(69 days)
The EL-DRY 4000 digitizes image data output from medical imaging apparatus in the form of video or digital signals, then records this printing data onto the Kodak DryView laser film by mean of semiconductor laser. The intended use of the EL-DRY 4000 is to produce radiological quality film copies of digital or video medical images.
The EL-DRY 4000 is a desk top radiographic Laser Imager. The EL-DRY 4000 The EL-DN I - 1000 10 a deen top edical imaging apparatus in the form of video or digital signals, then records this printing data onto the Kodak DryView laser film by mean of semiconductor laser. Digitized image data is processed to match the film size mcall of semiconductor laser 22gitLed . and formats (1,2,4,6,9,12,15,16, 20, 24), and these processed data converted into laser out put. Three different image-processing methods are available; selection is made via the imaging pad. This system is controlled by a micro-processor, and all parameters can be set using the imaging pad. Furthermore, necessary information such as format, system status, and error indicators are all shown on an LCD readout. In addition, 15 types of LUT (characteristic of film density levels) settings are available; selection is also made using the imaging pad. The intended use of the EL-DRY 4000 is to produce radiological quality film copies of digital or video medical images.
The provided 510(k) summary for the Elk Laser Imager, Model EL-DRY 4000, does not contain information related to acceptance criteria or the study that proves the device meets those criteria, as it is a device for printing medical images onto film, not an AI/ML powered diagnostic or screening device.
The document describes a medical image hard copy device (a laser imager) which digitizes and prints medical images onto film. As such, the typical "acceptance criteria" and "study" described in your prompt (which relate to the performance of diagnostic algorithms, AI/ML models, or clinical effectiveness in identifying conditions) are not applicable to this type of device.
Instead, the submission focuses on demonstrating substantial equivalence to an existing predicate device (Kodak DryView 8100) by comparing technical specifications and intended use. The "performance" in this context is about printing quality and functionality, rather than diagnostic accuracy.
Here's a breakdown of why it doesn't fit your requested format and what information is provided:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. The document compares specifications of the EL-DRY 4000 to the Kodak DryView 8100 predicate device. These are technical specifications (e.g., exposure method, film type, pixel size, throughput), not acceptance criteria for diagnostic performance.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This device is a printer. There is no "test set" of patient data in the context of 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. Ground truth for diagnostic purposes is not established for this device. Its function is to reproduce existing images accurately.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable.
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 is not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable.
8. The sample size for the training set
- Not Applicable. This device does not use a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
- Not Applicable.
Summary of Information Provided in the 510(k) for the Elk Laser Imager, Model EL-DRY 4000:
- Device Type: Medical Image Hard Copy Device (Laser Imager)
- Intended Use: To produce radiological quality film copies of digital or video medical images.
- Predicate Device: Kodak DryView 8100
- Demonstration of Performance/Equivalence: Via comparison of technical specifications between the proposed device and the predicate device (exposure method, film type, film size, pixel size, number of pixels, formats, interface, input numbers, output grayscale, image memory, contrast table, interpolation, calibration, magazine, throughput, power source, dimensions, weight).
- Software: Elk Corporation certifies that software is designed, developed, tested, and validated according to written procedures. Hazard analysis was performed.
- Safety Standards Applied: UL 2601-1, CSA-C22.2 #601-1, IEC 60101+A1+A2, IEC 60825, IEC 60601-2, MDD ANNEX I.
In essence, this is a hardware device for printing, and its regulatory submission focuses on demonstrating its physical/functional equivalence and safety, not on diagnostic accuracy derived from algorithmic performance.
§ 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.