(24 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. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allograft. The device is indicated for all the following indications: 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, and/or lordosis), tumor, stenosis, pseudoarthrosis, or failed previous fusion.
The Ballista/Ballista II instruments are intended to be used with Ballista/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 following indications: 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, and/or lordosis), tumor, stenosis, pseudoarthrosis, or failed previous fusion that warrant the use of a noncervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allograft.
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, 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. 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 submission is a line extension to Polaris Spinal System to add another style of Ballista rods to the system.
The provided text describes a 510(k) premarket notification for the "Polaris Spinal System - Ballista II Rods," a non-cervical spinal fixation device. This submission is a line extension to add another style of Ballista rods to the existing system. The core assertion is that the new components are "substantially equivalent" to predicate devices, meaning they have the same or similar technological characteristics and do not raise new issues of safety or effectiveness.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness (Substantial Equivalence) | The new Ballista II rods are substantially equivalent to predicate rods (K121130 & K061441) with respect to intended use and indications, technological characteristics, and principles of operation. No new issues of safety or effectiveness are presented. |
| Mechanical Performance | An engineering analysis concluded that mechanical testing was not required for this specific style of rod because the combination of components did not create a new worst-case construct. |
| Compatibility with System Instruments | Validation testing was conducted to verify that the modified rods can be used with the system's instrumentation. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable in the context of this submission. The "study" here is primarily an engineering analysis and validation testing, not a clinical study on human subjects or a dataset in the typical sense for AI/machine learning.
- Data Provenance: Not applicable. The validation testing would have been performed in a laboratory setting by the manufacturer, Biomet Spine. The data is internal to the company.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Number of Experts: Not applicable. This submission focuses on engineering analysis and mechanical/compatibility testing, not on establishing ground truth from expert interpretations of medical data.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. There is no human interpretation of data requiring adjudication mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC comparative effectiveness study was not done. The submission focuses on device equivalence from a mechanical and functional perspective, not on comparing human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done:
- No, a standalone study (in the context of an algorithm's performance) was not done. This is a hardware device submission, not an AI or software device submission.
7. The Type of Ground Truth Used:
- Ground Truth: The "ground truth" in this context is defined by established engineering principles, mechanical testing standards for spinal implants, and the functional compatibility requirements with existing instrumentation. This is engineering/performance data and manufacturing specifications.
8. The Sample Size for the Training Set:
- Not applicable. This submission does not involve an AI system with a "training set."
9. How the Ground Truth for the Training Set was Established:
- Not applicable. This submission does not involve an AI system with a "training set."
Summary of the Study Proving Device Meets Acceptance Criteria:
The "study" in this context consists of an engineering analysis and validation testing.
- Engineering Analysis: This analysis was conducted to determine if new mechanical testing was required for the different style of rod. The conclusion was that because the new component combination did not create a "new worst-case construct" compared to the predicate devices, additional general mechanical testing of the rod itself was not deemed necessary to demonstrate substantial equivalence for the main mechanical properties.
- Validation Testing: This testing specifically verified the compatibility and functionality of the modified rods with the existing Polaris Spinal System instrumentation. This ensures that surgeons can safely and effectively use the new rods with the established toolset.
The overall approach to proving the device meets acceptance criteria (which is primarily substantial equivalence) relies on demonstrating that the new components maintain the same intended use, indications, technological characteristics, and principles of operation as legally marketed predicate devices, and that the minor modifications do not introduce new safety or effectiveness concerns, supported by engineering analysis and specific compatibility testing.
§ 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.