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Both devices are designed to digitize medical images from x-ray film.

The Canon Film Scanner is a desktop size x-ray film digitizing system with CCD linear sensor. Features high throughput due to high speed scan and automatic film feeder with 100 sheet capacity. DICOM and FTP protocol on TCP/IP are supported.

The provided 510(k) summary for the Canon Film Scanner 300 (K960839) does not contain information regarding acceptance criteria or a study proving the device meets acceptance criteria related to its performance in medical image interpretation or diagnostic accuracy.

This submission is from 1996 for an Image Digitizer, which is a device that converts analog X-ray film images into digital format. The focus of this type of device at that time (and often still) is on technical specifications like scanning speed, resolution, and digital output formats, rather than diagnostic accuracy, as it is a tool for digitizing existing images, not interpreting them.

Here's a breakdown of why the requested information is absent based on the provided document:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on comparing technical characteristics to a predicate device, not on diagnostic performance metrics.
2. Sample size used for the test set and the data provenance: Not applicable. No clinical or performance study involving a test set for diagnostic accuracy is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment related to diagnostic performance is mentioned.
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: No. This type of study is for evaluating the impact of an AI algorithm on human readers' diagnostic performance. This device is a film digitizer, not an AI algorithm for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This device is a hardware film scanner, not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a film digitizer would relate to the fidelity of the digital image to the original film, not diagnostic findings.
8. The sample size for the training set: Not applicable. This device does not use a "training set" in the context of machine learning.
9. How the ground truth for the training set was established: Not applicable.

What the document does indicate regarding testing:

• Non-clinical Tests: "Software evaluation is being performed to show substantial equivalence." This suggests that the testing focused on the software's ability to digitize and manage images, likely ensuring compliance with standards or matching the predicate device's functionality.
• Clinical Tests: "N/A" - This explicitly states that no clinical tests were performed. This is typical for devices that do not directly inform clinical diagnosis (like a film digitizer, where the diagnostic information is already present on the film and simply being converted).

In summary, the provided 510(k) summary is for a film digitizer from 1996 and does not include any information about diagnostic performance, acceptance criteria related to diagnostic accuracy, or studies involving human readers or AI algorithms. The focus is on technical equivalence and software functionality for image digitization.

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