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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.

The subject of this submission is the design of Fixed Length Cross Connectors for the Apelo" Pedicle Screw System and additional smaller sizes, 20mm through and including 42mm. The Atlas Spine Fixed Length Cross Connectors will provide surgeons additional smaller sizes from which to choose based on the patients' anatomies. The Atlas Spine Fixed Length Cross Connectors will be manufactured from medical grade titanium alloy, Ti-6AI-4V (ELI), in accordance with ASTM F-136.

The provided text is a 510(k) Premarket Notification for the Atlas Spine Pedicle Screw System. This document is a regulatory submission for a medical device that demonstrates substantial equivalence to a legally marketed predicate device. The information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is typically associated with studies evaluating the performance of AI/ML-driven diagnostic or prognostic devices, or software as a medical device (SaMD).

This 510(k) submission, however, is for a physical orthopedic implant (pedicle screw system), not a diagnostic or AI-enabled device. Therefore, the detailed performance metrics and study design elements requested in the prompt are not applicable to this type of submission.

Here's why the information cannot be provided from this document:

• Device Type: This is a physical orthopedic implant (pedicle screw system), not a diagnostic device or a software product requiring AI performance evaluation.
• Regulatory Pathway: A 510(k) for such devices primarily focuses on demonstrating "substantial equivalence" to a predicate device in terms of intended use, design, materials, and functional characteristics (e.g., mechanical testing, biocompatibility). It does not typically involve clinical performance studies in the way an AI/ML device would, especially not with "acceptance criteria" related to sensitivity, specificity, or other diagnostic performance metrics.
• Missing Information: The document does not contain any information regarding:
  • Acceptance criteria for diagnostic or prognostic performance.
  • Reported device performance in terms of diagnostic accuracy.
  • Sample sizes for test sets (as there isn't a "test set" in the context of AI performance).
  • Data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types (pathology, outcomes data, expert consensus).
  • Training set size or how ground truth for a training set would be established, as these terms are irrelevant to a physical implant's 510(k).

The document explicitly states the basis for substantial equivalence:

• Same indications for use
• Same operating principle
• Same raw materials
• Similar manufacturing environments
• Same packaging configurations
• Same sterilization process
• Implanted using the same surgical techniques and similar equipment types

The conclusion explicitly states "This conclusion is based on the devices' similarities in indications for use, design, function, materials and mechanical function." This indicates the focus is on engineering and material equivalence, not clinical diagnostic performance.

Therefore, I cannot provide the requested table and study details as they are not relevant to or present in the provided 510(k) document for the Atlas Spine Pedicle Screw System.

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