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When used as an Intervertebral Body Fusion Device:

The Virtu C cervical spine devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine (C2-T1). The Virtu C device is intended to be used with autograft and/or allograft bone (allogenic bone graft comprised of cancellous and/or corticocancellous bone graft). The Virtu C device is intended to be used with a FDA cleared cervical supplemental fixation system. Patients should receive 6 weeks of non-operative treatment prior to treatment.

When used as a Vertebral Body Replacement Device:

The Virtu C device is indicated for use in the thoracolumbar spine (T1-L5) for partial or total replacement of a damaged, collapsed or unstable vertebral body due to trauma/fracture or tumor to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Virtu C device is intended to be used with autograft and/or allograft bone. The Virtu C device is intended to be used with a FDA cleared supplemental fixation device such as a lumbar pedicle screw system.

The Met 1 Technologies Virtu C Spinal Intervertebral Body Fusion Device is a cervical intervertebral body fusion device that is implanted into the invertebral body space to improve stability of the spine while supporting fusion. A variety of implant sizes are provided to accommodate individual patient anatomy. The implants are manufactured from VESTAKEEP® i4 R PEEK per ASTM F2026 and have tantalum markers per ASTM F560.

The Met 1 Technologies Virtu C Spinal Vertebral Body Replacement Device is a thoracolumbar vertebral body replacement device that is implanted to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. A variety of implant sizes are provided to accommodate individual patient anatomy. The implants are manufactured from VESTAKEEP® i4 R PEEK per ASTM F2026 and have tantalum markers per ASTM F560.

The provided document is a 510(k) summary for the Virtu C Spinal Implant, a medical device for spinal fusion and vertebral body replacement. This document primarily focuses on demonstrating substantial equivalence to predicate devices, and therefore does not contain information about a study proving device performance against acceptance criteria in the typical sense of a clinical or image-based AI study with metrics like sensitivity, specificity, or AUC.

Instead, the "performance data" referred to in this document relates to mechanical testing of the implant. The acceptance criteria are implicit in the fact that the device "demonstrated substantial equivalence" to predicate devices through these mechanical tests.

Here's an breakdown of the requested information based on the provided text, acknowledging that many fields will be "Not Applicable" due to the nature of this submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for the mechanical tests, but typically involves a set number of physical implant samples per test. This is not a "test set" in the context of clinical AI/imaging data.
• Data Provenance: Not applicable. These are mechanical laboratory tests of physical devices, not data derived from patients or real-world usage.

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

• Number of Experts: Not applicable. Ground truth for mechanical testing is established by adherence to ASTM standards and engineering principles, not through expert clinical consensus.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Mechanical test results are quantitative and objective, typically not requiring subjective adjudication.

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

• MRMC Study: No, this document does not describe an MRMC study. This type of study is relevant for diagnostic imaging devices or AI algorithms that assist human readers, not for purely mechanical implants.
• Effect Size of Human Reader Improvement: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance Study: No, this document does not describe a standalone performance study. This term is typically used for AI algorithms. The "performance data" here refers to the mechanical performance of the physical implant.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the mechanical tests, the "ground truth" (or reference standard) is the established performance characteristics and safety profiles of the identified predicate devices, as well as the specifications and limits defined by the relevant ASTM test standards (e.g., F2077, F2267). The device being tested must perform equivalently to these standards and predicates.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This is not an AI or machine learning device that requires a training set.

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

• Ground Truth Establishment: Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study described is a series of mechanical performance tests conducted on the Virtu C Spinal Implant System. These tests are:

• Static axial compression per ASTM F2077
• Static torsion per ASTM F2077
• Static subsidence per ASTM F2267
• Static expulsion per ASTM F-04.25.02.02
• Dynamic axial compression per ASTM F2077
• Dynamic torsion per ASTM F2077

The document states that the device was tested in these modes and "demonstrated substantial equivalence" to the predicate devices. This implies that the results of these tests fell within acceptable limits defined by the ASTM standards and were comparable to the known performance of the predicate devices. The acceptance criteria are, therefore, implicitly tied to meeting the performance characteristics of the legally marketed predicate devices and adhering to the specifications of the referenced ASTM standards. No specific raw data or quantitative results from these tests are provided in this 510(k) summary, only the conclusion that substantial equivalence was demonstrated.

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The VIRTU Lumbar Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1) with up to Grade 1 spondylolisthesis or retrolisthessis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at the involved level may be treated with the VIRTU Lumbar Spacer System.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the VIRTU PLIF/TLIF System.

The VIRTU Lumbar Spacer System is designed for use with autogenous bone graft to facilitate fusion. The system is also intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

The VIRTU Posterior Lumbar Spacer System consists of implants, trials and instruments. The VIRTU Lumbar Spacer System may be implanted bilaterally using a posterior (PLIF) approach, or as a single device employing a transforaminal (TLIF) approach.

This document describes a 510(k) premarket notification for the "VIRTU Lumbar Spacer System", a medical device. As such, it does not present independent clinical studies or acceptance criteria for AI/ML device performance. Instead, it demonstrates substantial equivalence to predicate devices based on non-clinical performance data.

Therefore, many of the requested categories for AI/ML device performance (like sample size for test set, ground truth experts, MRMC studies, standalone performance, training set size, etc.) are not applicable to this submission.

However, I can extract information related to the device's non-clinical performance acceptance criteria and the study that proves it meets them.

1. A table of acceptance criteria and the reported device performance

Based on the document, the acceptance criteria are implicitly tied to demonstrating performance "sufficient for its intended use" and "substantially equivalent to legally marketed predicate devices." While specific numerical acceptance criteria are not explicitly stated in the provided text, the device was tested against recognized ASTM standards. The reported device performance is that it met these standards and was found to be substantially equivalent.

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

The document does not specify the sample size for the mechanical tests. The data provenance is "non-clinical testing" conducted by the submitter (Met 1 Technologies, LLC). This is laboratory testing, not human patient data.

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. This is mechanical testing to established engineering standards, not human expert consensus. The "ground truth" is adherence to the specified ASTM testing methodologies and achieving results comparable to predicate devices.

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

Not applicable. This is mechanical testing, not a clinical trial with human disagreement.

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. This is a spinal implant device, not an AI diagnostic tool.

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

Not applicable. This is a spinal implant device, not an AI algorithm.

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

For the non-clinical performance data, the "ground truth" is adherence to established mechanical testing standards (ASTM standards) and the resultant data demonstrating the device's mechanical properties. The benchmark for "sufficient" is implied to be comparable performance to predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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