(36 days)
The SpineSmith Cequence Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjunct to fusion in the treatment of 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
- Spinal Stenosis
- Tumors
- . Trauma (i.e. fracture)
The Cequence anterior cervical plates are preassembled and are offered in both a constrained and semi-constrained configuration. Cequence consists of four (4) primary components: 1) anterior plate, 2) self-tapping bone screws, 3) locking screws and 4) locking plate.
Acceptance Criteria and Device Performance Study for SpineSmith Cequence Anterior Cervical Plate System
The SpineSmith Cequence Anterior Cervical Plate System's acceptance criteria and performance are established through mechanical testing demonstrating substantial equivalence to a predicate device.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device | Mechanical test results demonstrate that the proposed Cequence System is substantially equivalent to the predicate device. |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document refers to "mechanical test results" in general, but does not specify the number of devices or iterations tested.
- Data Provenance: Not explicitly stated, however, the data would be generated in a laboratory setting as part of the device's design verification and validation. This is a prospective study in that tests are conducted on newly manufactured devices.
3. Number and Qualifications of Experts for Ground Truth
- Not applicable. The ground truth for this device is established through objective mechanical testing against a predicate device, not through expert consensus on clinical cases.
4. Adjudication Method for Test Set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective assessments (e.g., image interpretation), which is not relevant to mechanical testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is a medical device for spinal fixation, and its performance is evaluated through mechanical testing, not by human readers interpreting images. Therefore, an MRMC study is not relevant.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This device is a physical implant, not an algorithm. Its performance is inherent to its design and material properties demonstrated through mechanical testing.
7. Type of Ground Truth Used
- Mechanical Test Standards and Predicate Device Performance: The ground truth is based on established mechanical testing standards relevant to spinal implants and the performance characteristics of a legally marketed predicate device. This involves objective, quantifiable measurements.
8. Sample Size for Training Set
- Not applicable. This is a physical medical device, not an algorithm that requires a training set.
9. How Ground Truth for Training Set Was Established
- Not applicable. This is a physical medical device, not an algorithm that requires a training set.
§ 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.