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The Nuvasive® PEEK Corpectomy Railed System is a partial or total vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The PEEK Corpectomy Railed System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft material may be used at the surgeon's discretion.

The NuVasive PEEK Corpectomy Railed System is a vertebral body replacement system manufactured from Polyetheretherketone (PEEK) Optima LT-1 conforming to ASTM F2026. The PEEK Corpectomy Railed System is made up of two primary components: a core and a set of endcaps. The core is offered in a variety of shapes and sizes to suit individual pathology and anatomical conditions of the patient. The modular endcaps are offered in multiple footprints and lordosis options.

The device contains pins made of either titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3 or tantalum conforming to ASTM F560 or ISO 13782 to serve as radiopaque markers. The System is provided non-sterile, and is designed to be sterilized by the user before each use.

This document is a 510(k) summary for a medical device called the "NuVasive® PEEK Corpectomy Railed System." It details the device's characteristics and its substantial equivalence to other legally marketed predicate devices.

Here's an analysis of the provided text in relation to your request for acceptance criteria and study information:

This document describes a medical device submission (510(k)), which primarily focuses on demonstrating "substantial equivalence" to a predicate device rather than proving performance against specific acceptance criteria for a novel AI/software product. Therefore, much of the information you requested regarding AI device performance and acceptance criteria in that context is not present. This is a traditional medical device (implant) and not an AI or software device.

However, I can extract the relevant information available within the document:

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

The document does not explicitly present a table of "acceptance criteria" with numerical targets for performance metrics in the way a software or AI device might. Instead, it relies on demonstrating mechanical equivalence to predicate devices through non-clinical testing. The "acceptance criteria" here are implicitly that the device performs at least as well as the predicate devices or meets established ASTM standards for spinal implants.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not explicitly stated in the summary for the non-clinical tests. These tests typically involve a defined number of device units (e.g., 5 or 10 per configuration) but the exact numbers are not provided.
• Data Provenance: Not applicable in the context of mechanical device testing. The tests are performed on the device itself, not on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. Mechanical testing does not involve human experts establishing ground truth in the way medical imaging or diagnostic AI would. The "ground truth" is derived from the physical properties and behavior of the device under stress, measured by engineering methods.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as this refers to human expert judgment, which is not part of mechanical 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

No. This is a physical medical device, not an AI or software product, so MRMC studies are not relevant.

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

Not applicable. This is a physical medical device; there is no algorithm or software component. The document explicitly states: "This device does not contain software or electrical equipment."

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

The "ground truth" for the mechanical testing is the established performance characteristics and safety profiles of the legally marketed predicate devices, along with the requirements specified in relevant ASTM standards (F2077). The test results must demonstrate that the subject device's performance is comparable or superior to these benchmarks.

8. The sample size for the training set

Not applicable. There is no "training set" for a physical device in the context of AI/machine learning.

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

Not applicable.

Summary of what the document does provide:

• Device Name: NuVasive® PEEK Corpectomy Railed System
• Intended Use: Partial or total vertebral body replacement in the thoracolumbar spine (T1 to L5) for tumor or fracture, to restore height, and decompress spinal cord/neural tissues. To be used with supplemental internal spinal fixation systems.
• Material: Polyetheretherketone (PEEK) Optima LT-1 conforming to ASTM F2026, with titanium alloy (Ti-6Al-4V) or tantalum radiopaque markers.
• Manufacturing State: Provided non-sterile, user-sterilized.
• Predicate Devices: NuVasive Mesh (K032476), NuVasive X-Core Expandable VBR System (K142205), Osteotech VBR (K012254), Medtronic Verte-Stack® Spinal System (K070173), and Novel VBR Spinal System (K050553).
• Performance Data: Nonclinical testing performed included static and dynamic axial compression, static and dynamic torsion (both per ASTM F2077), push-out testing, and subsidence analysis.
• Conclusion of Performance Data: "The results demonstrate that the subject PEEK Corpectomy Railed System is substantially equivalent to predicate devices. No non-clinical studies were conducted." (Note: The phrase "No non-clinical studies were conducted" seems contradictory to the previous list of non-clinical tests. This is likely a typo in the original FDA document or means 'no further non-clinical studies were needed beyond what was presented').

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