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The Apelo™ Pedicle Screw System is intended for noncervical pedicle fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.

Being proposed in this Special 510(k) is the introduction of line extensions to the existing Apelo™ Pedicle Screw System. The proposed line extensions consist of new sizes of solid monoaxial and polyaxial pedicle screws and cannulated monoaxial and polyaxial pedicle screws without fenestrations. The new design and sizes of pedicle screws will be offered in order to provide surgeons a variety of screws from which to choose for open and minimally invasive procedures based on patients' anatomies.

The provided text describes a Special 510(k) Premarket Notification for the Apelo™ Pedicle Screw System, which is a medical device. This document does NOT contain information about acceptance criteria or a study proving that the device meets those criteria in the context of an AI/machine learning application.

Instead, this document describes a traditional medical device submission to the FDA, focusing on:

• Substantial Equivalence: The primary objective of a 510(k) submission is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use and either the same technological characteristics or different technological characteristics that do not raise new questions of safety and effectiveness.
• Device Modification (Line Extension): The specific purpose of this Special 510(k) is to introduce new sizes of solid and cannulated pedicle screws as line extensions to an existing system.
• Mechanical Testing: The document mentions "Dynamic compression bending testing according to ASTM F1717" was conducted to show that the proposed screws do not create a new worst-case construct. This is a standard engineering test for spinal fixation devices to assess their mechanical performance and safety, not a clinical study involving human or AI performance.

Therefore, I cannot extract the requested information (acceptance criteria, device performance tables, sample sizes for test/training sets, ground truth details, expert qualifications, MRMC studies, standalone studies, etc.) because this document pertains to a mechanical device submission, not an AI-powered device or software as a medical device (SaMD). The concepts of "acceptance criteria" and "study" in this context refer to engineering specifications and mechanical tests, not statistical performance metrics for an algorithm.

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The Atlas Spine Pedicle Screw System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.

The Atlas Spine Pedicle Screw System is a titanium alloy (6Al-4V ELI per ASTM F136) device consisting of a variety of non-sterile, single use components. The system consists of an assortment of polyaxial and monoaxial screws, cross connectors, rods, collar assemblies, offset receptacle bases and straight receptacle bases.

The provided document is a 510(k) summary for the Atlas Spine Pedicle Screw System. It describes a medical device, its intended use, and its substantial equivalence to previously cleared devices. However, this document does not contain any information about acceptance criteria, device performance, a specific study proving acceptance criteria, sample sizes, ground truth establishment, or expert involvement for AI/device performance assessment.

The "Performance Data" section merely states: "Data were submitted to characterize the Atlas Spine Pedicle Screw System." without providing any details of what that data was or what it showed. This suggests the data primarily related to mechanical testing to ensure the device met engineering standards rather than clinical performance based on a study with a test set, ground truth, or human-in-the-loop assessments as typically found for AI/imaging devices.

Therefore, I cannot fulfill the request for a table of acceptance criteria and device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or details on training/test sets and ground truth. This type of information is not present in the provided 510(k) summary.

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