(90 days)
The Drystar 4500M is a free-standing printer used to print diagnostic images on transparent film for viewing on a standard view box. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable, including digital mammography.
The Drystar 4500M is a dry, B/W printer, using the direct thermal printing principle to establish continuous-tone images with medical diagnostic image quality. The printer can be sold with one or two film input trays; one can contain 8 x 10 film and the other 10 x 12 film. Film may be loaded in full daylight. The printer is a network-only printer. The Drystar 4500M uses a thicker film for mammography than is used for regular medical images in order to provide a wider range of optical densities. The printer also handles borders for mammography images in a different manner than for regular medical images. Otherwise, the device is very similar to the Drystar 4500.
This document is a 510(k) summary for the Agfa Drystar 4500M, a medical image hard copy device. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or a comprehensive study report on device performance against specific metrics.
Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted from the provided text.
Here is what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific numeric acceptance criteria for device performance (e.g., optical density range, resolution, accuracy) for mammography images are explicitly stated in the provided text. The document states the device provides "continuous-tone images with medical diagnostic image quality" and uses "a thicker film for mammography...to provide a wider range of optical densities." However, these are qualitative descriptions, not measurable acceptance criteria with corresponding performance numbers.
| Acceptance Criteria (Inferred from context) | Reported Device Performance |
|---|---|
| Provision of continuous-tone images with medical diagnostic image quality | The Drystar 4500M uses a direct thermal printing principle to establish continuous-tone images with medical diagnostic image quality. |
| Provision of a wider range of optical densities for mammography | The Drystar 4500M uses a thicker film for mammography to provide a wider range of optical densities. |
| Compliance with electrical safety standards (EN 60601-1-1 and UL-2601) | Device was tested for electrical safety according to EN 60601-1-1 and UL-2601, and found to be the same as the predicate Drystar 4500. |
| Compliance with electromagnetic compatibility standards (EN 60601-1-2) | Device was tested for electromagnetic compatibility according to EN 60601-1-2, and found to be the same as the predicate Drystar 4500. |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not mentioned.
- Data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not mentioned. The document focuses on the technical characteristics of the printer and its substantial equivalence, not on human interpretation of images printed by the device for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as there is no mention of a test set involving human readers or diagnostic performance evaluation.
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:
Not applicable. This device is a printer, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a printer; it does not perform algorithmic analysis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The "ground truth" for a printer would typically relate to its output quality (e.g., optical density, resolution, uniformity) rather than diagnostic accuracy. No specific measurement standards or "ground truth" for image quality were detailed.
8. The sample size for the training set:
Not applicable. This device is a printer and does not use machine learning models that require a training set.
9. How the ground truth for the training set was established:
Not applicable. This device is a printer and does not use machine learning models.
Summary of what the document does provide:
The document primarily focuses on demonstrating the substantial equivalence of the Drystar 4500M to legally marketed predicate devices (Drystar 4500 and Kodak Dryview 8610 Laser Imager for Mammography). The "study" mentioned consists of:
- Comparison of technological characteristics: Stating that the Drystar 4500M is "identical" to the Drystar 4500 and "very similar" to the Kodak 8610 in terms of technology.
- Testing for electrical safety and electromagnetic compatibility: The device was tested for electrical safety (EN 60601-1-1 and UL-2601) and electromagnetic compatibility (EN 60601-1-2), and its electrical systems and chassis were found to be the same as the predicate Drystar 4500, which had already undergone these tests.
The core argument for acceptance is based on the device's similarity to existing cleared devices, particularly for its intended use in printing mammography images. No new clinical performance studies or specific image quality metrics are provided in this summary.
§ 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.