(69 days)
The Inertia™ MIS Pedicle Screw System is 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 (T1 to S2): severe spondylolisthesis (grades 3 and 4) of the L5-SI vertebra: degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; spinal stenosis; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).
The Inertia™ MIS Pedicle Screw System consists of rods, polyaxial screws and set screws. Rods are available in either straight or pre-contoured (curved) forms and in a variety of lengths. Polyaxial screws are available in a variety of diameter-length combinations. Set screws are used to fasten the rod and polyaxial screw. The purpose of this 510(k) is to add cannulated pedicle screws to the Inertia™ MIS Pedicle Screw System.
The provided 510(k) summary for the Inertia™ MIS Pedicle Screw System describes a mechanical testing study to demonstrate substantial equivalence to a predicate device. This study focuses on engineering performance, not AI/ML-driven diagnostic or assistive capabilities. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, sample size for training set, etc.) are not applicable to this type of device and study.
Here's a breakdown of the available information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Defined in the Design Control Activities Summary according to ASTM F1717 for static, dynamic compression bending, and static torsion. | The results "demonstrate that the acceptance criteria defined in the Design Control Activities Summary were met." |
Details of the study that proves the device meets the acceptance criteria:
- Sample size used for the test set and the data provenance: Not applicable. This was mechanical testing, not a study involving patient data. The "test set" would refer to the physical devices tested.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by engineering standards (ASTM F1717) and measurement, not expert consensus.
- Adjudication method for the test set: Not applicable. This was mechanical testing against predefined engineering standards.
- 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: No. This device is a pedicle screw system, a physical implant. It does not involve AI or human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is a physical medical device, not an algorithm.
- The type of ground truth used: Mechanical testing data compared against the performance requirements outlined in the ASTM F1717 standard and the company's "Design Control Activities Summary."
- The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study:
The study was a mechanical testing study conducted according to ASTM F1717. It involved testing the "worst case" subject Inertia™ MIS Pedicle Screw System and comparing its performance to the predicate Inertia™ Pedicle Screw System. The tests performed were:
- Static compression bending
- Dynamic compression bending
- Static torsion
The results of these tests were reported to have met the acceptance criteria defined in the Design Control Activities Summary. This demonstrates the substantial equivalence of the new cannulated pedicle screws to the predicate device in terms of mechanical performance.
§ 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.