(144 days)
The NexLink OCT Occipital Cervical Plating System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following indications: degenerative disc disease (neck pain of discogenic origin with degeneration of the disk as confirmed by patient history and radiological studies), spinal stenosis. fracture/dislocation, atlantoaxial fracture with instability, occipito-cervical dislocation, revision of previous cervical spine fusion surgery and tumors.
The Cancellous and Cortical Bone Screws (3.5mm and 4mm diameters; 6mm-20mm threaded lengths) are used with the NexLink OCT Occipital Cervical Plating System to allow for occipital fixation and limited to occipital fixation only. The 4mm Cannulated Side Loading Closed Screws are limited to placement in the upper thoracic spine (T1-T3) for additional stabilization of the indications specified above.
NexLink OCT is the re-design and modernization of the existing OctaFix svstem. The scope of the NextLink OCT Cervical Plating System will include 1) a modular occipital plate, 2) a selection of precontoured rods, 3) hooks and 4) a refined set of instrumentation. The scope of the project is for Next ink OCT to integrate as an option to the current Nex-Link System. The NexLink OCT Occipital Cervical Plating System components are temporary implants that are used to stabilize the spine (occiput-T3) during the development of a solid spinal fusion in patients with degenerative disease, trauma (including fractures), and tumor pathology.
The provided text describes the NexLink OCT Cervical Plating System. However, it does not contain information about the acceptance criteria, device performance from a study, sample sizes, expert qualifications, adjudication methods, MRMC studies, or ground truth details. The document explicitly states that "Clinical data and conclusions were not needed for this device." and relies on "Laboratory and bench testing results" to demonstrate substantial equivalence to a predicate device.
Therefore, many of the requested details cannot be extracted from the provided text.
Here is a summary of what can be extracted and the reasons why other information is unavailable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Demonstrates substantial equivalence to predicate device based on laboratory and bench testing. |
Reasoning: The document states, "Laboratory and bench testing results demonstrate that the proposed device is substantially equivalent to the predicate device." However, it does not specify what specific acceptance criteria these tests were designed to meet (e.g., specific thresholds for strength, fatigue life, etc.), nor does it provide quantitative results of these tests.
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: Not applicable. No clinical test set was used.
- Data Provenance: Not applicable. The "testing" was non-clinical (laboratory and bench testing).
Reasoning: The document explicitly states, "Clinical data and conclusions were not needed for this device." The evaluation was based on non-clinical laboratory and bench testing.
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. No "ground truth" for a clinical test set was established as no clinical data was required or used.
Reasoning: As no clinical data was used, there was no need for experts to establish ground truth for a clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication was used.
Reasoning: No clinical data, no clinical test set, therefore no adjudication method applies.
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. An MRMC comparative effectiveness study was not done.
Reasoning: This is a medical device (cervical plating system), not an AI/software device involving human readers or interpretation of medical images. The concept of "human readers improve with AI" is not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (cervical plating system), not an algorithm or AI.
Reasoning: See above.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The "ground truth" for this device's evaluation was based on engineering and material standards for mechanical testing to demonstrate substantial equivalence to a predicate device, rather than clinical outcomes or diagnostic accuracy.
Reasoning: The device's performance was evaluated through "Laboratory and bench testing results." This implies a comparison to established engineering specifications and benchmarks relevant to spinal implants, not clinical ground truth in the diagnostic sense.
8. The sample size for the training set
- Not applicable. This device is a physical medical implant, not a machine learning model that requires a training set.
Reasoning: The concept of a "training set" belongs to machine learning and AI, which are not relevant to this physical device.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
Reasoning: See above.
§ 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.