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The Mout Blanc Spinal System is intended for noncervical pedicle fixation from the T1 to S1 vertebrae and sacral/iliac screw fixation in skeletally mature patients as an adjunct to fission for the following indications: degenerative disc disease (defined as back pain of discogence 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.

The Spineway Mont Blanc Spinal System is an implant device made from a titanium alloy TI 6Al 4V-ELI. It is to be implanted from the posterior approach. The screws are available as monobloc and monobloc reduction (traction) screws and polyaxial reduction (traction) screws in diameters from 4.0-8.0 mm and in lengths from 25-55 mm and polyaxial iliac screws of 7 and 8mm diameters with lengths from 55mm to 110mm. Rods are available in 5.5mm diameter in lengths from 40-500 mm. Hooks are available in various sizes to attach to the thoracic and lumbar spine. Transverse connectors are available in various sizes to attach to the two parallel rods. Associated instrumentation to complete the procedure is provided.

This document is a 510(k) premarket notification for a medical device and, as such, does not contain the detailed study information typically found in a scientific publication or clinical trial report. The provided text outlines the regulatory submission for the Mont Blanc Spinal System but does not describe a study that proves the device meets specific acceptance criteria in terms of a clinical or AI-based performance evaluation.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device based on pre-clinical mechanical testing and similarities in design, materials, and intended use.

Here's an breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

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

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

• Sample Size for Test Set: Not applicable in the context of this regulatory submission. The "test set" here refers to the actual physical devices undergoing mechanical testing, not a data set for an AI model. The number of samples for mechanical testing is not specified.
• Data Provenance: The device is manufactured by Spineway S.A. in Ecully, France. The pre-clinical testing was performed according to ASTM F1717-10, an international standard for spinal implant fatigue testing.

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. This document describes mechanical component testing, not a clinical study involving expert interpretation or ground truth establishment in a medical imaging or diagnostic context.

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

• Not applicable. This pertains to clinical data interpretation, not mechanical testing.

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 document is about a spinal implant system, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness is discussed.

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, not an algorithm.

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

• The "ground truth" for the mechanical testing is based on established engineering principles and the specifications within the ASTM F1717-10 standard. The "truth" is whether the device meets the mechanical performance requirements defined by this standard for similar predicate devices.

8. The sample size for the training set

• Not applicable. This document does not describe an AI/machine learning model, so there is no training set.

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

• Not applicable. As above, no AI/machine learning model is described.

In summary: The provided FDA 510(k) submission describes a spinal implant system and its regulatory clearance based on substantial equivalence to a predicate device. The "study" referenced is a set of pre-clinical mechanical tests (static compression bend, static torsion, dynamic compression bend) performed according to the ASTM F1717-10 standard. The document does not provide quantitative performance results for these tests, but concludes that they were sufficient to demonstrate equivalence. It does not involve a clinical study, human readers, AI, or any methodologies related to establishing ground truth from expert consensus or patient outcomes.

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