(94 days)
The product is intended as an X-Ray source for diagnosis. Operators of the Nano-x Cart X-Ray System are healthcare professionals familiar with and responsible for the X-Ray examinations being performed.
Indication for Use – The device is designed to perform radiographic X-Ray examinations of hands, wrists, and fingers, on adult patients.
Limitations for use – This device is not intended for general radiographic X-Ray examinations other than the indicated use, or for mammographic, angiographic, interventional, or fluoroscopic applications. This device is not intended for pediatric use.
The Nanox Cart X-Ray system is a mobile X-Ray system designed to perform radiographic X-Ray examinations of hands, wrists, and fingers, on adult patients. The system facilitates X-ray examinations in situations where it is not possible to transport the patient to a ward with fixed equipment.
The Nanox Cart X-Ray system consists of a mobile system enclosure; an X-Ray tube assembly consists of the X-ray Tube, Cooling Fluid, electronics, and casing; a pulse generator and a highvoltage generator; a microprocessor that provides increased exposure consistency and efficient operation; and a touch-based screen LCD which provides a simple and user-friendly interface and technique selection.
The Nanox Cart is specified and designed to operate only with a Flat Panel Digital X-ray Detector Model EVS3643, manufactured by DRTECH Inc. (K162552)
The intended operators of the Nanox Cart X-ray System are healthcare professionals familiar with and responsible for the X-ray examinations being performed.
To minimize electrical, mechanical, and radiation hazards, the Nanox Cart X-ray System adheres to recognized and established industry practices and standards.
Here's a summary of the acceptance criteria and study information for the Nanox Cart X-ray System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state a table of quantitative acceptance criteria from a clinical performance study. Instead, it relies on a qualitative assessment from a phantom imaging study. The implicit acceptance criterion from the phantom study is:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Images are "as good as an X-Ray system available in market" and "as good as images produced by the predicate Device." | The Nanox Cart is capable of supplying X-Rays to generate radiographies. Professional evaluation and comparison with a predicate device demonstrated the output images are "as good as" an X-Ray system available in the market and "as good as images produced by the predicate Device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document refers to the use of "commercial products manufactured by Kyoto Kagaku" as phantoms. It doesn't specify a numerical sample size for the test set of phantoms. It states "The phantoms represent different hands."
- Data Provenance: The study was a phantom imaging study, not involving human subjects. The phantoms were "commercial products manufactured by Kyoto Kagaku." The study was conducted by Nano-x Imaging Ltd. (Israel).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Three experts ("clinical evaluations of three experts")
- Qualifications of Experts: Not specified in the document.
4. Adjudication Method
The document states, "Professional evaluation of the output and professional comparison between the Nanox Cart X-Ray system and predicate device's output demonstrate that the outcome images of the Nanox Cart X-Ray system are as good as an X-Ray system available in market. Based on the clinical evaluations of three experts it can be concluded that the Nanox Cart X-Ray system operates as intended and generates images that are as good as images produced by the predicate Device."
This suggests a consensus or independent review by the three experts, but a specific adjudication method (e.g., 2+1, 3+1) is not detailed. It appears to be a qualitative assessment leading to a conclusion of "as good as."
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
No MRMC comparative effectiveness study was mentioned. The device is an X-ray system, not an AI-powered diagnostic tool, so reader improvement with AI assistance is not applicable in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is an X-ray imaging system, not an algorithm, and is used with a human operator. The performance evaluation focused on the quality of the generated X-ray images.
7. The Type of Ground Truth Used
The ground truth for the phantom study was implicitly the inherent properties and known structures of the commercial phantoms. The evaluation by experts compared the generated images against a qualitative standard of "as good as" images from a predicate device or other market-available systems. This is more akin to expert consensus on image quality rather than a definitive pathology or outcomes data from patients.
8. The Sample Size for the Training Set
No training set is mentioned as this device is an X-ray imaging system, not an AI/ML algorithm that requires training data in the traditional sense.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no mention of a training set for an AI/ML 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.