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The Camber Spine Technologies SPIRA-VTM Open Matrix Corpectomy Cage is indicated for use in the Thoracolumbar Spine (T1-L5) to replace collapsed, or an unstable vertebral body due to tumor or trauma (i.e., fracture). The Camber Spine Technologies SPIRA-VTM Open Matrix Corpectomy is intended to be used with additional FDA-cleared supplementary fixation systems.

The Camber Spine Technologies SPIRA-VTM Open Matrix Corpectomy Cage system must be used with autogenous graft material.

Device Description

The Camber Spine Technologies SPIRA-VIM Open Matrix Corpectomy Cage is a device that has spiral supports to allow for a hollow chamber to permit packing with autogenous bone to facilitate fusion. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place.

AI/ML Overview

The provided document is a 510(k) premarket notification letter for a medical device called the "Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage." This document focuses on demonstrating that the new device is substantially equivalent to existing, legally marketed predicate devices. It does not describe an AI medical device or a study involving human readers or AI assistance.

Therefore, many of the requested criteria related to AI performance, human expert evaluation, and multi-reader multi-case studies are not applicable to this document.

However, I can extract information related to the device's performance testing and acceptance criteria as described in the summary:

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

Test Method	Acceptance Criteria	Reported Device Performance
Static Compression	Defined by predicate device performance (presumably, the device should be at least as strong as the predicate).	Met the acceptance criteria defined by predicate device performance.
Static Torsion	Defined by predicate device performance.	Met the acceptance criteria defined by predicate device performance.
Dynamic Compression	Defined by predicate device performance.	Met the acceptance criteria defined by predicate device performance.
Dynamic Torsion	Defined by predicate device performance.	Met the acceptance criteria defined by predicate device performance.
Subsidence	Defined by predicate device performance.	Met the acceptance criteria defined by predicate device performance.
Expulsion	Defined by predicate device performance.	Met the acceptance criteria defined by predicate device performance.
Particulate Analysis (ASTM F1877-16)	Not explicitly stated what the acceptance criteria were for particulate analysis, but it would involve limits on particle size and quantity.	Performed, and results demonstrate met criteria (implicit from the summary).

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

This document describes mechanical testing of a physical device, not an AI model or clinical data.
The "test set" in this context refers to the physical samples of the SPIRA-V™ Open Matrix Corpectomy Cage that underwent mechanical testing. The exact number of samples tested for each criterion is not specified in the provided text.
"Data provenance" is not applicable in the sense of patient data origin; instead, it would relate to how the physical test specimens were manufactured and handled, which is not detailed here.

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

Not applicable. This is a mechanical device, not an AI system requiring expert interpretation for ground truth establishment.

4. Adjudication method for the test set:

Not applicable. No adjudication of human interpretations is involved as it's mechanical testing. The "ground truth" for mechanical properties is determined by the physical measurements themselves against established standards.

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:

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used:

For the mechanical tests, the "ground truth" is established through physical measurements against validated ASTM (American Society for Testing and Materials) standards and comparison to the mechanical performance of legally marketed predicate devices. The aim is to show the device is "as mechanically sound as predicate devices."

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable.

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