(72 days)
The Hitachi SX-VA30 C-Arm Fluoroscopic/Angiographic System is intended to visualize anatomical structures by converting a pattern of xradiation into an image through electronic amplification and recording, and, when used with injection of contrast medium, to visualize the heart or blood vessels.
The Hitachi SX-VA30 C-Arm Angiographic/Fluoroscopic System is a single plane, ceiling suspended C-Arm system intended for angiographic and related diagnostic and therapeutic procedures requiring fluoroscopic and radiographic imaging. It is configured with other components such as high voltage generator, x-ray tube assembly, DSA system, etc., to form a complete fluoroscopy and angiography system. The C-arm is disposed on the isocenter and is movable in a wide range to permit studies of the patient's whole body from the head to the foot from a number of angles. The SX-VA30 system consists of the SX-VA30 Ceiling-traveling C-Arm Support with ceiling track rails, the control electronics box, the display panel, and the table-side control panel. The SX-VA30 is also configured with the DFA-100-30 digital subtraction angiography system, and several other components which have been previously cleared by FDA as a part of K945400. While the system is configured with a digital imaging system as standard, conventional film radiography may be employed as an option. In the digital domain, acquired images may be stored in a variety of formats. During acquisition cycles, the progress of the study can be monitored as it occurs, largely eliminating the need for studies to be redone.
This 510(k) submission (K964990) describes the Hitachi SX-VA30, an angiographic X-ray system. The document does not contain information about acceptance criteria or a study proving the device meets these criteria in the context of device performance metrics like sensitivity, specificity, or accuracy.
The "F. TESTING" section of the document primarily focuses on safety and regulatory conformance testing, not performance evaluation in a clinical or diagnostic accuracy sense. The tests mentioned are:
- Electrical Safety
- Conformance to the General Rules for Medical X-Ray Equipment. JIS Z 4701-1988 (Japanese Industrial Standard)
- Conformance to the applicable provisions of the FDA Performance Standards for Ionizing Radiation Emitting Products (21 CFR 1020), particularly the section for Fluoroscopic Equipment (21 CFR 1020.32).
These are standard regulatory and safety checks for medical devices that emit radiation, ensuring the device is safe and functions as an imaging system. They do not address the clinical performance or diagnostic capabilities of the device in terms of how accurately it can detect or characterize certain conditions, which is what acceptance criteria and performance studies typically measure for AI/CADe devices.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document states: "The SX-VA30 was tested in the same manner as was the previously cleared SF-VA100." This suggests an equivalence argument based on similar design and safety testing, rather than a new clinical performance study.
Summary of missing information based on the provided text:
- Table of acceptance criteria and the reported device performance: Not provided. The document focuses on safety and regulatory compliance, not clinical performance metrics.
- Sample size used for the test set and the data provenance: Not applicable, as there's no clinical performance test set mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is an imaging system, not an AI algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.