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Cadence and Fortitude are vertebral body replacement devices that are intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with bone graft.

Cadence™ is a hollow device with texture on two opposing flat sides. The device is crafted titanium alloy (ASTM F136) and is offered in a tapered style of various sizes.

Fortitude™ is a hollow device with texture on two opposing flat sides. The device is crafted from titanium alloy (ASTM F136) and is offered in straight and tapered styles of various sizes.

This is a 510(k) premarket notification for a medical device (Spinal Concepts Inc. CadenceTM and FortitudeTM Vertebral Body Replacement systems). This type of submission is for demonstrating substantial equivalence to a predicate device, not for establishing new performance criteria through clinical studies in the same way a PMA (Premarket Approval) would.

Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria for AI/ML device performance. The "Mechanical Testing" mentioned is a general statement about functional requirements, not a detailed study with specific acceptance criteria related to a machine learning algorithm.

To explicitly answer your questions based only on the provided text:

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

   • Not provided. The document states: "Mechanical testing demonstrated that Cadence™ and Fortitude™ exhibit the functional requirements to support their use as vertebral body replacements under normal physiologic loads in the spine." This is a general statement, not a table of specific acceptance criteria and performance data.

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

   • Not applicable. This is not a study involving a test set of data for an AI/ML device.

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. This is not a study involving ground truth for an AI/ML device.

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

   • Not applicable. This is not a study involving adjudication for an AI/ML device.

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 MRMC comparative effectiveness study was done or reported.

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

   • Not applicable. This is not a standalone algorithm.

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

   • Not applicable.

8. The sample size for the training set:

   • Not applicable.

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

   • Not applicable.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, supported by general mechanical testing. It does not involve AI/ML technology or clinical studies with detailed performance metrics as you've outlined for AI acceptance criteria.

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