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The Innvotec Surgical SEC VBR is intended for partial vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable portion of a vertebral body, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.

The Innvotec Surgical SEC VBR 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. The Innvotec Surgical SEC VBR is always to be used with supplemental internal spinal fixation. Additionally, the Innvotec Surgical SEC VBR may be used with bone graft.

The SEC VBR acts as a spacer to maintain proper vertebral body spacing and angulation following partial corpectomy. The SEC VBR is manufactured from Ti6Al4V and stainless steel. The SEC VBR is for single level anterior spinal use from T1-L5.

This 510(k) submission for the Innvotec Surgical SEC VBR does not describe a study that uses acceptance criteria based on human or AI performance metrics. Instead, it’s a premarket notification for a medical device (spinal intervertebral body fixation orthosis) seeking substantial equivalence to existing devices.

The "acceptance criteria" and "study" described in the document relate to the physical performance and safety of the device itself, not the performance of an AI or human-AI system in tasks like disease detection or image interpretation.

Here's an analysis based on the provided text, outlining why the requested information cannot be fully provided in the context of this device and what information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation for Missing Information Regarding AI/Human Performance Studies:

The Innvotec Surgical SEC VBR is a physical medical implant, a spinal vertebral body replacement device. The 510(k) submission process for such devices focuses on demonstrating substantial equivalence to already legally marketed predicate devices in terms of:

• Intended Use
• Design and Materials
• Performance (e.g., mechanical strength, fatigue resistance, biocompatibility)
• Safety and Effectiveness

The provided text does not contain any information about:

• AI algorithms or software.
• Interpretation of medical images by humans or AI.
• Diagnostic performance (e.g., sensitivity, specificity).
• Human readers, experts, or their interpretations.
• Training or test sets for AI models.
• Ground truth derived from expert consensus or pathology for diagnostic purposes.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.

Therefore, the following sections cannot be answered based on the provided document as they are not relevant to the type of device and submission described.

2. 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 information pertains to studies evaluating the diagnostic/interpretive performance of an algorithm or human-AI system. The provided document describes the physical testing of a medical implant and its demonstration of substantial equivalence to predicate devices, primarily through adherence to ASTM standards.

3. 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. There is no "ground truth" in the diagnostic sense or expert review process described for the performance of this physical implant. The "ground truth" for the device's performance would be the scientific and engineering principles and the requirements defined by standards like ASTM F2077.

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

• Not applicable. This refers to a method used to resolve discrepancies in expert interpretation, which is not part of this device's regulatory submission.

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. No MRMC study was performed or is relevant for this type of medical implant.

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

• Not applicable. No algorithm is described for this physical device.

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

• The "ground truth" for this device's regulatory review is based on adherence to recognized performance standards (ASTM F2077), material specifications (Ti6Al4V and stainless steel), and established principles of biomechanical engineering and biocompatibility for spinal implants. There is no expert consensus or pathology data mentioned in the context of performance testing within this document.

8. The sample size for the training set

• Not applicable. No training set for an AI algorithm is mentioned or relevant to this device.

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

• Not applicable. No training set for an AI algorithm is mentioned or relevant to this device.

In summary: The provided 510(k) summary focuses on demonstrating that the Innvotec Surgical SEC VBR is substantially equivalent to predicate devices by meeting established standards for physical device performance (e.g., biomechanical testing per ASTM F2077). It does not involve AI, human interpretation of data, or studies related to diagnostic accuracy.

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