Search Results

The Drystar AXYS is a free-standing dry film 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 AXYS 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 AXYS 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 printer is sold with two film 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.

The provided document is a 510(k) summary for the Drystar AXYS, a medical image hardcopy device (printer). It primarily focuses on demonstrating substantial equivalence to a predicate device (Drystar 5500) rather than providing detailed acceptance criteria and a study proving device performance against those criteria in the context of clinical AI/software performance.

Therefore, many of the requested sections (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not available in this specific document, as it describes a hardware device that prints images, not an AI or software algorithm that analyzes them.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not define specific "acceptance criteria" for clinical performance of an AI/software device, nor does it report performance metrics relevant to an AI/software's diagnostic accuracy (e.g., sensitivity, specificity, AUC).

Instead, the closest equivalent to "performance" for this device relates to its printing capabilities and compliance with manufacturing standards.

2. Sample Size Used for the Test Set and Data Provenance

• Not Applicable. This document describes a medical printer, not a diagnostic AI/software that would have a "test set" of patient data for performance evaluation. The "testing" mentioned refers to engineering and quality assurance activities for hardware and software functionality, as well as compliance with standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Not Applicable. As above, no clinical test set requiring expert-established ground truth is described.

4. Adjudication Method for the Test Set

• Not Applicable. No clinical test set or adjudication is mentioned.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was Done

• No. This document does not mention any MRMC studies. The device is a printer, not a diagnostic aid that would involve human readers interpreting images with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

• Not Applicable. The device is a printer, not an algorithm. Therefore, there is no "standalone performance" study in the context of an AI/software algorithm.

7. The Type of Ground Truth Used

• Not Applicable. For a printer, "ground truth" in the clinical AI sense (e.g., pathology, outcomes data) is not relevant. The "truth" would involve whether the printed image accurately reflects the digital image data, has appropriate density, resolution, and is free from artifacts, which would be assessed through technical specifications and quality control, not clinical ground truth.

8. The Sample Size for the Training Set

• Not Applicable. This is a hardware printer, not an AI model that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As above, no training set or its ground truth is relevant for this device.

Summary of the Study (as described in the 510(k) summary):

The "study" described in the document is primarily an equivalence demonstration. It focuses on showing that the Drystar AXYS is substantially equivalent to a previously cleared predicate device, the Drystar 5500.

The key points of the equivalence demonstration and "testing" mentioned are:

• Comparison to Predicate: Detailed comparison of hardware and software characteristics to the Drystar 5500 (though the detailed table 3.1 is not provided in this excerpt).
• Intended Use Equivalence: Stating that the Drystar AXYS has the same indications for use as the Drystar 5500.
• Technological Equivalence: Asserting that the technological characteristics are "identical" to the predicate device.
• Quality Control Procedures: Stating that the device includes an automatic QC procedure to comply with MQSA. This is a crucial "test" for the mammography application.
• Consensus Standards Compliance: Testing against and meeting "a number of consensus standards for safety and electromagnetic compatibility."

In essence, the "study" for this device is a regulatory submission proving that a new version of a printer performs its basic function (printing diagnostic images) and meets relevant safety and quality standards, effectively demonstrating it is as safe and effective as a device already on the market. It does not involve clinical performance studies in the way one would assess a diagnostic AI or software.

Ask a specific question about this device