(91 days)
The 5.5 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 anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft. 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 lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion.
The 5.5 Polaris Percutaneous Instruments are intended to be used with the 5.5 Polaris implants. The 5.5 Polaris Percutaneous Instruments when used with the 5.5 Polaris Spinal System cannulated screws and percutaneous rods, are indicated 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, and lordosis), turnor, stenosis, pseudarthrosis, and failed previous fusion that warrant the use of a non-cervical 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.
The 5.5 Polaris Mini-Open Instruments, when used with the 5.5 Polaris Spinal System implants are indicated to provide the surgeon with a minimally invasive 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, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion that warrant the use of a non-cervical 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.
This submission is a line extension to the EBI 5.5 Helical Flange Spinal System to add new Polaris components, which may be used with the other 5.5mm components in order to build various types of spinal constructs.
This document describes a 510(k) premarket notification for a medical device, the 5.5 Polaris Spinal System. The provided text, however, focuses on the administrative details, indications for use, and a declaration of substantial equivalence to predicate devices, rather than a detailed study report with specific acceptance criteria and performance data.
Therefore, based solely on the provided text, I cannot extract concrete information for most of the requested categories. The document asserts that the device is "substantially equivalent" to predicate devices, implying that it meets the same implicit performance standards, but it does not present those standards or device performance in a quantifiable manner as would be found in a detailed study report.
Here's a breakdown of what can be inferred or directly stated from the provided text, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The document relies on "substantial equivalence" to predicate devices. | The document states: "Based upon the mechanical testing, the 5.5 Polaris Spinal System is substantially equivalent for its intended use to other spinal systems currently on the market." No specific performance metrics (e.g., strength, durability, fatigue life) or their values are provided. |
Explanation: The 510(k) summary focuses on establishing substantial equivalence rather than presenting a standalone performance study against pre-defined acceptance criteria. It mentions "mechanical testing" generally but does not detail the specific tests, their acceptance criteria, or the numerical results.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document refers to "mechanical testing" but does not provide details on the number of devices or components tested.
- Data Provenance: Not specified. The country of origin of the data (if any physical testing was conducted) and whether it was retrospective or prospective is not mentioned.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and not provided. The study appears to be mechanical testing of the device itself, not clinical data requiring expert review for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable and not provided. This would typically be relevant for clinical studies involving expert interpretation, not mechanical testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study was not done. This type of study is relevant for imaging or diagnostic devices where human readers interpret results, often with and without AI assistance. The 5.5 Polaris Spinal System is a physical spinal fixation device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This concept is not applicable as the device is a physical spinal implant system, not a software algorithm.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied in AI/diagnostic studies is not relevant here. For a physical device like a spinal system, performance is assessed through mechanical testing against engineering specifications, and "effectiveness" is primarily linked to its mechanical properties and safety when implanted. The document implies that "mechanical testing" was performed to demonstrate performance. The "ground truth" would be the engineering standards and established performance ranges for similar predicate devices.
8. Sample Size for the Training Set
No training set information is provided. This is not a machine learning or AI-driven device that would typically involve training sets.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device type.
§ 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.