(29 days)
The Drystar 5300 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.
The Drystar 5300 is a dry process, B/W medical image printer, using the direct thermal printing principle to establish continuous-tone images with medical diagnostic image quality. The printer has one film input tray, which can contain either 11x14 or 14x17 film. The printer is a networkonly printer.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Drystar 5300M, structured as requested:
Acceptance Criteria and Device Performance Study for Drystar 5300M
This submission is a 510(k) for a medical image hardcopy device, the Drystar 5300M. The primary method for demonstrating substantial equivalence is through comparison to predicate devices, namely the Drystar 5500 and Drystar 2000/3000. For this type of device (a printer), the "performance" is generally related to its ability to print diagnostic quality images and meet safety/EMC standards. The document primarily focuses on establishing equivalence based on shared technological characteristics and existing predicate device clearances.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Test | Reported Device Performance |
|---|---|---|
| Technological Equivalence | "Same technological characteristics" as predicate devices (Drystar 3000 and 5500) | Met: Drystar 5300 "has the same technological characteristics" and "All use a thermal process to produce medical images." |
| Electrical Safety | Compliance with EN 60601-1-1 and UL-2601 | Met: Device was tested for electrical safety according to these standards, as described in the 510(k) for the Drystar 4500. Electrical systems are "the same across the different models of the Drystar family of printers." |
| Electromagnetic Compatibility (EMC) | Compliance with EN 60601-1-2 | Met: Device was tested for EMC according to this standard, as described in the 510(k) for the Drystar 4500. Electrical systems and chassis are "the same across the models of the Drystar family of printers." |
| Intended Use | Printing diagnostic images on transparent film for viewing on a standard view box; hard copy of images from medical imaging devices. | Met: Drystar 5300 "has the same indications for use as the legally marketed Drystar 5500." |
| Image Quality (Implied) | "Medical diagnostic image quality" (mentioned in device description) | Implied Met: The device uses a "direct thermal printing principle to establish continuous-tone images with medical diagnostic image quality." The equivalence claim suggests it meets this standard, though no specific quantitative metrics or reader studies are provided in this summary to explicitly prove "diagnostic image quality" outside of the substantial equivalence framework. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a substantial equivalence submission, not a study with a traditional "test set" of medical images or patient data in the sense of an AI algorithm.
- For electrical safety and EMC testing, the "sample" would be the Drystar 5300 device itself. The tests were performed on the device. No specific number of units tested is provided, but it's presumed to be a sufficient number for type testing.
- The data provenance is related to the internal testing of the Agfa Corporation, as they would have conducted the safety and EMC evaluations. The document refers to testing "as described in the 510(k) for the Drystar 4500," suggesting a reliance on established testing protocols and potentially previous reports for analogous devices from the same family.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a submission for a medical image printer, not a diagnostic algorithm that requires expert ground truth establishment for a test set of medical cases. The "ground truth" for the printer's function is its ability to physically print, and for safety/EMC, it's compliance with established engineering standards.
4. Adjudication Method for the Test Set
Not applicable, for the same reasons as above.
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
No. This device is a printer, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or included.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device (printer), not a standalone algorithm.
7. The Type of Ground Truth Used
- For technical characteristics and safety/EMC, the "ground truth" is adherence to established engineering standards (EN 60601-1-1, UL-2601, EN 60601-1-2) and the demonstrated equivalence of the device's design and function to previously cleared predicate devices.
- For "medical diagnostic image quality," the ground truth is implicitly defined by the ability of the predicate devices (Drystar 5500, Drystar 2000/3000) to produce images deemed acceptable for diagnostic viewing. The Drystar 5300 claims to achieve this same standard through its thermal printing process. No external pathology or outcomes data is referenced for this printer specifically in relation to image quality acceptance.
8. The Sample Size for the Training Set
Not applicable. This is a hardware device (printer), not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.