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The Inertia™ 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 the thoracic, lumbar, and sacral spine (T1 to S2): severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; spinal stenosis; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

When used as a cervical intervertebral fusion devices are indicated for use at one level in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The ded for use with autogenous bone graft and with supplemental fixation systems cleared for use in the cervical spine (e.g., the Blade® Anterior Cervical Plate System).

When used as a lumbar intervertebral fusion devices the HONOUR™ devices are indicated for use at one or two contiguous levels in the lumbar soine, from L2-S1. in skeletally mature patients who have had six months of -nonoperative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous graft and with supplemental fixation systems cleared for Use in the lumbar spine (e.g., the Inertia® Pedicle Screw System).

When used as a vertebral body replacement devices are indicated for use in the thoracolumbar spine (TI-LS) for partial replacement (i.e., partial vertebrectory) of a diseased vertebral body resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues. and to restore the height of a collapsed vertebral body. The device is intended for use with autograft and with supplemental internal fixation systems cleared for use in the thoracolumbar spine (e.g., the Inertia® Pedicle Screw System).

The Facet Fixx System is intended to spine as an aid. to fusion through bilateral immobilization of the facet joints. For transfacet fixation, the screws are interior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the spinous process. through the lamina, through the inferior articular process, across the facet joint and into the pedicle.

The Facet Fixx System is intended for bilation, with or without bone graft, at single or multiple levels from C2 to S1 inclusive. The Facet Fixx System is indicated for treatment of any or all of the following:
· Degenerative disc disease (DOD) as defined by back pain of discogenic origins confirmed by history and radiographic studies

• · Degenerative disease of the facets with instability
• · Trauma (i.e. fracture or dislocation)
• · Spondylolisthesis
• · Spondylolysis
  · Pseudoarthrosis and failed previous fusion which are symptomatic or which may cause secondary instability or deformity

The Struxxure™ System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusions for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), turnor, pseudarthrosis or failed previous fusion.

The Inertia Pedicle Screw System consists of rods, polyaxial screws and set screws. Rods are available in either straight or pre-contoured (curved) forms and in a variety of lengths. Polyaxial screws are available in a variety of diameter-length combinations. Set screws are used to fasten the rod and polyaxial screw.

The HONOUR™ Spacer System is a collection of radiolucent cage devices. The basic shape of these implants is a structural column: The superior and inferior surfaces are open with serrations to facilitate implant stability. The implants are available in an assortment of height, length, width and anteroposterior angulation combinations to accommodate a variety of anatomic requirements.

The Facet Fixx™ System is a posterior facet spinal fixation system consisting of screws with and without washers. The cannulated screw is offered partially or fully threaded in various diameter and length combinations.

Struxxure TM consists of plates and screws in a variety of sizes. Plates from 1to 5-levels are offered. Fixed and variable angle screws are available in two diameters in both self-tapping and self-drilling versions.

Nexxt Spine spinal systems implants are manufactured from a variety of medical grade materials including titanium alloy (Ti-6Al-4V ELI) per ASTM F136, CP Titanium (Grade 2 or 4) per ASTM F67, Zeniva® ZA-500 polyetheretherketone per ASTM F-2026 or tantalum per ASTM F-560.

The provided text is a 510(k) summary for several spinal systems (Inertia, Honour, Facet Fixx, Struxxure) from Nexxt Spine. This document focuses on demonstrating substantial equivalence to predicate devices, primarily by showing identical technological characteristics, and does not include performance data or a study on acceptance criteria for the device itself.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance data from this document. The section "Performance Data" on page 3 of 3 explicitly states: "Performance data is not provided in this submission."

This means the document does not contain:

• A table of acceptance criteria and reported device performance.
• Details on sample size for test sets, data provenance, number/qualifications of experts, or adjudication methods for ground truth.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.
• Type of ground truth used or sample size/ground truth establishment for training sets.

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The Facet FixxTM System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle. The Facet Fixx System is intended for bilateral facet fixation, with or without bone graft, at single or multiple levels from C2 to S1 inclusive. The Facet Fixx System is indicated for treatment of any or all of the following: Degenerative disc disease (DDD) as defined by back pain of discogenic origins confirmed by history and radiographic studies, Degenerative disease of the facets with instability, Trauma (i.e. fracture or dislocation), Spondylolisthesis, Spondylolysis, Pseudoarthrosis and failed previous fusion which are symptomatic or which may cause secondary instability or deformity.

The Facet FixxTM System is a posterior facet spinal fixation system consisting of screws with and without washers. The cannulated screw is offered partially or fully threaded in various diameter and length combinations.

This device is a spinal fixation system, not an AI/ML device. Therefore, the questions related to AI/ML device performance and study design are not applicable. The provided text describes the device, its intended use, materials, and a comparison to predicate devices, focusing on mechanical performance.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not explicitly stated as a "test set" in the context of an algorithm. For mechanical testing, the number of samples tested for static/dynamic cantilever bending and axial pullout is not specified.
• Data Provenance: The mechanical testing was likely conducted in a laboratory setting, not with human patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable as this is a mechanical device, not an AI/ML diagnostic or prognostic system requiring expert-established ground truth.

4. Adjudication Method for the Test Set:

• Not applicable. Mechanical testing involves objective measurements rather than expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

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

6. Standalone Performance Study:

• Not applicable. This is not an AI/ML algorithm. The performance established is the mechanical performance of the device itself.

7. Type of Ground Truth Used:

• Mechanical Testing Results: The "ground truth" here is the objective measurement of the device's mechanical properties (static and dynamic cantilever bending, axial pullout strength) against established ASTM standards (F2193 and F543) and comparable predicate devices.

8. Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device that uses a training set.

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

• Not applicable.

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