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The Precice Max System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones in patients age 18 years and older and indicated for limb lengthening of the femur and tibia in pediatric patients (greater than 12 years old).

The subject Precice Max System has identical indications for use as the predicate Precice Intramedullary Limb Lengthening System (K220234), which is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, and bone transport of long bones in bones in patients age 18 years and older and indicated for limb lengthening of the femur and tibia in pediatric patients (greater than 12 years old). The subject system is designed to achieve limb correction through gradual lengthening or compression and provide intramedullary fixation for fractures of long bones. The Precice Max System includes similar devices as within the predicate Precice Intramedullary Limb Lengthening System (K220234): nail, endcaps, locking screws, surgical instruments, and remains compatible with the external remote controllers (ERC) (ERC 1, cleared via K113219; ERC 2P, cleared via K131490; or ERC 3P, cleared via K170169; or ERC 4P, cleared via K202348). The Precice Max intramedullary nail is available in various designs, lengths, and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The screws are also available in a variety of different lengths and diameters. The subject device components are manufactured from medical grade titanium alloy per ASTM F136 Standard Specification for Wrought Titanium-6Aluminum- 4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The Precice Max nail is implanted using locking screws and reusable surgical instruments.

This is a 510(k) summary for the Precice Max System, an orthopedic device, not an AI/ML powered medical device. Therefore, many of the requested categories are not applicable. However, I will extract the information that is available within the provided document.

Here's the breakdown of the acceptance criteria and study information available from the 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

For this orthopedic device, the "acceptance criteria" are typically defined by recognized ASTM standards for implantable devices, and "device performance" is demonstrated by meeting or exceeding these standards. The document states that testing was performed to demonstrate substantial equivalence to the predicate device.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" is a nonclinical performance verification testing program. The document explicitly states:

"Nonclinical performance verification testing was performed to demonstrate that the subject Precice Max System is substantially equivalent to the predicate device, Precice Intramedullary Limb Lengthening System (K220234)."

2. Sample size used for the test set and the data provenance

This information is not provided in the 510(k) summary. For nonclinical performance testing of medical devices, sample sizes are typically determined by statistical methods and regulatory guidance for biomechanical testing, but the specifics are generally not included in the public 510(k) summary. Data provenance for such tests is typically from internal lab testing conducted by the manufacturer or a contracted lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as this is not an AI/ML device relying on expert-established ground truth from a test set. The performance is assessed against established engineering standards (ASTM).

4. Adjudication method for the test set

This is not applicable. The performance is assessed against established engineering standards (ASTM) through physical testing.

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

This is not applicable. This is an orthopedic implant, not an AI/ML diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This is an orthopedic implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on established engineering standards (ASTM) for implantable devices, representing objective physical and mechanical properties.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device that requires a training set. The device's design and manufacturing rely on established engineering principles and materials science.

9. How the ground truth for the training set was established

This is not applicable.

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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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