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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

1. Acceptance criteria and reported device performance (in terms of sensitivity, specificity, etc.)
2. Sample sizes for test set and data provenance
3. Number of experts and qualifications for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study
6. Standalone algorithm performance
7. Type of ground truth (pathology, outcomes data, etc.)
8. Sample size for training set
9. 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.

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