(148 days)
Europa (Alternative: AiRTouch) portable X-ray system is intended for use by trained or qualified doctors to produce diagnostic X-ray images of extremities in adult and pediatric(over 12 years old) patients. These images are obtained using anatomical structures captured by film or image processing systems (workstation) after an examination involving radiation exposure with cassette IP, CR, or DR (portable flat panel). Only intended for stand-mounted use.
EUROPA(Alternative: AiRTouch) portable X-ray System generates X-ray with variable tube current and voltage (kVp) to take diagnostic X-rays of extremities for adult and pediatric patients. It operates on 22.2VDC supplied by a rechargeable Lithium-Ion Polymer battery pack. The X-ray tube head, X-ray controls and power source are assembled into a single portable X-ray enclosure. EUROPA(Alternative: AiRTouch) portable X-ray System includes high voltage generator, X-ray tube, a control board (PCB), rechargeable battery, LCD user interface, X-ray beam limiting device, and a remote-control switch (hand switch). Operating principle is that x-ray generated by high voltage electricity into x-ray tube, which penetrates patients' extremities and makes x-ray images on receptor. EUROPA(Alternative: AiRTouch) Portable X-ray System is intended to be used by trained clinicians or technicians for both adult and pediatric(over 12 years old) patients.
EUROPA(Alternative: AiRTouch) portable X-ray is intended to be mounted on a tripod stand.
The provided FDA 510(k) clearance letter for the Europa Portable X-ray System is primarily a regulatory document affirming substantial equivalence to a predicate device. It details the device's technical specifications and how they compare to the predicate, as well as the non-clinical testing performed to meet electrical safety and radiation protection standards.
However, the document does NOT contain the information typically found in a study proving a device meets acceptance criteria related to its diagnostic performance (e.g., accuracy, sensitivity, specificity, or human perception improvement with AI assistance). The "clinical images" mentioned appear to be for general image quality assessment, not a structured clinical study with quantifiable metrics against defined acceptance criteria.
Therefore, I cannot extract the detailed information requested regarding acceptance criteria and a study proving the device meets performance acceptance criteria. The document focuses on showing the device is substantially equivalent to a predicate device based on its technical specifications and adherence to safety and performance standards for X-ray equipment.
The relevant section related to "performance" in this document refers to:
- Non-clinical testing: Adherence to various IEC and CFR standards related to electrical safety, electromagnetic disturbances, radiation protection, and X-ray tube assemblies.
- "Clinical images" assessment: A qualitative statement that "Clinical images taken with EUROPA 85 and EUROPA 90 have presented overall appropriate image quality of the anatomical structures, both bony and soft tissues of the upper and lower extremities." This is not a quantitative performance study.
To answer your request based solely on the provided text, the following points are all "Not Provided" or "Not Applicable" because the document is a regulatory clearance letter focused on substantial equivalence rather than a detailed performance study report.
Summary of Device Acceptance Criteria and Performance (Based on the provided K244049 document):
The provided document, an FDA 510(k) clearance letter, primarily serves to demonstrate that the Europa (Alternative: AiRTouch) Portable X-ray System is substantially equivalent to a predicate device (EZER Portable X-ray System, K193535). The "acceptance criteria" discussed are largely related to technical specifications, electrical safety, radiation performance, and adherence to recognized standards, rather than a specific clinical performance study measuring diagnostic accuracy or reader improvement.
No clinical study details regarding diagnostic performance metrics (e.g., sensitivity, specificity, AUC) are provided in this document. The "clinical images" mentioned appear to have been part of a qualitative assessment of overall image quality for regulatory submission, not a formal quantitative performance study.
Detailed Breakdown of Requested Information:
| Feature | Description (Based on Provided Document) |
|---|---|
| 1. Table of Acceptance Criteria & Reported Performance | Acceptance Criteria (Implicit/Inferred from Non-Clinical Testing): |
| - Compliance with IEC 60601-1 (Basic safety & essential performance) | |
| - Compliance with IEC 60601-1-2 (Electromagnetic disturbances) | |
| - Compliance with IEC 60601-1-3 (Radiation protection in diagnostic X-ray equipment) | |
| - Compliance with IEC 60601-2-28 (X-ray tube assemblies) | |
| - Compliance with IEC 60601-2-54 (X-ray equipment for radiography and radioscopy) | |
| - Compliance with IEC 62133 (Secondary cells and batteries safety) | |
| - Compliance with 21 CFR 1020 Subchapter J (Performance Standards for Ionizing Radiation Emitting Products), 21 CFR 1020.30 (Diagnostic x-ray system and their major components), and 21 CFR 1020.31 (Radiographic Equipment). | |
| - Qualitatively "appropriate image quality of the anatomical structures, both bony and soft tissues of the upper and lower extremities" (for clinical images taken with EUROPA 85 and EUROPA 90). | |
| Reported Device Performance (against the above): | |
| - "Testing was performed successfully according to the following standards:" (followed by the list above). | |
| - "Clinical images taken with EUROPA 85 and EUROPA 90 have presented overall appropriate image quality of the anatomical structures, both bony and soft tissues of the upper and lower extremities." | |
| - "Performance evaluation (test) reports and the device inspection report confirmed that the EUROPA(Alternative: AiRTouch) Portable X-ray Systems are suitable for its intended use and the instructions for use." | |
| 2. Sample size and data provenance (test set) | Not Provided. The document mentions "Clinical images taken," but does not specify the sample size (number of images, number of patients), or their provenance (country of origin, retrospective/prospective collection method). It's likely these were internal test images for qualitative assessment. |
| 3. Number/Qualifications of experts for ground truth | Not Provided. No details on experts used for "ground truth" (if any beyond qualitative assessment by internal personnel) are given. |
| 4. Adjudication method for test set | Not Provided. Since no formal clinical performance study with clear "ground truth" establishment is detailed, no adjudication method is mentioned. |
| 5. MRMC comparative effectiveness study? Effect size? | Not Applicable/Not Provided. The device is an X-ray system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with/without AI assistance is not relevant to this type of device based on the information provided. |
| 6. Standalone (algorithm only) performance? | Not Applicable. This is a hardware X-ray system, not a diagnostic algorithm. Therefore, "standalone" performance in the sense of an algorithm operating independently is not relevant. The performance is the device's ability to produce quality X-ray images. |
| 7. Type of ground truth used | Implicit/Qualitative. For the image quality assessment, the "ground truth" seems to be a qualitative judgment by evaluators that the images showed "appropriate image quality of the anatomical structures." There is no mention of pathology, clinical outcomes, or expert consensus in a formal, quantifiable sense. For the safety and performance standards (IEC/CFR), the ground truth is adherence to the specified technical parameters and safety limits defined by those standards. |
| 8. Sample size for training set | Not Applicable. This document describes an X-ray system, not an AI/Machine Learning model that would typically have a "training set" for an algorithm. |
| 9. How ground truth for training set was established | Not Applicable. As above, no AI/ML model is described, so no training set or its associated ground truth establishment process is relevant to this document. |
§ 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.