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The MESA and DENALI Systems (including ARI Staples) and the EVEREST Spinal System are cleared for the following indications:

Posterior 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; pseudoarthosis; 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 MESA. DENALI and EVEREST Spinal Systems are indicated as an adjunct to fusion to treat adolescent idiopathic scollosis when used for posterior non-cervical fixation in pediatric patients. The MESA, DENALI and EVEREST 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 (Denali and Mesa) Spinal Systems are top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation systems consisting of pedicle screws, rods, hooks and rod connectors. The purpose of this 510(k) is to add revision connectors and rods to the system.

Function: The systems function as spinal fixation devices to provide support and stabilization of the posterior thoracic and lumbar spine.

This FDA 510(k) summary describes the Range (Denali and Mesa) Spinal Systems. However, it does not contain the kind of detailed information about acceptance criteria and a study that proves the device meets those criteria, as typically found in submissions for AI/ML-driven medical devices.

The document pertains to a traditional medical device (spinal fixation system) and thus the "acceptance criteria" and "study" refer to mechanical performance evaluations, not AI/ML performance.

Based on the provided text, the answer is that the document does not contain the requested information regarding acceptance criteria and a study proving an AI/ML device meets them.

Here's a breakdown of why the requested information cannot be extracted from this document, and what is present:

• 1. A table of acceptance criteria and the reported device performance: This document reports that "Mechanical testing in accordance with ASTM F1717 (including static torsion, static compression and dynamic compression bending) was conducted on constructs representing the worst case components." It states, "The test results revealed that the proposed implants were substantially the same as the predicate devices."
  • Missing: Specific numerical acceptance criteria (e.g., minimum torque, maximum displacement) and the corresponding numerical results from the K2M device. The report only states "substantially the same."
• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
  • Missing: This information is not relevant to a mechanical test of a spinal implant and is therefore not provided.
• 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):
  • Missing: This information is not relevant to mechanical testing, which relies on physical measurements and established ASTM standards, not expert interpretation.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
  • Missing: Not applicable for a mechanical performance study.
• 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:
  • Missing: This is relevant for AI/ML diagnostic or assistive devices, not for a spinal fixation system.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
  • Missing: Not applicable for a traditional medical device.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
  • Existing (for mechanical testing): The "ground truth" would be the established acceptable ranges or performance levels defined by the ASTM F1717 standard for spinal implant mechanical properties and comparison to predicate devices' performance.
• 8. The sample size for the training set:
  • Missing: No training set is involved for a mechanical implant.
• 9. How the ground truth for the training set was established:
  • Missing: No training set or ground truth in the AI/ML sense is established for this device.

In summary, the provided document is for a traditional spinal implant and reports mechanical testing for substantial equivalence, not performance criteria or studies related to AI/ML algorithms, expert review, or clinical data interpretation.

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