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The nvª, nvª, and nv are intended for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device systems must be used with supplemental fixation and autograft to facilitate fusion and are implanted via an anterior, posterior, or transforaminal approach. Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation or anterior buttress plate with posterior supplemental fixation.

The nv4, nvP, and nvb are intervertebral body fusion devices used in the lumbar spine following discectomy. All devices are manufactured from PEEK Optima LT1 per ASTM F2026 or PEEK Optima HA Enhanced and include tantalum markers per ASTM F560 for radiographic visualization.

The devices have multiple footprints to adapt to the general shape of the vertebral endplates and have a hollow center to accommodate bone graft. The devices are implanted via a variety of approaches including anterior, posterior, or transforaminal. Each footprint is available in multiple heights to accommodate patient variability and there are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability, and prevent back out and migration.

The provided text describes a medical device, the nvª, nvP, and nvb intervertebral body fusion devices, and their 510(k) premarket notification to the FDA. However, it does not contain information about acceptance criteria, device performance from a clinical study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to AI/ML device testing.

This document pertains to the regulatory clearance of a physical medical implant (intervertebral body fusion device) based on its substantial equivalence to previously cleared predicate devices, primarily through non-clinical engineering analysis of mechanical performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details as they would apply to an AI/ML device, because this document is about a physical medical device and its mechanical performance, not an AI/ML algorithm.

The document explicitly states:

• "No FDA performance standards have been established for the nv4, nv7, and nv1." (Page 4)
• "The following was performed to demonstrate safety per methods of the previous submission: Engineering analysis comparison of mechanical performance in compression/ compression shear, subsidence, and expulsion (reference ASTM F2077 and F2267). The results of the engineering analysis indicate that the nv3, nvP and nv system is substantially equivalent to the predicate devices." (Page 4)

This indicates that the safety and effectiveness were demonstrated through engineering analysis and comparison to predicate devices, not through a clinical study involving human or AI evaluation with performance metrics like sensitivity, specificity, etc.

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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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