(238 days)
The GALAXY MIS Screw System is intended to provide immobilization of the posterior, non-cervical spine as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. The GALAXY MIS Screw System can be used in an open approach and a percutaneous approach with MIS instrumentation.
The GALAXY MIS Screw System consists of GALAXY MIS SCREW (cannulated polyscrews), GALAXY MIS ROD (straight type rods and pre-bent type rods) and GALAXY Set Screw (set screw components) that can be inserted via percutaneous surgical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy (ASTM F 136). The implants will be provided non-sterile.
This FDA submission is for a medical device, the GALAXY MIS Screw System, which is a pedicle screw spinal system used for spinal fixation. As such, the submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing rather than clinical studies involving human patients or complex AI algorithms. Therefore, many of the requested categories regarding clinical study details (like sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable in this context.
Here's the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Standard) | Reported Device Performance (Summary) |
|---|---|
| ASTM F1717 (Static Compression) | Met standard; results support substantial equivalence. |
| ASTM F1717 (Tension) | Met standard; results support substantial equivalence. |
| ASTM F1717 (Torsion) | Met standard; results support substantial equivalence. |
| ASTM F1717 (Dynamic Compression Bending) | Met standard; results support substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. For non-clinical (mechanical) testing, sample sizes typically refer to the number of devices or components tested, and provenance is not relevant.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable. Ground truth, in the context of clinical studies and AI, refers to expert-validated diagnoses or outcomes. This submission involves non-clinical mechanical testing, where the "ground truth" is defined by the physical properties measured against engineering standards.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods are used in clinical studies to resolve disagreements among experts or raters. Mechanical tests are typically performed according to standardized protocols without expert adjudication in this sense.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is a surgical implant, not an AI-powered diagnostic tool, and therefore no MRMC study would be conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical testing was defined by the acceptance criteria established in the ASTM F1717 standard for various mechanical properties (static compression, tension, torsion, dynamic compression bending). This is a technical standard rather than an expert consensus, pathology, or outcomes data in the clinical sense.
8. The Sample Size for the Training Set
This is not applicable. This is a physical medical device, not an AI model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
This is not applicable, as there is no training set for this device.
§ 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.