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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.

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The Lancer Pedicle Screw System is intended to provide immobilization 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 thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion (pseudoarthrosis), degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors.

When used as a pedicle screw system, the Lancer Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The Lancer Pedicle Screw System is comprised of polyaxial pedicle screws, rods and crosslinks. The system consists of a variety of color coded top loading pedicle screws. The rods are Ø5.5mm and are available in straight and pre-lordosed (curved) configurations. The cross linkage assemblies fit over the rods to supply torsional stability to the construct.

The provided document is a 510(k) summary for the Lancer Pedicle Screw System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information you're asking for, which is typical for AI/ML device evaluations or drug trials (e.g., acceptance criteria tables with performance, sample sizes for test/training sets in an AI context, expert ground truth establishment for AI, MRMC studies, standalone algorithm performance, and training data details), is largely not applicable to this specific document.

However, I can extract the relevant "acceptance criteria" information in the context of what is provided in a 510(k) for a device like this, which primarily relates to non-clinical performance and substantial equivalence.

Here's a breakdown of the available information:

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

For a pedicle screw system, "acceptance criteria" are not reported as clinical performance metrics (like sensitivity/specificity for an AI model). Instead, acceptance criteria are met by demonstrating a device's substantial equivalence to predicate devices in terms of intended use, design, materials, and mechanical strength, along with meeting certain recognized standards for mechanical testing.

• Static compression bending
• Static torsion
• Dynamic compression bending |

Study that proves the device meets acceptance criteria:

The study proving the device meets its "acceptance criteria" (i.e., demonstrates substantial equivalence and mechanical performance) is the non-clinical testing conducted in accordance with ASTM F1717. The document states:

• "The Lancer Pedicle Screw System is substantially equivalent to the predicate devices in terms of indications for use, design, material, function and strength."
• "The following tests were conducted per ASTM F1717: Static compression bending, Static torsion, Dynamic compression bending."

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

• Sample Size for Test Set: This concept doesn't apply to this 510(k) in the way it would for an AI/ML device or clinical trial. The "test set" here refers to the actual physical devices (Lancer Pedicle Screw System components) that underwent mechanical testing. The specific number of physical samples tested is not reported in this summary, but device manufacturers typically test multiple units to meet ASTM F1717 standards.
• Data Provenance: Not applicable in the context of clinical data provenance. The data comes from in-vitro mechanical testing performed on the device components.

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)

• This question is not applicable. There is no "ground truth" in the clinical AI sense for this device as no clinical data or image interpretation by experts was involved for regulatory submission. Mechanical tests are typically performed by engineers/technicians in a laboratory setting according to established standards.

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

• This question is not applicable. Adjudication methods are relevant for clinical endpoints, especially in situations involving human interpretation or subjective assessments. Mechanical tests are objective measurements.

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

• This question is not applicable. An MRMC study is a type of clinical study used to evaluate diagnostic imaging systems or AI devices. The Lancer Pedicle Screw System is a physical implant, not an imaging or diagnostic device.

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

• This question is not applicable. This is not an AI algorithm.

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

• The "ground truth" for the mechanical performance of the device is defined by the acceptance criteria within the ASTM F1717 standard (e.g., minimum loads, fatigue life, etc.). The device passes if it meets or exceeds these pre-defined mechanical benchmarks, which are typically derived from historical data on predicate devices and clinical expectations for device durability.

8. The sample size for the training set

• This question is not applicable. There is no "training set" for physical mechanical devices in the context of this 510(k). The device's design and manufacturing process are informed by engineering principles and prior device knowledge, but not by a data-driven "training" process in the AI sense.

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

• This question is not applicable.

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