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The Seiko ColorPoint™ model 1700 medical imager & Video Capture Box systems are indicated for converting the electronic signals from medical imaging modalities into hard copy suitable for diagnosis and record keeping.

The Seiko ColorPoint™ Medical Imager and Video Capture systems are designed for medical imaging applications printing color or monochrome images on paper and or film media.

Please note: The provided text is a 510(k) summary for a medical imager and video capture box. It describes the device, its intended use, and its substantial equivalence to a predicate device. It does NOT contain information about acceptance criteria, a specific study designed to prove device performance against those criteria, or details regarding ground truth, expert adjudication, or sample sizes related to performance evaluation.

Therefore, I cannot populate most of the requested fields as the information is not present in the provided document.

Here's what can be extracted and what cannot:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a performance study with a test set. It's a regulatory submission for substantial equivalence.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. (See above)
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. (See above)
4. 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 a medical imager and video capture system, not an AI-powered diagnostic tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is hardware for producing hard copies of images; it's not an algorithm with standalone performance.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
7. The sample size for the training set: Not applicable. (See above – not an AI/algorithm-based device)
8. How the ground truth for the training set was established: Not applicable. (See above)

Summary of available information from the document:

• Device Name: Seiko Instruments, ColorPoint™ 1700 Medical Imagers and Video Capture Box (VCX) systems (specifically ColorPoint™ 1720 Medical Imagers and Video Capture Box CX-1000 series).
• Intended Use: Converting electronic signals from medical imaging modalities into hard copy suitable for diagnosis and record keeping.
• Predicate Device: Seiko Instruments Inc. ColorPoint™ Model 820 Medical Imager (K971760).
• Regulatory Decision: Substantially Equivalent.
• Key Argument for Equivalence: The new device's technological characteristics are similar to the predicate, and it does not contact the patient or control life-sustaining devices. Images are interpreted by a physician, allowing for human intervention. The device complies with voluntary standards and has undergone a hazard analysis classifying potential hazards as MINOR.

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