(268 days)
The ICON™ Modular Spinal Fixation System is intended for posterior, non-cervical pedicle fixation. Pedicle fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft bone. The device is indicated for all of the following indications:
- Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies,
- Spondylolisthesis,
- Trauma (i.e., fracture or dislocation),
- Spinal stenosis
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- Tumor,
- Pseudoarthrosis, and
- Failed previous fusion
The ICON™ Modular Spinal Fixation System components may be used with certain components of the Orthofix SFS system, including rods, rod connectors and cross-connectors.
The ICON™ Modular Spinal Fixation System is a temporary, titanium alloy, multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws to the non-cervical spine. The ICON Modular Spinal Fixation System consists of multi-axial pedicle screws, mono-axial pedicle screws. reduction screws, set screws, multi-axial bodies, offset bodies, cross connectors and rods. The ICON Modular Spinal Fixation System may be used with rods, crossconnectors, hooks, spacers, staples, washers, and axial connectors from the Orthofix Spinal Fixation System. The ICON Modular Spinal Fixation System's titanium implants are not compatible with components or metal from any other manufacturer's system.
The provided text describes a 510(k) premarket notification for a medical device called the ICON™ Modular Spinal Fixation System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving enhanced clinical safety or effectiveness through extensive clinical trials. Therefore, the information typically requested in your prompt regarding acceptance criteria for device performance in a clinical context, sample sizes for test and training sets for algorithms, ground truth establishment by experts, and MRMC studies, is generally not applicable to this type of regulatory submission for a spinal fixation system.
Instead, the acceptance criteria and study proving the device meets them revolve around mechanical performance and equivalence to predicate devices.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standards) | Reported Device Performance (Summary) |
|---|---|
| Static Compression Bending | "Mechanical testing... was conducted in accordance to ASTM F1717-04 standard... Test results demonstrated that the new, proposed changes are substantially equivalent to predicate devices..." |
| Dynamic Compression Bending | "Mechanical testing... was conducted in accordance to ASTM F1717-04 standard... Test results demonstrated that the new, proposed changes are substantially equivalent to predicate devices..." |
| Static Torsion | "Mechanical testing... was conducted in accordance to ASTM F1717-04 standard... Test results demonstrated that the new, proposed changes are substantially equivalent to predicate devices..." |
| Static Grip Strength | "Mechanical testing... was conducted in accordance to... ASTM F1798-97 standard for grip strength. Test results demonstrated that the new, proposed changes are substantially equivalent to predicate devices..." |
| Substantial Equivalence | "Based on mechanical performance evaluations, and equivalence in configuration, indications for use, and fundamental scientific technology, the modified ICON™ Modular Spinal Fixation System is substantially equivalent to the predicate devices. In addition, an extensive clinical comparison of experience with the ICON system compared to literature, MDR reports and FMEA evaluations indications that the ICON system is as safe and as effective as predicate devices, and is expected to perform at least as safely and effectively as the cited predicate devices." |
Note: The specific numerical results (e.g., maximum load, cycles to failure) for each test are not provided in this summary but would have been part of the full 510(k) submission. The "reported device performance" here is a high-level summary of the conclusion drawn from those tests – that the device is substantially equivalent to the predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document does not specify the sample size for the mechanical tests. Typically, mechanical testing involves a set number of samples per configuration (e.g., screw type, rod length) to meet the requirements of the ASTM standards.
- Data Provenance: The data is generated from in vitro mechanical testing performed by the manufacturer, Orthofix Inc., located in Lewisville, Texas, USA. It is not clinical data, so terms like "country of origin of the data," "retrospective," or "prospective" are not applicable in a clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This submission relies on in vitro mechanical testing against established industry standards (ASTM F1717-04, ASTM F1798-97) and comparison to predicate devices, not on expert adjudication of clinical outcomes or images. Therefore, clinical "ground truth" established by experts in the context of device performance is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As explained above, this is a mechanical testing and substantial equivalence submission, not a clinical study involving expert adjudication.
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 is a hardware medical device (spinal fixation system), not a diagnostic or AI-driven imaging device. Therefore, MRMC studies and AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context is adherence to the performance requirements of the referenced ASTM standards (ASTM F1717-04 and ASTM F1798-97), as well as demonstrating substantial equivalence in mechanical performance and technological characteristics to the identified predicate devices. This is determined by engineering and material science principles, not clinical ground truth.
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of mechanical testing for a spinal fixation system.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
§ 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.