(59 days)
The Invictus™ OsseoScrew® System (for use with the Invictus™ Spinal Fixation System and the transition rods from the Invictus™ CT Spinal Fixation System) is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The Invictus OsseoScrew is a pedicle screw system that consists of pedicle screws and associated general instruments. Implant components are available in a variety of sizes to suit the individual pathology and anatomical conditions of the patient. The subject cannulated polyaxial pedicle screws are in diameters of 6.5 mm and 7.5 mm with lengths ranging from 40 to 55 mm. The Invictus OsseoScrew is designed to be compatible with the Invictus Spinal Fixation System screws, hooks, rods, connectors, and cross-connectors for the thoracolumbar spine and Invictus CT Spinal Fixation System for the cervical (C1 to C7) to thoracic (T1-T3) spine. The Alphatec Spine Invictus OsseoScrew System is an implantable pedicle screw device whose core is manufactured from titanium alloy (Ti-6A1-4V ELI) conforming to ASTM F136 and the expandable screw shank is manufactured from CP2 Titanium conforming to ASTM F67 which are both industry recognized standards.
The device described is the Invictus™ OsseoScrew® System, a pedicle screw system. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting comprehensive clinical study data for device performance against specific acceptance criteria for AI/ML.
Based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device. The document pertains to a medical implant and its mechanical performance.
Therefore, many of the requested fields cannot be filled based on the provided text.
Here's an analysis of the information that can be extracted or inferred from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
Not applicable. The document discusses nonclinical testing for mechanical properties of the implant, not performance criteria for an AI/ML powered device. The "performance data" section lists mechanical tests according to ASTM standards for spinal implant systems. The "results demonstrate that the subject device is substantially equivalent to other predicate devices for nonclinical testing," implying that the performance met regulatory expectations for substantial equivalence based on these mechanical tests.
2. Sample size used for the test set and the data provenance:
Not applicable. This information is relevant for AI/ML studies, not for the mechanical testing of a pedicle screw system described here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This information is relevant for AI/ML studies, not for the mechanical testing of a pedicle screw system described here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This information is relevant for AI/ML studies, not for the mechanical testing of a pedicle screw system described here.
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 information is relevant for AI/ML studies, not for the mechanical testing of a pedicle screw system described here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical pedicle screw system, not an algorithm.
7. The type of ground truth used:
Not applicable. For the mechanical testing mentioned, the "ground truth" would be established by the physical properties and failure points observed during the ASTM standard tests, compared against industry standards and predicate device performance. It's not a concept of "ground truth" as used in AI/ML validation.
8. The sample size for the training set:
Not applicable. This information is relevant for AI/ML studies, not for the mechanical testing of a pedicle screw system described here.
9. How the ground truth for the training set was established:
Not applicable. This information is relevant for AI/ML studies, not for the mechanical testing of a pedicle screw system described here.
In summary, the provided document does not contain information related to the acceptance criteria or study design for an AI/ML powered medical device. It details a 510(k) submission for a physical medical implant (pedicle screw system) and its nonclinical mechanical testing for substantial equivalence.
§ 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.