(57 days)
The Direct Digitizer, REGIUS Model 210 is an X-ray image reader which uses a stimulable phosphor plate (Plate) as X-ray detector installed in a separate cassette. It reads the image recorded on the Plate and transfers the image data to an externally connected device such as a host computer, an order input device, an image display device, a printer, an image data filing device, and other image reproduction devices. REGIUS Model 210 also reads the image data of long areas of anatomy and to verify the position for a radiotherapy location. It is designed and intended to be used by trained medical personnel in a clinic, a radiology department in a hospital and in other medical facilities.
This device is not intended for use with FFDM systems
The Direct Digitizer, REGIUS Model 210 is an X-ray image reader which uses a stimulable phosphor plate (Plate) as X-ray detector installed in a separate cassette, and reads the Image recorded on the Plate by inserting a cassette in the entrance slot of this device. By means of laser scan and photoelectric method, this device reads the X-ray image data created in form of a latent image on the Plate exposed by an external X-ray generating device, and converts the read data into digital. REGIUS Model 210 also enables to use of multiple cassette to obtain images of long areas of anatomy and then to present the images as a single composite image (Long Length Imaging feature), and to use Read-Only Cassettes and Exposure-Only Cassettes used for Radiotherapy localization.
Different points between REGIUS Model 210 and REGIUS Model 190, which is approved 510(k) number: K052095 is that REGIUS Model 210 has higher processing capacity than REGIUS Model 190. To increase the processing capacity, the software algorithm is modified. However, the hardware remains unchanged. The exterior appearance is slightly modified.
The basic operations of REGIUS Model 210 such as a starting, a shut down, a registration-of-patient, a setting of a various condition are operated with the optional Image Processing Work Station, REGIUS CONSOLE CS-2000/3000 (510(k) cleared, K051523, July 20, 2005). Then the image data transfer to an externally connected device such as a host computer, an order input device, an image display device, a printer, an image data filing device, and other image reproduction devices.
This document is for a 510(k) premarket notification for a medical device called the "Direct Digitizer, REGIUS Model 210". The document establishes substantial equivalence to a predicate device and includes information about the device's intended use and classification. However, it does not contain the specific details about acceptance criteria, study design, or performance metrics that are requested in your prompt. This is typical for a 510(k) summary, which focuses on regulatory compliance and equivalence rather than detailed clinical trial results.
Therefore, I cannot provide the requested information from the provided text. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study or effect size.
- Standalone performance of the algorithm.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily focuses on:
- Device Identification: Company, correspondent, submission date, registration number, trade name, classification name, and classification.
- Predicate Device: Direct Digitizer, REGIUS Model 190 (K052095).
- Device Description: An X-ray image reader using a stimulable phosphor plate (Plate) to convert X-ray images into digital data. It also supports Long Length Imaging and Read-Only/Exposure-Only Cassettes for Radiotherapy localization. The key difference from the predicate is a modified software algorithm for higher processing capacity, while hardware remains unchanged.
- Intended Use: For trained medical personnel in clinics, radiology departments, and other medical facilities to read X-ray images from phosphor plates and transfer data to external devices. Not intended for use with FFDM systems.
- Substantial Equivalence: Claimed to be substantially equivalent to the REGIUS Model 190.
- Compliance Standards: IEC 60601-1 (Safety), IEC 60601-1-2 (EMC), 21 CFR 1040.10, IEC 60825-1 (Radiation safety).
§ 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.