(105 days)
The Mout Blanc Spinal System is intended for noncervical pedicle fixation from the T1 to S1 vertebrae and sacral/iliac screw fixation in skeletally mature patients as an adjunct to fission for the following indications: degenerative disc disease (defined as back pain of discogence origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Spineway Mont Blanc Spinal System is an implant device made from a titanium alloy TI 6Al 4V-ELI. It is to be implanted from the posterior approach. The screws are available as monobloc and monobloc reduction (traction) screws and polyaxial reduction (traction) screws in diameters from 4.0-8.0 mm and in lengths from 25-55 mm and polyaxial iliac screws of 7 and 8mm diameters with lengths from 55mm to 110mm. Rods are available in 5.5mm diameter in lengths from 40-500 mm. Hooks are available in various sizes to attach to the thoracic and lumbar spine. Transverse connectors are available in various sizes to attach to the two parallel rods. Associated instrumentation to complete the procedure is provided.
This document is a 510(k) premarket notification for a medical device and, as such, does not contain the detailed study information typically found in a scientific publication or clinical trial report. The provided text outlines the regulatory submission for the Mont Blanc Spinal System but does not describe a study that proves the device meets specific acceptance criteria in terms of a clinical or AI-based performance evaluation.
Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device based on pre-clinical mechanical testing and similarities in design, materials, and intended use.
Here's an breakdown of the requested information based on the provided text, highlighting what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Type of Test) | Reported Device Performance (Summary) | Notes |
|---|---|---|
| Static compression bend | Not explicitly quantified in this document. | The document states "The pre-clinical testing performed per ASTM F1717-10 includes: - Static compression bend." It does not provide specific performance values or pass/fail criteria. The conclusion implies these tests were met to demonstrate substantial equivalence. |
| Static torsion | Not explicitly quantified in this document. | The document states "The pre-clinical testing performed per ASTM F1717-10 includes: - Static torsion." It does not provide specific performance values or pass/fail criteria. |
| Dynamic compression bend | Not explicitly quantified in this document. | The document states "The pre-clinical testing performed per ASTM F1717-10 includes: - Dynamic compression bend." It does not provide specific performance values or pass/fail criteria. |
| Substantial Equivalence | Determined to be substantially equivalent to K112684. | The primary "acceptance criterion" for this regulatory submission is demonstrating substantial equivalence to a predicate device (Mont Blanc system, K112684) in regard to indications for use, materials, function, sizes, and mechanical test results. The FDA's letter confirms this determination. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of this regulatory submission. The "test set" here refers to the actual physical devices undergoing mechanical testing, not a data set for an AI model. The number of samples for mechanical testing is not specified.
- Data Provenance: The device is manufactured by Spineway S.A. in Ecully, France. The pre-clinical testing was performed according to ASTM F1717-10, an international standard for spinal implant fatigue testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This document describes mechanical component testing, not a clinical study involving expert interpretation or ground truth establishment in a medical imaging or diagnostic context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This pertains to clinical data interpretation, not mechanical testing.
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
- Not applicable. This document is about a spinal implant system, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness is discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical spinal implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the mechanical testing is based on established engineering principles and the specifications within the ASTM F1717-10 standard. The "truth" is whether the device meets the mechanical performance requirements defined by this standard for similar predicate devices.
8. The sample size for the training set
- Not applicable. This document does not describe an AI/machine learning model, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no AI/machine learning model is described.
In summary: The provided FDA 510(k) submission describes a spinal implant system and its regulatory clearance based on substantial equivalence to a predicate device. The "study" referenced is a set of pre-clinical mechanical tests (static compression bend, static torsion, dynamic compression bend) performed according to the ASTM F1717-10 standard. The document does not provide quantitative performance results for these tests, but concludes that they were sufficient to demonstrate equivalence. It does not involve a clinical study, human readers, AI, or any methodologies related to establishing ground truth from expert consensus or patient outcomes.
§ 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.