(84 days)
The CuattroDR, when used with a cleared digital image capture device, provides for the capture of digital images in place of conventional film radiographic examinations.
The device is intended to be available for retrofit on existing or planned x-ray machines with a cleared digital image capture device.
The device is intended for use by trained and qualified personnel in the acquisition and review of radiographic images. The product is not intended for mammography or fluoroscopy applications.
The CuattroDR device is a software application capable of acquiring x-ray images from commonly commercialized digital flat panels on a Windows based computer workstation. The software can use traditional mouse and keyboard inputs as well as touch screen monitors as an alternative. The use of the CuattroDR software enables the user to use a traditional x-ray generator and capture x-rav images without film. The images are processed and then presented to the user on a touch screen computer monitor, within 12 seconds after the x-ray exposure. The software also has capabilities to send images to hospital medical PACS systems and digital media for archival. In addition to this functionality, the CuattroDR software provides a user interface for generator control in the process of acquiring digital images.
The provided text describes the CuattroDR device, a software application for acquiring and processing digital X-ray images. The submission aims to demonstrate substantial equivalence to predicate devices, but does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets them.
The document discusses:
- Indications for Use: The CuattroDR is for capturing digital images in place of conventional film radiographic examinations, intended for retrofit on existing X-ray machines with cleared digital image capture devices. It's for use by trained personnel and not for mammography or fluoroscopy.
- Technological Characteristics: It outlines features like image acquisition, processing, viewing, DICOM 3.0 compliance, and generator control. It compares these features to two predicate devices (Visaris Avanse and Cuattro UnoMD/CloudDR).
- Determination of Substantial Equivalence: This is based on non-clinical performance data (bench testing).
- Bench Testing: This involved verification and validation testing, focusing on differences between the CuattroDR and Cuattro UnoMD (CloudDR). The testing utilized a Sedecal SHFR generator, five different cleared wired digital image detectors from two manufacturers, and appropriate anatomical phantoms.
- Basic Functionality Tested: Establishing/Maintaining Communications, Exposure Feedback, kVp Control, mAs Control, Focal Spot Control, mA and Time Controls, Unintentional Exposure Prevention, Generator Technique Validation Feature.
- Advanced Functionality Tested: AEC Control, Workstation Assignment, Patient Size Adjustment.
The document explicitly states that the determination of substantial equivalence is based on non-clinical performance data (bench testing) and does not refer to clinical studies or patient data.
Therefore, I cannot provide answers to the following questions from the input because the information is not present in the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, the effect size of how much human readers improve with AI vs without AI assistance
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document focuses on demonstrating substantial equivalence through non-clinical bench testing of its technical and functional characteristics against predicate devices, rather than presenting a clinical study with detailed performance metrics and ground truth establishment.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.