(155 days)
When intended to promote fusion of the cervical spine and occipito-cervicothoracic junction (occiput-T3), the PROTEX™ CT Spinal System is indicated for: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors.
The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. Occipital bone screws are limited to occipital fixation; they are not intended for fixation of the posterior cervical spine.
The PROTEX™ CT System can also be linked to titanium rod systems ranging in diameter from 3.7mm to 6.5mm, including the PROTEX™ System, using parallel connectors.
The PROTEX™ CT Spinal System consists of rods, polyaxial screws, hooks, locking caps, t-connectors, lateral connectors, parallel connectors, and occipital clamps. The implants are composed of titanium alloy.
This document is a 510(k) summary for the PROTEX™ CT Cervicothoracic Spinal System, a medical device. It focuses on mechanical testing for performance evaluation, not on AI/ML device performance. Therefore, most of the requested information regarding acceptance criteria for AI, study design for AI models, and ground truth establishment is not applicable.
Here's the relevant information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states: "Mechanical testing was conducted to evaluate performance as a basis for substantial equivalence." However, it does not explicitly list the acceptance criteria or the specific numerical results of this mechanical testing within the provided text. To determine the acceptance criteria, one would typically refer to the full mechanical testing report that was submitted with the 510(k), which is not included here. The "reported device performance" is implied to have met the necessary thresholds for substantial equivalence to predicate devices, allowing for clearance.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the provided text, but implied to be mechanical performance thresholds for substantial equivalence to predicate devices. | Not explicitly stated in the provided text, but implied to have met the necessary thresholds for substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not applicable as the document describes a mechanical device and its testing, not an AI/ML-based device that would utilize a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable for the same reason as above. Ground truth establishment is relevant for algorithm performance validation, not for mechanical device testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable.
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
This information is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable. The "ground truth" for a mechanical device is typically its physical properties and performance under stress, which are measured directly.
8. The sample size for the training set
This information is not applicable as this is a mechanical device, not an AI/ML model that undergoes training.
9. How the ground truth for the training set was established
This information is not applicable.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.