(101 days)
The Direct Digitizer, REGIUS MODEL 190 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 190 is used to obtain image data of long areas of anatomy such as the whole spine or the whole lower leg.
REGIUS MODEL 190 is also used to obtain image data to verify the position for a radiotherapy location.
It is designed intended to use in a clinic, a radiology department in a hospital and in other medical facilities.
It is not intended for use with digital mammography system.
The Direct Digitizer, REGIUS MODEL 190 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 the REGIUS MODEL 190. By means of laser scan and photoelectric method, the 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. The signal processing is made to the digital image data such as the digital filtering, the gain-offset correction and the shading collection. Then the REGIUS MODEL 190 is capable of transferring 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.
The modifications are 1) Applicable cassette size is increased. 2) Read-Only cassettes are added, 3) Exposure-Only cassettes are added, and 4) Function of a reader console is upgraded.
The purpose of modification is to enable to use of multiple cassettes 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 obtain images to verify the position for a radiotherapy location.
Here's a breakdown of the acceptance criteria and study information for the Direct Digitizer REGIUS MODEL 190, based on the provided text.
This submission is a 510(k) premarket notification for a modified device, seeking to demonstrate substantial equivalence to a predicate device. Therefore, the "study" described is primarily focused on demonstrating that the modifications do not introduce new risks or alter the fundamental performance that made the predicate device safe and effective. The acceptance criteria are essentially that the modified device performs comparably to the predicate device and meets relevant safety and performance standards.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety Standard Compliance: UL60601-1, IEC60601-1 | Complies |
| Electromagnetic Compatibility (EMC) Compliance: FCC, IEC60601-1-2 | Complies |
| Radiation Safety Compliance: 21 CFR 1040.10 | Complies |
| Substantial Equivalence to Predicate Device (K042386): |
- Image reading mechanism (X-ray image reader using stimulable phosphor plate)
- Core functionality (reading images, converting to digital, signal processing, transferring data)
- Intended use (general X-ray imaging, not for mammography)
- Safety profile (no new risks) | The modified device retains the same fundamental image reading mechanism and core functionalities.
The modifications relate to increased applicable cassette sizes, addition of Read-Only and Exposure-Only cassettes for Long Length Imaging, and radiotherapy localization.
The modifications do not change the basic intended use.
"Risk analysis is the same as our current REGIUS MODEL 190, K042386. (We consider no new risk will arise and therefore we did not conduct a new risk analysis.)"
"Software information is also the same as current REGIUS MODEL 190, K042386." |
| Functional Performance of New Features: - Long Length Imaging (ability to obtain single composite images from multiple plates for extended anatomy like whole spine/lower leg)
- Radiotherapy Localization (ability to use for position verification with specialized cassettes) | The device "enable[s] to use of multiple cassettes to obtain images of long areas of anatomy and then to present the images as a single composite image (Long Length Imaging feature)."
The device "enable[s] image reading similar to ordinary X-ray exposure by replacement of the photostimulable phosphor plates" for Long Length Imaging.
"One method of photographic procedure to produce images used to verify the position is the method using REGIUS MODEL 190, Photostimulable Phosphor Plate and exposure cassette containing metal plate..."
For radiotherapy localization, it "enable[s] image reading identical to ordinary X-ray exposure by replacement of the photostimulable phosphor plate after exposure." |
Study Information
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Sample size used for the test set and the data provenance:
- The document does not explicitly describe a "test set" in terms of a specific number of images or patients. The evaluation appears to be based on adherence to standards and a comparison of technical specifications and intended uses with the predicate device.
- No information on data provenance (country of origin, retrospective/prospective) is provided, as specific clinical data is not presented.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no external "test set" requiring expert ground truth establishment is described in this submission. The evaluation is focused on engineering and regulatory compliance rather than clinical interpretation by experts.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable, as no external "test set" requiring adjudication is described.
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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:
- No MRMC comparative effectiveness study was done. This device is an X-ray image digitizer, not an AI-powered diagnostic tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is a standalone device in the sense that it performs its function (digitizing X-ray images) without direct human intervention in the digitization process itself (once the cassette is inserted). However, it is not an "algorithm only" in the modern sense of an AI algorithm, and its performance is evaluated based on its technical specifications for imaging, not diagnostic accuracy. The document states, "The signal processing is made to the digital image data such as the digital filtering, the gain-offset correction and the shading collection." This is internal signal processing, not a standalone diagnostic algorithm aiming for clinical endpoints.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this type of device (an image digitizer) is primarily its technical performance specifications (e.g., image quality, resolution, processing speed, accuracy of composite image creation) and its ability to consistently produce images compatible with downstream diagnostic review, rather than a clinical diagnosis. The "ground truth" used for demonstrating substantial equivalence is the performance and safety profile of the predicate device and compliance with relevant technical standards (UL60601-1, IEC60601-1, FCC, IEC60601-1-2, 21 CFR 1040.10).
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The sample size for the training set:
- Not applicable. This device is not an AI/machine learning device that requires a training set in the conventional sense. Its "training" would be part of its engineering design and calibration processes.
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How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of AI for this device.
§ 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.