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The Omnia Medical VBR is a vertebral body replacement system indicated for use in skeletally mature patients to replace a collapsed, damaged, diseased, or unstable vertebral body due to tumor or trauma (i.e. fracture) or for reconstruction following corpectomy performed to achieve decompression of the spinal tissues. The device is intended for use in the cervical spine (from C3 to C7) and in the thoracolumbar spine (from T1-L5). The device is intended for use with supplemental fixation cleared by the FDA for use in the cervical, thoracic, or lumbar spine and is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

The Omnia Medical VBR is manufactured from PEEK-OPTIMA™ HA Enhanced and tantalum markers conforming to ASTM F560. This implant is available in two footprint sizes and offers spacers and endplates which allow for fine adjustments of the height and lordosis to accommodate various patient anatomy. The device features a hollow center and through holes for use with autograft to encourage formation of new bone. The device is intended to be used with supplemental fixation.

Based on the provided text, the document is a 510(k) Premarket Notification from the FDA to Omnia Medical, LLC, regarding their VBR (Vertebral Body Replacement) system. This document is a clearance letter, not a study report, and therefore does not contain the detailed information typically found in a study proving a device meets acceptance criteria for an AI/ML powered device. The document focuses on establishing substantial equivalence to existing predicate devices based on design, materials, and mechanical testing for a physical medical implant, not a diagnostic or prognostic algorithm that would require human-in-the-loop or standalone performance studies against acceptance criteria related to accuracy, sensitivity, or specificity.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details, as these are not relevant to the approval of this type of device (a spinal implant) based on the provided text.

The closest relevant information is about "Mechanical Testing," which supports the device's substantial equivalence.

Mechanical Testing Information (as described in the document, which serves as the "study" for this type of device):

• Study Purpose: To demonstrate substantial equivalence to predicate devices.
• Tests Conducted:
  • Static and dynamic compression per ASTM F2077
  • Static and dynamic torsion per ASTM F2077
  • Subsidence per ASTM F2267
  • Expulsion testing
• Data Provenance: The data for these tests was "presented in the reference predicate submission (K172323)." This implies the data was collected previously for another submission and reused, rather than newly generated for this specific K191778 submission.
• Device Status: "No new device designs or worst-case sizes are being introduced."
• Conclusion: The previously submitted data supports the expanded indications for use.

Summary of absent information (and why, given the document type):

1. A table of acceptance criteria and the reported device performance, sample size, data provenance: Not applicable in the context of an FDA 510(k) clearance letter for a physical implant, where performance is demonstrated through mechanical testing against standards, not clinical accuracy metrics.
2. Number of experts, qualifications, adjudication method: Not applicable for mechanical testing of a physical implant. These relate to human interpretation of data, typically for AI/ML or diagnostic devices.
3. MRMC comparative effectiveness study: Not applicable. This is for assessing the impact of AI assistance on human readers, relevant for diagnostic AI.
4. Standalone (algorithm only) performance: Not applicable. This identifies if a device is a standalone AI algorithm.
5. Type of ground truth: Not applicable in the traditional sense. The "ground truth" for a physical implant's mechanical properties is adherence to established ASTM standards under specific testing conditions.
6. Sample size for training set & how ground truth for training set was established: Not applicable. These pertain to the development of AI/ML algorithms.

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The Omnia Medical VBR is a vertebral body replacement system indicated for use to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e. fracture). The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The device is intended for use with supplemental fixation cleared for use in the thoracolumbar spine and is to be used with autograft and/or allograft.

The Omnia Medical VBR is manufactured from PEEK-OPTIMA™ HA Enhanced conforming to ASTM F2026 and tantalum markers conforming to ASTM F560. This implant is available in two footprint sizes and offers spacers and endplates which allow for fine adjustments of the height and lordosis to accommodate various patient anatomy. The device features a hollow center and through holes for use with autograft or allograft to encourage formation of new bone. The device is intended to be used with supplemental fixation.

The FDA 510(k) K172323 submission for the Omnia Medical VBR (Vertebral Body Replacement) provides the following information regarding its acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document summarizes the type of mechanical testing performed, but does not explicitly state numerical acceptance criteria or specific reported performance values. The primary acceptance criterion appears to be demonstrating substantial equivalence to the predicate device (Vu Mesh VBR, K070381) through these mechanical tests.

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions that mechanical testing was performed per ASTM F2077 and ASTM F2267. These standards typically specify the number of samples required for such tests. However, the exact sample sizes used in this specific study are not explicitly stated in the provided text.

Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Given that it's mechanical testing of a device, the data would have been generated experimentally in a lab setting, likely in the US where Omnia Medical, LLC is located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable as the study described is a mechanical performance test of a medical device, not a human or animal study requiring expert-established ground truth. The "ground truth" for mechanical testing is based on established engineering principles and ASTM standards.

4. Adjudication Method for the Test Set:

This information is not applicable for mechanical performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not conducted. This type of study is typically performed for diagnostic or AI-assisted interpretation devices involving human readers. The Omnia Medical VBR is a physical implant, and its evaluation focuses on mechanical integrity.

6. If a Standalone Performance Study Was Done:

Yes, a standalone performance study was done in the form of mechanical testing of the device itself (algorithm only without human-in-the loop performance, if we consider the device's inherent mechanical properties as its "algorithm"). The document states: "Substantial equivalence is supported by the results of mechanical testing including static and dynamic compression per ASTM F2077, static and dynamic torsion per ASTM F2077, subsidence per ASTM F2267, and expulsion testing." This indicates the device's performance was evaluated independently against established standards.

7. The Type of Ground Truth Used:

The "ground truth" for this study was based on established engineering standards and regulatory requirements (ASTM F2077, ASTM F2267) which define acceptable mechanical properties for spinal implants. The device's performance was compared to these standards and to the characteristics of a legally marketed predicate device.

8. The Sample Size for the Training Set:

This information is not applicable. Mechanical testing does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable.

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