Search Results

Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S1 vertebra in skelcially mature patients reveiving fusion by autogenous bone graft having implants attached to the lumbar and sucral spine ( L3 10 sacrum) with removal of the implants after the attainment of a solid fusion.

Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion, in skeletally mature patients, for the following indications: 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.c. fracture or dislocation); spinal stenosis; curvatures ( i.c. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Except for the ARI staples, the Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical lixation in pediatric patients. The Runge Spinal System for pediatric use is intended to be used with autografi. Pediatric pediale screw fixation is limited to a posterior approach.

Device Description

The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, hooks and rod connectors. The purpose of this submission is to add modified rods and hooks and to incorporate previously cleared implants that were not included in the pediatric submission.

Materials: The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What they tested for)	Reported Device Performance (How the device performed)
Static/dynamic compression bending and static torsion (worst-case constructs)	Constructs representing the worst case components were previously tested in static/dynamic compression bending and static torsion in accordance with ASTM F1717 and were determined to be substantially equivalent to predicate devices. The modified implants were determined to not represent a new worst case.
Substantial Equivalence to Predicate Devices	Substantially equivalent in design, function, material, and intended use to predicate devices and other devices currently marketed.

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

Sample Size: The document refers to "Constructs representing the worst case components." It does not specify a numerical sample size but implies a selection of representative configurations rather than a large statistical sample of individual implants.
Data Provenance: The study was a comparison to previously tested predicate devices. The document does not explicitly state the country of origin or whether the data for the Range Spinal System was retrospective or prospective, but it's implied to be data generated to support the 510(k) submission.

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

This document describes a mechanical performance study, not a clinical study involving ground truth established by medical experts for a test set. Therefore, this section is not applicable to this submission. The "ground truth" here is the performance according to ASTM standards and comparison to predicate devices.

4. Adjudication Method for the Test Set

This document describes a mechanical performance study, not a clinical study requiring adjudication of expert interpretations. Therefore, this section is not applicable to this submission. The results were likely validated by engineers and testing personnel.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This is a submission for a spinal fixation system, and the studies described are mechanical performance tests comparing the device to predicates, not clinical studies evaluating human reader performance with or without AI assistance.

6. Standalone Performance Study (Algorithm only without Human-in-the-loop performance)

This question is not applicable. The device is a physical spinal implant system, not an algorithm or AI software. The performance studies conducted were mechanical strength and durability.

7. Type of Ground Truth Used

The "ground truth" for this submission is based on engineering standards (ASTM F1717) and direct comparative mechanical testing against predicate devices. The performance of the Range Spinal System was measured against established benchmarks for spinal fixation devices.

8. Sample Size for the Training Set

This question is not applicable. This is not an AI/machine learning device that requires a training set. The "training" for such a device is the engineering design and manufacturing process to meet specified standards.

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

This question is not applicable. As stated above, this is not an AI/machine learning device.

Ask a Question

Ask a specific question about this device

Page 1 of 1