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When used as a pedicle screw fixation system in the non-cervical posterior spine (TI-SI) in skeletally mature patients, the VICEROY Spine 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 and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) curvatures (i.e., scoliosis, and/or lordosis, (7) turnor, (8) failed previous fusion (i.e. pseudarthrosis).

The VICEROY Spine System consists of four or more pedicle screws and two VICEROY solid rods in a symmetric, bilateral arrangement. The pedicle screws are placed axially in the pedicles with two screws in the cephalad position and two screws in the caudad position. The VICEROY rods are secured in the heads of the pedicle screws so that fixed stabilization is provided between the cephalad and caudad vertebrae. Cross-links can be used if additional stabilization is necessary. The VICEROY Spine System is fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to the ASTM F136, Standard Specifications for Wrought Titanium-6Aluminum-4VanadiumELI (Extra Low Interstitial) Alloy or Surgical Implant Applications.

The provided text describes a 510(k) premarket notification for a medical device called the VICEROY Spinal System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through clinical studies or extensive standalone algorithm evaluation. The "performance summary" section refers to mechanical testing of the device, not a study of its clinical or diagnostic accuracy.

Therefore, many of the requested fields regarding acceptance criteria related to diagnostic performance or clinical outcomes, and the type of study that proves it, are not applicable or cannot be extracted from this document.

Here's a breakdown of what can be extracted:

Acceptance Criteria and Device Performance (Mechanical Testing)

The document states: "Testing was performed to support the equivalence of the proposed pedicle screw system in accordance with FDA Guidance 'Guidance for Industry and FDA Staff: Spinal System 510(k)s.' The following testing was performed in accordance with ASTM F1717: static compression bending, static torsion, and dynamic compression bending."

This indicates that the acceptance criteria are adherence to ASTM F1717 standards for the specified mechanical tests, and the device performs in a manner equivalent to predicate devices under these tests. However, specific numerical acceptance values or detailed performance results (e.g., specific bending moment values, torsion limits) are not provided in this summary. The document only states that the testing supports equivalence.

Study Details (Mechanical Testing)

1. Sample size used for the test set and the data provenance: Not specified in the document. Mechanical testing typically uses a certain number of device samples, but this information is not provided. The data provenance is implied to be from the manufacturer's internal testing as part of the 510(k) submission process.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is mechanical testing of a physical device, not related to expert interpretation or ground truth establishment for diagnostic purposes.
3. Adjudication method for the test set: Not applicable.
4. 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 device is a pedicle screw spinal system, not an AI-powered diagnostic tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant, not an algorithm.
6. The type of ground truth used: For mechanical testing, the "ground truth" would be the engineering specifications and performance characteristics defined by ASTM F1717, to which the device's measured performance is compared.
7. The sample size for the training set: Not applicable. There is no concept of a "training set" for this type of mechanical testing.
8. How the ground truth for the training set was established: Not applicable.

Summary of what the document does convey:

• The VICEROY Spinal System is a medical device intended for spinal stabilization.
• The manufacturer is seeking substantial equivalence to existing predicate devices (ACME Spinal System, Moss Miami, and Expedium Spinal System).
• Substantial equivalence is claimed based on materials, design, indications for use, operational principles, and mechanical testing.
• Mechanical testing was performed according to ASTM F1717 standards for static compression bending, static torsion, and dynamic compression bending.
• The document implies the device met the requirements of these standards and demonstrated performance equivalent to the predicate devices.

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