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The VLIFT -s system is a device intended to replace a vertebral body or an entire vertebra. It is for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body or vertebra resected or excised during total and partial corpectomy and vertebrectorny procedures due to tumor or trauma (i.e., fracture).

For both corpectorny and vertebrectorny procedures, VLIFT -s system is intended to be used with supplemental internal fixation systems. The supplemental internal fixation systems that may be used with VLIFT -s system include, but are not limited to, Stryker Spine plate or rod systems (e.g., Xia Spinal System, Radius® Spinal System, Mantis® Percutaneous Spinal System, Thore Plating System, Trio +Spinal System). The use of bone graft with VLIFT® -s system is optional.

The VLIFT®-s Distractible In-situ (DIS) Vertebral Body Replacement system is intended for use as an aid in spinal fusion and consists of a single, pre-assembled distractible implant. The hollow cylindrical center may be adjusted continuously via an inner concentric ring. The hollow core of the cage allows for packing bone graft. The use of bone graft with VLIFT®-s is optional. As the implant is distracted via its inner concentric ring, additional, slotted openings appear.

The VLIFT®-s cages are available in various diameters and heights.

Modular end caps snap into each end of the VLIFT®-s implant. Serrated teeth at the rim of the end cap attachments help to anchor the implant to the end plates of the vertebral bodies. The VLIFT®-s end caps are available in both flush and contoured designs and are offered in a variety of angles.

Extension pieces are available for each diameter for the VLIFT®-s implants. Extension pieces may be used to achieve the desired height. The use of extension pieces is optional.

The provided text is a 510(k) summary for the Stryker Spine VLIFT®-s Vertebral Body Replacement System. It describes the device, its intended use, and claims substantial equivalence to predicate devices, primarily based on material, design, indications for use, and mechanical performance.

However, this document does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in terms of clinical outcomes or diagnostic accuracy. It is a regulatory submission demonstrating substantial equivalence to previously approved devices for mechanical performance, not a clinical trial report or a diagnostic accuracy study.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated based on the document, and what cannot:

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

• Cannot be provided. The document states: "Testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s issued May 3, 2004 was completed for the Stryker Spine VLIFT®-s Vertebral Body Replacement System." This indicates that mechanical and material testing against established guidance was done, but the specific acceptance criteria (e.g., specific load ultimate strength, fatigue life cycles) and the quantitative results are not included in this summary.

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

• Cannot be provided. The summary mentions "testing... was completed," which refers to mechanical testing of the implants themselves, not a clinical study on human subjects. Therefore, terms like "test set" in the context of clinical data, data provenance, or retrospective/prospective study design are not applicable here.

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 question pertains to clinical or diagnostic studies where expert consensus is used to establish ground truth for human-reviewed data. The provided document concerns a medical device's mechanical substantial equivalence, not a diagnostic algorithm or a clinical trial with human subjects.

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

• Not applicable. See point 3.

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 a physical medical implant, not an AI or diagnostic imaging device. No MRMC study was performed as it's outside the scope of this device type.

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

• Not applicable. This is a physical medical implant, not an algorithm.

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

• The ground truth for this device's testing would be defined by engineering standards. For example, the "ground truth" for fatigue testing would be the number of cycles to failure under specified loads, and for ultimate strength, it would be the maximum load sustained before failure. This is not clinical ground truth.

8. The sample size for the training set

• Not applicable. This document describes a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.

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

• Not applicable. See point 8.

In summary: The provided 510(k) summary is a regulatory document addressing the substantial equivalence of a physical medical implant (Vertebral Body Replacement System) to predicate devices, primarily based on engineering and material characteristics. It explicitly states that "Documentation is provided which demonstrates the Stryker Spine VLIFT®-s Vertebral Body Replacement System to be substantially equivalent to its predicate devices in terms of its material, design, indications for use, and mechanical performance" and that "Testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k) 's issued May 3, 2004 was completed". This indicates that the "acceptance criteria" and "study" are focused on mechanical engineering and material property testing against FDA guidance, not clinical or diagnostic performance evaluated with human subjects or AI algorithms. The details of these engineering tests (specific criteria, results, sample sizes of test specimens) are not included in this summary.

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