(256 days)
The Highgate Curved Rod System is intended for unilateral screw fixation of the anterolateral thoracolumbar spine from To to L5. The Highgate Curved Rod System is intended to provide stabilization of a spinal segment as an adjunct to spinal fusion. Indications for the use of this device include spondylolisthesis (Grades 1 and 2), spinal stenosis, pseudarthrosis, failed fusion or degenerative disc disease (DDD) defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Highgate Curved Rod System is not intended for patients having severe spondylolisthesis (Grades 3 and 4), deformities or curvatures, tumor or trauma i.e. vertebral fracture.
The Highgate Curved Rod System is available in titanium alloy (Ti6A14V, ASTM F136) and includes rods and screws. Lateral and end screws are used to attach the rod to the thoracolumbar spine. Rods are offered in two curvatures and have circular openings accommodate the screws.
The provided text describes the Highgate Curved Rod System, a medical device for spinal fixation, and its approval through a 510(k) premarket notification. However, it does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or details regarding performance evaluation with human readers or standalone AI performance. The document primarily focuses on the device's description, materials, intended use, and substantial equivalence to existing devices.
Therefore, many of the requested details cannot be extracted from the given text. Below is an attempt to answer the questions based only on the provided information, noting where information is absent.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | "Static and fatigue mechanical testing were supplied in support of the Highgate Curved Rod System 510(k) premarket notification." (Specific performance metrics or comparison against a benchmark are not provided in the summary.) |
| Substantial Equivalence to predicate devices | "The Highgate Curved Rod System was determined to be substantially equivalent to several commercially available systems." (Specific criteria for 'substantial equivalence' are not detailed in this summary for performance.) |
| Indications for Use (correct application conditions) | The device is intended for "unilateral screw fixation of the anterolateral thoracolumbar spine from T10 to L5" as an adjunct to spinal fusion for conditions like "spondylolisthesis (Grades 1 and 2), spinal stenosis, pseudarthrosis, failed fusion or degenerative disc disease (DDD)." It is not intended for "severe spondylolisthesis (Grades 3 and 4), deformities or curvatures, tumor or trauma i.e. vertebral fracture." |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified. The document refers to "mechanical testing" but does not detail the number of units tested.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The provided text describes mechanical testing and a 510(k) submission, not a study involving expert-established ground truth for a diagnostic device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This information is not relevant to the type of device and study described (mechanical testing for spinal implants).
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:
- No. The document describes a spinal implant (mechanical device) and its mechanical testing, not an AI-based diagnostic tool that would undergo an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical spinal implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the mechanical testing, the "ground truth" would be engineering standards and specifications for material strength, fatigue life, and structural integrity. Specific standards or methods are not detailed beyond "Static and fatigue mechanical testing were supplied."
- For the clinical indications, the ground truth would be established medical diagnoses and the medical literature supporting the use of such devices for those conditions, referred to in the substantial equivalence comparison.
8. The sample size for the training set:
- Not applicable. This is a mechanical device, not a machine learning model.
9. How the ground truth for the training set was established:
- Not applicable. This is a mechanical device, not a machine learning model.
§ 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.