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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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