(104 days)
The Diamond Anterior Cervical Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
- Degenerative Disc Disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies)
- Trauma (including fractures) .
- Tumors .
- Deformities or curvatures (including kyphosis, lordosis, or scoliosis) ●
- Pseudarthrosis .
- . Failed previous fusion
- . Spondylolisthesis
- . Spinal Stenosis.
Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine
The Diamond Anterior Cervical Plate System is made of a medical grade titanium alloy and Nitinol, and consists of plates and screws of various lengths to accommodate single or multilevel fusions and variations in patients' anatomy. One level plates range from 22mm to 34mm. Two level plates range from 36mm. Three level plates range from 53mm to 77mm. Four level plates range from 68mm to 92mm. All plates are 18mm wide and have an average thickness of 2.5mm. The screws range in sizes from 12 mm to 18 mm and come in diameters of 4.0mm and 4.3mm.
This document describes the 510(k) summary for the Diamond Anterior Cervical Plate System.
Here's an analysis of the provided text, focusing on the requested information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical integrity tested according to ASTM F1717 standard for static and dynamic tests. | "The Diamond Anterior Cervical Plate System was mechanically tested using ASTM 1717. Tests included were: Static Compression Bending, Static Torsion, Static Tension Bending, and Dynamic Compression Bending." |
| Device performance is substantially equivalent to predicate devices. | "The pre-clinical testing performed indicated that the Diamond Anterior Cervical Plate is substantially equivalent to the predicate devices and is adequate for the intended use." |
| Material composition equivalent to predicate devices. | "The Diamond Anterior Cervical Plate System and Medtronic Orion Anterior Cervical Plating System are both composed of Titanium Alloy and Nitinol. Synthes Spine CSLP and X-Spine ACT system are both composed of Titanium Alloy." |
| Dimensions (width, thickness, lengths) equivalent to predicate devices. | "The dimensions of Synthes Spine CSLP variable plate is 18mm wide and 2.5mm thick which is roughly equivalent to the Diamond Anterior Cervical Plate which is 18mm wide and has an average thickness of 2.5mm. The Diamond Anterior Cervical Plate System is also provided in the same lengths as the X-Spine ACT system." |
2. Sample size used for the test set and the data provenance
The document only mentions "pre-clinical testing" and does not specify the sample size for the mechanical tests (number of plates/screws tested). Data provenance (e.g., country of origin, retrospective/prospective) is not provided as the study is a mechanical test rather than a clinical study with patient data.
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 performance study, not a study requiring expert-established ground truth on clinical images or patient outcomes.
4. Adjudication method for the test set
Not applicable. This is a mechanical device performance study.
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 a mechanical device, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by the ASTM F1717 standard physical performance requirements for intervertebral body fixation orthoses. Compliance with these established engineering standards serves as the ground truth.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is a mechanical device and not an AI/machine learning model.
9. How the ground truth for the training set was established
Not applicable, as there is no training set. The "ground truth" for evaluating the mechanical device is based on established engineering standards (ASTM F1717).
§ 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.