(18 days)
The "Easy Moving"M" Mobile X-ray Unit (Model SM-HF) is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic 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 "Easy Moving"M" Mobile X-ray Unit (Model SM-HF)" is a mobile unit which operates from 120 V 50-60~ AC or batteries. It is easy to operate and permits a swift radiographic procedure, a feature which applies to all conventional exposure techniques on all parts of the body. The system is composed of a base unit housing the high voltage generator and controls and a turnable arm with rotatable tube head. It allows one to take exposures of patients in standing, sitting or laying position. Owing to its compact design "Easy Moving™™ Mobile X-ray Unit is a low-cost radiography system which takes up little space and is quick to set up and operate.
The provided text describes a 510(k) premarket notification for a mobile X-ray unit. Rather than detailing acceptance criteria and a study proving the device meets them in the traditional sense of a clinical trial with performance metrics, this submission is focused on demonstrating substantial equivalence to a predicate device.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) submission doesn't present a table of acceptance criteria in terms of specific performance thresholds for diagnostic accuracy, sensitivity, or specificity. Instead, the acceptance criteria are implicitly defined by the characteristics and performance of the predicate device, the IROM IMAGING, INC MXR-2000 MOBILE X-RAY UNIT (K010304). The "performance" of the new device is its similarity to the predicate.
| Characteristic | Acceptance Criteria (Predicate Device K010304) | Reported Device Performance (Easy Moving™ Mobile X-Ray System) |
|---|---|---|
| Intended Use | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic 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. | SAME |
| Performance Standard | 21 CFR 1020.30 | SAME |
| Electrical Safety | Electrical Safety per Underwriters Laboratories Standard UL-2601 (IEC-60601) and IEC 60601, Underwriters Laboratories Standard UL187: UL Standard for Safety for X-Ray Equipment. | SAME, plus EMC: IEC 60601-1-2 |
| Safety and Effectiveness | Bench and user testing indicates that the predicate device is safe and effective. | Bench and user testing indicates that the new device is as safe and effective as the predicate devices. |
The core acceptance criterion is that the new device is "as safe and effective" and "substantially equivalent" to the predicate device. The performance is reported as meeting or exceeding these equivalency standards for the specified characteristics.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "bench and user testing" but does not specify a sample size for either. There is no information provided regarding data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. Given the nature of a substantial equivalence claim for an X-ray unit, the "ground truth" for comparative effectiveness would likely involve expert evaluation of image quality or overall clinical utility, but no details are given.
4. Adjudication Method for the Test Set
The adjudication method is not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of an MRMC comparative effectiveness study or any effect size related to human readers improving with or without AI assistance. This submission pertains to an X-ray hardware device, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
This information is not applicable/not provided. The device is an X-ray unit, not an algorithm. Therefore, a standalone algorithm performance study was not conducted or reported.
7. Type of Ground Truth Used
The type of "ground truth" used for evaluation is not explicitly stated. However, considering "bench and user testing" was performed, the ground truth would likely be based on:
- Technical specifications conformance: Ensuring the device meets relevant electrical and radiation safety standards (e.g., 21 CFR 1020.30, UL standards, IEC standards).
- Qualitative assessment of image quality: During "user testing," qualified personnel (doctors or technicians) would evaluate the diagnostic quality of images produced by the new device in comparison to images from the predicate device. This would implicitly form the "ground truth" for functionality and diagnostic utility.
8. Sample Size for the Training Set
This information is not applicable/not provided. The submission is for a medical device (X-ray unit), not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided as there is no training set for an algorithm.
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.