(32 days)
- The MRH ALFA system is a radiographic system used for producing X-ray images of the human body, including all anatomical regions such as the head, thorax, column, abdomen, extremities and internal organs. The system is designed to be used with conventional film or CR systems and can be interfaced with a digital detector, but neither the X-Ray detector nor the image acquisition system are part of the MRH ALFA radiographic system. The acquisition system comes as a separate system.
The MRH ALFA system is not intended for use in mammography, fluoroscopy or angiography. The MRH ALFA system is intended for adults and pediatric patients. The pediation is as follow:
- · Child (3-12 yrs.), approximately 12 kg (26 lb.) to 51 kg (114 lb.)
- · Adolescent (12-21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.)
- The MRH II system is a radiographic system used for producing X-ray images of the human body, including all anatomical regions such as the head, thorax, column, abdomen, extremities and internal organs. The system is designed to be used with conventional film or CR systems and can be interfaced with a digital detector, but neither the X-Ray detector nor the image acquisition system are part of the MRH II radiographic system. The acquisition system comes as a separate system.
The MRH II system is not intended for use in mammography, fluoroscopy or angiography. The MRH II system is intended for adults and pediatric patients. The pediatric population is as follow:
- · Child (3-12 yrs.), approximately 12 kg (26 lb.) to 51 kg (114 lb.)
- · Adolescent (12-21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.)
- The MRH IIE system is a radiographic system used for producing X-ray images of the human body, including all anatomical regions such as the head, thorax, column, abdomen, extremities and internal organs. The system is designed to be used with conventional film or CR systems and can be interfaced with a digital detector, but neither the X-Ray detector nor the image acquisition system are part of the MRH IIE radiographic system. The acquisition system comes as a separate system.
The MRH IIE system is not intended for use in mammography, fluoroscopy or angiography. The MRH IIE system is intended for adults and pediatric patients. The pediatric population is as follow:
- · Child (3-12 yrs.), approximately 12 kg (26 lb.) to 51 kg (114 lb.)
- · Adolescent (12-21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.)
The MRH ALFA, MRH II & MRH IIE Radiographic Systems designed and manufactured by CMR are general purpose, computed radiography (CR) X-ray systems used for diagnostic imaging (analog radiology) of adults and pediatric patients for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The devices are designed to meet the requirements of basic radiology procedures and produces a low radiation dose to the patient, while acquiring its images.
The provided text is a 510(k) Premarket Notification from the FDA for a new radiographic system. It does not describe a study proving a device meets acceptance criteria related to an AI/ML or diagnostic performance claim but rather demonstrates substantial equivalence to a predicate device.
Specifically, it focuses on the safety and performance of the X-ray system itself (MRH ALFA, MRH II & MRH IIE Radiographic Systems) compared to a previously cleared predicate device (ARiX RAD Radiographic System). The submission does not involve clinical testing or performance claims that would require acceptance criteria related to accuracy, sensitivity, or specificity of image interpretation, an AI algorithm, or human reader performance.
Therefore, I cannot extract the information required in your request bullet points (1-9) because this submission is about a conventional X-ray hardware system, not a diagnostic AI/ML device or a comparative effectiveness study involving human interpretation.
Here's why:
- No acceptance criteria for diagnostic performance: The document's "Summary of Safety and Performance Testing" (Section 11) lists standards related to electrical safety, electromagnetic compatibility, radiation safety, usability, and biocompatibility – all for the hardware itself. There are no performance metrics for diagnostic accuracy or image interpretation.
- No "device performance" in terms of diagnosis: The device's "performance" is demonstrated by passing the listed safety and electrical standards, not by its ability to detect or diagnose conditions in images.
- No test set data, ground truth, or experts for diagnostic interpretation: Since it's a hardware submission, there's no mention of a test set of medical images, ground truth establishment, or expert radiologists interpreting images for diagnostic accuracy.
- No AI/ML component: The devices are described as "general purpose, computed radiography (CR) X-ray systems used for diagnostic imaging (analog radiology)." There is no indication of an AI or machine learning component.
- No MRMC study: A Multi-Reader Multi-Case study would assess how human readers perform, usually with and without AI assistance. This is irrelevant for this hardware submission.
- No standalone algorithm performance: The device is the X-ray machine itself, not an algorithm.
- No training set data: Training sets are relevant for AI/ML models, which are not discussed here.
In summary, the provided document is a regulatory submission for X-ray hardware, demonstrating substantial equivalence to a predicate device based on manufacturing, safety, and physical performance standards, not on diagnostic performance or AI algorithm validation.
§ 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.