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510(k) Data Aggregation
(24 days)
The Quantum Spinal System components are non-cervical spinal fixation devices intended for use as an adjunct to fusion 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.
The Quantum Spinal System components are non-cervical spinal fixation devices. Materials used to manufacture the implants and instruments of this system are in conformance with ASTM Standard Specifications.
The provided 510(k) summary for the K080518 Quantum Spinal System does not contain information on acceptance criteria for a device, diagnostic or AI algorithm, nor a study proving it meets such criteria. Instead, it describes a medical device (spinal fixation system) and its intended use, material, and regulatory classification.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering performance data (e.g., mechanical testing) for spinal implants, rather than clinical performance data from studies involving human subjects in the way an AI/diagnostic device would be evaluated.
Therefore, I cannot provide the requested information in the table format or answer the specific questions related to AI/diagnostic device evaluation, as these details are not present in the provided text.
The "Performance Data" section states: "Testing per recognized ASTM standards was presented." This refers to laboratory-based mechanical and materials testing according to established engineering standards for medical implants. These tests usually evaluate properties like fatigue strength, pull-out strength, and corrosion resistance, which is different from a diagnostic performance study.
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(80 days)
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.
Quantum Spinal System
This document is a 510(k) premarket notification for the Pioneer Quantum Spinal System. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices already on the market.
Therefore, I cannot provide the requested information. The document explicitly states:
"Comparisons of device performance data, materials, indications and design/function to predicate devices were provided in making a determination of substantial equivalence."
This indicates that the submission relied on comparing the new device to existing, legally marketed devices rather than presenting novel performance studies against predefined acceptance criteria for the Quantum Spinal System itself.
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