(16 days)
Synthes 6.5mm Midfoot Fusion Bolt is indicated for fracture fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Synthes 6.5mm Midfoot Fusion Bolt is a solid metallic fixation bolt which is intended to be used in procedures involving the foot and ankle. The 6.5mm Midfoot Fusion Bolt is partially threaded on both ends and will be available in versions composed of implant quality stainless steel and titanium alloy.
The provided text is a 510(k) summary for the Synthes 6.5mm Midfoot Fusion Bolt. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, primarily through mechanical testing and comparison of design, materials, and intended use. It does not contain information about acceptance criteria or a study proving device performance in a clinical or AI-assisted context.
Therefore, I cannot populate the requested table or answer the questions related to clinical study design, AI performance, ground truth, or expert involvement. The information provided is for a traditional medical device (implantable screw/bolt) and not an AI/ML-driven diagnostic or therapeutic device.
Here's a breakdown of what can be extracted from the document based on the request, and why other parts cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not describe acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) nor does it report clinical device performance data. The "performance" discussed implicitly within a 510(k) for an implantable device like this typically refers to mechanical and material properties (e.g., fatigue strength, tensile strength, biocompatibility), which are usually compared against the predicate device or established standards. These specific performance metrics and their acceptance criteria are not detailed in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. This question refers to a test set for assessing clinical performance, likely for AI/ML. The document does not describe any clinical test sets or performance studies.
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)
- Cannot be provided. This question pertains to establishing ground truth for evaluating a diagnostic or AI system. The document does not mention any such expert panel or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. This refers to a method used to resolve discrepancies in ground truth establishment, typically in clinical studies of diagnostic tools. Not applicable to this document.
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
- Cannot be provided. This document is silent on any MRMC studies or AI assistance. The device is a surgical implant, not a diagnostic or AI tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. Not applicable. The device is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No ground truth for clinical performance is discussed. For an implant like this, "ground truth" might refer to successful implantation, fracture healing, or lack of adverse events, but no such data is presented here.
8. The sample size for the training set
- Cannot be provided. Not applicable to a physical implant. This refers to training data for AI/ML models.
9. How the ground truth for the training set was established
- Cannot be provided. Not applicable for the same reasons as above.
In summary, the provided content for the Synthes 6.5mm Midfoot Fusion Bolt is a regulatory submission for a traditional Class II medical device. It focuses on physical equivalence and safety through design, material comparison, and potentially mechanical testing (though not detailed here), rather than clinical performance studies that would involve acceptance criteria for diagnostic accuracy, AI performance, or human reader effectiveness.
§ 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.