Search Results

The Synthes 3.5 mm Conical Screws are intended to be used with existing Synthes LCP plating systems for fixation and interfragmentary compression of various bones, such as the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia and fibula, particularly in osteopenic bone.

The 3.5 mm conical screws are self-tapping, have a stardrive or hex drive recess, and are manufactured from stainless steel and titanium. The 3.5 mm conical screws are available in various lengths ranging from 40-95 mm.

The provided text is a 510(k) summary for the Synthes 3.5mm Conical Screws. This type of regulatory document focuses on demonstrating substantial equivalence to a predicate device, primarily through comparing device characteristics and intended use. It does not contain information about acceptance criteria or specific study results that would typically be found for a device like AI software or diagnostics.

Therefore, I cannot provide the requested information. The document focuses exclusively on the administrative and regulatory aspects of device classification and equivalence rather than performance studies that would measure metrics like sensitivity, specificity, or reader improvement.

To directly answer your request based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not available. The document is about substantial equivalence, not performance metrics.
2. Sample size used for the test set and the data provenance: Not available. No "test set" in the context of device performance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available. No ground truth establishment is described.
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 applicable. This is a bone fixation screw, not an AI-assisted device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a bone fixation screw, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available.
8. The sample size for the training set: Not applicable. No training set is mentioned for a physical medical device like this.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device