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

Non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (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, 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 and/or allograft. 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, hooks and rod connectors. The purpose of this submission is to add Mesa Hooks to the system.

Materials: The proposed devices are manufactured from Titanium Alloy per ASTM F136 and ASTM F1472.

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

Purpose of Submission: To add Mesa Hooks.

The provided text is a 510(k) summary for a medical device, the Range/Mesa/Denali Spinal System. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for proving 'acceptance criteria' in the rigorous, quantitative sense of a new, novel AI-powered device or a drug.

For a medical device like a spinal fixation system, the "acceptance criteria" are primarily related to biocompatibility, mechanical performance, and substantial equivalence to existing, legally marketed devices. The "study that proves the device meets the acceptance criteria" refers to the pre-clinical mechanical testing and the comparison to predicate devices, rather than clinical trials or AI-specific performance metrics.

Therefore, many of the requested points are not applicable to this type of regulatory submission and device. I will address the relevant points based on the provided document and note where information is not present or not applicable.

Acceptance Criteria and Study Proving Device Meets Criteria

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

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

• Sample Size: The document states "Constructs representing the worst case components were tested." It does not specify the exact number of samples tested for static and dynamic compression bending.
• Data Provenance: The testing was conducted in accordance with ASTM F1717, which are recognized standards for mechanical testing of spinal implant constructs. The location of the testing is not specified, but it would typically be a lab qualified to perform such tests on medical devices. The data is prospective, generated specifically for this submission.

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

This is not applicable to a submission for a mechanical spinal fixation system. "Ground truth" in this context refers to the defined mechanical properties and performance standards (e.g., ASTM F1717) and the performance of predicate devices. Expert consensus in the traditional sense of clinical interpretation (like image reading) is not part of this evaluation.

4. Adjudication method for the test set

Not applicable. The "test set" here refers to mechanical testing results, which are objectively measured against defined standards, not subject to human interpretation 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 mechanical implant, not an AI-powered diagnostic or assistive tool. MRMC studies are related to clinical interpretation and AI assistance, which is irrelevant for this product.

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

Not applicable. This device is a mechanical implant, not an algorithm.

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

The "ground truth" for this device's performance is established by:

• Engineering Standards: Adherence to recognized ASTM standards (F136, F1472 for materials; F1717 for mechanical testing).
• Performance of Legally Marketed Predicate Devices: The key "ground truth" for substantial equivalence is that the new device performs at least as well as, and has similar characteristics to, devices already cleared for market (K2M Range/Mesa/Denali Spinal System (K052398, K042635 K070229, K121630, K140529), Medtronic CD Horizon (K091445)).

8. The sample size for the training set

Not applicable. This device is a mechanical implant, not an AI model requiring a training set.

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

Not applicable. As above, there is no "training set" for this type of device.

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