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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 Spinal System components are non-cervical spinal fixation devices intended as an adjunct to fusion for use as a pedicle screw system (T1 - S2), posterior hook (TI-L5) sacral/iliac screw fixation or as an anterolateral fixation system (T8 - L5). Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

The Quantum Spinal System (including MIS) consists of a variety of rods, fixed and polyaxial screws, transverse connectors, and locking caps used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.

The Quantum Spinal System (including MIS) are intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic and/or lumbar spine. The implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

The Quantum Spinal System (including MIS) components are comprised of Titanium Alloy Ti6A14V per ASTM F136. A subcomponent of the locking cap, a spring clip, is comprised of nitinol (NiTi) per ASTM F 2063. All components of the Quantum Spinal System (including MIS) HA Coated Pedicle Screws (Non-Cannulated and Cannulated) are comprised of Titanium Alloy Ti6Al4V per ASTM F136 and have a hydroxyapatite (HA) coating.

The purpose of this submission is to include HA coated pedicle screws to the Quantum Spinal System (including MIS).

This document describes the acceptance criteria and the study conducted for the Pioneer Quantum Spinal System (including MIS) HA Coated Pedicle Screws (Non-Cannulated and Cannulated). This is a medical device, and the evaluation for substantial equivalence to a predicate device is based on non-clinical mechanical tests, not an AI/algorithm-based system. Therefore, many standard AI/ML study components (like sample sizes for test/training sets, ground truth by experts, MRMC studies, standalone algorithm performance) are not applicable.

Here's the breakdown based on the provided text, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implicitly states that the performance met the criteria by concluding "the subject device demonstrates substantial equivalence to the listed predicate devices" based on the performed mechanical tests. Specific numerical acceptance criteria are not detailed in this summary.

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

Since this is a mechanical device evaluation, the "test set" refers to the physical devices and components subjected to testing, not a dataset of patient information.

• Sample Size for Test Set: Not explicitly stated as a number of devices/components, but the described tests would have involved multiple samples to ensure reproducibility and statistical significance.
• Data Provenance: The tests were conducted by the manufacturer, Pioneer Surgical Technology. The data is based on laboratory mechanical testing (non-clinical) of prototype or production-representative devices. There is no information about country of origin of data or retrospective/prospective in the context of patient data.

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

• Not Applicable. This is a mechanical device. "Ground truth" in this context would be physical measurements and engineering analyses, not expert medical opinion on clinical data.

4. Adjudication Method for the Test Set

• Not Applicable. As per point 3, there's no "adjudication" in the sense of reconciling expert opinions on medical cases. The evaluation is based on objective mechanical testing results against engineering standards and comparison with predicate devices.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• No. This is a medical device, not an AI/algorithm. MRMC studies are used for evaluating diagnostic software/algorithms.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Mechanical Performance Standards and Predicate Device Comparison: The "ground truth" for the device's performance is its ability to withstand specific forces, torques, and cycles as demonstrated by the mechanical tests (Pedicle Screw Insertion and Removal Torques, Static Flexion-Extension Test, Dynamic Flexion-Extension) and its equivalence to the previously cleared predicate devices in terms of material properties and performance. Compliance with FDA guidance for hydroxyapatite-coated implants also serves as a "ground truth" for material safety and performance.

8. The Sample Size for the Training Set

• Not Applicable. This is a medical device, not an AI/algorithm.

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

• Not Applicable. This is a medical device, not an AI/algorithm. Design and manufacturing processes are iteratively developed and tested against engineering specifications, but there isn't a "training set" in the machine learning sense.

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The Quantum Spinal System components are non-cervical spinal fixation devices intended for use as a pedicle screw system (T1 - S2), a posterior hook and sacral/iliac screw fixation system or as an anterolateral fixation system (T8 - L5). Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

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This document describes the Quantum Spinal System, a medical device, and its regulatory clearance through the 510(k) pathway. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way that an AI/ML device submission would.

The provided text describes a traditional medical device (spinal fixation system) and its substantial equivalence to predicate devices, rather than an AI/ML device with performance metrics like accuracy, sensitivity, or specificity. Therefore, many of the requested fields are not applicable to the information contained in the provided document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in a quantifiable way typical for AI/ML device performance. The document states:

2. Sample size used for the test set and the data provenance:

• Not applicable / Not provided. This document describes a spinal implant, not a data-driven device that requires a "test set" in the AI/ML sense. The performance data refers to mechanical and material testing, not clinical data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable / Not provided. Ground truth, in the context of AI/ML, refers to labels or diagnoses provided by experts on a dataset. This information is not relevant to the clearance of a spinal implant.

4. Adjudication method for the test set:

• Not applicable / Not provided. Adjudication methods are used in AI/ML studies to resolve disagreements among experts in labeling data. This is not pertinent to the current device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable / Not provided. This device is a surgical implant, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

• Not applicable / Not provided. There is no algorithm for this device.

7. The type of ground truth used:

• Not applicable / Not provided. The "ground truth" for a spinal implant's safety and effectiveness is established through engineering testing (e.g., biomechanical strength, material compatibility), pre-clinical studies, and clinical experience with similar predicate devices, rather than a "ground truth" for data labeling. The regulatory decision is based on substantial equivalence to predicate devices which have an established safety and effectiveness profile.

8. The sample size for the training set:

• Not applicable / Not provided. This device does not involve machine learning; therefore, there is no "training set."

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

• Not applicable / Not provided. As there is no training set for an AI/ML model, this question is not relevant.

In summary: The provided document is a 510(k) summary for a traditional medical device (spinal fixation system). The regulatory review for such devices focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through engineering performance data (e.g., mechanical testing conforming to ASTM standards), material safety, and similarity in design and intended use. The concepts of "acceptance criteria" and "study proving device meets acceptance criteria" for AI/ML devices, involving test sets, ground truth, experts, and reader studies, are not applicable to this type of traditional device clearance.

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