(48 days)
The Polaris Spinal Growth System is indicated in patients with potential growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities, including early-onset scoliosis, which are associated with or at risk of thoracic insufficiency syndrome.
The Polaris Spinal Growth System may be used with any cleared traditional Polaris Spinal System construct, including any cleared Polaris Spinal System compatibilities.
The Polaris Spinal Growth System is a non-cervical spinal fixation device made from titanium alloy (Ti-6Al-4V) per ASTM F136 and Cobalt Chrome Alloy (Co-28Cr-6Mo) per ASTM F1537. The system is comprised of Growth Connectors which are intended to be used with the Polaris Spinal System implants and instruments. The design and size offerings of the Polaris Spinal Growth System connectors are identical to those currently available in the Polaris Spinal System but are indicated for growth rod constructs. These growth rod constructs typically require repeated plannedlengthening procedures until a determination is made that the patient is ready for a final fusion procedure. After the spine is fused, these devices serve no functional purpose and may be removed.
The provided text describes a 510(k) submission for a medical device called the "Polaris Spinal Growth System." This submission is a declaration of substantial equivalence to a predicate device, as opposed to a new device requiring extensive clinical trials and complex acceptance criteria for AI/Software-as-a-Medical-Device (SaMD) performance.
The document primarily focuses on mechanical testing to demonstrate that the Polaris Spinal Growth System performs as intended and is substantially equivalent to existing, legally marketed devices. It does not contain information relevant to AI/SaMD performance, such as:
- Acceptance criteria for an algorithm's diagnostic or therapeutic performance. The device is a physical implant, not a software algorithm.
- Study design for evaluating algorithm performance (test sets, ground truth, expert review, MRMC studies).
- Sample sizes for training sets for machine learning models.
- Effect size for human reader improvement with AI assistance.
Therefore, I cannot extract the information required to answer your prompt in detail. The available information relates to the acceptance criteria for the mechanical performance of a physical implant, not the performance of an AI/SaMD.
Here's what I can provide based on the document, focusing on the mechanical performance. Please note that this is not related to AI/SaMD and will not fill all requested fields:
Acceptance Criteria and Device Performance (for Mechanical Properties):
| Acceptance Criterion (for Mechanical Testing) | Reported Device Performance |
|---|---|
| Function as intended for static compression bending | Met |
| Function as intended for dynamic compression bending | Met |
| Function as intended for static torsion | Met |
| Function as intended for axial grip strength | Met |
| Function as intended for torsional grip strength | Met |
| Function as intended for flexion/extension moment grip strength | Met |
Study Details (for Mechanical Testing):
- Sample size used for the test set and data provenance: The document states "mechanical testing of the Polaris Spinal Growth System constructs were assessed and tested." It does not specify the exact number of constructs tested (sample size) or where these tests were physically performed (data provenance in terms of country of origin). It is not a clinical study with retrospective/prospective human data.
- Number of experts used to establish ground truth: Not applicable. Ground truth for mechanical testing is based on engineered specifications and standardized test methods (ASTM F1717, ASTM F1798).
- Adjudication method: Not applicable. Mechanical tests have objective, measurable outcomes.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This is not a study assessing human readers or AI assistance.
- Standalone (algorithm only) performance: Not applicable. This device is a physical implant.
- Type of ground truth used: Engineering standards (ASTM F1717, ASTM F1798) for mechanical properties.
- Sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document details the regulatory clearance for a traditional medical device (spinal implant) based on mechanical testing and substantial equivalence, not an AI/SaMD. As such, it does not contain the information requested in your prompt regarding AI/SaMD performance evaluation.
§ 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.