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The NITINEX Memory Compression Staple is intended for hand and foot bone fragments osteotomy fixation and joint arthrodesis.

The NITINEX Memory Compression Staple is a single-use bone fixation appliance intended to be permanently implanted. The implantation of the NITINEX Memory Compression Staple facilitates hand and foot bone fragment osteotomy fixation and joint arthrodesis. NITINEX Staples are compression staples made of shape memory nickel titanium alloy, nitinol. Vilex LLC will offer NITINEX Staples ranging in width from 8-mm to 30-mm with leg lengths ranging from 8-mm to 30-mm.

The provided text is an FDA 510(k) summary for a medical device called the "NITINEX Memory Compression Staple." It focuses on demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance.

Therefore, the document does not describe acceptance criteria or a study that proves the device meets specific performance criteria in terms of clinical accuracy or diagnostic performance, such as those typically found for AI/ML-based medical devices. The assessments performed are primarily nonclinical (mechanical and corrosion testing) to confirm the device's physical properties are equivalent to the predicate.

Here's why the requested information cannot be extracted from this document:

• This is not an AI/ML device: The NITINEX Memory Compression Staple is a physical implant (a bone fixation device). The acceptance criteria and performance studies described in your prompt (e.g., diagnostic accuracy, human reader improvement with AI, ground truth establishment) are relevant for software as a medical device (SaMD) or AI-powered diagnostic tools, not for physical implants.
• 510(k) for physical devices focuses on substantial equivalence: For devices like the NITINEX staple, the 510(k) pathway primarily requires demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is typically done through comparisons of indications for use, technological characteristics, and non-clinical performance data (like mechanical strength and corrosion resistance). Clinical studies for physical implants are often more involved and specific to the device's function (e.g., healing rates, complication rates), but they are not detailed in a 510(k) summary in the way an AI performance study would be.
• The "performance data" mentioned is nonclinical: The document explicitly states: "The following nonclinical tests were performed to demonstrate the substantial equivalence of the subject device to the predicate device: Static Pullout Testing per ASTM F564-17, Bend Testing per ASTM F564-17, Cyclic Polarization Corrosion Testing per ASTM F2129-19a." These are mechanical and material property tests, not clinical performance studies involving human subjects or expert readers.

Therefore, I cannot fill out the requested table or answer the questions related to AI/ML device performance. The information provided in the document simply does not contain details about:

• Acceptance criteria for diagnostic accuracy (sensitivity, specificity, AUC)
• Sample size for test sets in an AI/ML context
• Data provenance for clinical images or patient data
• Number/qualifications of experts for ground truth establishment
• Adjudication methods for ground truth
• MRMC studies or effect sizes of human reader improvement with AI assistance
• Standalone algorithm performance
• Type of ground truth (pathology, outcomes data, expert consensus for diagnosis)
• Training set sample size or how training set ground truth was established

The document confirms the device passed the specified nonclinical tests and was found to be substantially equivalent to the predicate device in terms of mechanical strength, performance, and corrosion resistance.

If you intended to ask about the acceptance criteria and study for an AI/ML-based medical device, this document is not the correct source of information.

Ask a specific question about this device