Search Results

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.

Ask a specific question about this device

When used as a vertebral body replacement, the X-spine Calix PC System is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The Calix device, when used as a vertebral body replacement, can be packed with either allograft or autograft.

When used as an intervertebral body fusion device, the X-spine Calix PC System is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implanted via an open, anterior approach and packed with autogenous bone. Patients should receive 6 weeks non-operative treatment prior to treatment with the Calix intervertebral body fusion device.

For all indications, this device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical, thoracic or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

The X-spine Calix PC System is a generally box-shaped device with various holes located throughout its geometry and teeth on the superior and inferior surfaces. The device is made from polyetheretherketone (Invibio PEEK-Optima LT1). The devices contain radiographic markers made from tantalum per ASTM F560. The technological difference between this system and the current Calix Spinal Implant System is the addition of a commercially pure titanium (CP Ti) coating per ASTM F1580 applied to the superior and inferior surfaces of each device.

The provided text describes a medical device, the Calix™ PC Spinal Implant System, and non-clinical testing performed to establish its substantial equivalence to predicate devices. However, the document does not contain information regarding a study involving acceptance criteria, device performance, or human-in-the-loop performance using AI.

Therefore, I cannot fulfill the request to provide information based on the provided input for acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

The document focuses on non-clinical biomechanical and coating characterization testing to demonstrate substantial equivalence to previously approved predicate devices, which is a common pathway for 510(k) clearances. It is not an efficacy or diagnostic performance study in the context of AI or human interpretation.

Summary of what the document does provide regarding testing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present acceptance criteria in a quantitative table with specific performance metrics and their corresponding values. It lists the types of tests conducted:

The "reported device performance" is not quantified in the document beyond stating that "biomechanical testing results indicate that the Calix PC Spinal Implant System is substantially equivalent to predicate device performance and is as effective, and performs at least as safely and effectively as the cited predicate devices." Specific numerical results or pass/fail criteria are not detailed.

Further information regarding your specific questions, as it relates to the provided text:

2. Sample sizes used for the test set and the data provenance: Not applicable. The tests are non-clinical (biomechanical and material characterization) performed on device constructs and test coupons, not on human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for non-clinical engineering tests is based on established ASTM standards and FDA guidance, not expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 document describes a medical device for spinal implant, not an AI-powered diagnostic or interpretive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests, the "ground truth" would be defined by the parameters and acceptance criteria set forth in the ASTM standards and FDA guidance documents cited for each test (e.g., specific load endurance, displacement limits, or bond strength thresholds).
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.

Ask a specific question about this device