(94 days)
The Omega Medical Imaging, LLC Nyquist.IQ Image Processor is intended for use in Radiographic/fluoroscopic applications including cardiac, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging. The Nyquist.IQ is intended solely to be integrated only with Omega Medical Imaging CS-series-FP Systems.
Nyquist.IQ is a dynamic digital image processing system. The system application is based on a PC Windows operating system functioning on a PC based CPU. The object-oriented software performs real-time image processing and full procedure storage. The DICOM compliant connectivity provides the tools to transmit patient demographics, examination, and image data digitally.
Nyquist.IQ is not a standalone device, but functions as a component for FDA cleared Omega CS-series-FP platform. Nyquist IQ is an image processor that interfaces, with to acquire and digitize x-ray exposure from the Omega medical CS-series-FP.
The Nyquist.IQ operates in connection with the Varex's 3030 or the Teledyne 3030 flat panel detectors. This is demonstrated in the substantial equivalence section of the Nyquist.IQ is intended for the Omega CS-series-FP with Optional Accessory Device CA-100S / FluoroShield platform.
The Nyquist.IQ is intended solely to be integrated only with Omega Medical Imaging CS-series-FP systems.
The Nyquist.IQ image processor. The fundamental performance characteristics of the Nyquist.IQ interventional fluoroscopic imaging Processor system consists of:
- ) Real-time image visualization of patient anatomy during procedures
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Imaging techniques and tools to assist interventional procedures.
- 2 Post-processing functions after interventional procedures.
- 2 Storage of reference/control images for patient records.
- Σ Compatibility to images of other modalities via DICOM
- 2 Compatibility with the already FDA cleared CA-100S / FluoroShield AI Exposure Reduction Technology. (K182834)
This array of functions provides the physician the imaging information required to achieve minimally invasive interventional procedures.
The Nyquist.IQ image processor is available as a Model IPS-100 configuration and is similar to the currently marketed and predicate image processor MX-200 in CS-series-FP with optional CA-100S / FluoroShield Device.
This document is an FDA 510(k) clearance letter for the Omega Medical Imaging, LLC Nyquist.IQ Image Processor. It is a declaration of substantial equivalence to a predicate device, not a detailed study report with acceptance criteria and performance metrics for an AI/ML-driven device.
Therefore, this document does not contain the specific information required to answer your request regarding acceptance criteria and a study proving a device meets those criteria for an AI/ML product.
The information provided in the input primarily focuses on regulatory classification, indications for use, technological characteristics, and a comparison to predicate devices for a traditional medical imaging processor. It explicitly states:
- "The Nyquist.IQ did not require clinical study data since substantial equivalence to the currently marketed predicate device Omega CS-series-FP with Optional Accessory Device CA-100S / FluoroShield was demonstrated with the following attributes:
- ∑ Indication for use.
- A Technological characteristics.
- ) Non-clinical performance testing; and
- ∑ Safety and effectiveness." (Page 6)
- It also mentions a "FluoroShield AI Exposure Reduction Technology" associated with a predicate device (K182834), but it does not describe a performance study for the Nyquist.IQ as an AI/ML device itself. The Nyquist.IQ appears to be an image processor that interfaces with this existing technology, rather than being the AI/ML device itself.
To answer your specific questions, I would need a document that details a performance study, including acceptance criteria, for a software component with AI/ML functionality. This document does not provide such details.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.