(79 days)
Fuji Medical Dry Laser Imagers, models DRYPIX 7000, DRYPIX 5000 and FM-DP L are indicated for use in providing diagnostic quality medical images on film for aid in physician diagnosis, including the printing of images and associated identification information from various digital imaging source modalities, including but not limited to, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Ultrasound, Computed Radiography, Digital Radiography, Digital Mammography and Nuclear Medicine.
Fuji Medical Dry Laser Imagers models DRYPIX 7000, DRYPIX 5000 and FM-DP L are image recording devices that use laser exposure and thermal development to print on medical dry imaging films the digital image data that is sent from medical diagnostic imaging modalities. Image processing is performed on the obtained digital images, and via laser exposure, and thermal development the le perfermou on tilm. The main difference between the FM-DP L device and the DRYPIX devices are image throughput. The only difference in the DRYPIX devices is that the DRYPIX 7000 is a 220 Vac version while the DRYPIX 5000 is a 110 Vac version.
Based on the provided document, the device in question is the Fuji Medical Dry Laser Imagers (models DRYPIX 7000, DRYPIX 5000, and FM-DP L). This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than independent performance studies with detailed acceptance criteria and standalone performance metrics as one might find for an AI/CADe device.
Therefore, much of the requested information (acceptance criteria table with reported performance, sample sizes for test/training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth specifics for training) is not available or applicable in this type of submission for this particular device.
Here's what can be extracted and inferred from the document:
1. A table of acceptance criteria and the reported device performance:
This device is a Medical Image Hardcopy Device (printer). Its performance is primarily assessed through its ability to provide "diagnostic quality medical images on film for aid in physician diagnosis." The 510(k) summary does not provide specific quantitative acceptance criteria or reported performance metrics (e.g., spatial resolution, Dmax/Dmin, throughput accuracy, or specific image quality scores) that would typically be associated with software or diagnostic devices. Instead, substantial equivalence to predicate devices is the primary "acceptance criterion" for regulatory clearance in this context.
| Acceptance Criteria (Inferred from Substantial Equivalence to Predicate Devices) | Reported Device Performance (Inferred) |
|---|---|
| Diagnostic Quality Images: Ability to produce medical images on film suitable for physician diagnosis. | Assumed to meet diagnostic quality standards, as it is considered substantially equivalent to already cleared devices (Agfa LR 5200 Laser Film Recorder and Kodak DRYVIEW 8610 Laser Imager) which are established for producing diagnostic quality images. |
| Image Recording Functionality: Process digital image data from various modalities and print them via laser exposure and thermal development. | Functions as described, processing digital image data from CT, MRI, Ultrasound, CR, DR, Digital Mammography, and Nuclear Medicine into film output. |
| Safety and Efficacy: No new safety and efficacy issues compared to predicate devices. | A hazard analysis was performed, and the device is deemed a "minor level of concern." Compliance with relevant standards (21 CFR 1040.10, UL 60601-1, IEC 60601-1-2, DICOM) is stated, indicating the device meets established safety and performance protocols for medical electrical equipment and imaging communication. |
| Image Throughput: Production speed of images. | The document notes differences in "image throughput" between the FM-DP L and DRYPIX devices, implying this is a design consideration, but no specific performance numbers are given. |
| Voltage Compatibility: Power requirements. | DRYPIX 7000 is 220 Vac, DRYPIX 5000 is 110 Vac, indicating different models meet different electrical standards/customer needs. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not Applicable/Not provided. As this is a hardcopy device and the submission focuses on substantial equivalence rather than a new clinical claim based on image analysis, there is no mention of a "test set" of medical images or patient data in the context of a performance study for diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not Applicable/Not provided. This information is irrelevant for a device that prints images. The "ground truth" for a printer would be its adherence to technical specifications for image reproduction, rather than expert interpretation of medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not Applicable/Not provided. There is no "test set" in the context of diagnostic interpretation that would require an adjudication method.
5. 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:
Not Applicable. This device is an imager (printer), not an AI/CADe system. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not Applicable. This device performs a physical function (printing images), not an algorithmic diagnostic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For a medical image hardcopy device, the "ground truth" refers to its technical specifications and ability to accurately reproduce digital images onto film with diagnostic quality. The document indicates compliance with DICOM, which is a standard for handling, storing, printing, and transmitting medical imaging information, suggesting accurate reproduction of originating image data is a key aspect. The assessment relies on engineering and quality control, not medical ground truth like pathology for diagnostic accuracy. The substantial equivalence argument relies on the predicate devices having met appropriate standards for diagnostic image quality.
8. The sample size for the training set:
Not Applicable. This device does not use machine learning, so there is no "training set."
9. How the ground truth for the training set was established:
Not Applicable. As no training set exists, no ground truth needed to be established for it.
In summary, the provided document for the Fuji Medical Dry Laser Imagers (K033377) is a 510(k) summary demonstrating substantial equivalence to predicate devices (Agfa LR 5200 and Kodak DRYVIEW 8610). It does not contain the detailed performance study information typically associated with AI/CADe devices or new diagnostic algorithms, as the device's function is to print diagnostic quality medical images on film, rather than to interpret them.
§ 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.