(53 days)
The Sniper® System is a non-cervical spinal fixation system intended for posterior pedicle screw fixation (11-S2/ ilium) in skeletally mature patients. The Sniper® Spine System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The Sniper® Spine System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S2/ilium), and for whom the device is intended to be removed after solid fusion is attained.
The Sniper® Spine System percutaneous instruments are intended to be used with the Sniper® System Implants. The instruments, when used with the percutaneous cannulated screws and percutaneous rods, are intended to provide the surgeon with a percutaneous approach for posterior spinal surgery for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The instruments are also intended to provide a percutaneous approach for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S2/ilium), and for whom the device is intended to be removed after solid fusion is attained.
The Sniper® Spine System consists of a selection of non-sterile, single use, titanium allov screw and connector components, and titanium allov and cobalt chrome alloy rod components that are assembled to create a rigid spinal construct. The components of the Sniper® Spine System are attached to the non-cervical spine in order to stabilize the spine during fusion of the vertebral bodies, and are intended to be removed after spinal fusion is achieved.
The provided document describes the Sniper® Spine System and its clearance by the FDA based on substantial equivalence. This type of device is a medical implant, and the approval process for such devices differs significantly from that of AI/ML-driven software as a medical device (SaMD).
Therefore, many of the requested criteria, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone algorithm performance," and "ground truth for training set," are not applicable (N/A) to this specific device and the regulatory submission described. The document does not detail a study involving AI/ML performance metrics.
Instead, the submission relies on the concept of substantial equivalence to predicate devices through comparisons of technological characteristics, indications for use, materials, and mechanical performance testing.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for this type of device are primarily related to safety and effectiveness demonstrated through mechanical testing and comparison to legally marketed predicate devices. The "reported device performance" refers to the mechanical testing outcomes, which are deemed acceptable if they meet established standards and are comparable to predicate devices.
| Acceptance Criteria (Implied from Mechanical Testing) | Reported Device Performance |
|---|---|
| Mechanical stability and strength under various loading conditions (e.g., static axial compression, static torsion, dynamic axial compression bending) in accordance with ASTM F1717 standard for spinal implants. | "Performance evaluations were previously conducted on constructs representing the worst case components (including static torsion, static axial compression and dynamic axial compression bending in accordance with ASTM F1717)." |
"Engineering rationales determined that the proposed implants were substantially the same as the predicate devices." (Implies the testing met or was comparable to the predicate's performance) |
| Biocompatibility of materials (Titanium alloy, Cobalt chrome alloy) | The device consists of "non-sterile, single use, titanium alloy screw and connector components, and titanium alloy and cobalt chrome alloy rod components." (Implies material selection based on known biocompatible materials for spinal implants) |
| Similarity in intended use, indications for use, and technological characteristics to predicate devices. | "The substantial equivalence of the subject Sniper® Spine System to the predicates is shown by similarity in intended use, indications for use, materials and performance." (This is the overarching conclusion of the submission, indicating it meets the criteria for substantial equivalence). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document refers to "constructs representing the worst case components" for mechanical testing, but does not specify the exact number of samples (e.g., a specific N-number) tested for each type of mechanical evaluation.
- Data Provenance: The data comes from mechanical performance evaluations described as being conducted "previously." The country of origin is not specified but would typically be a testing lab, likely in the US, given the FDA submission. This is not medical data (e.g., patient data) provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- N/A. This applies to human-interpreted medical image or diagnostic data, not to mechanical testing of physical implants. The "ground truth" here is the adherence to mechanical standards (ASTM F1717) and engineering principles for structural integrity.
4. Adjudication Method for the Test Set
- N/A. This applies to expert review and consensus on clinical data. For mechanical testing, the results are objectively measured against established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- N/A. This type of study is relevant for AI/ML diagnostic tools that impact human reader performance. The Sniper® Spine System is a physical implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- N/A. This device is not an algorithm or software. It is a physical medical implant.
7. The Type of Ground Truth Used
- For the physical device, the "ground truth" is defined by established engineering standards (ASTM F1717) for spinal implant mechanical properties and the performance characteristics of legally marketed predicate devices. The testing aims to demonstrate that the device meets these engineering benchmarks and performs similarly to already approved devices.
8. The Sample Size for the Training Set
- N/A. This concept applies to AI/ML algorithms that learn from data. This submission is for a physical medical device.
9. How the Ground Truth for the Training Set Was Established
- N/A. As above, this is not applicable for a physical implant 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.