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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 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 stcnosis: curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor: pscudarthrosis: 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 allografi. 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.

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

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 sterile packaging.

This document is a 510(k) summary for the Range/Mesa/Denali Spinal System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies or establishing novel acceptance criteria for device performance beyond what is already accepted for predicate devices.

Therefore, the provided text does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert adjudication, or MRMC studies.

Here's why and what information is available:

• No specific acceptance criteria or reported device performance: The document states that "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) and the Range Spinal System was found to be substantially the same as predicate devices." This indicates that the device met existing standards (ASTM F1717) and was comparable to previously approved devices, but specific acceptance criteria and detailed performance metrics are not listed in this summary.
• No human subject studies (test set, training set, ground truth): The K141873 submission is for a spinal fixation system, which is a physical implant. The evaluation described ("static torsion, static compression and dynamic compression bending in accordance with ASTM F1717") refers to mechanical testing of the device components, not studies involving human patients or a process that would require a test set, training set, ground truth, or expert adjudication as typically seen in AI/diagnostic device submissions.
• No Multi-Reader Multi-Case (MRMC) study or Standalone AI performance: Since this is a physical medical device (spinal fixation system) and not an AI or diagnostic algorithm, these types of studies are not applicable and are not mentioned.

Summary of available information based on the request (with explanations for missing data):

Reported Device Performance: No specific numerical performance values are reported. The conclusion is that the device is "substantially the same" as predicate devices based on these performance evaluations. |
| 2. Sample size and data provenance (test set) | Not applicable. The evaluation involved mechanical testing of device constructs, not data from a human test set. |
| 3. Number/qualifications of experts (ground truth) | Not applicable. Ground truth is not established by experts for mechanical testing of a physical device. |
| 4. Adjudication method (test set) | Not applicable. No adjudication method is relevant for mechanical testing. |
| 5. MRMC comparative effectiveness study | No. This is a physical spinal fixation system, not an AI or diagnostic tool that would involve human readers or MRMC studies. |
| 6. Standalone performance (algorithm only) | No. This is a physical spinal fixation system, not an algorithm. |
| 7. Type of ground truth used | Not applicable. The "ground truth" for this type of device is compliance with mechanical testing standards (e.g., ASTM F1717) and demonstrating equivalence to predicate devices, which is based on engineering principles and test results, not expert consensus, pathology, or outcomes data in the context of human studies. |
| 8. Sample size for training set | Not applicable. There is no "training set" for a physical medical device. |
| 9. How ground truth for training set was established | Not applicable. There is no "training set" for a physical medical device. |

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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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