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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. 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 skeletally mature patients recciving 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 Small Stature connectors and transition Rail/Rods to the system.

The provided document is a 510(k) summary for the K2M Range Spinal System, specifically for "Small Stature, Additional Components." This document is a premarket notification to the FDA for a medical device and does not describe a study involving patient data or AI. Instead, it focuses on demonstrating substantial equivalence to previously cleared predicate devices through design and performance characteristic comparisons.

Therefore, most of the requested information regarding acceptance criteria, device performance metrics, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this type of submission.

Here's an attempt to answer based on the information available and the nature of a 510(k) submission for spinal systems:

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

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

This submission does not involve a "test set" in the context of patient data or algorithm performance. The "testing" referred to is mechanical testing of physical implants. The document does not specify the number of implants tested or the provenance of any data beyond mechanical testing according to ASTM standards. It's a regulatory submission affirming mechanical equivalence.

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. There is no "ground truth" derived from expert review of patient data in this submission. The "ground truth" for substantial equivalence is based on engineering and regulatory review of device specifications and mechanical test results against established predicate devices.

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

Not applicable. There is no expert adjudication of a test set in this context.

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 is a medical device submission for a spinal implant system, not an AI-based diagnostic or assistive technology.

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

Not applicable. This device is a physical spinal implant system, not a software algorithm.

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

Not applicable. The "ground truth" for this 510(k) submission is the pre-established safety and effectiveness of the identified predicate devices, as demonstrated through their prior FDA clearance and mechanical testing standards (ASTM and ISO). Substantial equivalence is established by showing the new device shares fundamental technological characteristics and performance (mechanically) without raising new questions of safety or effectiveness.

8. The sample size for the training set

Not applicable. There is no training set involved as this is a physical medical device, not an AI model.

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

Not applicable. There is no training set for an AI model.

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