(139 days)
EZER Portable X-Ray system is a portable x-ray source with a fixed tube current and voltage for producing diagnostic x-ray images of extremities using digital or film image receptors. Its use is intended to be used by trained clinician or technicians for both adult and pediatric subjects age 2 and above.
It is not intended to replace a radiographic system with variable tube current and voltage (KVp) which may be required for full optimization of image quality and radiation exposure for different exam types.
EZER Portable X-ray System generates and controls X-ray with a fixed tube current and voltage (kVp) in order to take diagnostic X-rays of extremities for adult and pediatric patients. It operates on 22.2VDC supplied by a rechargeable Lithum-Ion Polymer battery pack. The X-ray tube head. X-ray controls and power source are assembled into a single hand-held enclosure. EZER Portable X-ray System includes high voltage generator, X-ray tube, a control board (PCB), rechargeable battery, LCD user interface, X-ray beam limiting cone, and a remote control switch (hand switch). Operating principle is that x-ray generated by high voltage electricity into x-ray tube, which penetrates extremities and makes x-ray images on receptor. INTEL stick PC is integrated with EZER so the user can see X-ray image from LCD display without a computer. EZER Portable X-ray System is intended to be used by trained clinicians or technicians for both adult and pediatric patients.
The embedded 7" TFT display in EZER Portable X-ray is not intended to be used for diagnosis.
Here's a breakdown of the acceptance criteria and study information for the EZER Portable X-ray System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with specific numerical thresholds for performance metrics. Instead, it describes a subjective comparison study against a predicate device. The primary "acceptance criterion" appears to be demonstrating similar overall quality to the predicate device.
| Performance Aspect | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Image Quality | Similar overall quality compared to the predicate device (NOMAD MD Handheld X-ray System) | Images taken from EZER have similar quality overall compared with Nomad MD. Images from EZER show no other radiographic abnormalities or issues with diagnostic images. |
| Safety - Operators/Patients | Conformance to relevant safety standards and guidance documents (IEC, EN, CFR standards) | Testing performed successfully according to relevant standards; Device development utilized "Radiation Safety Consideration for X-ray Equipment Designed for Hand-Held Use" and "The Content of Premarket Submissions for Software Contained in Medical Devices" guidance documents. |
| Intended Use | Meeting the stated Indications for Use (diagnostic x-ray images of extremities for adults and pediatrics age 2+) | Confirmed as suitable for its intended use and user instruction. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in terms of number of images or cases. The document mentions "Images taken from the predicate and subject devices were reviewed." This implies a set of images was used, but the quantity is not specified.
- Data Provenance: Not explicitly stated. The study details do not mention the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: One (1) expert.
- Qualifications: An American board-certified radiologist. No specific number of years of experience is provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Only a single expert reviewed and rated the images, so there was no multi-reader consensus or adjudication process described. The expert directly compared and rated the images.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. Only a single radiologist performed the image comparison.
- Effect Size: Not applicable, as no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. The EZER Portable X-ray System is an X-ray imaging device, not an AI algorithm. The study described is an evaluation of the image output generated by the device, which is then interpreted by a human expert. The device does include an embedded display for reference, but it's explicitly stated "not intended to be used for diagnosis."
7. The Type of Ground Truth Used
- Type of Ground Truth: "Expert comparison/rating." The ground truth was established by a single American board-certified radiologist who reviewed and rated images from both the subject device and the predicate device. This is a form of subjective expert evaluation.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. The EZER Portable X-ray System is a hardware device (X-ray system) and not an AI or machine learning algorithm that requires a training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth: Not applicable, as the device is not an AI/ML system requiring a training set with established ground truth.
§ 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.