(30 days)
The MonoPoly Pedicle Screw system is intended to help provide immobilization and stabilization of the spinal segments as an adjunct to fusion in skeletally mature patients of the thoracic, lumbar and/or sacral spine (T1-S1), specifically as follows:
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the MonoPoly Pedicle Screw System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) spinal tumor, and/or (6) failed previous fusion (pseudarthrosis).
When used as a non-cervical and non-pedicle screw fixation system, the MonoPoly Pedicle Screw System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) trauma (fracture, dislocation), (5) pseudarthrosis, (6) tumor resection and/or (7) failed previous fusion.
The MonoPoly Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle screws sizes, couplers, a set screw, cross links, a washer, rods and hooks. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-Eli). This premarket notification addresses the introduction of cannulated versions of the MonoPoly pedicle screw component of the system.
The provided text describes a 510(k) summary for the MonoPoly Pedicle Screw System, specifically addressing the introduction of cannulated versions of the pedicle screw component. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device.
Key takeaway: This document describes a medical device (pedicle screw system), not an AI/ML device. Therefore, the questions related to AI/ML device performance, ground truth, expert consensus, and training/test sets are not applicable.
However, I can extract the relevant device information and acceptance criteria as outlined for a traditional medical device submission.
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
This submission is for a traditional medical device (pedicle screw system), not an AI/ML device. Therefore, the concepts of sensitivity, specificity, F1 score, ROC AUC, ground truth establishment, reader studies, and training/test sets for AI/ML models are not applicable.
The acceptance criteria for this device are established by demonstrating substantial equivalence to a predicate device through conformity to recognized standards and verification of mechanical properties.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Evidence |
|---|---|---|
| Material Composition | All implantable components manufactured from medical grade titanium alloy (Ti6Al4V-Eli). | Device components are confirmed to be manufactured from medical grade titanium alloy (Ti6Al4V-Eli). |
| Functional Equivalence | Device should provide immobilization and stabilization of spinal segments as an adjunct to fusion for specified indications. | The modification (cannulated versions) does not adversely affect performance and is substantially equivalent to the predicate device in its intended use. |
| Mechanical Properties | Mechanical properties evaluated as per ASTM F1717-04. Device must meet the performance requirements of this standard for spinal implant assemblies. | Mechanical properties were evaluated as per ASTM F1717-04. The submission implies compliance with this standard for substantial equivalence. |
| Safety | No adverse effect on performance or safety compared to the predicate device due to the introduction of cannulated versions. | The modification to the original device does not adversely affect performance. |
| Intended Use | Intended use aligns with the predicate device for specified indications (e.g., degenerative disc disease, fracture, spondylolisthesis in T1-S1 spine for skeletally mature patients). | The stated "Indications for Use" for the MonoPoly Pedicle Screw System match those of the predicate device. |
Study Proving Device Meets Acceptance Criteria:
The study conducted to prove the device meets acceptance criteria is primarily bench testing to confirm mechanical properties and a comparison to the predicate device to establish substantial equivalence.
- Study Type: Mechanical testing (bench testing) and comparative analysis with a predicate device.
- Methodology: Mechanical properties were evaluated according to the recognized international standard ASTM F1717-04, which specifies test methods for spinal implant assemblies in a spinal construct. This standard would involve testing parameters such as static and dynamic bending strength, stiffness, and fatigue resistance under simulated physiological loading conditions.
- Conclusion: The submission concludes that "The modification to the original device does not adversely affect performance and the modified device is substantially equivalent to the unmodified predicate device."
Regarding the AI/ML-specific questions, they are not applicable as this is not an AI/ML device.
2. Sample size used for the test set and the data provenance: Not applicable (not an AI/ML device). The "test set" here refers to the physical devices subjected to mechanical testing. The sample size for ASTM F1717-04 testing would typically involve a statistically relevant number of devices to ensure robustness of results, but the document does not specify this number. Data provenance would be from laboratory bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable (not an AI/ML device). "Ground truth" in this context is determined by the physical properties and performance metrics established by standardized mechanical tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable (not an AI/ML device). Adjudication methods are relevant for human interpretation of data, not for direct mechanical testing results.
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 (not an AI/ML device). MRMC studies are for evaluating diagnostic performance with human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable (not an AI/ML device). This refers to AI algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable (not an AI/ML device). The "ground truth" for this medical device is based on established engineering principles, material science, and performance standards (e.g., ASTM F1717-04).
8. The sample size for the training set: Not applicable (not an AI/ML device).
9. How the ground truth for the training set was established: Not applicable (not an AI/ML device).
§ 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.