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The AIS Modulift VBR System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The AIS Modulift VBR System is intended for use with supplemental spinal fixation systems such as the Aesculap MACS TL or S4 Systems. The AIS Modulift VBR System may be used with bone graft.

The AIS Modulift VBR System is an adjustable vertebral body replacement device that is implanted into the vertebral body space to improve stability of the system is comprised of spacers and foot plates of various heights and sizes to fit the anatomical needs of a wide variety of patients. The device can be adjusted to the required height after implantation. Once it is adjusted to the desired height the column is mechanically locked in place by means of locking screws (grub screws). Each spacer has an axial hole to allow grafting material to be packed inside the device. Spikes on the end of the foot plates improve the anchoring of the implant to the vertebral body. The foot plates of the device are available in various lordotic and kyphotic angles. Components are manufactured from titanium alloy (Ti6Al4V) per ASTM F-136, and cobalt chrome (CoCr) per ASTM F1537.

The document describes the AIS Modulift VBR System, an adjustable vertebral body replacement device. This device is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). It is intended for use with supplemental spinal fixation systems and may be used with bone graft.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes non-clinical performance testing of the device. It does not provide details on specific sample sizes for each test beyond stating that "non-clinical testing was performed." The data provenance is from laboratory testing performed on the device itself, not from human data or clinical studies.

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

Not applicable. The "ground truth" for this device's performance is established by a set of ASTM and draft standards for orthopedic implants, which define the testing methodology and acceptance criteria. There is no mention of human experts establishing ground truth for the performance tests, as these are engineering and material science tests.

4. Adjudication method for the test set:

Not applicable. The tests are based on engineering standards, and the results are objective measurements against specified criteria, not subjective interpretations requiring adjudication.

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 device (vertebral body replacement system), not an AI/software device that requires human readers or clinical image interpretation.

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

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

7. The type of ground truth used:

The ground truth used for demonstrating device performance is based on established engineering standards and safety/performance benchmarks for spinal implants, specifically various ASTM standards (F2077, F2267, F1877) and a draft ASTM standard (F-04.25.02.02). The device's performance is compared against these standards and against predicate devices.

8. The sample size for the training set:

Not applicable. This refers to a physical medical device, not a machine learning model.

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

Not applicable. This refers to a physical medical device, not a machine learning model.

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