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The Vu e.POD Vertebral Body Replacement is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (ie. fracture).

The Vu e.POD Vertebral Body Replacement is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. Bone graft material is recommended for packing in the interior opening of the device prior to implantation.

The Vu e.POD Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems, such as the Theken Surgical. LLC, BodyForm Thoracolumbar Fixation System (K983622, Approved 12/98) or the Theken Surgical, LLC, Coral Spinal System (K041592, Approved 9/04).

The Vu e•POD Vertebral Body Replacement is comprised of PEEK concave cages with fenestrations and radii on all sides and toothed spikes used in combination with a titanium spacer component. The cages and spacer can be locked together into a variety of geometric configurations to fit each individual patient's pathology. The toothed spikes of the concave cages engage with the superior and inferior end plates of the neighboring vertebral bodies to resist rotation and migration. The Vu e•POD Vertebral Body Replacement may be used individually or in a pair depending on the surgical need, however, the device is always implanted with the construct oriented vertically.

The provided documentation describes a 510(k) submission for the "Vu e•POD Vertebral Body Replacement" device. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting a de novo clinical study with specific acceptance criteria and detailed reporting of reader performance. Therefore, the information requested in your prompt regarding acceptance criteria, study details, expert involvement, and reader performance (human or AI) is not typically part of a 510(k) summary for a spinal implant.

Instead, the submission focuses on demonstrating that the new device has the same indications for use, basic design, operating principle, materials, surgical techniques, supplemental fixation requirements, manufacturing environment, sterilization process, and packaging configurations as the predicate devices. The "study" mentioned is primarily a series of mechanical tests and design comparisons rather than a clinical trial.

Here's a breakdown based on the provided text, addressing your points where possible and noting where the information is not applicable to this type of regulatory submission:

Acceptance Criteria and Device Performance

Since this is a 510(k) submission, the "acceptance criteria" revolve around demonstrating substantial equivalence to the predicate device, not necessarily quantitative performance metrics against a predefined clinical or diagnostic standard in the way an AI/diagnostic device might have. The "device performance" is therefore implicitly that it functions equivalently to the predicate devices.

Note: The above table reflects the criteria for demonstrating substantial equivalence, which is the core "acceptance criterion" for a 510(k) device. Specific quantitative performance metrics like sensitivity, specificity, or reader improvement in an MRMC study are not applicable to this submission type.

Study Details (as inferable from a 510(k) for a spinal implant):

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

   • Test Set Sample Size: Not applicable in the context of a clinical trial. The "test set" here would refer to the physical devices subjected to mechanical testing. The number of devices tested is not specified but would typically follow ISO/ASTM standards for medical device testing.
   • Data Provenance: Not applicable. The "data" primarily consists of mechanical test results and material characterization, not patient data.

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 clinical/diagnostic sense is not established for this type of device. The ground truth for mechanical testing would be established by validated test methods and engineering principles. Expertise would come from engineers/scientists performing the tests, not medical professionals interpreting diagnostic data.

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

   • Not applicable. This concept pertains to resolving discrepancies among expert readers in diagnostic studies. For mechanical testing, resolution of discrepancies would follow standard engineering practices or test method protocols.

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 done, and it is not relevant for this type of device (a vertebral body replacement implant). This is a surgical implant, not a diagnostic AI device.

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

   • No, a standalone algorithm performance study was not done. This device is not an algorithm or AI.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not applicable in the clinical/diagnostic sense. For the mechanical testing performed, the "ground truth" is based on established engineering principles, material specifications (ASTM standards for PEEK, Tantalum, Titanium), and validated test protocols designed to assess mechanical properties like strength, fatigue, and stability.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of an algorithm or AI for this device.

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

   • Not applicable. There is no "training set" for this device.

In summary: The provided document is a 510(k) summary for a medical implant, the Vu e•POD Vertebral Body Replacement. Its regulatory pathway relies on demonstrating "substantial equivalence" to existing cleared predicate devices, primarily through comparison of design, materials, indications for use, and mechanical testing, rather than extensive clinical trials or performance assessments against specific diagnostic criteria. Therefore, most of the questions pertaining to AI/diagnostic study design (like sample size, number of experts, ground truth, MRMC studies) are not applicable to this submission.

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