Search Results

RANGE /DENALI/MESA and SMALL STATURE and ARI are cleared for the following indications: Non-cervical fixation as an adjunct to following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondy lolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis: and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system the Range Spinal System may also be used for the same indications as an adjunct to 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 fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft. Pediatric pedicle screw fixation is linited to a posterior approach.

The Range/Mesa/Denali Spinal System is a top-loading, multiple component, posterior (thoraciclumbar) spinal fixation system which consists of pedicle screws, rods, hooks and rod connectors The subject 510(k) adds additional screws and connectors to the system.

Function: The system functions as a spinal fixation device to provide support and stabilization of the posterior thoracic and lumbar spine.

The provided text is a 510(k) premarket notification from the FDA for a medical device called the "Range/Denali/Mesa Spinal System." This type of document focuses on establishing substantial equivalence to previously cleared devices rather than presenting new clinical study data with specific acceptance criteria and performance metrics for a novel device.

Therefore, the document does not contain the information requested in your prompt regarding:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set.
3. Data provenance (country of origin, retrospective/prospective).
4. Number of experts used to establish ground truth.
5. Qualifications of experts.
6. Adjudication method.
7. MRMC comparative effectiveness study.
8. Standalone (algorithm only) performance.
9. Type of ground truth used (pathology, outcomes data, etc.)
10. Sample size for the training set.
11. How ground truth for the training set was established.

Instead, the document states:

• Non-clinical Performance Evaluation: "Performance evaluations were previously conducted on constructs representing the worst case components (including static torsion, static compression and dynamic compression bending in accordance with ASTM F1717). Engineering rationales determined that the proposed implants were substantially the same as the predicate devices." (Page 4)

This indicates that the evaluation was based on non-clinical mechanical testing of the device's components against recognized standards (ASTM F1717) and engineering rationales to demonstrate substantial equivalence to predicate devices, not on human clinical data or the performance of an AI algorithm evaluated against ground truth established by experts.

The core of a 510(k) submission is to show that a new device is "substantially equivalent" to an already legally marketed device (predicate device), meaning it has the same intended use and the same technological characteristics, or if it has different technological characteristics, that the new characteristics do not raise different questions of safety and effectiveness. This typically relies on testing against standards and comparison to predicates, not de novo clinical studies with acceptance criteria as one might see for AI/ML devices or novel therapies.

Ask a specific question about this device