Search Results
Found 1 results
510(k) Data Aggregation
(266 days)
When intended for stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput -T3), the Nextgen Altius OCT System is intended for use with allograft or autograft and indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); pseudoarthrosis; spinal stenosis; trauma, (i.e., fracture or dislocation); atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.
The occipital bone screws are limited to occipital fixation only.
The use of pedicle screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
The Nextgen Altius OCT System can also be linked to the Biomet Polaris Systems via transitional rods or using Altius Rod Connectors or Polaris Dominoes. Please refer to the individual system's package insert for a list of indications for use for each system.
This submission is a line extension to Nextgen Altius OCT System to add an alternate style of multiaxial screws to the system.
The provided documents describe findings for a spinal fixation system, not an AI/ML device. Therefore, the questions related to AI/ML device performance (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training) cannot be answered from the provided text.
However, I can extract information related to the device's mechanical performance and the study conducted.
Here is the information based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (What was tested) | Reported Device Performance (How the device performed) |
|---|---|
| Static interconnection testing | Met all mechanical test requirements based on worst-case construct testing. |
| Compression bending fatigue | Met all mechanical test requirements based on worst-case construct testing. |
| Dissociation testing | Met all mechanical test requirements based on worst-case construct testing. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for individual tests. The text refers to "worst-case construct testing."
- Data Provenance: Not applicable. This refers to mechanical testing, not clinical data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not expert consensus.
4. Adjudication method for the test set
Not applicable. Mechanical tests have pass/fail criteria based on engineering standards.
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 device is not an AI/ML diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical spinal fixation system.
7. The type of ground truth used
For mechanical testing, the "ground truth" or reference criterion is based on established engineering standards (ASTM F1717, ASTM F1798) and relevant FDA guidance (FDA's Guidance for Industry and FDA Staff - Spinal System 510(k)s dated May 3, 2004).
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
Ask a specific question about this device
Page 1 of 1