(274 days)
The SnapHammer Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the SnapHammer Hammertoe Correction System can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).
The SnapHammer Hammertoe Correction System is comprised of an additively manufactured titanium fixation device attached to a snap-off post. The snap-off post aids in a quick insertion and snaps off after implant has been threaded in. The implants are offered in Ø3.0mm and Ø3.50mm diameters and in lengths ranging from 12mm. The system includes drills, implant inserters, and sizers manufactured from medical grade stainless steel.
This document is a 510(k) premarket notification for a medical device called the "SnapHammer Hammertoe Correction System." It aims to demonstrate the device's substantial equivalence to previously cleared predicate devices.
However, the provided text does not contain information about a study that proves the device meets specific acceptance criteria based on human-in-the-loop performance, nor does it provide a table of acceptance criteria and reported device performance directly related to an AI/Software as a Medical Device (SaMD) product.
Instead, this document describes a hardware medical device (a bone fixation fastener) and the non-clinical (mechanical) testing performed to demonstrate its safety and efficacy.
Therefore, I cannot fulfill the request to provide:
- A table of acceptance criteria and reported device performance for an AI/SaMD.
- Sample size used for a test set or data provenance for an AI/SaMD.
- Number of experts or their qualifications for establishing ground truth for an AI/SaMD test set.
- Adjudication method for an AI/SaMD test set.
- MRMC comparative effectiveness study results.
- Standalone performance for an AI/SaMD.
- Type of ground truth used for an AI/SaMD.
- Training set sample size or how its ground truth was established for an AI/SaMD.
The document discusses "non-clinical testing" for the orthopedic implant, which includes:
- Mechanical Performance: Torsion, driving torque, and axial pullout (per ASTM F543), as well as static and dynamic bending.
- Additive Manufacturing: Tensile testing per ASTM F3001 and residual powder removal (particle analysis per ASTM F1877).
It concludes that based on these tests, the device does not raise new issues of safety or efficacy compared to the predicate devices. This implies that the acceptance criteria for these mechanical tests were met, demonstrating equivalence. However, the specific quantitative acceptance criteria or results for these mechanical tests are not detailed in this publicly available summary.
In summary, this document is about a physical medical device (hardware) and its mechanical testing, not a software or AI-based medical device. Therefore, the requested information regarding AI/SaMD acceptance criteria and study design is not present.
§ 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.