(13 days)
The Drystar 5500M is a free standing device used to print diagnostic conventional and mammography 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.
The device is the new Drystar 5500 and it is a dry, B/W printer, using the direct thermal printing principle to produce continuous-tone images with medical diagnostic image quality onto plastic sheets which can be viewed on a light box. The device has two input trays. Each tray can be adjusted to five different sizes (in inches) of film, including 8x10, 10x12, 11x14, 14x14 and 14x17. Three different types of film can be used in this new device, two for general purpose radiography and a new type of film for mammography, Drystar DT 2 M. The new mammography film comes in only two sizes 8x10 and 10x12. It is thicker than the general purpose radiography film 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 cleared original Drystar 5500.
The provided document describes the Agfa Drystar 5500 printer, a medical image hard copy device, and focuses on its substantial equivalence to previously cleared devices. It does not contain information about studies proving the device meets specific acceptance criteria related to its performance in image quality or diagnostic accuracy studies in the way a diagnostic AI device report would.
Instead, the "acceptance criteria" for this device are primarily related to its functional equivalence to predicate devices and compliance with regulatory standards for safety and electromagnetic compatibility.
Here's an analysis based on the provided text, while acknowledging that a diagnostic performance study as one might expect for an AI device is NOT present:
Acceptance Criteria and Device Performance (as inferred from the document):
| Acceptance Criteria Category | Criterion Description (Inferred) | Reported Device Performance (as stated in document) |
|---|---|---|
| Functional Equivalence (General Printing) | Produce continuous-tone B/W images with medical diagnostic image quality on plastic sheets. | The device uses "direct thermal printing principle to produce continuous-tone images with medical diagnostic image quality onto plastic sheets." |
| Mammography Image Printing | Ability to print mammography images on film suitable for diagnostic viewing. | "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." |
| Film Compatibility | Support use with general purpose radiography film and a new type of mammography film (Drystar DT 2 M). | "Three different types of film can be used in this new device, two for general purpose radiography and a new type of film for mammography, Drystar DT 2 M." |
| Film Sizes | Accommodate specific film sizes for general radiography and mammography. | "Each tray can be adjusted to five different sizes (in inches) of film, including 8x10, 10x12, 11x14, 14x14 and 14x17. The new mammography film comes in only two sizes 8x10 and 10x12." |
| Optical Density (Mammography) | Provide a wider range of optical densities for mammography film. | Mammography film "is thicker... in order to provide a wider range of optical densities." |
| Mammography Quality Standards Act (MQSA) Compliance | Meet compliance requirements of the MQSA. | "The Drystar 5500 contains an automatic QC procedure that assures compliance with the Mammography Quality Standards Act (MQSA) of the FDA." |
| Safety and Electromagnetic Compatibility | Compliance with relevant consensus standards for safety and electromagnetic compatibility. | "It was also tested against and met a number of consensus standards for safety and electromagnetic compatibility." |
| Substantial Equivalence (General) | Be substantially equivalent in intended use and technological characteristics to predicate devices (Drystar 4500M, Drystar 5500). | The document's primary conclusion is that "This pre-market submission has demonstrated Substantial Equivalence." |
Study Details (Based on available information):
The document does not describe a "study" in the sense of a clinical trial or performance evaluation with human readers and ground truth data for diagnostic accuracy. Instead, it refers to regulatory compliance and functional testing.
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Sample size used for the test set and the data provenance: Not applicable in the context of image quality or diagnostic accuracy studies. The testing mentioned refers to functional, safety, and regulatory compliance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no mention of a test set with ground truth established by experts for diagnostic performance.
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Adjudication method for the test set: Not applicable. There is no mention of a test set requiring adjudication in this context.
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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 diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a printer, not an algorithm.
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The type of ground truth used: Not applicable for diagnostic performance. The "ground truth" here would be functional specifications, regulatory standards, and physical measurements (e.g., optical density, film size, continuous tone output).
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The sample size for the training set: Not applicable. This device is a printer, not a machine learning algorithm.
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How the ground truth for the training set was established: Not applicable.
Summary from the document:
The Agfa Drystar 5500 printer submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices (Drystar 4500M and previous Drystar 5500). The "study" aspects mentioned are internal functional testing, compliance with the Mammography Quality Standards Act (MQSA) via an automatic QC procedure, and adherence to consensus standards for safety and electromagnetic compatibility. These tests confirm the device's ability to mechanically and functionally operate as intended and meet relevant regulatory requirements for a medical image hard copy device, particularly for mammography output. It is not a study assessing diagnostic performance or AI effectiveness.
§ 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.