(88 days)
The FLUSION-9001 fluoroscopic C-arm Mobile X-ray System is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to digital subtraction angiography, orthopedical, abdominal, vascular, cardias, critical care and emergency room procedures.
The FLUSION-9001 fluoroscopic C-arm Mobile X-ray System consists of a high voltage (HV) inverter generator, a tube support unit, an X-ray beam limiting device, mobile cart, a detector, operating software, and a tube, and is primarily used in a hospital for diagnosis of diseases in skeletal. respiratory and urinary systems such as the skull, spinal column, chest, abdomen, extremities, and other body parts. This device is not intended to be used for mammography applications.
FLUSION-9001 fluoroscopic C-arm Mobile X-ray System is a solution to produce radiological images of patient during medical operations. This inverter control X-ray unit visualizes the anatomical structure on screen, which is obtained by X-ray fluoroscopy and a flat panel detector. This system can be applied in emergency room, operation room, cast room or etc. of a hospital.
The provided document is a 510(k) summary for the FLUSION-9001 Fluoroscopic C-arm Mobile X-ray System. It focuses on demonstrating substantial equivalence to predicate devices based on technical specifications and adherence to recognized standards.
Therefore, the document does not contain information about acceptance criteria for device performance in a clinical study, or a study specifically designed to prove the device meets such criteria in terms of diagnostic accuracy or impact on human readers.
The information provided describes the device's technical specifications and compares them to predicate and reference devices, along with compliance with relevant industry standards and regulations for medical devices.
Here's a breakdown of what is available and what is not:
1. A table of acceptance criteria and the reported device performance
- Not Available: The document does not provide a table of acceptance criteria for diagnostic performance outcomes (e.g., sensitivity, specificity, accuracy) or reported performance metrics from a clinical study. The tables present technical specifications of the device and its comparators (e.g., X-ray tube heat capacity, detector DQE, pixel matrix).
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Available: There is no mention of a test set, sample size, or data provenance related to a clinical performance study. The testing performed focuses on non-clinical aspects like electrical, mechanical, software, and risk management.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Available: Since there is no mention of a clinical test set or ground truth establishment, this information is not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Available: There is no information on any adjudication method for a clinical test set.
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
- Not Available: The document describes a fluoroscopic C-arm Mobile X-ray system, which is an imaging device, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers would not be applicable or expected for this device nor is it mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Available: As noted above, this is an imaging acquisition device, not an algorithm, so standalone performance is not relevant in the context of diagnostic algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Available: There is no mention of ground truth as it pertains to clinical diagnostic performance.
8. The sample size for the training set
- Not Available: This device is a hardware system, not a machine learning model, so there is no training set in the context of AI/ML.
9. How the ground truth for the training set was established
- Not Available: See point 8.
What the document does describe (Non-clinical testing for substantial equivalence):
The document details the non-clinical testing performed to establish substantial equivalence (refer to section VIII. Non clinical testing and IX. Conclusion):
- Standards Adherence: The device successfully underwent testing according to various IEC and EN standards related to medical electrical equipment, including safety, electromagnetic compatibility, and specific requirements for X-ray equipment (e.g., EN 60601-1, EN 60601-1-2, IEC 60601-1-3, IEC 60601-2-43, IEC 60601-2-54).
- Guidance Document Utilization: The development informed by FDA guidance documents regarding software in medical devices, 510(k) submissions for solid-state X-ray imaging devices, cybersecurity, and pediatric information for X-ray imaging devices.
- Regulatory Compliance: Conformance to 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 1020.32 (Fluoroscopic Equipment).
The conclusion states that based on these tests and comparisons to predicate devices, the FLUSION-9001 system is considered substantially equivalent in its design, mechanical and electrical performance, making it suitable for its intended use.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.