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The Trabecular Metal Vertebral Body Replacement System is comprised of vertebral body replacement devices intended for use in 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 existing, commercially available Trabecular Metal Vertebral Body Reconstruction System is intended for use in thoracolumbar (TI-L5) surgical cases to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Trabecular Metal Vertebral Body Reconstruction System is wholly comprised of Trabecular Metal Porous Tantalum (tantalum deposited on a vitreous carbon skeleton) and is available in a variety of configurations to accommodate the anatomical requirements of different patients.

The Trabecular Metal Vertebral Body Replacement System Instrumentation Set which is the subject of this premarket notification is intended for use in these thoracolumbar surgical cases and facilitates the implantation of the Trabecular Metal Vertebral Body Replacement implant system. The provisionals size the surgical site in order to determine the appropriate TM-400 implant size. The straight inserter and tamp facilitate implantation of the TM-400 implant via anterior or lateral lumbar approach. All instruments included in the set are made from 17-4 stainless steel.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study for the Trabecular Metal Vertebral Body Replacement System Instrumentation:

Device Description:
The device in question is the Trabecular Metal™ Vertebral Body Replacement System Instrumentation Set. This set facilitates the implantation of the Trabecular Metal Vertebral Body Replacement implant system in thoracolumbar (T1-L5) surgical cases. The instruments (provisional sizers, straight inserter, and tamp) are made from 17-4 stainless steel.

Lack of Specific Acceptance Criteria and Performance Data in the Summary:
It's crucial to note that the provided 510(k) summary does not explicitly state specific numerical acceptance criteria or detailed device performance metrics in a table format. The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance targets for the instrumentation set itself.

The key statement regarding performance is: "The results of testing and analyses conducted demonstrate that the worst cases of the proposed instruments adequately meet the predetermined requirements established for its mechanical performance." This is a high-level summary and lacks the granular detail requested.

Given this, I will construct the table based on the most relevant information provided about the study's scope and outcome.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample Size: Not specified. The document refers to "worst cases of the proposed instruments" and "testing and analyses," but does not provide a numerical sample size for the test set.
   • Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether it was retrospective or prospective. It is implied to be laboratory/bench testing.

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

   • This information is not provided in the 510(k) summary. The testing described appears to be mechanical/bench testing of instruments rather than a clinical study requiring expert assessment of outcomes or images.

3. Adjudication method for the test set:

   • Not applicable / Not provided. The study described is mechanical testing, which typically involves objective measurements against engineering specifications rather than human adjudication.

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:

   • No. An MRMC study was not conducted. This device is a surgical instrumentation set, not an AI-powered diagnostic tool. Therefore, a study comparing human reader performance with and without AI assistance is irrelevant and was not performed.

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

   • Not applicable. This device is a manual surgical instrument set, not an algorithm or AI system. Standalone performance of an algorithm is not relevant here.

6. The type of ground truth used:

   • The "ground truth" for this type of device (surgical instruments) would be engineering specifications and mechanical performance requirements. The test results would be compared against these predefined physical and functional specifications. The summary states "predetermined requirements established for its mechanical performance."

7. The sample size for the training set:

   • Not applicable / Not provided. This is a hardware surgical instrument set, not a machine learning or AI model. Therefore, there is no "training set" in the context of an algorithm.

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

   • Not applicable. As a manual surgical instrument set, there is no "ground truth for a training set" as would be relevant for an AI device. The design and manufacturing would adhere to established engineering principles and material science.

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