(71 days)
The SeaSpine Cabo ACP (Anterior Cervical Plate) System is intended for anterior cervical fixation (C2-T1) for the following indications:
· Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
- · Spondylolisthesis,
- · Trauma (i.e., fracture or dislocation),
- · Spinal Stenosis,
- · Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis).
- · Tumor,
- · Pseudoarthrosis,
- · and failed previous fusion
The SeaSpine Cabo ACP (Anterior Cervical Plate) System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The Cabo plates include locking pins that cover the heads of the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the plate. The Cabo ACP (Anterior Cervical Plate) System implant components are made from titanium alloy per ASTM F136. Associated instruments are available to facilitate the implantation of the device.
This FDA 510(k) uses a traditional comparison to a predicate device and engineering analysis rather than a study involving acceptance criteria and device performance evaluation in the context of clinical or diagnostic accuracy. Therefore, most of the requested information regarding AI/algorithm performance and clinical study details is not applicable to this document.
Here's a breakdown of what can be extracted based on the provided text, and where the requested information is not present:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria and device performance in a table format as would be typical for clinical or algorithm-based performance studies. Instead, it relies on demonstrating substantial equivalence to a predicate device through non-clinical mechanical testing.
| Acceptance Criteria (General Principle for 510(k)) | Reported Device Performance (from Non-Clinical Testing) |
|---|---|
| Equivalent or superior mechanical performance to the predicate device. | "The SeaSpine Cabo ACP (Anterior Cervical Plate) System demonstrated equivalent performance to the predicate system through engineering analysis of static axial compression and torsion, and dynamic axial compression per ASTM F1717." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical test set or data provenance is mentioned. The equivalence is based on non-clinical mechanical testing of the device itself.
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 based on expert review is established as this is a mechanical device, not a diagnostic or AI algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is described.
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 not an AI/diagnostic device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (an anterior cervical plate system), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance demonstration is based on mechanical testing standards (ASTM F1717), not clinical outcomes, pathology, or expert consensus in an AI context. The performance is measured against predefined mechanical properties and compared to a predicate device.
8. The sample size for the training set
Not applicable. There is no training set for a physical medical device.
9. How the ground truth for the training set was established
Not applicable. No training set is relevant here.
§ 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.