(192 days)
Radix Cervical Plate is intended for anterior screw fixation of the cervical spine.
Indications for use include:
- degenerative disc disease (ddd) defined as back 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
- failed previous fusion
The Radix Cervical Plate is a one or two level plate that is secured to the anterior cervical vertebral bodies with unicortical bone screws. The plate is available in twelve lengths ranging from 38mm to 60mm in lengthe. It has six holes to receive the bone screws. The screw holes allow variable angulation of the screws.
Ease of intra-operative handling is enhanced by pre-contouring the plates in two directions to facilitate adaptation to the patient's anatomy and self-tapping uni-cortical screws, which shorten operating time. The acrews are 03.9mm and are available in five lengths, 10mm to 18mm. The self-tapping thread of the screws eliminates are ed or preliminary tapping.
The provided text describes a 510(k) summary for the "Radix Cervical Plate," a medical device for spinal fixation. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study details, and AI-related aspects is not present in the document.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The "acceptance criteria" for a 510(k) submission like this are generally demonstrating substantial equivalence to a previously legally marketed device (predicate device) in terms of intended use, technological characteristics, and safety/effectiveness. This is typically shown through non-clinical testing and comparison.
- Reported Device Performance: The document states: "Testing was performed according to ASTM 1717 with results comparable to other cervical plates." This is a general statement about performance, but no specific numerical results or benchmarks are provided. Also, the "performance" here refers to mechanical integrity, not clinical outcomes related to the indications.
| Acceptance Criteria (Implied for 510(k)) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (Synthes Anterior CLSP System (K030866) and EBI VueLock Cervical Plate (K010003)) in design, material, intended use, and technological characteristics. | "The Radix Cervical Plate is similar in material, plate lengths, ability to angulate and lock the bone screws, precontoured plates and indications." |
| Mechanical integrity and safety (e.g., strength, durability). | "Testing was performed according to ASTM 1717 with results comparable to other cervical plates." |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. This document describes a non-clinical (mechanical) testing scenario, not a clinical trial with a "test set" of patient data. ASTM 1717 is a standard for mechanical testing of spinal implant constructs, which would involve physical samples of the device, not a population of patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Ground truth definition by experts is relevant for clinical studies, especially those involving image analysis or diagnostic accuracy. This document details non-clinical mechanical testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. Adjudication methods are used in clinical trials to resolve discrepancies in expert opinions on patient outcomes or diagnoses. This is a non-clinical submission.
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. This device is a physical spinal implant, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. As above, this is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical testing (ASTM 1717), the "ground truth" would be established engineering principles and the mechanical properties/specifications defined by the ASTM standard. There's no biological "ground truth" in this context.
8. The sample size for the training set:
- Not applicable / Not provided. "Training set" is a concept for machine learning models. This document describes a physical medical device and its non-clinical testing.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. See point 8.
§ 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.