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RANGE /DENALI, MESA and SMALL STATURE and ARI are cleared for the following indications:

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. scollosis, 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 skelctally 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.

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.e. fracture or dislocation); spinal stenosis: curvatures ( i.e. 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 fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft. Pediatric pediatric pedicle screw fixation is limited to a posterior approach.

The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, locking set screws, and hooks.

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.

The purpose of this submission is to add modified Small Stature components (screws, hooks and connectors) to the system.

The provided text describes a 510(k) submission for the Range Spinal System, focusing on adding modified Small Stature components. This is a premarket notification for a medical device seeking substantial equivalence to legally marketed predicate devices, not a study reporting on the performance of an AI algorithm or diagnostic device. Therefore, much of the requested information (e.g., acceptance criteria for a diagnostic device, sample sizes for training/test sets, expert adjudication, MRMC studies, ground truth details) is not applicable to this document.

However, I can extract the relevant information regarding the device's acceptance criteria (in terms of performance) and the study that demonstrates it meets these criteria based on the provided text.

Here's a breakdown of the applicable information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated. The text refers to "modified implants" and "predicate devices" but does not quantify the number of implants or tests performed.
• Data Provenance: Not explicitly stated, but the testing was conducted in accordance with ASTM standards, suggesting a controlled testing environment rather than patient data. It is neither retrospective nor prospective in the context of a human study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not applicable. This document describes physical testing of spinal implants, not a diagnostic device requiring expert interpretation for ground truth.

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

• This information is not applicable as it pertains to expert review of diagnostic data, which is not relevant here.

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 information is not applicable. This is not an AI-assisted diagnostic device, and no human reader studies are mentioned.

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

• This information is not applicable. This document describes physical device testing, not an algorithm.

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

• The "ground truth" in this context is the performance of the predicate devices as established through prior testing (static and dynamic compression, static torsion per ASTM). The modified implants' performance in these same physical tests serves as the comparison to demonstrate substantial equivalence.

8. The sample size for the training set

• This information is not applicable. There is no training set as this is not a machine learning or AI device.

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

• This information is not applicable. There is no training set. The "ground truth" for the comparison was established by the previously validated performance of the predicate devices.

Summary of the Study:

The study proving the device meets its acceptance criteria is a mechanical performance study. The "modified implants" of the Range Spinal System were subjected to physical tests:

• Static compression
• Static torsion
• Dynamic compression

These tests were performed in accordance with ASTM standards. The results of these tests were then compared directly to the performance of predicate devices that had undergone the same battery of tests previously. The conclusion was that the modified implants were "substantially equivalent" to the predicate devices in these mechanical performance aspects, as well as in design, function, material, and intended use. This substantial equivalence determination allowed the device to proceed to market.

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