(77 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. This is a 510(k) addressing substantial equivalence, not a performance trial against specific criteria. | The document states the device is "substantially equivalent" to its predicate device (ColorPoint™ Model 820 Medical Imager K971760). No specific performance metrics or thresholds are reported. |
Study Details
- 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.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. (See above)
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. (See above)
- 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.
- 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.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable. (See above – not an AI/algorithm-based device)
- 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.
§ 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.