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The Quantum Spinal System components are non-cervical spinal fixation devices intended for use as a posterior pedicle screw system (T1 - S2) 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, pseudoarthosis, and failed previous fusion.

The Quantum Spinal System components are non-cervical spinal fixation devices. The Pioneer Quantum Spinal System implants are substantially equivalent to the components of a previously cleared Pioneer spinal system, with similar materials, performance, and indications for use demonstrated. Material: Biocompatible alloys in conformance with ASTM Standard Specifications.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Quantum Spinal System:

This device, the Quantum Spinal System, is a Class III medical device (Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Body Fixation Orthosis, Spondylolisthesis Spinal Fixation Device System and Pedicle Screw Spinal System). For Class III devices, especially those going through a 510(k) pathway, clinical studies are not typically the primary means of demonstrating safety and effectiveness but rather substantial equivalence to a predicate device.

Therefore, the information provided focuses on the technical performance testing rather than a clinical study involving human patients and outcomes data in the way one might expect for a digital health or diagnostic AI device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The FDA 510(k) summary for this type of device often provides a high-level overview. Detailed numerical acceptance criteria (e.g., specific fatigue cycles or load limits) and their exact results are contained within the full 510(k) submission, which is not fully provided in this extract. The summary confirms that such testing was performed and met the necessary standards for substantial equivalence.

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

This document describes a spinal implant, not an AI/software device. Therefore, the concept of a "test set" in the context of diagnostic performance or AI model validation does not apply.

• Sample Size: The "testing per recognized ASTM standards" refers to mechanical and material testing of the device components. The sample size would be dictated by the specific ASTM standards for mechanical testing (e.g., number of implants tested for fatigue, static bending, etc.). This information is not explicitly detailed in the provided summary but would be part of the full submission.
• Data Provenance: Not applicable in the context of a clinical test set. The data provenance relates to engineering testing conducted by the manufacturer according to regulatory standards. This is not retrospective clinical data or prospective clinical data from human subjects.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. For a spinal implant device cleared via a 510(k) pathway, "ground truth" is established through:

• Engineering specifications and recognized standards (ASTM): These define acceptable mechanical properties, material composition, and biocompatibility.
• Comparison to a legally marketed predicate device: The safety and effectiveness are largely based on demonstrating equivalence to an already approved device.
• Pre-clinical testing: This may include bench testing, cadaveric testing, and potentially animal studies, but not typically human clinical expert-driven ground truth in the way an AI diagnostic device would.

4. Adjudication Method for the Test Set

Not applicable. See point 3. Adjudication methods (like 2+1, 3+1) are common in clinical trials or diagnostic studies where there's variability or disagreement among human readers or experts, which is not the case for the type of engineering performance data this device relies upon for 510(k) clearance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices (especially imaging-based AI) to assess the impact of AI on human reader performance. For a spinal implant, the effectiveness is demonstrated through its mechanical stability, biocompatibility, and intended use as a fixation device, and implicitly, the established safety and effectiveness of its predicate device.

6. Standalone (Algorithm Only) Performance

No, standalone performance is not applicable. The Quantum Spinal System is a physical medical device (spinal implant), not a software algorithm or an AI device.

7. Type of Ground Truth Used

The "ground truth" for this device's clearance via the 510(k) pathway is primarily:

• Engineering Standards and Specifications: Meeting the requirements of recognized ASTM standards for mechanical strength, fatigue, and material properties.
• Predicate Device Equivalence: The safety and effectiveness are established by demonstrating that the device is substantially equivalent to a previously cleared legally marketed device (K041167) in terms of materials, performance, and indications for use.
• Biocompatibility Data: Conformance to ASTM standards for biocompatible alloys.

There is no mention of expert consensus from clinical cases, pathology, or specific patient outcomes data being used as "ground truth" for the 510(k) process outlined in this summary.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. The concept of a "training set" is not relevant here.

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

Not applicable. See point 8.

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