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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 Inertia™ Pedicle Screw System is 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 (T1 to S2): severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; spinal stenosis; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

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 provided text describes a 510(k) summary for the "Inertia™ Pedicle Screw System" and details the device's characteristics and performance testing. However, it does not include information about AI algorithms, ground truth establishment for AI, expert consensus, or multi-reader multi-case studies. This submission is for a traditional medical device (pedicle screw system), not an AI/ML-driven device.

Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation cannot be filled from the provided document.

Here's a breakdown of the available information based on the request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance
The document describes mechanical performance testing on the device itself, not a test set of data like an image dataset. The "sample size" here refers to the number of constructs tested. The text does not specify the exact number of constructs tested, but typical mechanical testing involves multiple samples to ensure statistical validity.

• Sample size for test set: Not explicitly stated (refers to "worst case Inertia™ Pedicle Screw System construct" without specifying the number of samples).
• Data Provenance: Not applicable in the context of device mechanical testing (no country of origin or retrospective/prospective data collection as for clinical data).

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

• Not applicable as this is a mechanical device performance study, not an AI/ML-driven medical image analysis or diagnostic study requiring expert ground truth.

4. Adjudication Method for the Test Set

• Not applicable as this is a mechanical device performance study.

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

• No. This is a traditional medical device (pedicle screw system), not an AI/ML device.

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

• No. This is a traditional medical device (pedicle screw system), not an AI/ML device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this device is its physical and mechanical performance against established engineering standards (ASTM F1717) and comparison to predicate devices, rather than a clinical ground truth like pathology or expert consensus. The "ground truth" is adherence to these mechanical standards.

8. The Sample Size for the Training Set

• Not applicable. This is a traditional medical device, not an AI/ML device that requires a training set.

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

• Not applicable. This is a traditional medical device, not an AI/ML device.

Ask a specific question about this device

The Inertia™ Pedicle Screw System is 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

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 provided text is a 510(k) summary for the Inertia™ Pedicle Screw System. It outlines the device's classification, description, intended use, and materials. Crucially, it states that "Documentation was provided which demonstrated the Inertia Pedicle Screw System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in basic design, intended use, indications, anatomic sites and mechanical performance."

This indicates that the acceptance criteria for this device were based on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices, not on a new clinical study or AI performance metrics. Therefore, the questions related to clinical study design, AI performance, expert adjudication, and training/test set details are not applicable in this context.

Here's the information derived from the provided text:

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

• Equivalence in basic design
• Equivalence in intended use
• Equivalence in indications
• Equivalence in anatomic sites
• Equivalence in mechanical performance |

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

Not applicable. The acceptance was based on substantial equivalence to predicate devices, not a clinical test set.

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. The acceptance was based on substantial equivalence to predicate devices, not a clinical test set requiring expert ground truth.

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

Not applicable. The acceptance was based on substantial equivalence to predicate devices, not a clinical test set requiring 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 device is a pedicle screw system, not an AI-assisted diagnostic or treatment device.

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

Not applicable. This device is a pedicle screw system, not an AI algorithm.

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

Not applicable. The acceptance was based on substantial equivalence to predicate devices, not a clinical study requiring ground truth.

8. The sample size for the training set

Not applicable. The acceptance was based on substantial equivalence to predicate devices, not machine learning model training.

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

Not applicable. The acceptance was based on substantial equivalence to predicate devices, not machine learning model training.

Ask a specific question about this device