Search Results

The THUNDERBOLT™ Minimally Invasive and LANCER™ Open Pedicle Screw Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (DDD: defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

When used in a posterior percutaneous approach with MIS instrumentation, the THUNDERBOLT™ System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); spinal stenosis; deformities; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion.

The THUNDERBOLT™ and LANCER™ Pedicle Screw System is an implant device made from titanium alloy TI 6Al 4V-ELI. It is to be implanted from the posterior approach. The screws are available in diameters from 4.5-9.5mm and in lengths from 25-110mm. Rods are available in 5.5mm diameter in lengths from 30-440mm and in an array of configurations including, straight and pre-lordosed configurations. Rods are available in both titanium alloy Ti 6Al 4V-ELI and Cobalt Chrome alloy Co-28Cr-6Mo. The system includes set screws, pedicle screws, cross connectors and rods along with the associated instrumentation to complete the procedure and implant construct.

The provided document is a 510(k) summary for a medical device (THUNDERBOLT™ and LANCER™ Pedicle Screw Systems) and is primarily focused on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting detailed performance studies against specific criteria.

Therefore, most of the information requested cannot be extracted from this document, as it does not contain the level of detail regarding clinical trials, acceptance criteria, ground truth establishment, or human reader studies.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and reported device performance:

• Acceptance Criteria: Not explicitly stated as pass/fail criteria from a clinical trial in this document. The "Performance Standards" section refers to ASTM standards for mechanical testing, which implies the device must meet the requirements of these standards.
• Reported Device Performance: The document states: "The tests included static axial compression bending, static torsion and dynamic axial compression bending. The test results are substantially equivalent to those of the predicate devices." No specific numerical performance metrics are provided.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the document. This document details in-vitro mechanical testing, not clinical data with human subjects or a test set of patient data.
• Data Provenance: The document only mentions that "Performance testing was completed by an independent laboratory." No details on geographic origin or retrospective/prospective nature are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This document describes a 510(k) submission for a physical medical implant (pedicle screw system), which relies on mechanical performance testing rather than expert-derived ground truth for image analysis or diagnostic accuracy.

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

• Not applicable. This is not a study involving human readers or a diagnostic algorithm that would require adjudication.

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 is for a medical implant, not an AI/diagnostic software.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Not applicable. For mechanical testing, the "ground truth" would be the physical properties and performance characteristics as measured by the specified ASTM standards. These are objective measures rather than expert consensus or pathology.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, and the document focuses on mechanical testing, not a machine learning model with a training set.

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

• Not applicable. Similar to point 8, there is no training set mentioned or implied in the context of this device and testing.

Ask a specific question about this device