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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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ViZion + DR is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion + allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.

The ViZion + DR system represents the straightforward integration of a new digital x-ray receptor panel and our previously cleared software. This is a MODIFICATION of our clearance K112661 wherein we have changed the supplier of the panel. ViZion + DR is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) ViZion + is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the Viztek PACS and the new receptor panel were not changed. Our main predicate is ViZion DR, K112661, wherein we combined our OPAL-RAD software with a new digital panel. We now also offer two sizes of panels: 14" x 17" and 17" x 17" panels.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Viztek ViZion + DR device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary (K123644) does not outline specific numerical acceptance criteria for image quality metrics. Instead, it relies on a qualitative assessment for substantial equivalence.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "Clinical images were acquired," implying a set of images, but the exact number is not provided.
• Data Provenance: The document does not specify the country of origin of the data. It is implied to be retrospective or a limited prospective acquisition for the purpose of the 510(k) submission, as it involves comparison to existing predicate devices. The study is described as a clinical image evaluation, not a large-scale clinical trial.

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

• Number of Experts: "a board certified radiologist" (singular).
• Qualifications: "board certified radiologist." No further details on years of experience are provided.

4. Adjudication Method for the Test Set

• Adjudication Method: "a board certified radiologist who concluded the images from the new panel are as good as or better than the images acquired with the predicate panel." This indicates a single reader assessment, not a multi-reader adjudication method (like 2+1 or 3+1).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The evaluation was performed by a single board-certified radiologist.
• Effect Size: Not applicable, as no MRMC study was conducted.

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

• This device is a digital flat panel X-ray detector system, not an AI algorithm. Therefore, a standalone performance study in the context of an AI algorithm is not applicable. The device itself is the imaging system, and its performance is assessed directly (both technically and clinically).

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the clinical image evaluation was expert opinion/consensus, specifically the judgment of a single board-certified radiologist comparing the new panel's images to those from predicate panels. There is no mention of pathology or outcomes data for establishing ground truth in this submission.

8. The Sample Size for the Training Set

• This submission describes a hardware modification (a new digital panel combined with existing software) and its equivalence to predicate devices, not the development or training of a new AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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

• Not applicable, as there is no training set for an AI algorithm.

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Intended for use by a qualified/trained doctor or technologist. As part of a radiographic system, the KrystalRad 660 is intended to acquire digital radiographic images. It is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.

This device is simply the combination of two cleared devices, the same Wireless Portable Detector as used in the FD-W I (K90062) marketed by Philips Medical Systems and the image processing software cleared in our K080522 DDR MAK Series. Alternately the image processing software is the same as in Omil'ision, K. 100403 made by Modern Module Inc. The Wireless Portable Detector consists of three main parts: Portable in radiography detector (x-ray sensitive part); Docking station which is directly connected to the radiographic workshow and a backup cable which can connect the decector to the docking station if the wireless connection cable which can connect the detector to the docking if the wireless connection cannot be used. Detector size: 35 x 43 cm (14 x 17") Image matrix size: 3000 pixels x 2400 pixels. Pixel size 144 um Image matrix size: 3000 pixels x 2400 pixels. Pixel size: 144 µm, 1mage resolution up to 3.5 LP/mm. The device is intended as an upgrade to existing film x-ray systems. It should be installed by a qualifics trained by a qualifics trained

The KrystalRad 660 Digital Radiographic Portable Retrofit System's acceptance criteria and study details are provided below based on the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state acceptance criteria in quantitative terms (e.g., minimum sensitivity, fidelity metrics). Instead, it focuses on demonstrating substantial equivalence to predicate devices. The primary performance metric is the qualitative comparison of clinical images and integration testing.

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

The document states, "Clinical images were acquired and compared to our predicate images." However, it does not specify the sample size for the test set (number of images or patients).

The data provenance is not explicitly stated regarding its country of origin or whether it was retrospective or prospective. It only mentions "clinical images were acquired," which could imply prospective acquisition, but this is not confirmed.

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

The document does not provide information on the number of experts used or their qualifications to establish ground truth for the clinical images. The comparison is described simply as "compared to our predicate images," suggesting an internal comparison rather than a formal expert review process for ground truth.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method for the test set. The statement "no significant differences between them" suggests a qualitative assessment without detailing a specific process like 2+1 or 3+1 consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this submission. The study focuses on demonstrating equivalence to predicate devices, not on comparing human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device is a hardware combination (digital X-ray panel and image processing software). The "performance" being evaluated is the image quality and functionality of this combined system itself. Therefore, the "standalone" performance in this context refers to the system acquiring images, which was done by collecting and comparing clinical images. It's not an "algorithm-only" performance in the sense of an AI diagnostic aid.

7. The Type of Ground Truth Used

The ground truth for the comparison was based on "our predicate images." This implies comparing images from the KrystalRad 660 system to images produced by the previously cleared predicate devices (Philips Wireless Portable Detector FD-W17 K090625 and the image processing software from K080582 DDR MAK Series or K100403 OmniVision). The "ground truth" is therefore the established image quality and clinical utility of the predicate devices.

8. The Sample Size for the Training Set

The device is a combination of two already cleared predicate devices. The "study" described is a comparison and integration test of this combination, not the development or training of a new algorithm. Therefore, there is no specific "training set" mentioned for the KrystalRad 660 as it's not a de novo AI algorithm requiring training. The image processing software itself (cleared under K080582 or K110040) would have had its own validation/training, but details are not provided here for KrystalRad 660.

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

As stated in point 8, there isn't a "training set" for the KrystalRad 660 as a new device. The ground truth for the predicate image processing software or detector would have been established during their original clearance, likely involving various methods (e.g., expert review, physical phantoms for image quality metrics), but these details are not provided in this submission for K112132. The KrystalRad 660 leverages the already established "ground truth" (i.e., safety and effectiveness) of its predicate components.

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