephew CONQUEST FN is indicated for displaced and undisplaced intracapsular femoral neck fractures.
The subject internal fixation plating system is comprised of contoured locking bone plates and compatible locking and non-locking bone screws. All described implant devices are manufactured from implant-grade stainless steel (316L) and designed for single-use. They will be provided in a sterile packaged option and will be sterilized via Gamma irradiation.
The provided text describes mechanical testing conducted for the CONQUEST FN device to demonstrate its substantial equivalence to predicate devices. However, it does not contain information about a study involving human readers or AI assistance. Therefore, questions related to MRMC studies, human reader improvement with AI, and standalone AI performance cannot be answered from the provided text.
Here's the information extracted from the document regarding the acceptance criteria and the study that proves the device meets the acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Axial Pullout Strength Evaluation (CONQUEST FN Locking screws) | Met the acceptance criteria (Specific numerical criteria not provided) | Exhibited similar or superior axial pullout strength compared to the predicate. |
| Insertion Torque Performance (CONQUEST FN locking screws) | Met the acceptance criteria (Specific numerical criteria not provided) | Exhibited similar or superior insertion torque performance compared to the predicate. |
| Removal Torque Performance (CONQUEST FN Locking screws) | Met the acceptance criterion (Specific numerical criteria not provided) | Expected to have acceptable torsional performance with regard to removal torque. |
| Torsional Strength Evaluation (CONQUEST FN Locking Screws) | Met the acceptance criteria (Specific numerical criteria not provided) | Exhibited similar or superior torsional strength compared to the predicate. |
| Construct Fatigue Testing (CONQUEST FN System) | Met the acceptance criteria (Specific numerical criteria not provided) | Expected to have similar construct stability during fatigue as compared to the predicate. |
| Construct Fatigue Evaluation (CONQUEST FN System vs. Three Cannulated Screws in a Simulated Femoral Neck Fracture Model) | Met the acceptance criteria (Specific numerical criteria not provided) | Exhibited similar or superior construct fatigue as compared to the predicate. |
| Construct Fatigue Evaluation (One-hole CONQUEST FN locking plate vs. Three Cannulated Screw) | Met the acceptance criteria by having at least similar or superior construct fatigue performance as compared to the predicate. | Met the acceptance criteria by having at least similar or superior construct fatigue performance as compared to the predicate. (Note: The text implies directly meeting the criteria, which is "similar or superior," not just "similar or superior performance" as a result). |
2. Sample Size for the Test Set and Data Provenance:
The document describes pre-clinical mechanical testing. Typically, for such tests, "sample size" refers to the number of devices or constructs tested. The specific number of samples for each test (e.g., how many screws for pullout strength, how many constructs for fatigue) is not provided in the given text.
The data provenance is from pre-clinical mechanical testing conducted by Smith & Nephew, Inc. The country of origin is not explicitly stated for the testing, but Smith & Nephew is based in Memphis, Tennessee, USA. The data is prospective as it was generated specifically for the 510(k) submission to compare the new device against predicates.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This question is not applicable to this type of mechanical testing. Ground truth in this context is established by the physical testing methods and the measured mechanical properties, not by expert consensus on images or pathology.
4. Adjudication Method for the Test Set:
This question is not applicable to mechanical testing. Adjudication methods like 2+1 or 3+1 are used for expert reviews, typically in image interpretation or clinical trials, not for direct physical measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:
No, an MRMC comparative effectiveness study was not done. The provided text focuses exclusively on pre-clinical mechanical testing of a bone fixation device, not on AI-assisted diagnostic or interpretative tasks. Therefore, there is no information on human reader improvement with or without AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm performance study was not done. The device being described is a physical medical implant (bone fixation system), not a software algorithm or AI device.
7. The Type of Ground Truth Used:
The ground truth used for these tests is mechanical performance metrics derived from standardized or accepted pre-clinical testing methods (e.g., axial pullout strength, insertion torque, torsional strength, fatigue life). The comparison is against established predicate device performance as a benchmark for substantial equivalence.
8. The Sample Size for the Training Set:
This question is not applicable. The CONQUEST FN is a physical implant, not an AI model requiring a "training set."
9. How the Ground Truth for the Training Set was Established:
This question is not applicable as there is no training set for a physical implant device.
§ 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.