(51 days)
The Renovis Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7).The system is indicated for use in the temporary stabilization of the anterior spine during the development of fusion in patients with the following conditions:
· 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
- · tumor
- · pseudoarthrosis
- · failed previous fusion
WARNING: The Renovis Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
The Renovis Anterior Cervical Plate System consists of various shapes and sizes of plates and screws, and associated instruments. The plates are available in multiple lengths to accommodate single or multi-level surgeries. The plates and screws are manufactured from titanium alloy and the locking clip is manufactured from nickel-titanium alloy.
The provided document describes a 510(k) premarket notification for the Renovis Anterior Cervical Plate System. This is a medical device submission, and the content focuses on demonstrating substantial equivalence to a predicate device rather than describing a study with acceptance criteria and device performance in the way one might for an AI/algorithm-based diagnostic product.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not provided in this type of document. This document details the physical and mechanical performance of an implantable medical device, not the diagnostic performance of a software or AI.
However, I can extract the relevant information from the performance testing section.
Acceptance Criteria and Study for Renovis Anterior Cervical Plate System
The Renovis Anterior Cervical Plate System is a physical medical device. Its "performance" refers to its mechanical and material properties, not diagnostic accuracy. The "acceptance criteria" are implicitly met by passing the specified ASTM standards and internal protocols.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria (Implicitly met by standard) | Reported Device Performance (as stated in document) |
|---|---|---|
| Static Axial Compression Bending (ASTM F1717) | Acceptable (as per ASTM F1717) | Found to be acceptable |
| Static Torsion (ASTM F1717) | Acceptable (as per ASTM F1717) | Found to be acceptable |
| Dynamic Axial Compression Bending (ASTM F1717) | Acceptable (as per ASTM F1717) | Found to be acceptable |
| Corrosion Testing (ASTM F2129) | Acceptable (as per ASTM F2129) | Found to be acceptable |
| Auger Emission Spectroscopy (AES) analysis of nitinol clip | Acceptable (as per internal protocol/standard) | Found to be acceptable |
| Screw Push-out Testing (per protocol) | Acceptable (as per internal protocol) | Found to be acceptable |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. For mechanical testing of medical devices, sample sizes are typically determined by statistical methods for engineering testing (e.g., to achieve a certain confidence level or power for a material property) but are usually much smaller than clinical study sample sizes.
- Data Provenance: Not applicable in the context of this device's performance testing. These are laboratory-based mechanical and material tests.
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" as it relates to expert consensus for diagnostic performance does not apply. The "truth" is determined by standardized laboratory measurements.
4. Adjudication method
- Not Applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No. This is a mechanical device, not a diagnostic tool requiring human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- N/A (for "ground truth" in diagnostic terms). The "truth" is established by adherence to specified ASTM standards and internal engineering protocols for mechanical and material properties. For example, for corrosion testing, the "ground truth" is that the device passes or fails the specified electrochemical impedance parameters defined by ASTM F2129.
8. The sample size for the training set
- Not Applicable. This is a physical medical device. There is no "training set" in the context of machine learning or algorithms. Its design and manufacturing process are validated, but not "trained."
9. How the ground truth for the training set was established
- Not Applicable.
§ 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.