(228 days)
The Inertia™ 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-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; spinal stenosis; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
The Inertia™ 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 provided text describes a 510(k) summary for the "Inertia™ Pedicle Screw System" and details the device's characteristics and performance testing. However, it does not include information about AI algorithms, ground truth establishment for AI, expert consensus, or multi-reader multi-case studies. This submission is for a traditional medical device (pedicle screw system), not an AI/ML-driven device.
Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation cannot be filled from the provided document.
Here's a breakdown of the available information based on the request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material: Components manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136. | The Inertia™ Pedicle Screw System components are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136. (Meets) |
| Technological Characteristics: Same as predicates: rod-based pedicle screw system with polyaxial screws, titanium alloy material, rod and screw sizes within the range of predicate systems, and same intended use. | The Inertia™ Pedicle Screw System possesses the same technological characteristics as the predicates. These include: basic design (rod-based pedicle screw system having polyaxial screws), material (titanium alloy), sizing (rod and screw sizes are within the range of those in the predicate systems), and intended use (as described). (Meets) |
| Mechanical Performance: Perform as well as or better than predicate devices according to ASTM F1717 for static compression bending and torsion, and dynamic compression bending of the worst-case construct. | The mechanical results demonstrated that the Inertia™ Pedicle Screw System performs as well as or better than the predicate devices. (Meets) |
2. Sample Size Used for the Test Set and Data Provenance
The document describes mechanical performance testing on the device itself, not a test set of data like an image dataset. The "sample size" here refers to the number of constructs tested. The text does not specify the exact number of constructs tested, but typical mechanical testing involves multiple samples to ensure statistical validity.
- Sample size for test set: Not explicitly stated (refers to "worst case Inertia™ Pedicle Screw System construct" without specifying the number of samples).
- Data Provenance: Not applicable in the context of device mechanical testing (no country of origin or retrospective/prospective data collection as for clinical data).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable as this is a mechanical device performance study, not an AI/ML-driven medical image analysis or diagnostic study requiring expert ground truth.
4. Adjudication Method for the Test Set
- Not applicable as this is a mechanical device performance study.
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
- No. This is a traditional medical device (pedicle screw system), not an AI/ML device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is a traditional medical device (pedicle screw system), not an AI/ML device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device is its physical and mechanical performance against established engineering standards (ASTM F1717) and comparison to predicate devices, rather than a clinical ground truth like pathology or expert consensus. The "ground truth" is adherence to these mechanical standards.
8. The Sample Size for the Training Set
- Not applicable. This is a traditional medical device, not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. This is a traditional medical device, 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.