(92 days)
The Tangis Anterior Cervical Plate 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 Tangis Anterior Cervical Plate 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-drilling and self-tapping bone screws using an anterior approach. Plates are available in a variety of lengths (20 mm – 92 mm), addressing multiple levels of fixation (one to four). The plate incorporates graft visualization holes on the longitudinal center line for intraoperative visualization. Bone screws are available in three diameters (3.75 mm, 4.25 mm, and 4.75 mm) and a variety of lengths (10 mm - 20 mm). All components are made from titanium alloy per ASTM F136.
The provided document describes a 510(k) premarket notification for the Tangis Anterior Cervical Plate, a medical device used for spinal fixation. It establishes substantial equivalence to predicate devices based on non-clinical testing.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from industry standards) | Reported Device Performance (Tangis Anterior Cervical Plate) |
|---|---|
| Static Compression per ASTM F1717: No explicit quantitative acceptance criteria are given in this document. | Demonstrated substantial equivalence to predicate devices. |
| Dynamic Compression per ASTM F1717: No explicit quantitative acceptance criteria are given in this document. | Demonstrated substantial equivalence to predicate devices. |
| Static Torsion per ASTM F1717: No explicit quantitative acceptance criteria are given in this document. | Demonstrated substantial equivalence to predicate devices. |
Note: The document states "No FDA performance standards have been established for the Tangis Anterior Cervical Plate. The following tests were performed to demonstrate safety based on current industry standards." This indicates that the device was tested against recognized industry standards (ASTM F1717), and its performance was found to be comparable to accepted predicate devices, implying it met the unstated performance expectations within those standards. Without specific numerical thresholds from the report or the ASTM standard itself, exact quantitative acceptance criteria cannot be listed here.
2. Sample Size Used for the Test Set and Data Provenance
This is an in-vitro non-clinical study involving mechanical testing of the device itself. Therefore, the concept of a "test set" in terms of patient data or clinical samples does not apply. The "sample size" would refer to the number of devices or constructs tested for each mechanical test. This information (e.g., how many plates were subjected to static compression) is not provided in the document.
Data provenance (country of origin, retrospective/prospective) is not applicable as this is a non-clinical mechanical testing study.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not applicable. Ground truth for clinical outcomes or diagnoses is not established in this non-clinical mechanical testing study. The "ground truth" here is the physical measurement of mechanical properties, which is objective and does not require expert interpretation in the way clinical data would.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" in the context of expert review or clinical adjudication for this non-clinical mechanical study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a non-clinical mechanical testing study. MRMC studies are relevant for evaluating the performance of diagnostic or screening devices typically involving human readers interpreting images or data.
6. Standalone Performance Study
Yes, in a sense. The mechanical tests (static and dynamic compression, static torsion) were performed on the device itself (algorithm only, without human-in-the-loop performance) to evaluate its structural integrity and performance against industry standards. This is the standalone performance of the physical device.
7. Type of Ground Truth Used
For this non-clinical study, the "ground truth" is established by the physical measurements and mechanical properties of the device under specific test conditions as defined by ASTM F1717. This is an objective, quantitative measurement of material and structural performance, not a subjective interpretation of clinical data.
8. Sample Size for the Training Set
Not applicable. There is no "training set" in the context of an AI/ML algorithm or clinical data for this non-clinical mechanical testing study.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no 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.