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Intended for use by a qualified/trained doctor or technologist. As part of a radiographic system, the KrystalRad "New Series" is intended to acquire digital radiographic images. It is suitable for all routine radiography exams, including specialist areas like intensive care or trauma work, excluding fluoroscopy, angiography and mammography.

This device represents the combination of already cleared software and already cleared digital receptor panels. This device is a functional replacement for radiographic film. It serves as an upgrade to film based or older digital panel diagnostic x-ray systems. Digital radiography uses digital X-ray sensors instead of traditional photographic film. Advantages include time efficiency through bypassing chemical processing and the ability to digitally transfer and enhance images. Also less radiation can be used to produce an image of similar contrast to conventional radiography. This gives advantages of immediate image preview and availability; elimination of costly film processing steps; a wider dynamic range, which makes it more forgiving for over- and under-exposure; as well as the ability to apply special image processing techniques that enhance overall display of the image.

This document describes the premarket notification (510(k)) for the KrystalRad "New Series" Digital Radiographic Portable Retrofit System. The device is intended as an upgrade for radiographic film-based or older digital panel diagnostic x-ray systems.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly define "acceptance criteria" in a quantitative manner for performance metrics like sensitivity, specificity, or image quality scores. Instead, the demonstration of safety and effectiveness relies on establishing substantial equivalence to a predicate device (KrystalRad 660, K112132). The "acceptance criteria" in this context are primarily the absence of significant differences in technical characteristics and diagnostic quality, and compliance with relevant safety and performance standards.

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

• Sample Size for Test Set: The document states that "Clinical images were acquired and compared to our predicate images by a board certified radiologist." However, it does not specify the number of clinical images or cases used in this comparison.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given the context of a 510(k) submission to the FDA, it is highly likely that the images would have been collected in a manner compliant with US regulations, potentially from a US healthcare setting. The term "acquired" suggests prospective collection for the purpose of the comparison, but this is not definitively stated.

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

• Number of Experts: One (1) board certified radiologist.
• Qualifications of Experts: Board certified radiologist. No further details on years of experience or specific sub-specialty are provided.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Only one radiologist was used for comparison, so there was no need for an adjudication method. The radiologist directly compared the images from the new device to those from the predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improvement with AI vs Without AI Assistance:

• MRMC Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not performed, nor was it applicable. This device is a digital X-ray panel and software system, not an AI-assisted diagnostic tool. Its purpose is to acquire and display images, not to interpret them or provide AI assistance to readers. Therefore, there is no AI component for human readers to improve with, and no effect size on human reader performance is reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Standalone Performance Study: No, a standalone performance study in the context of an "algorithm only" or AI performance was not done, nor was it applicable. The device is a hardware and software system for image acquisition and display, not an AI algorithm. Its performance is assessed through its ability to produce diagnostically acceptable images, not through an independent algorithm's diagnostic accuracy.

7. The Type of Ground Truth Used:

• Type of Ground Truth: The "ground truth" for the clinical image comparison was established by the expert opinion (board certified radiologist), who assessed the "diagnostic quality" and "significant differences" of the images from the new device compared to the predicate device. This is a form of expert consensus, although with only one expert, it's essentially a single expert's opinion. There is no mention of pathology, outcomes data, or other objective measures for ground truth.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: The document does not mention a training set in the context of machine learning or AI development. This device is a digital X-ray system, and its development process, as described, involves engineering and integration of already cleared components. No AI model training is indicated.

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

• Ground Truth for Training Set: Not applicable, as there is no mention of a training set or AI model development.

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