(26 days)
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.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.