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The Sony UP-DF500 FilmStation™ Digital Film Imager is a thermal printer intended for use in printing high-resolution diagnostic images from CT, MRI or other compatible medical imaging systems. The Sony UP-DF500 is intended for use by medical radiologists or other appropriately trained medical personnel.
The Sony UP-DF500 FilmStation™ Digital Film Imager is a general purpose thermal printer and is intended for use as an accessory to a wide variety of medical imaging systems for digitally printing black and white still images with DICOM format. The Sony UP-DF500 is connected to a DICOM network and the image from a compatible medical imaging system is transmitted via the DICOM network.
This document is a 510(k) Summary for the Sony UP-DF500 FilmStation™ Digital Film Imager, a thermal printer used for medical imaging. The 510(k) submission seeks to demonstrate substantial equivalence to existing predicate devices.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state specific acceptance criteria in terms of quantitative performance metrics (e.g., resolution, spatial accuracy, density range, diagnostic accuracy). Instead, it focuses on demonstrating substantial equivalence to predicate devices based on overall purpose, function, and intended use.
The "reported device performance" is implicitly demonstrated through the claim of substantial equivalence and the device's technological characteristics aligning with the predicate devices. The core "performance" being evaluated is its ability to produce high-resolution diagnostic images comparable to other legally marketed thermal printers.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not mention a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). This type of information is typically associated with clinical performance studies, which are not detailed in this 510(k) summary for a hardcopy device. The focus here is on engineering and functional equivalence rather than diagnostic accuracy on patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Since no specific test set or clinical performance study is described, there's no mention of experts or their qualifications used to establish ground truth for a test set.
4. Adjudication Method:
Given the lack of a detailed clinical performance study with a test set, there is no adjudication method mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:
The device is a thermal printer, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not conducted and is irrelevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device is a standalone thermal printer. Its "performance" is in printing images, not in making diagnostic interpretations. So, in a sense, its operation is "standalone" in its function of printing. However, this is not a standalone diagnostic algorithm in the context of typical AI medical device evaluations. The performance being evaluated is the quality of the hardcopy output itself, independent of human interpretation until the image is presented to a human.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
Given the nature of the device as a thermal printer, the "ground truth" would likely relate to the accuracy of image reproduction – e.g., how closely the printed image matches the digital image data in terms of resolution, gray scale, and spatial fidelity, rather than a clinical ground truth like pathology for diagnostic accuracy. The document does not specify how this ground truth (for image reproduction quality) was established or evaluated.
8. The Sample Size for the Training Set:
The document does not mention a training set sample size. This type of information is pertinent to machine learning algorithms, which are not applicable to a thermal printer in this context.
9. How the Ground Truth for the Training Set was Established:
As there is no mention of a training set, there is no information on how its ground truth was established.
Summary of Acceptance Criteria and Study (Based on Inference from 510(k) Format):
Based on the nature of a 510(k) for a medical image hardcopy device, the "acceptance criteria" and "study" are not presented in the format often seen for diagnostic algorithms. Instead, acceptance is based on demonstrating substantial equivalence to already legally marketed predicate devices.
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Acceptance Criteria (Inferred):
- Functionality: The device must perform the same overall function as predicate devices (printing high-resolution diagnostic images from CT, MRI, etc.).
- Intended Use: The device must share the same intended use as predicate devices (for use by medical radiologists or other appropriately trained medical personnel for diagnostic purposes).
- Technological Characteristics: The device must have technological characteristics (e.g., thermal printing technology, DICOM connectivity) that are sufficiently similar to predicate devices, or any differences do not raise new questions of safety or effectiveness.
- Image Quality: Although not explicitly quantified, the implicit acceptance criterion is that the printed image quality (resolution, gray scale, lack of artifacts) must be diagnostically acceptable and comparable to the output of predicate devices.
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Study That Proves the Device Meets Acceptance Criteria (Inferred):
The "study" is the 510(k) submission process itself, which involves:- Comparison to Predicate Devices: A detailed comparison of the Sony UP-DF500 FilmStation™ to the specified predicate devices (Agfa Drystar 4500, Codonics Horizon Series, Fuji Medical Dry Imager FM-DP 2636, Kodak Dry View 8610 Laser Imager) regarding their intended use, technological characteristics, and performance.
- Engineering and Performance Testing (not detailed in this summary): While not explicitly described in the provided sections, a 510(k) submission would typically include engineering tests and performance data to demonstrate that the device meets its design specifications and produces images equivalent in quality to predicate devices. This would cover aspects like resolution, Dmax/Dmin, uniformity, and artifact levels, likely tested against industry standards or internal specifications, rather than a clinical study with patient cases. The FDA's review and ultimate clearance (FEB 0 4 2003) signify that these factors were deemed acceptable.
In essence, for this type of device, the "study" is a technical comparison and evaluation of the device's technical specifications and output quality to ensure it is as safe and effective as existing legally marketed devices, rather than a clinical trial assessing diagnostic accuracy with expert readers.
§ 892.2040 Medical image hardcopy device.
(a)
Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.