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The SSP Vertebral Body Replacement is a complete or partial vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to provide anterior and middle column support after removal or resection of a damaged, collapsed, or unstable vertebral body due to tumor or trauma (e.g., fracture).

The SSP Vertebral Body Replacement is intended to be used with the Specialty Spine Products Pedicle Screw System or with supplemental internal fixation systems cleared for the conditions listed above, and is intended to be used with bone graft. It is designed to provide anterior column support even in the absence of fusion for a prolonged period.

The SSP Vertebral Body Replacement is a hollow cylinder available in either 12 mm or 14 mm diameter, with height ranging from 7 mm to 13 mm in 1 mm increments. The various sizes of these implants accommodate individual patient anatomy and pathology. Wall thickness is approximately 1.5 mm. The wall of the device features an open architecture consisting of one or two rows of circumferential holes (depending on height). The ends are notched circumferentially to form a row of "teeth" along the superior and inferior margins.

This 510(k) submission for the SSP Vertebral Body Replacement describes a mechanical device, not an AI/ML-driven device or diagnostic tool. Therefore, the typical acceptance criteria and study designs associated with AI performance (like sensitivity, specificity, AUC, MRMC studies, standalone performance, etc.) are not applicable to this document.

The "acceptance criteria" for this type of medical device primarily revolve around mechanical safety and efficacy demonstrating substantial equivalence to predicate devices, as determined through a combination of:

• Mechanical Testing: To ensure the device can withstand the physiological loads and stresses it will experience in the human body.
• Biocompatibility Testing: To ensure the materials used are safe for implantation.
• Design and Material Equivalence: Comparison to legally marketed predicate devices.
• Clinical Justification/Indications for Use: Alignment with established medical practice and predicate device usage.

Based on the provided document, here's an attempt to address the prompts by reinterpreting them for a mechanical device submission where applicable, and explicitly stating when information is not present or relevant:

Acceptance Criteria and Study to Prove the Device Meets Acceptance Criteria for SSP Verteral Body Replacement

1. Table of Acceptance Criteria and Reported Device Performance

Note: This 510(k) summary does not contain detailed mechanical test results or biocompatibility data. For mechanical devices, proving "substantial equivalence" to legally marketed predicate devices (which have already met safety and effectiveness standards, including mechanical performance) often forms the primary basis for "acceptance." The FDA's letter states the device "is substantially equivalent...to legally marketed predicate devices."

Regarding the remaining questions, which are highly specific to AI/ML device evaluations:

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This is a mechanical implant, not an AI/ML diagnostic or predictive device that uses test sets of data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in the context of AI/ML diagnostic performance is not relevant for this mechanical device. The "ground truth" for this device would be its mechanical integrity and biocompatibility, typically established through laboratory testing and material science principles, or clinical outcomes for predicate devices, not expert image review.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set for AI/ML performance is involved.
• 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. An MRMC study is designed for AI-assisted diagnostic tasks, not for evaluating a spinal implant.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. There is no algorithm or AI component in this device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the AI/ML context. For this device, "ground truth" is established through engineering principles, material standards, and clinical experience with predicate devices. This includes demonstrating appropriate mechanical strength, fatigue resistance (not detailed in this summary, but would be expected in the full submission), and biological compatibility.
• 8. The sample size for the training set: Not applicable. This device does not involve machine learning; therefore, there is no training set.
• 9. How the ground truth for the training set was established: Not applicable. As above, no training set.

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