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The Trabecular Metal Vertebral Body Replacement System 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 Trabecular Metal Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Trabecular Metal Vertebral Body Replacement may be used with bone graft.

The Trabecular Metal Vertebral Body Replacement System is designed to be a replacement for a single diseased or damaged vertebral body and the adjacent disc when spinal surgery through an anterior approach is indicated. The Trabecular Metal Vertebral Body Replacement (VBR) System is comprised wholly of Trabecular Metal Porous Tantalum. The VBR is available to accommodate replacement of a vertebral body in the thoracolumbar spine. The device is available in a variety of cross sections and heights to properly tension the spine. The superior and inferior surfaces of the device have a pattern of ripples to provide increased stability.

The provided text describes a 510(k) premarket notification for a medical device, the Zimmer Trabecular Metal Vertebral Body Replacement System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a study proving the device meets those criteria in the way one would expect for a novel AI/software as a medical device (SaMD).

Here's an analysis based on the information provided, highlighting what is present and what is not:

Acceptance Criteria and Device Performance Study (as per provided text)

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are implied as meeting or being equivalent to the predicate devices and applicable standards. Specific numerical thresholds for each test (e.g., "withstanding X N of static compression") are not provided in this summary.

2. Sample Size and Data Provenance for Test Set

• Sample Size (Test Set): Not explicitly stated. The documentation refers to "test data" and "performance testing" but does not specify the number of units or samples tested for each mechanical test.
• Data Provenance: Not explicitly stated. Given the nature of mechanical and biocompatibility testing for a physical implant, the data would typically be generated in laboratory settings. There is no indication of patient data (e.g., country of origin, retrospective/prospective) because this submission is not focused on clinical performance in patients but rather on mechanical and chemical properties.

3. Number and Qualifications of Experts for Ground Truth

• Not applicable to this type of device submission. The ground truth for mechanical and biocompatibility testing is typically based on standardized testing procedures and material science principles, not expert consensus on interpretations of data like in diagnostic imaging.

4. Adjudication Method for Test Set

• Not applicable. Adjudication methods (like 2+1, 3+1) are relevant for human interpretation tasks, especially in diagnostic studies, not for the direct measurement of mechanical properties or biocompatibility of an implant.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not applicable. This study type is used to evaluate the impact of AI on human reader performance for diagnostic tasks (e.g., imaging). The Trabecular Metal Vertebral Body Replacement System is a physical implant, not a diagnostic AI device.

6. Standalone Performance (Algorithm Only)

• Not applicable. This concept pertains to AI algorithms. The device is a physical implant, so there is no "algorithm only" performance to assess in this context.

7. Type of Ground Truth Used

• Mechanical Testing Results: The "ground truth" for the mechanical tests would be the measured physical properties (e.g., strength, durability) obtained through standardized engineering tests, compared against established performance benchmarks for predicate devices and relevant ASTM/ISO standards.
• Biocompatibility Data: The "ground truth" for biocompatibility would be the results of laboratory tests (e.g., cytotoxicity, sensitization, irritation) according to ISO 10993 series standards, demonstrating that the material does not elicit an unacceptable biological response.

8. Sample Size for Training Set

• Not applicable. There is no "training set" in the context of this device. Training sets are relevant for machine learning algorithms, which are not described here.

9. How Ground Truth for Training Set Was Established

• Not applicable. (See point 8).

Summary of what the document indicates for substantial equivalence:

The Zimmer TMT Trabecular Metal Vertebral Body Replacement System demonstrated substantial equivalence by showing that it performs equivalently to the cited predicate devices (K010378, K021025, K021967, K022563, K031823, and K032527) based on mechanical performance data and biocompatibility data. The mechanical tests included static compression, dynamic compression, static torsion, dynamic torsion, and abrasion. The conclusion was that the device will perform as intended and is equivalent to the predicate devices.

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