(77 days)
The mont blanc system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral/iliac spine.
This mont blanc system is intended for posterior noncervical pedicle fixation and non-pedicle fixation (from T1 to S1) for the following indications in skeletally mature patients:
· 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;
- · deformities (i.e., scoliosis, kyphosis, and/or lordosis);
- · spinal tumor,
- · pseudoarthrosis; and
- · failed previous fusion.
The mont blanc system is intended to be used with autograft and/or allograft.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Mont Blanc and Mont Blanc MIS Spinal Systems metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Mont Blanc and Mont Blanc MIS Spinal Systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The mont blanc MIS system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
This mont blanc MIS system is intended for posterior noncervical pedicle fixation and non-pedicle fixation (from T1 to S1) utilizing a percutaneous minimally approach for the following indications in skeletally mature patients:
· 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;
- · deformities (i.e., scoliosis, kyphosis, and/or lordosis);
- · spinal tumor,
- · pseudoarthrosis; and
- · failed previous fusion.
The mont blanc MIS system is intended to be used with autograft and/or allograft.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Mont Blanc MIS Spinal Systems metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The Mont Blanc and Mont Blanc MIS Spinal Systems are intended to be used with autograft and/or allograff. Pediatric pedicle screw fixation is limited to a posterior approach.
The Spineway mont blanc & mont blanc MIS Spinal Systems are implant device systems comprised of a titanium alloy Ti 6Al-4V ELI per ISO 5832-3 and Cobalt-Chrome per ISO 5832-12. The fenestrated screws are polyaxial screws in diameters from 5.0 – 8.0 mm and in lengths from 30 – 55 mm. 6 fenestration holes are present in screws of length 35 mm or longer, 3 fenestration holes are present in screws of length 30 mm.
Dual connectors and domino connectors are available to connect 2 parallel rods together, lliac lateral connectors are available to create an Iliac fixation, and Axial connectors are available to connect 2 coaxial rods together.
Associated instrumentation to complete the procedure is provided reusable and non-sterile.
The provided FDA 510(k) summary (K191726) for the mont blanc & mont blanc MIS Spinal Systems does not contain information typically associated with acceptance criteria and study designs for AI-powered medical devices. Instead, it focuses on demonstrating substantial equivalence for a traditional implantable medical device (spinal fixation system) through mechanical testing.
Therefore, many of the requested categories (such as AI performance metrics, sample size for test/training sets, expert qualifications, adjudication methods, or MRMC studies) are not applicable to this document. The study described is a performance testing study for physical implants, not an AI efficacy study.
Here's a breakdown of the information that is available or not applicable/provided based on the document:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated as "acceptance criteria" but inferred from performance testing) | Reported Device Performance (Summary of results) |
|---|---|
| Equivalence to predicate devices in mechanical performance. (Inferred standard: must meet or exceed the predicate's performance under specified ASTM standards). | "The result showed that the worst-case constructs were substantially equivalent to legally marketed devices." Specifically, mechanical testing per ASTM F1717-15 was performed, including Static Compression Bending, Static Torsion, Torque to Failure, and Dynamic Compression Bending. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in terms of numerical quantity but refers to "worst-case constructs comprised of Screws, Rods, Locking Screws, & Connectors." This implies a set of physical prototypes or manufactured units selected to represent the most challenging mechanical scenarios.
- Data Provenance: Not applicable in the context of clinical data. This refers to in-vitro mechanical testing conducted by the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. Ground truth for mechanical testing is established by engineering specifications and objective measurements against ASTM standards, not by expert interpretation of clinical data.
4. Adjudication Method for the Test Set
- Not applicable. This relates to clinical expert review, which is not part of mechanical performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This type of study is for evaluating the impact of AI assistance on human reader performance, which is not relevant for a spinal implant device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This device is a physical spinal implant, not an algorithm.
7. The Type of Ground Truth Used
- Not explicitly stated as "ground truth" but based on: Objective measurements from mechanical testing (Static Compression Bending, Static Torsion, Torque to Failure, Dynamic Compression Bending) against established engineering standards (ASTM F1717-15) and comparison to predicate device performance.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical implant, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set for an AI model is described.
§ 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.