(112 days)
The ARIX RAD 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 design 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 ARIX RAD radiographic system. The acquisition system comes as a separate system.
The ARiX RAD system is not intended for use in mammography, fluoroscopy or angiography.
The ARiX RAD system is intended for adults and pediatric patients. The pediation is as follows:
- · 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 ARiX RAD Radiographic System designed and manufactured by Compañía Mexicana de Radiología (CMR) is a general purpose, computed radiography (CR) X-ray system 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 device is designed to meet the requirements of basic radiology procedures.
The ARIX RAD Radiographic system is capable of interfacing with AeroDR, PaxScan 4336W, Venu1717 detector in trigger mode. However, it is also capable of operating with external triggering devices providing the Hand-switch activation signals and the X-Ray Enable signal of the digital system as an external authorization for the X-Ray emission.
The provided text describes the ARiX RAD Radiographic System and its substantial equivalence to a predicate device (Sedecal Millennium Plus). It outlines technical specifications and conformity to various standards but does not contain information on acceptance criteria for a device's performance based on diagnostic accuracy, sensitivity, or specificity, nor does it present a study proving the device meets such criteria.
The document focuses on demonstrating that the ARiX RAD Radiographic System is substantially equivalent to a legally marketed predicate device (Sedecal Millennium Plus) through comparisons of intended use, technological characteristics, and conformance to recognized safety and performance standards for X-ray systems. It explicitly states that clinical investigations were not required as the indications for use are equivalent to the predicate device, which has a proven safety and effectiveness record.
Therefore, many of the requested items (acceptance criteria, reported device performance figures, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and effect sizes) are not available in the provided text, as the regulatory submission did not mandate such studies for this type of device and its specific pathway to market.
Below, I will extract and summarize the information that is available in the provided text, and explicitly note when requested information is absent.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on compliance with harmonized standards for X-ray equipment, electrical safety, EMC, and radiation safety. The "reported device performance" refers to the device successfully passing the required tests for these standards. There are no diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) provided as this was not a clinical performance study.
| Acceptance Criteria (Compliance with Standards/Regulations) | Reported Device Performance |
|---|---|
| IEC 60601-1 (+ ES60601-1) - General Requirements for Basic Safety and Essential Performance | Passed required testing |
| IEC 60601-1-2 - Electromagnetic Compatibility | Passed required testing |
| IEC 60601-1-3 - General Requirements for Radiation | Passed required testing |
| IEC 60601-1-6 - Usability | Passed required testing |
| IEC 60601-2-54 - X-ray Equipment for Radiography and Radioscopy | Passed required testing |
| ISO 10993-1, -5, -10 - Biological Evaluation of Medical Devices (Cytotoxicity, Irritation, Sensitization) | Passed required testing |
| ISO 14971 - Risk Analysis (FMEA) | Complied |
| 21 CFR Part 1020.30 and 21 CFR Part 1020.31 (Performance Standards for X-Ray Systems) | Complied |
| FDA Guidance Documents (e.g., Software, Solid State X-ray Imaging, Pediatric Information, Cybersecurity) | Complied |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable (N/A). The document describes non-clinical performance data (testing against various standards) rather than clinical testing with a "test set" of patients or data. The testing involved a final finished device unit.
- Data provenance: N/A. The testing was non-clinical, performed on the device itself for compliance with engineering and safety standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: N/A. This information is not relevant to the non-clinical testing performed.
- Qualifications of experts: N/A.
4. Adjudication method for the test set
- Adjudication method: N/A. Not a clinical study requiring ground truth adjudication.
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
- MRMC study done: No.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone study done: No. This device is an X-ray radiographic system, not an AI algorithm.
7. The type of ground truth used
- Type of ground truth: N/A. The "ground truth" for the non-clinical tests was successful adherence to the quantitative and qualitative requirements of the listed international and national standards (e.g., electrical safety, radiation output, EMC, usability, biocompatibility).
8. The sample size for the training set
- Sample size for training set: N/A. This is not an AI/machine learning device. The document describes a traditional medical device (radiographic system) for which no "training set" in the machine learning sense would be used. The device's design, development, and manufacturing stages included internal quality assurance and quality control measures.
9. How the ground truth for the training set was established
- Ground truth for training set: N/A.
§ 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.