(98 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, 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 Ballista/ 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 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, 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, lateral connectors, plugs, fixation washers, rod connectors/dominos, various cross connectors and accessories. This submission is to clear modifications to Polaris Translation Screw and to update the labeling.
Here's a summary of the acceptance criteria and study information for the Polaris Spinal System - Translation Screw, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Mechanical Testing | Static Compression Bending (ASTM F1717) | Met all mechanical test requirements based on worst-case construct testing. | Device met all mechanical test requirements based on the worst-case construct testing. |
| Static Torsion (ASTM F1717) | Met all mechanical test requirements based on worst-case construct testing. | Device met all mechanical test requirements based on the worst-case construct testing. | |
| Dynamic Compression Bending Fatigue (ASTM F1717) | Met all mechanical test requirements based on worst-case construct testing. | Device met all mechanical test requirements based on the worst-case construct testing. | |
| Resistance to cantilever loading or non-axial torque | Ability to resist cantilever loading or non-axial torque comparable to the predicate device. | Testing verified the ability of the subject device to resist cantilever loading or non-axial torque compared to the predicate device. | |
| Substantial Equivalence | Intended Use | Substantially equivalent to predicate devices. | Substantially equivalent to Polaris Spinal System predicate devices (K131615, K123549, K090203, K061441). |
| Indications for Use | Substantially equivalent to predicate devices. | Substantially equivalent to Polaris Spinal System predicate devices. | |
| Design | Substantially equivalent to predicate devices. | Substantially equivalent to Polaris Spinal System predicate devices. | |
| Materials | Substantially equivalent to predicate devices. | Substantially equivalent to Polaris Spinal System predicate devices. | |
| Manufacturing Methods | Substantially equivalent to predicate devices. | Substantially equivalent to Polaris Spinal System predicate devices. | |
| Sterility | Substantially equivalent to predicate devices. | Substantially equivalent to Polaris Spinal System predicate devices. | |
| Fundamental Technology | Substantially equivalent to predicate devices. | Substantially equivalent to Polaris Spinal System predicate devices. | |
| Operational Principles | Substantially equivalent to predicate devices. | Substantially equivalent to Polaris Spinal System predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes mechanical testing as the primary method to demonstrate performance. For this, the sample size is not explicitly stated as a number of devices or constructs, but it mentions testing was performed on "worst-case construct testing." There is no information about country of origin or whether the data was retrospective or prospective, as this pertains to physical device testing rather than clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The performance data is based on mechanical laboratory testing against established ASTM standards and direct comparison to predicate devices, not on expert assessment of a test set.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the evaluation is based on objective mechanical testing in a laboratory setting, not on human adjudication of cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not performed, nor is it relevant to this type of device (spinal fixation system modification). This document focuses on the mechanical substantial equivalence of a medical device, not the interpretive accuracy of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical spinal implant, not an algorithm or AI system. Its performance is inherent in its mechanical properties and design.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- ASTM F1717 Standard: This standard dictates specific methods for static and fatigue testing of spinal implant constructs in a vertebrectomy model. Compliance with this standard represents a recognized and accepted "ground truth" for mechanical performance in this domain.
- Predicate Device Performance: The primary ground truth for demonstrating "substantial equivalence" is the established safety and effectiveness of the legally marketed predicate devices (K131615, K123549, K090203, and K061441). The subject device's performance is compared directly to these.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device submission.
§ 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.