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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 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): 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 non-cervical fixation in pediatic patients. The RANGE Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatic pedicle screw fixation is limited to a posterior approach.

The Range/Denali/Mesa Spinal System is a top-loading, multiple component, posterior (thoraciclumbar) spinal fixation system consisting of pedicle screws, rods, hooks and rod connectors. The purpose of this 510(k) is to add Mesa Hook-Claws to the system.

Function: The system functions as a spinal fixation device to provide support and stabilization of the posterior thoracic and lumbar spine.

This document is a 510(k) premarket notification for the K2M Range/Denali/Mesa Spinal System. It does not describe a study involving a device that uses artificial intelligence or machine learning, therefore, the requested information for acceptance criteria and study details cannot be extracted from the provided text.

The document discusses a spinal fixation system, its indications for use, comparison to predicate devices, and non-clinical mechanical performance evaluation. It confirms the mechanical testing was performed according to ASTM F1717 standards, which are physical tests, not AI model evaluations.

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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 stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudoarthosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral 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 non-cervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Range/Denali/Mesa Spinal System is a top-loading, multiple component, posterior (thoraciclumbar) spinal fixation system which consists of pedicle screws, rods, hooks and rod connectors. The subject 510(k) adds additional screws and rods to the system.

Function: The system functions as a spinal fixation device to provide support and stabilization of the posterior thoracic and lumbar spine.

This document is a 510(k) premarket notification for a medical device called the RANGE/DENALI/MESA Spinal System. It's a regulatory submission to the FDA, not a clinical study report. Therefore, much of the requested information regarding acceptance criteria and clinical study details is not present in this type of document.

However, I can extract what is available and clarify what is not.

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

This document does not provide explicit acceptance criteria or reported device performance in the context of a clinical study. Instead, it describes a "Technological Comparison to Predicate(s)" and "Non-clinical Performance Evaluation."

• Acceptance Criteria (Implicit from Non-clinical Testing): The implicit acceptance criterion for the non-clinical performance evaluation is that the proposed implants (new screws and rods) are "substantially the same as the predicate devices" in terms of design features, materials, and sizes, and perform comparably in "worst case components" testing.
• Reported Device Performance (Non-clinical):
  • Performance evaluations were previously conducted on constructs representing the worst-case components.
  • Tests included: static torsion, static compression, and dynamic compression bending.
  • These tests were performed in accordance with ASTM F1717.
  • "Engineering rationales determined that the proposed implants were substantially the same as the predicate devices."

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

This document describes non-clinical performance evaluations (mechanical testing), not a clinical test set involving human subjects. Therefore, information about human sample size, data provenance (country, retrospective/prospective) is not applicable or 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)

This is not applicable as there is no clinical test set or ground truth established by medical experts for device performance in this document. The "ground truth" for the non-clinical testing is compliance with ASTM F1717 and comparability to predicate devices.

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

This is not applicable as there is no clinical test set or adjudication process described.

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

No, an MRMC comparative effectiveness study was not done. This device is a spinal fixation system (physical implant), not an AI diagnostic tool.

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

No, this is not an algorithm or AI device.

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

For the non-clinical performance evaluation, the "ground truth" is adherence to ASTM F1717 standards and demonstrating substantial equivalence in mechanical properties to previously cleared predicate devices. There is no clinical ground truth established or used in this submission.

8. The sample size for the training set

This is not applicable as this is not an AI/machine learning device that requires a training set.

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

This is not applicable for the same reason as above.

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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); spondy lolisthesis; 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. Pediatric pedicle screw fixation is linited to a posterior approach.

The Range/Mesa/Denali Spinal System is a top-loading, multiple component, posterior (thoraciclumbar) spinal fixation system which consists of pedicle screws, rods, hooks and rod connectors The subject 510(k) adds additional screws and connectors to the system.

Function: The system functions as a spinal fixation device to provide support and stabilization of the posterior thoracic and lumbar spine.

The provided text is a 510(k) premarket notification from the FDA for a medical device called the "Range/Denali/Mesa Spinal System." This type of document focuses on establishing substantial equivalence to previously cleared devices rather than presenting new clinical study data with specific acceptance criteria and performance metrics for a novel device.

Therefore, the document does not contain the information requested in your prompt regarding:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set.
3. Data provenance (country of origin, retrospective/prospective).
4. Number of experts used to establish ground truth.
5. Qualifications of experts.
6. Adjudication method.
7. MRMC comparative effectiveness study.
8. Standalone (algorithm only) performance.
9. Type of ground truth used (pathology, outcomes data, etc.)
10. Sample size for the training set.
11. How ground truth for the training set was established.

Instead, the document states:

• Non-clinical Performance Evaluation: "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). Engineering rationales determined that the proposed implants were substantially the same as the predicate devices." (Page 4)

This indicates that the evaluation was based on non-clinical mechanical testing of the device's components against recognized standards (ASTM F1717) and engineering rationales to demonstrate substantial equivalence to predicate devices, not on human clinical data or the performance of an AI algorithm evaluated against ground truth established by experts.

The core of a 510(k) submission is to show that a new device is "substantially equivalent" to an already legally marketed device (predicate device), meaning it has the same intended use and the same technological characteristics, or if it has different technological characteristics, that the new characteristics do not raise different questions of safety and effectiveness. This typically relies on testing against standards and comparison to predicates, not de novo clinical studies with acceptance criteria as one might see for AI/ML devices or novel therapies.

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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 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); turnor: 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/Mesa/Denali Spinal System is a top-loading, multiple component, posterior (thoraciclumbar) spinal fixation system which consists of pedicle screws, rods, hooks and rod connectors The subject 510(k) adds Mesa 2 implants and connectors to the system.

Function: The system functions as a spinal fixation device to provide support and stabilization of the posterior thoracic and lumbar spine.

The provided text is related to a 510(k) premarket notification for a spinal fixation system, not a device that would typically have acceptance criteria and performance evaluated through clinical studies with ground truth. This document is a regulatory clearance from the FDA for a medical device (Range/Denali/Mesa Spinal System) based on its substantial equivalence to previously marketed predicate devices.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training and test sets cannot be extracted from this document. The document describes a "non-clinical performance evaluation" based on mechanical testing, not a study involving human data or AI algorithms.

Here's why and what information is available:

• Device Type: The device is a "Spinal Fixation System" (pedicle screws, rods, hooks, connectors) which is an implantable medical device used in orthopedic surgery. These devices are typically cleared based on mechanical performance, material compatibility, and substantial equivalence to existing devices, rather than human clinical studies with "ground truth" as you'd find for diagnostic AI algorithms.
• Regulatory Pathway: This is a 510(k) submission, which means the manufacturer is demonstrating that their new device is substantially equivalent to a legally marketed predicate device. This often relies on comparative analysis of design, materials, and mechanical testing, rather than extensive human clinical trials to establish efficacy or diagnostic performance.
• "Performance Evaluation" mentioned: The document states: "Performance evaluations were conducted on constructs representing the worst case components (including static torsion, static compression and dynamic compression bending in accordance with ASTM F1717) and the proposed implants were found to be substantially the same as predicate devices." This refers to mechanical testing in a lab setting, not a clinical study involving patients or AI.

In summary, there is no information in the provided text to fulfill your request for acceptance criteria and study details related to device performance in a clinical setting, as this document pertains to the regulatory clearance of a physical implantable device based on substantial equivalence and mechanical testing.

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