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The TM-400 device is a Vertebral Body Replacement device intended for use in the thoracolumbar spine (T1 – L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The TM-400 device is intended for use with supplemental internal fixation systems, and may be used with autograft or allograft.

The TM-400 device is also intended for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. The TM-400 device is intended for use with supplemental internal fixation and autogenous bone graft.

The TM-400 Device is an oval shaped ALIF device for interbody fusion of the anterior column of the spine. The TM-400 Device is currently cleared to accommodate the replacement of a vertebral body in the thoracic and lumbar region of the spine. Use of this device is expanded to include use as an interbody fusion device. TM-400 Device is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-S1. The device is available in a variety of cross sections and heights to accommodate variations in the individual pathology and anatomic condition of the patient. TM-400 implants are also available in two lordotic angles 7 degree and 13 degree. The superior and inferior surfaces of the device contain a pattern of teeth to provide for initial stability. The device also has slots to mate with the insertion instrument. The TM-400 device is wholly comprised of Trabecular Metal Porous Tantalum. Surgical instrumentation for use with the proposed system are fabricated from surgical grade stainless steel and other applicable materials.

The provided text is a 510(k) summary for the Zimmer Trabecular Metal Technology, Inc. TM-400 Device. This document describes a medical device and its equivalence to predicate devices, focusing on its mechanical performance rather than AI/software performance. Therefore, most of the requested information regarding AI study design and performance criteria is not applicable.

Here's the information that can be extracted or that is not applicable, based on the document:

Acceptance Criteria and Device Performance

This document describes a medical device (an intervertebral body fusion device), not an AI/software device. The "acceptance criteria" discussed are related to the mechanical performance of the physical implant, rather than the performance of an algorithm. The study described is mechanical testing, not a clinical or AI performance study.

Note: The document states that "The results of testing and analyses conducted demonstrate that the proposed system adequately meets the predetermined requirements established for its mechanical performance." Specific numerical performance data for these tests (e.g., actual compression load, torsion values) are not provided in this summary.

Study Details (for AI/Software - Not Applicable Here)

1. 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 not an AI/software device, and there is no test set of data as would be used for an AI algorithm. The "test set" here refers to physical samples of the device undergoing mechanical stress tests in a lab.
2. 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. Ground truth, in the context of expert consensus, is not relevant for mechanical testing of a physical implant. The "ground truth" for mechanical performance would be the physical properties as measured by scientific instruments following standardized test methods.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   • Not Applicable. Adjudication methods are used in clinical studies or for establishing ground truth from expert opinions, which is not relevant for mechanical testing.
4. 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-assisted device, so no MRMC study involving human readers and AI was conducted.
5. 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.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   • Not Applicable. The "ground truth" for the device's mechanical performance is derived from the results of standardized mechanical tests (ASTM standards) in a laboratory setting, not from expert consensus, pathology, or outcomes data in the traditional sense.
7. The sample size for the training set:
   • Not Applicable. There is no training set as this is not an AI/machine learning device.
8. How the ground truth for the training set was established:
   • Not Applicable. There is no training set for this device.

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