(87 days)
retrieving medical images stored on magneto optical disk (removable media) and makes monochrome 8" x 10" film copies in a six on one format. It also passes color images to color film recorders via a SCSI bus.
The Aspect Electronics, Inc. Opticam is a multi format camera used for retrieving medical images stored on magneto optical disk (removable media) and makes monochrome 8" x 10" film copies in a six on one format. It also passes color images to color film recorders via a SCSI bus.
The provided text is a summary statement for the Aspect Opticam Film Recorder, Multi Format Camera, submitted in 1996. It is an older document primarily focused on establishing substantial equivalence for a medical device that essentially records images to film. As such, it predates many of the rigorous clinical study requirements and AI-specific evaluation metrics that are standard today.
Therefore, much of the requested information (acceptance criteria in the typical sense of quantitative metrics, detailed study designs, sample sizes for test/training sets, ground truth establishment, MRMC studies, standalone performance, etc.) is not present in the provided summary. The document focuses more on hardware safety, general effectiveness validation by comparison, and substantial equivalence to a predicate device.
Here's an attempt to extract what little information is available and explain the absence of the rest:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Image Quality (Hard Copy vs. Original CRT) | "Image quality of the device has been validated by radiologists who compared hard copy images with the original CRT." (Implicitly, the image quality was deemed acceptable by these radiologists.) |
| Safety Standards Compliance | Hardware components are "off-the-shelf computer components that have IEC 601 certification." Unit has "CSA Mark." Computer equipment complies with "part 18 of the FCC rules." |
| No significant influence on safety or effectiveness compared to predicate device | "[Any differences] between the Aspect Opticam System and the equivalent device have no significant influence on safety or effectiveness." (Stated as a conclusion for substantial equivalence). |
| No expected death or injury from failure or design flaw | "It is our conclusion that there is no hardware device or software component that we know of in the Aspect Opticam System whose failure or latent system design flaw would be expected to result in death or injury to a patient." |
Additional Information (Based on provided text)
- Sample size used for the test set and the data provenance: Not specified. The document only mentions "Extensive testing" by "programmers, by non-programmers and by potential customers."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. It states "Image quality of the device has been validated by radiologists," but does not mention the number or specific qualifications (e.g., years of experience).
- Adjudication method: Not specified.
- 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/not done. This device is a film recorder, not an AI-powered diagnostic tool. Its purpose is to accurately reproduce images, not interpret them. The concept of "human readers improve with AI" doesn't apply to this product.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/not done. The device does not contain a diagnostic algorithm. Its function is to convert digital images to film. "Standalone performance" in the context of an algorithm is not relevant here. The software is explicitly stated to be "only used for control purposes and has no bearing on image quality."
- The type of ground truth used: For image quality, the ground truth was the "original CRT" image, against which the "hard copy images" were compared by radiologists. Therefore, it's essentially expert comparison to a reference standard (the original digital display).
- The sample size for the training set: Not applicable. There is no mention of a "training set" in the context of machine learning or AI, as the device does not employ such technologies.
- How the ground truth for the training set was established: Not applicable, as there is no training set mentioned.
Summary of Limitations:
This document is for a film recorder from 1996. The regulatory and testing standards for such a device were vastly different from those applied to modern AI/ML medical devices. The "validation of effectiveness" described is rudimentary by today's standards for diagnostic devices, focusing on direct comparison of output (film) to input (CRT) by human observers (radiologists) rather than quantitative performance metrics or large-scale clinical studies. There is no AI or algorithm involved in image processing or interpretation, so many of the requested criteria are irrelevant.
§ 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.