(63 days)
The Smith & Nephew Interference Screws are used for fixation of ligaments and tendons in patients requiring ligament or tendon repair.
The Smith & Nephew Titanium Interference Screws are available in various geometric configurations. The Smith & Nephew Titanium Interference Screws arc made with titanium alloy material. The range in diameters and lengths, combined with the variations in geometric configurations, provide the surgeon with a wide variety of sizes/configurations to choose from. Screws are available in both cannulated and non-cannulated styles. The screws may be purchased either sterile or non-sterile, to be sterilized by the end user.
The provided text describes a 510(k) summary for Smith & Nephew Titanium Interference Screws. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study data for acceptance criteria directly.
Here's an analysis of the provided text in relation to your requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal "acceptance criteria" with numerical thresholds as one might expect from a rigorously designed clinical or performance study for a novel device. Instead, it relies on demonstrating substantial equivalence to predicate devices. The primary performance assertion is for mechanical properties.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical properties (insertion torque and pullout force) comparable to predicate devices. | Comparison of the results of the insertion torque testing and pullout force demonstrated that there were no statistically significant differences between the Smith & Nephew Titanium Interference Screw and the predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "insertion torque testing and pullout force" but does not specify the sample size used for these tests. It also does not provide information on data provenance (e.g., country of origin, retrospective/prospective nature). These tests appear to be bench or pre-clinical engineering tests rather than clinical data from patients.
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)
This is not applicable as the provided document pertains to mechanical performance testing of an orthopedic implant rather than diagnostic accuracy or clinical interpretation studies involving expert human readers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the same reason as above. There is no mention of adjudication as it's not a diagnostic or clinical interpretation study.
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
This is not applicable. This document describes an orthopedic implant (screws) and its mechanical performance compared to predicate devices. It does not involve AI or human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable, as the device is a physical orthopedic implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical performance data (insertion torque and pullout force), the "ground truth" would be the measured values obtained from the specific testing methodologies (e.g., force gauges, torque meters) performed in a lab setting. The comparison is made against the performance of predicate devices, implying those predicate devices' performance serves as a benchmark for acceptable mechanical characteristics.
8. The sample size for the training set
This is not applicable. This is a 510(k) for an orthopedic implant, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.