(89 days)
The Tether™ ACFS is indicated for trauma, deformity (lordosis, kyphosis and scoliosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, scollosis); pocudour.hrools; provised as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.), spondylolisthesis, and spinal stenosis.
The Tether™ ACFS is indicated for temporary stabilization of the spine from C2 to C7 during the time interval required for arthrodesis.
The Tether ACFS is a titanium alloy anterior cervical plate fixation system. The Tether AOTO 13 a titaniam anoy and come in a variety of lengths. Screws Prates are pre-contoured in two planos, and two different styles; fixed and variable in two diametors, cororal rengine are used to build a rigid fixation angle and variable angle screws are used to build a non-rigid construct. Hybrid constructs are possible by combining fixed and variable angle screws. A locking constructs are possible by comemages the plate hole upon entry into the plate and provides a mechanical lock against screw back-out.
The provided 510(k) summary for the Theken Surgical Company's Tether™ ACFS (Anterior Cervical Plate Fixation System) is for a medical device (spinal implant) and does not contain information related to software or AI performance. Therefore, many of the requested fields about AI-specific acceptance criteria, study design, and ground truth establishment cannot be answered from this document.
However, I can extract the general "performance data" provided for this medical device and present it.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-clinical: | |
| Stiffness | Characterized |
| Strength | Characterized |
| Fatigue Life | Characterized |
Explanation: The document states, "Static and fatigue testing was performed. Properties of stiffness, strength, and fatigue life were characterized." This implies that the device met pre-defined acceptance criteria for these mechanical properties, which are standard for spinal implants, allowing it to be considered substantially equivalent to the predicate device. However, the specific quantitative values for these criteria or the test results are not detailed in this summary.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. Testing would have involved a number of manufactured devices or prototypes.
- Data Provenance: Not specified, but generally, such non-clinical performance testing is conducted in a laboratory setting by the manufacturer or a contracted testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is a mechanical device, and "ground truth" for performance is established through engineering and biomechanical testing standards, not expert medical opinion.
4. Adjudication method for the test set
- Not applicable. Performance is based on objective measurements against 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 is not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an AI/software device.
7. The type of ground truth used
- Ground Truth: Engineering standards and biomechanical testing protocols for spinal implants (e.g., ASTM standards for static and fatigue testing).
8. The sample size for the training set
- Not applicable. This is not an AI/software device. The concept of a "training set" is not relevant here.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/software device.
§ 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.