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The Quantum - MIS Cannulated System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and /or lordosis), spinal tumor, and failed previous fusion (pseudoarthrosis). In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3-S1) with removal of the implants after the attainment of a solid fusion.

The Quantum - MIS Cannulated System implants are substantially equivalent to the components of a previously cleared Pioneer spinal system, with similar materials, performance, and indications for use demonstrated.

The provided text describes a 510(k) summary for a medical device called the "Quantum - MIS Cannulated System." This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the way a clinical or standalone performance study for an AI/ML device would.

Therefore, many of the requested items (e.g., sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of submission.

Here's a breakdown of the available information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria with corresponding reported performance values in the format of a table as would be expected for a clinical or AI performance study. Instead, it relies on demonstrating equivalence through adherence to recognized standards and similar characteristics to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is a 510(k) submission for a physical medical device (pedicle screw system), not an AI/ML device or diagnostic test that would typically have a "test set" in the sense of patient data. The "testing" referred to is likely mechanical and material testing, not a clinical trial or performance study on patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. Ground truth as typically defined for AI/ML or diagnostic studies (e.g., expert consensus on images, pathology results) is not relevant for this type of device submission.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.

Not applicable. This is not an AI-assisted diagnostic device where MRMC studies would be conducted.

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

Not applicable. This is not an algorithm-based device.

7. The Type of Ground Truth Used

The "ground truth" for this device, in the context of its regulatory submission, is primarily established by:

• Adherence to recognized ASTM standards for material properties and mechanical performance.
• Demonstrated equivalence to predicate devices that have already been legally marketed and proven safe and effective.
• Biocompatibility testing of materials.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for physical medical devices in this context.

9. How the Ground Truth for the Training Set was Established

Not applicable.

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