(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/Ballista II instruments are intended to be used with Ballista II/Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista II instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for the above indications.
For pediatric patients, the Polaris 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 tumor 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, Nextgen Altius 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 F 136, unalloyed titanium per ASTM F 67, stainless steel per ASTM F 138 or ASTM F 1314 and Cobalt Chrome Alloy (Co-28Cr-6Mo) per ASTM 1537. The system includes screws, various types and sizes of rods, locking nuts, hooks. lateral connectors, plugs. fixation washers, rod connectors/dominos and various cross connectors. Various instruments are also available for use by the surgeon to facilitate implantation of the device. This line extension is to expand the indications for use for Polaris Spinal System using previous cleared system components.
This document describes a 510(k) submission for the Polaris Spinal System, a medical device. The information provided heavily focuses on the comparison to predicate devices to establish substantial equivalence rather than detailing specific device performance or clinical studies with acceptance criteria for a novel AI or diagnostic device.
Therefore, many of the requested categories for a study proving device meets acceptance criteria are not directly applicable or are not explicitly stated in the provided text. The document is primarily a regulatory submission demonstrating equivalence, not a detailed performance study report.
Here's an analysis based on the provided text, highlighting what is available and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric / Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Strength (Static Compression Bending, Static Torsion, Dynamic Compression Bending per ASTM F1717) | Implicit historical data: "The implants included in the submission were previously tested for static compression bending, static torsion and dynamic compression bending per ASTM F1717." |
| Safety and Effectiveness for Pediatric Pedicle Screw Fixation (especially Adolescent Idiopathic Scoliosis) | "The assessment concluded that pedicle screw fixation is safe and effective for use in pediatric patients for the treatment of adolescent idiopathic scoliosis." (Based on clinical literature assessment) |
| Substantial Equivalence (Intended Use, Indications, Design, Materials, Manufacturing Methods, Sterility, Fundamental Technology, Operational Principles) | The Polaris Spinal System is deemed "substantially equivalent" to multiple predicate devices (Revere" 4.5 Stabilization System, CD Horizon" Spinal System, TSRH* Spinal System, and previous Polaris Spinal System versions) based on these characteristics. |
Missing Information/Not Applicable: The document does not specify quantitative acceptance criteria (e.g., "must achieve X N-m of torque" or "failure rate must be below Y%"). The "reported device performance" for mechanical strength is a statement that it was "previously tested" and "already demonstrated," indicating compliance with prior standards or predicate device performance, but no specific values or criteria are provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of a clinical study with a specific sample size.
- Mechanical Testing: While mechanical tests per ASTM F1717 were performed, the sample size for these tests is not mentioned.
- Clinical Literature Assessment: This involved reviewing "published clinical data." The number of patients or studies included in this assessment is not specified, nor is the country of origin, or whether it was retrospective or prospective. It's a review of existing data, not a new data collection.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The document does not describe a study involving expert-established ground truth for a test set. The clinical literature assessment likely involved review by the regulatory affairs team, but not in the context of establishing "ground truth" for a device performance study.
4. Adjudication Method for the Test Set
This information is not applicable as no "test set" requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done or mentioned. This device is a surgical implant, not a diagnostic imaging AI, so such a study would not typically apply in this direct comparison context.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
This information is not applicable. The Polaris Spinal System is a physical implant, not an algorithm. Standalone performance for mechanical devices relates to their physical integrity and function under simulated use, which is addressed by the ASTM F1717 testing.
7. Type of Ground Truth Used
- Mechanical Testing: The "ground truth" for mechanical testing would be the physical properties and performance metrics defined by the ASTM F1717 standard.
- Clinical Efficacy (for pediatric pedicle screw fixation): The "ground truth" was derived from a "clinical literature assessment," meaning conclusions drawn from existing published clinical data and expert consensus in the medical community about the safety and effectiveness of pedicle screw fixation for the stated conditions.
8. Sample Size for the Training Set
This information is not applicable, as there is no "training set" in the context of a medical device like this. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set" for this device.
§ 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.