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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 to 15mm. The system includes drills, implant inserters, and sizers manufactured from medical grade stainless steel.

The provided FDA 510(k) Clearance Letter for the "SnapHammer Hammertoe Correction System" describes a medical device, specifically a metallic bone fixation fastener. This document is a regulatory clearance for a physical medical device, not a software or AI-based medical device.

Therefore, the information requested in your prompt regarding acceptance criteria and studies for an AI/software medical device (e.g., sample size for test set, data provenance, number of experts, adjudication methods, MRMC study, standalone performance, ground truth, training set information) is not applicable to the provided document.

The document states:

• "No FDA performance standards have been established for the SnapHammer Hammertoe Correction System."
• The non-clinical testing performed focused on:
  • "Engineering analysis comparing device characteristics including materials, intended use and processes (cleaning and sterilization methods)"
  • "The steam sterilization process has been validated per ISO 17665-1 & 17665-2 to a sterility assurance level of 10⁻⁶"
• The basis for equivalence is that the device "maintain[s] the same features as the previously cleared devices, but steam sterilization is being added as an alternative sterilization method."
• "This modification does not change the intended use or performance of the device and does not raise additional questions of substantial equivalence."

In summary, this clearance is for a physical orthopedic implant and is based on demonstrating substantial equivalence to a predicate device, primarily by showing that a new sterilization method does not alter its safety or efficacy, rather than AI/software performance metrics.

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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.

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