(85 days)
The Digital X-ray Capture Device Saturn 8000-GS Systems is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammography applications).
The "Digital X-ray Capture Device (Saturn 8000-GS System)" (as Saturn 8000-GS System) is equipped with digital detector, X-ray generator interface, and image acquisition workstation. The digital detector is a flat panel detector. The input X-ray photons are absorbed in scintillator layer that creates a visible light photon, and then the photon is absorbed in TFT-array to create an electrical charge which is representation of the X-ray input. The charge is read-out by a matrix scan of the array that converts the charges into a modulated electrical signal. X-ray exposure can be triggered by detector, which initiate the exposure signal to the generator; or the exposure signal is triggered by the generator itself and the detector is acted as bucky receptor. The connection between generator and detector is via the hardware interface box (HB), which can also connect the hand switch. The Saturn 8000-GS System contains the operation workstation software, which is installed on acquisition ("AWS"), which contains monitor, keyboard and mouse, computer, electronics, and accessory storage. The resultant output signal can be transmitted to remote viewing sites, and/or it can be stored electronically for later viewing. The AWS is used for image acquisition, processing, and display. The AWS can also be used for database management and can send images to archive, review or filming.
The provided text describes a 510(k) submission for the "Saturn 8000-GS System" (a Digital X-ray Capture Device). It indicates that the device has been found substantially equivalent to a predicate device, the "New Medical Saturn 9000 system." However, the document does not contain specific acceptance criteria or a detailed study proving the device meets those criteria, as typically found in clinical performance studies.
The document primarily focuses on:
- General information about the device and company.
- The device's description and indications for use.
- Claim of substantial equivalence to a predicate device (New Medical Saturn 9000 system).
- Mention of bench testing and electrical safety testing to substantiate equivalence.
- Confirmation of satisfactory results for various safety and EMC standards (EN/IEC 60601 series).
- A conclusion that the device does not raise new issues of safety or effectiveness compared to predicate devices.
Therefore, based solely on the provided text, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, or MRMC studies for the Saturn 8000-GS System.
The document states: "Bench testing and electrical safety further substantiate equivalence to the predicate." and "Electrical, mechanical safety and performance testing according to standard EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-3 and EN/IEC 60601-2-32 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2007). All test results were satisfactory."
However, these are general safety and performance tests, not specifically a clinical study evaluating diagnostic accuracy or performance against specific acceptance criteria for image quality or clinical efficacy in the way your request implies for AI/ML device studies. The document claims equivalence based on these engineering/safety tests and comparison to a predicate device's technology (different flat panel detector, but similar overall system intended use).
In summary, the provided text does not contain the detailed clinical study information you requested.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.