(229 days)
The Mont Blanc Pedicle Screw System is intended for noncervical pedicle fixation from the T1 to S1 vertebrae in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic 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, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.
The Mont Blanc Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle screws and rods. The rods are provided straight and intended to interface with the screws, which are traditional saddle design. This device is intended to be used with bone graft to provide immobilization and stabilization of a spinal segment as an adjunct to fusion. The Mont Blanc Pedicle Screw System is fabricated from wrought Ti-6Al-4V (ISO 5832-3).
The provided text is a 510(k) summary for a medical device called the "Mont Blanc Pedicle Screw System." It describes the device, its intended use, and the basis for its substantial equivalence to previously cleared devices.
However, the questions you've asked are about "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of device performance, sample sizes for test and training sets, expert review, and ground truth establishment.
Based on the provided document, the device described is a pedicle screw system, which is an orthopedic implant. For this type of device, "performance testing" typically refers to mechanical testing to ensure the device's structural integrity and durability, rather than a clinical study evaluating diagnostic accuracy or algorithmic performance as would be the case for an AI/ML device.
Therefore, the information you are requesting about
- Acceptance criteria and reported device performance (in terms of sensitivity, specificity, etc.)
- Sample sizes for test set and data provenance
- Number of experts and qualifications for ground truth
- Adjudication method
- MRMC comparative effectiveness study
- Standalone algorithm performance
- Type of ground truth (pathology, outcomes data, etc.)
- Sample size for training set
- How training set ground truth was established
is not present in the provided 510(k) summary.
The document states:
- Performance Testing: "Testing performed indicates the Mont Blanc Pedicle Screw System is substantially equivalent to predicate devices. Testing included mechanical testing per ASTM F1717, including static and dynamic compression bending and static torsion." This refers to laboratory-based mechanical tests, not clinical studies.
- Acceptance Criteria: These would be defined by the ASTM F1717 standard for pedicle screw systems (e.g., minimum loads for static and dynamic failure, or deformation limits) but are not explicitly detailed in the summary.
- Device Performance: The documented performance is that it met the requirements of ASTM F1717, showing it is "substantially equivalent" to predicate devices. Specific numerical results from these tests (e.g., actual breaking strength values) are not provided in this summary.
In summary, this document does not contain the type of information you are asking for, which is typically found in submissions for AI/ML-driven diagnostic devices or devices that rely on complex data analysis and expert interpretation. It describes a traditional, passive mechanical implant.
§ 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.