(29 days)
The PrestoDR 4143, is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. PrestoDR 4143 allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities.
The PrestoDR 4143 is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) and CMT's proprietary technology, which incorporates state of the art objectoriented software and connectivity. The legally marketed PrestoDR Portable K 100400 has been modified: To integrate the Pixium 4143 flat panel digital detector (FPD), improve its cost effectiveness, aging technologies and components (hardware and software) have been redesigned. The device major functions, intended use and principle of operation were not changed.
The provided text is a 510(k) summary for the PrestoDR 4143 device. It states that the device has been redesigned and its safety and effectiveness were verified and validated according to 21CFR 820.30 regulations. However, it does not contain the detailed information requested regarding specific acceptance criteria, study methodologies, or performance data beyond a general statement that "Tests data demonstrate that the PrestoDR 4143 meets the required specifications."
Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC study details based solely on the provided text.
The information you are asking for typically resides in the detailed study reports submitted as part of the 510(k) premarket notification, which is not fully included in this summary.
Here's what can be extracted from the provided limited text:
- Device Name: PrestoDR 4143
- Submission Type: Special 510(k) Submission (meaning it's a modification to an already legally marketed device, K100400 PrestoDR 4143)
- Reason for Submission: To integrate a new flat panel digital detector (Pixium 4143 FPD), improve cost-effectiveness, and redesign aging technologies and components (hardware and software). The major functions, intended use, and principle of operation were not changed.
- Safety & Effectiveness Statement: "The device has been designed verified and validated complying with 21CFR 820.30 regulations. Tests data demonstrate that the PrestoDR 4143 meets the required specifications. No adverse affects have been detected."
- Substantial Equivalency: The manufacturer believes the PrestoDR 4143 is substantially equivalent in terms of safety and effectiveness to the predicate device, K100400 PrestoDR 4143.
In summary, the provided document does not contain the level of detail necessary to answer the specific questions about acceptance criteria, study design, or performance metrics.
§ 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.