(84 days)
The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization 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. 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, tracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, Scheuerman's disease, and/or lordosis,), turnor, 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 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, 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. This submission is to clear modifications to the Polaris Spinal System to include Hydroxyapatite (HA) Coated Screws and a variation in shaft geometry on the multiaxial screws.
This FDA 510(k) premarket notification describes the Biomet Spine, LLC's Polaris Spinal System. The provided document focuses on demonstrating substantial equivalence to predicate devices rather than providing a study proving performance against specific acceptance criteria in the manner typically seen for software or AI medical devices.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable to this type of submission. This document describes a medical device, specifically a spinal fixation system, not a software algorithm or AI. The "performance data" refers to mechanical testing against established standards for spinal implants.
Here's the information extracted from the document based on the provided request format, with explanations where certain information is not present or not applicable:
Acceptance Criteria and Study to Prove Device Meets Criteria: Polaris Spinal System (K141804)
This 510(k) submission for the Polaris Spinal System focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing performance against specific, quantifiable acceptance criteria for a novel functionality. The "acceptance criteria" here are implicitly meeting the performance and safety profiles of the predicate devices as demonstrated through mechanical testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Implicit via Substantial Equivalence to Predicates) | Reported Device Performance |
|---|---|
| Mechanical Strength & Durability | Static compression bending, static torsion, and dynamic compression bending fatigue per ASTM F1717 met requirements. |
| Biocompatibility (HA Coated Screws) | Followed FDA guidance document "Information Needed for Hydroxyapatite Coated Orthopedic Implants dated March 10, 1995" |
| Material Properties | 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. |
| Intended Use & Indications for Use | Same as, or similar to, predicate devices (K140123, K090203, K122226). |
| Fundamental Technology | Same as, or similar to, predicate devices (design, materials, manufacturing methods, sterility, operational principles). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. For mechanical testing of medical implants, "test sets" typically refer to the number of constructs or samples subjected to each mechanical test. The document mentions "worst-case construct testing" was performed, but does not specify the number of samples per test type.
- Data Provenance: Not applicable in the context of clinical data. The data provenance here refers to the mechanical testing conducted on the device components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. Ground truth for mechanical testing is established by adherence to recognized engineering standards (e.g., ASTM F1717) and internal protocols, not clinical expert consensus.
- Qualifications of Experts: Not specified. Testing would be performed by engineers and technicians specializing in biomechanical testing.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Performance is judged against predefined criteria within the ASTM standards, not by expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. This is not a software/AI device, but a physical implant. Therefore, MRMC studies are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance Study: Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this medical device submission is the adherence to established mechanical testing standards (specifically ASTM F1717) and FDA guidance documents for spinal systems and HA-coated implants. This ensures the device's physical properties meet recognized safety and performance benchmarks for spinal implants.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This refers to a physical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable.
§ 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.