(47 days)
The Intuitive Anterior Cervical System is intended for anterior screw fixation of the cervical spine (C2-C7). These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system are: degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
WARNING: The Intuitive Anterior Cervical System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
The Intuitive Anterior Cervical System comprises plate and screw components in a variety of sizes and lengths. Three styles of plate, including fixed, variable and corpectomy, are available. Primary, self-drilling primary and rescue screws are offered.
The provided text describes a medical device, the "Intuitive Anterior Cervical System," and its clearance process, which relies on demonstrating substantial equivalence to a predicate device. This is not the type of study typically associated with AI/ML devices where specific acceptance criteria are defined for algorithmic performance. Instead, it focuses on physical and mechanical performance.
Therefore, many of the requested categories related to AI/ML studies are not applicable to this document. I will fill in the relevant information and indicate when information is "Not Applicable" or "Not Provided" in the context of this device's regulatory submission.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Mechanical Performance: |
- Static compression bending
- Static torsion
- Dynamic compression bending | "The mechanical test results demonstrated that Intuitive performs as well as the predicate device." (Implies meeting or exceeding predicate's performance in these tests, which serves as the de facto acceptance criteria.) |
| Technological Characteristics: - Intended Use
- Design (plate-based fixation system having self-tapping screws in various sizes)
- Material (titanium alloy)
- Sizes (plate and screw sizes) | "The Intuitive Anterior Cervical System is identical to the predicate Fixed, Variable & Corpectomy Cervical Plate System [...] Therefore, the system possesses the same technological characteristics as the predicate." |
| Material Composition: - Plates and screws: titanium alloy (Ti-6Al-4V per ASTM F136)
- Screw-retaining central rail: nickel titanium alloy (NiTi per ASTM F2063) | The device is manufactured from these specified materials. Implicitly, meeting these material specifications is an acceptance criterion. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated as a number of "cases" or "patients" in the context of data for an AI/ML system. Instead, the testing refers to "a worst-case, cervical plate construct" for mechanical tests. The "sample" likely refers to the physical constructs tested according to ASTM F1717.
- Data Provenance: Not applicable in the context of patient data. The mechanical testing is laboratory-based.
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 in the sense of expert annotation for AI/ML performance is not relevant here. The "ground truth" for the mechanical tests would be the established scientific principles of material strength and durability, and the ASTM F1717 standard itself.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are for conflicting expert opinions in data labeling, which is not part of this type of device evaluation.
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 is a physical implant device, not an AI/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. See point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" used for this device's acceptance is based on mechanical testing standards (ASTM F1717) and the established performance of a legally marketed predicate device. The fundamental scientific principles governing material strength and biomechanics, as codified in the ASTM standard, serve as the basis for evaluating device performance.
8. The sample size for the training set
- Not Applicable. As this is not an AI/ML device, there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As this is not an AI/ML device, there is no "training set" and thus no ground truth established for it.
§ 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.