(93 days)
The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system for use with autograft and/or allograft. The Polaris Spinal System is indicated for the following conditions: 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), deformity or curvature (i.e., scoliosis, kyphosis, Scheuermann's disease, and/or lordosis,), tumor, stenosis, pseudoarthrosis, or failed previous fusion.
The Ballista and Cypher MIS instruments are intended to be used with Ballistal Cypher MIS /Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista/ Cypher MIS instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for the above indications.
For pediatric patients, the Polaris Spinal System may be used for posterior, non-cervical pedicle screw fixation as an adjunct to fusion to treat adolescent idiopathic scoliosis and is also indicated for treatment of the following conditions: spondylolisthesis/spondylolysis and fractures caused by turnor and/or trauma. Pedicle screw fixation is limited to a posterior approach.
The Polaris Spinal System may be used with the instruments in the AccuVision Minimally Invasive Spinal Exposure System to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The dominos in the Polaris Spinal System can be used to connect the Polaris Spinal System to the Altius Spinal System, Lineum OCT Spine System, the Array Spinal System, the Biomet Omega21 Spinal System, or the Synergy Spinal System to achieve additional levels of fixation. Please refer to the individual system's Package Insert for a list of the indications for use for each system.
The Polaris Spinal System is a non-cervical spinal fixation device made from titanium alloy (Ti-6Al-4V) per ASTM F136, unalloyed titanium per ASTM F67, stainless steel per ASTM F138 or ASTM F1314 and Cobalt Chrome Alloy (Co-28Cr-6Mo) per ASTM F1537. The system includes screws, various types and sizes of rods, locking nuts, hooks, lateral connectors, plugs, fixation washers, rod connectors/dominos, various cross connectors and accessories. Various instruments are also available for use by the surgeon to facilitate implantation of the device. This line extension is to add downsized components and additional rod and connector styles to the Polaris Spinal System.
Here's an analysis of the provided 510(k) summary regarding the Polaris Spinal System:
Acceptance Criteria and Device Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from FDA Guidance) | Reported Device Performance |
|---|---|
| Static compression bending | Met all mechanical test requirements |
| Static torsion | Met all mechanical test requirements |
| Dynamic compression bending fatigue (ASTM F1717) | Met all mechanical test requirements |
| Interconnection testing (ASTM F1798) | Met all mechanical test requirements |
Note: The document explicitly states that the device "met all mechanical test requirements based on the worst-case construct testing." The specific numerical thresholds for these acceptance criteria are not provided in this summary but would be detailed in the full test reports referenced by the FDA's "Guidance for Industry and FDA Staff - Spinal System 510(k)s dated May 3, 2004."
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "worst-case construct testing," implying that specific configurations were tested, but the number of samples per test type is not detailed.
- Data Provenance: This is a retrospective study in the sense that the testing was conducted on samples of the device components. The data is generated from laboratory mechanical testing, not from patient data or clinical trials. The country of origin of the data is implicitly the USA, where the testing was conducted to FDA guidance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This document describes a mechanical performance study, not a study requiring expert interpretation of medical images or patient data to establish ground truth. Therefore, this section is not applicable. The "ground truth" here is the physical performance of the device against established engineering standards.
4. Adjudication Method for the Test Set
Not applicable. As this is a mechanical performance study, there is no "adjudication method" in the clinical sense. The results are objective measurements against defined engineering standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for assessing the impact of AI on human reader performance, typically in diagnostic imaging. This document describes mechanical testing of a spinal implant system.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone performance study (in the context of an algorithm or AI) was not done. This document describes the mechanical performance of a physical medical device (spinal implant system).
7. Type of Ground Truth Used
The ground truth used for this study is based on established engineering standards and regulatory guidance for spinal implant testing, specifically:
- ASTM F1717, Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model
- ASTM F1798, Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
- FDA's Guidance for Industry and FDA Staff - Spinal System 510(k)s dated May 3, 2004
8. Sample Size for the Training Set
Not applicable. This is a study of a physical device's mechanical properties, not an AI or algorithm-based product that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, this question is not relevant.
§ 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.