(102 days)
The Tempus™ Cervical Plate System is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck 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, and failed previous fusion.
The Tempus™ Cervical Plate System consists of screws and plates. Screws are available in a variety of diameter-length combinations. Plates are available in a variety of lengths to accommodate fusion procedures from one to five levels of the cervical spine. Fixation is achieved by inserting bone screws through the openings in the vertebral bodies of the cervical spine. The Tempus™ Plates include locking pins that cover the heads of the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the plate. The plates and screws are manufactured from titanium alloy meeting requirements of ASTM F136, Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
This document details the performance data for the Tempus™ Cervical Plate System.
Here's an analysis of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Test Method) | Reported Device Performance |
|---|---|
| Static axial compression bending | Mechanically equivalent to predicate device |
| Static torsion | Mechanically equivalent to predicate device |
| Dynamic axial compression bending | Mechanically equivalent to predicate device |
2. Sample size used for the test set and the data provenance:
- The document does not specify the sample size (number of devices tested) for the mechanical tests.
- The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. However, given that it's a 510(k) submission to the FDA, the testing was conducted to meet US regulatory standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is a mechanical performance study of a physical device, not a diagnostic or AI-driven study involving human interpretation. Therefore, there were no experts used to establish ground truth in the context of clinical interpretation. The "ground truth" for these tests is defined by the ASTM F1717-11 standard and the mechanical properties of the predicate device.
4. Adjudication method for the test set:
- Not applicable as this is a mechanical engineering study, not one requiring expert adjudication of clinical findings.
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-driven device or a diagnostic device involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (cervical plate system), not an algorithm or AI system.
7. The type of ground truth used:
- The "ground truth" for the mechanical testing was established by the ASTM F1717-11 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model and the mechanical performance of the predicate device (Tempus™ Cervical Plate System - K120515). The objective was to demonstrate mechanical equivalence to a previously cleared device under standardized test conditions.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable for the same reason as above.
§ 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.