(246 days)
The Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
spondylolisthesis,
trauma (i.e. fractures or dislocations),
tumors.
deformity (defined as kyphosis, lordosis, or scoliosis),
pseudarthrosis.
failed previous fusion,
spinal stenosis
The Osteomed Implantes Anterior Cervical Plate System is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping bone screws using an anterior approach. Plates are available in a variety of lengths (22 mm - 110mm), addressing multiple levels of fixation (one to six). The Osteomed plate incorporates holes or vision ports on the longitudinal center line for intraoperative visualization and for screw fixation of bone graft. Bone screws are available in two diameters (Ø3.85 mm and Ø4.25 mm) and a variety of lengths (8mm - 20mm).
The provided document describes the Osteomed Implantes Anterior Cervical Plate System and its 510(k) submission to the FDA. This document does not contain information about a study proving the device meets specific acceptance criteria related to software algorithm performance, human-in-the-loop studies, multi-reader multi-case studies, or the use of experts for ground truth establishment.
Instead, this document details regulatory information for a medical device (an Anterior Cervical Plate System) and its non-clinical testing for substantial equivalence to predicate devices. The "acceptance criteria" referred to in the document are primarily related to mechanical performance standards for spinal implants, not algorithmic performance.
Here's an analysis based on the available information, addressing what can be answered and clearly stating what is not present:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Non-clinical Mechanical Testing) | Reported Device Performance |
|---|---|
| Static compression per ASTM F1717 | Results indicate equivalence to predicate devices. |
| Dynamic compression per ASTM F1717 | Results indicate equivalence to predicate devices. |
| Static torsion per ASTM F1717 | Results indicate equivalence to predicate devices. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the mechanical tests. Typically, these are engineering bench tests, not clinical human-based studies.
- Data Provenance: The tests are non-clinical (bench tests) performed to ASTM F1717 standards. The country of origin of this specific test data is not detailed, but the manufacturer is Osteomed Implantes, LTDA from Brazil.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable and not provided. The "ground truth" for mechanical testing is adherence to engineering standards and comparative performance against predicate devices, not expert consensus on medical images or patient outcomes.
4. Adjudication method for the test set:
- This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used for clinical or imaging studies where expert consensus is needed.
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 MRMC study was done. The document explicitly states: "No clinical studies were performed." This device is a physical implant, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done. This device is a physical implant, not an algorithm.
7. The type of ground truth used:
- For the non-clinical tests, the "ground truth" is adherence to the mechanical performance requirements and benchmarks set by the ASTM F1717 standard and the performance of the legally marketed predicate devices. It is not expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
- Not applicable and not provided. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable and not provided. This is not an AI/ML device.
Conclusion based on the provided document:
The Osteomed Implantes Anterior Cervical Plate System underwent non-clinical mechanical testing (static and dynamic compression, static torsion per ASTM F1717) to demonstrate substantial equivalence to predicate devices. The study concluded that the device is equivalent based on similarities in principles of operation, technology, materials, and indications for use, and the results of these non-clinical evaluations. No clinical studies were performed, and no information regarding algorithmic performance, human reader studies, or expert-derived ground truth for such studies is present because the device is a physical implant, not a software or AI-based diagnostic tool.
§ 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.