(126 days)
The icotec Anterior Cervical Plate 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 cervical spine (C2-T1) in whom life expectancy is of insufficient duration to permit achievement of fusion.
The icotec Anterior Cervical Plate System consists of plates and screws intended for use in anterior cervical fixation from C2 to T1. The system is developed to allow for conventional ventral approaches to the cervical spine. The icotec Anterior Cervical Plate System is available in various plate lengths and with selftapping screws for the specific adaption to the patient's anatomy. The icotec Anterior Cervical Plates are 18mm in width and come as 1- to 4-segmental implants with lengths ranging from 21 up to 94mm. The plates are precontoured to better fit patient anatomy. The screw holes in the plates are conical and threaded. The icotec ACP self-tapping screws are available in diameters of 4.0 and 4.25mm with lengths of 13 and 15mm. The fully threaded bone screws have threaded conical heads to firmly lock into the plate. The conical threaded screw heads are designed to block pullout while screw angulation in the cranial direction prevents screws from penetrating through the lower end plate of the vertebral body.
This document is a 510(k) premarket notification for a medical device, the icotec Anterior Cervical Plate System. It focuses on demonstrating substantial equivalence to predicate devices, rather than proving that the device meets specific performance criteria for an AI/ML product. Therefore, the requested information regarding acceptance criteria for AI/ML device performance, ground truth establishment, training sets, and MRMC studies is not present in this document.
The document details the device's indications for use, its description, and the predicate devices used for comparison. It also lists performance testing that was conducted, which primarily involves mechanical biocompatibility and structural integrity tests relevant to a spinal implant, not an AI/ML algorithm.
Here's a breakdown of the information that is available, and why the requested AI/ML specific information is absent:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Mechanical/Biocompatibility): The document states that "The nonclinical tests performed by the company, including static compression, static torsion and dynamic compression per ASTM F1717, met the pre-defined acceptance criteria." However, the specific numerical acceptance criteria (e.g., minimum load bearing capacity, maximum displacement) are not provided in this summary.
- Reported Device Performance (Mechanical/Biocompatibility): Similarly, the actual numerical results of these tests are not reported in this summary, only the qualitative statement that they "met the pre-defined acceptance criteria."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable for this type of device: This information typically pertains to clinical studies for AI/ML devices or drugs. For this mechanical implant, "sample size" would refer to the number of devices tested for mechanical properties, which is not detailed in this summary. There is no "data provenance" in the sense of patient data for an AI/ML algorithm.
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)
- Not Applicable: Ground truth establishment by experts is a concept for AI/ML model validation, not for the mechanical testing of a spinal plate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: Adjudication methods are used in clinical trials or AI/ML evaluations to resolve disagreements among readers/experts. This is not relevant to mechanical testing.
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: MRMC studies are used to evaluate diagnostic performance, especially for AI/ML algorithms assisting human readers. This device is a mechanical implant, not a diagnostic AI/ML tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This refers to the performance of an AI/ML algorithm in isolation. This device is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable (for AI/ML context): For mechanical testing, the "ground truth" would be engineering specifications and ASTM standards.
8. The sample size for the training set
- Not Applicable: There is no AI/ML model being trained for this device.
9. How the ground truth for the training set was established
- Not Applicable: There is no AI/ML model being trained for this device.
In summary, the provided document is a regulatory submission for a physical medical device (spinal implant) demonstrating substantial equivalence based on mechanical and biocompatibility testing, not an AI/ML diagnostic or therapeutic device. Therefore, the questions related to AI/ML specific acceptance criteria, study methodologies, and ground truth establishment are not addressed in this document.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.