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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.

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The intended use of the ED-3000 is to produce digital copies of radiological film.

The Model ED-3000 is a desk top laser image digitizer intended to produce digital copies of radiological film.

The ED-3000 is a desk top radiographic film digitizer incorporating a laser beam scanned in one direction, a mechanical stage that moves a sheet of film in the orthagonal direction, a light collector and photomutiplier and electronic circuitry for analog-to-digital conversion, system operation and connection to external networks.

The provided text is a 510(k) summary for the Nishimoto Sangyo Elk Laser Film Digitizer, Model ED-3000. It focuses on demonstrating substantial equivalence to a predicate device (Vidar VXR-LS) rather than providing a detailed study proving the device meets specific acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

Therefore, many of the requested details about acceptance criteria and study design are not present in the provided document. The document describes the device, its intended use, software development practices, hazard analysis, and safety concerns, but it does not include a performance study with acceptance criteria.

Here's a breakdown of the information that can be extracted, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in terms of performance metrics like accuracy, sensitivity, or specificity. The document focuses on demonstrating substantial equivalence based on technical specifications and functional attributes compared to a predicate device.
• Reported Device Performance: Instead of performance against acceptance criteria, the document provides a table comparing the technical specifications of the ED-3000 to its predicate device, the Vidar VXR-LS. This comparison serves as the primary 'proof' of equivalence for this type of device.

2. Sample size used for the test set and the data provenance

• Not provided. The document does not describe a performance study with a test set of data. The submission relies on technical specification comparison.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/Not provided. No test set with ground truth established by experts is mentioned.

4. Adjudication method for the test set

• Not applicable/Not provided. No test set or adjudication method is mentioned.

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

• No. This device is a film digitizer, not an AI-powered diagnostic tool. An MRMC study or AI assistance is not relevant to its function.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable/Not provided. This is not an algorithmic diagnostic device, but a hardware device for converting analog film to digital images. Its performance is characterized by its technical specifications (resolution, density range, etc.) rather than diagnostic accuracy.

7. The type of ground truth used

• Not applicable/Not provided. Since no performance study is described, no ground truth is mentioned. The "truth" for this device's function would be the accuracy of its digital representation compared to the original physical film, which is implicitly covered by the technical specifications for resolution, pixel size, and optical density.

8. The sample size for the training set

• Not applicable/Not provided. This device does not use machine learning or require a training set.

9. How the ground truth for the training set was established

• Not applicable/Not provided.

Summary of the "Study" (Demonstration of Substantial Equivalence):

The "study" in this context is the comparison of technical specifications between the new device (Elk Laser Film Digitizer, Model ED-3000) and its legally marketed predicate device (Vidar, VXR-LS, Laser Film Digitizer, K974315). The acceptance criterion, implicitly, is that the new device's specifications are substantially equivalent to or better than the predicate such that it raises no new questions of safety or effectiveness.

The document explicitly states: "The following product provides functions, which are substantially equivalent to this product. Please note that Nishimoto Sangyo is the Original Equipment Manufacturer (OEM) for the Vidar VXR-LS predicate device." This indicates that the new device is essentially a re-submission of a device for which Nishimoto Sangyo was already the OEM, reinforcing the substantial equivalence argument.

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