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The Precice Ankle Salvage System is indicated for tibio-talo-calcaneal fusions in adults. When used for tibio-talo-calcaneal fusion, the Precice Ankle Salvage System may be used for open and closed fracture fixation, pseudarthrosis, mal-unions, non-unions, or bone transport of long bones adjacent to the fusion site. The device may be used for subsequent limb lengthening once tibio-talo-calcaneal fusion has been achieved.

The Precice Ankle Salvage System is a tibio-talo-calcaneal fusion system that consists of the Precice Ankle Salvage nail, locking screws, end caps, and associated general instruments. The Precice Ankle Salvage nail is compatible with an accessory External Remote Controller (ERC). The Precice Ankle Salvage nail, endcap, and locking screws are supplied sterile by gamma radiation. The Precice Ankle Salvage nail contains an enclosed rare earth magnet, telescoping distraction rod, and planetary gearing which allows the length of the nail to be adjusted non-invasively by the ERC. Retraction of the Precice Ankle Salvage nail can be utilized to maintain compression across the tibio-talo-calcaneal ioints post-operatively. The Precice Ankle Salvage nail can also be used to subsequentially correct a limb length discrepancy that may result after the tibio-talo-calcaneal fusion procedure. The subject device is manufactured from medical grade Titanium alloy (Ti-6Al-4V) per ASTM F136. The Precice Ankle Salvage nail is available in various nail styles, diameters, and lengths to accommodate a variety of patient anatomies and surgeon preference. The locking screws are available in a variety of diameters, lengths, and thread styles. The ERC is available in several compatible models.

This document is a 510(k) Premarket Notification for the Precice Ankle Salvage System. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results of a device's performance against specific acceptance criteria in a human-in-the-loop or standalone AI context.

Therefore, most of the requested information regarding acceptance criteria, human reader improvement with AI assistance, sample size for test/training sets, expert qualifications, ground truth establishment, and adjudication methods cannot be extracted from the provided text because this document is a regulatory submission for a physical medical device (an intramedullary fixation rod system), not an AI/software as a medical device (SaMD).

The document describes non-clinical performance verification testing for the physical device's mechanical properties, not clinical performance for diagnostic or prognostic purposes typically associated with AI/SaMD.

Here's a breakdown of what can be extracted and what cannot:

Information that can be extracted:

• Device Name: Precice Ankle Salvage System
• Regulatory Class: Class II
• Product Code: HSB (Intramedullary Fixation Rod), HWC (Smooth or threaded metallic bone fixation fastener)
• Intended Use/Indications for Use: For tibio-talo-calcaneal fusions in adults, for fracture fixation, pseudarthrosis, mal-unions, non-unions, or bone transport of long bones adjacent to the fusion site. May be used for subsequent limb lengthening once fusion is achieved.
• Predicate Devices: Precice Ankle Salvage System (K200430) and Precice Intramedullary Limb Lengthening System (K220234).
• Material: Titanium alloy (Ti-6Al-4V) per ASTM F136.

Information that CANNOT be extracted from this document, as it pertains to AI/SaMD studies:

• Acceptance Criteria Table and Reported Device Performance (as pertains to AI/SaMD): Not applicable. The document lists mechanical tests for the physical device, not AI-driven performance metrics.
• Sample sizes used for the test set and data provenance: Not applicable for an AI study. The document refers to non-clinical mechanical testing, not a clinical study with patients/data.
• Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable. Ground truth for an AI diagnostic device is not relevant here.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not for this type of device.
• Effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Acceptance Criteria and Study for the Physical Device (as present in the document):

The document defines acceptance criteria for the mechanical performance of the physical implant and demonstrates its substantial equivalence to predicate devices through non-clinical performance verification testing.

1. A table of acceptance criteria and the reported device performance

Study that proves the device meets the acceptance criteria:

The study proving the device meets its acceptance criteria is the "Nonclinical performance verification testing" conducted by NuVasive Specialized Orthopedics, Inc.

• Type of Study: Non-clinical (benchtop) mechanical and material testing.
• Purpose: To demonstrate that the subject Precice Ankle Salvage System, with its new titanium material and minor design changes, is substantially equivalent in terms of mechanical performance to its predicate devices.
• Methodology: The device components were subjected to various mechanical tests (dynamic/static compression bending, torsion, tensile, axial pullout, insertion/ultimate torque) according to recognized ASTM standards (F1264, F543) and internal methods (Distraction and Retraction Force, Wear Debris Testing, Corrosion Assessment).
• Results/Conclusion: "The results demonstrate that the subject Precice Ankle Salvage System is substantially equivalent to the primary predicate." This implies that the device's performance metrics in these tests were comparable to or better than the predicate device, thereby meeting the necessary performance benchmarks for regulatory clearance.

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