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The Quix Digital Radiography Upgrade is based on a solid state imaging device and is intended for use in general radiographic examinations and applications wherever conventional film-screen systems may be used, excluding mammography, fluoroscopy, and angiography.

The Quix Digital Radiography Upgrade enables a conventional film-screen X-ray system to perform digital radiography exams by replacing the film-screen and the film-screen bucky with a digital bucky and operator console. The digital bucky incorporates a selenium-based flat panel detector with 16" x 17" imaging area. Images are displayed in approximately 10 seconds after exposure over a wide range of dose settings. The operator console provides local image storage and communicates with other network devices using DICOM 3.0 protocols.

The provided text is a 510(k) summary for the "Quix Digital Radiography Upgrade" device. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices. It focuses on comparing the new device's technical specifications and intended use against existing products.

Crucially, this document does not contain a study that proves the device meets acceptance criteria in the format typically used for performance claims of AI/ML-based devices (e.g., sensitivity, specificity, AUC, human reader studies).

Instead, the acceptance criteria for this type of device (a digital X-ray system) and the "study" demonstrating its equivalence are based on a comparison of its physical and performance specifications to those of existing, legally marketed predicate devices. The "acceptance criteria" are implied by the performance metrics of the predicate devices.

Here's an attempt to extract and interpret the information based on the provided text, acknowledging the limitations inherent in a 510(k) for a non-AI/ML device:

1. Table of acceptance criteria and the reported device performance

For a device like the Quix Digital Radiography Upgrade, the "acceptance criteria" are implicitly defined by the performance characteristics of its predicate devices. The "reported device performance" is the specifications of the Quix DR Upgrade.

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The Lodox whole-body x-ray scanner is mainly intended for use in trauma wards where multiple injuries can be medically diagnosed in a very short time. It can also be used for normal x-ray examinations as is currently practised with general-purpose single-shot x-ray machines. A full image area is 1800 mm by 680 mm, and can be reduced to any size down to 100 mm by 100 mm anywhere within the image area.

Lodox is a whole-body x-ray scanner that produces x-ray images that can be used for diagnostic purposes. It is an optical-based digital x-ray imager. It works by converting incident x-ray energy to visible light by use of a fluorescent screen optically coupled to a number of CCD cameras, which produce a digital image. The captured diagnostic image is stored in a database and is displayed on a highresolution, medical-quality monitor, where the diagnosis can be performed. The diagnostic image can be transmitted through a DICOM 3.0 compatible digital network for printing. The imaging area can be set from 100 mm x 100 mm x 680 mm on a special purpose patient trolley.

Here's a breakdown of the acceptance criteria and study information for the Lodox Digital Radiography System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally framed around achieving "substantial equivalence" to predicate devices (film radiography and an existing CT system) in terms of image quality and intended use. The performance metrics reported are primarily physical characteristics and a subjective clinical assessment.

Reported Device Performance (Specific Technological Characteristics):

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

• Sample Size: 39 human subjects
• Data Provenance: Not explicitly stated, but the company is based in South Africa. The phrasing "a range of anatomy was covered representative of general radiography" suggests these were clinical cases, likely prospective, where subjects were x-rayed by both methods.

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

• Number of Experts: Two radiologists.
• Qualifications: "a panel of two radiologists" - no further specific qualifications (e.g., years of experience) are provided in this document.

4. Adjudication Method for the Test Set

• The document states, "The results were examined by a panel of two radiologists and found substantially equivalent to film." This implies a consensus-based adjudication or individual review leading to a uniform conclusion, but a specific method like 2+1 or 3+1 is not detailed. It's possible they independently reviewed and then discussed to reach consensus, or reviewed together.

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, an MRMC comparative effectiveness study was not done in the context of AI assistance. This device is a diagnostic imaging system, not an AI-assisted diagnostic tool. The study compared the image quality of the Lodox system against conventional film radiography.

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

• This question is not applicable. The Lodox system is an X-ray imager, not an algorithm, and its performance is inherently linked to human interpretation of the images it produces. The study described is a comparison of the device's output (images) to conventional methods, which are then evaluated by human experts.

7. The Type of Ground Truth Used

• The ground truth used was expert consensus (the findings of the two radiologists) which compared the diagnostic quality of images from the Lodox system to images from conventional film radiography. Since the predicate is film radiography, the "ground truth" to which Lodox images were compared was essentially "diagnostically acceptable images from conventional film radiography" as assessed by experts.

8. The Sample Size for the Training Set

• The document does not provide information regarding a training set. This is consistent with the nature of the device; it's an imaging capture system, not an AI model that requires a discrete training phase. The "clinical testing" described serves as the validation of its performance, not a training set for an algorithm.

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

• This question is not applicable as no training set or AI model is described as part of the Lodox Digital Radiography System's development or evaluation in this document.

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Intended for use in general human radiography imaging similar to the optically coupled CCD based device cleared under 510(k) number K974863. Not to be used for mammography.

The Xplorer 1000 is an optical based digital x-ray imager. It works by converting incident x-ray energy to visible light by use of fluorescent screen. The visible light is deflected by a mirror to a high resolution CCD camera that produces a digital image. The device trigger mechanism ensures that image is captured when the x-ray beam is turned on. The device does not require any connection to the x-ray generator.

Here's a breakdown of the acceptance criteria and study as described in the provided documents for the Xplorer 1000 Digital X-ray Imager:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the Xplorer 1000 was to demonstrate equivalence to its predicate devices: the IMIX DIGITAL THORAX SYSTEM (K974863) and conventional radiographic film (21 CFR 892.1840). This equivalence was assessed in terms of intended use and radiographic performance.

Table of Acceptance Criteria and Reported Device Performance:

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CANON X-RAY DIGITAL CAMERA CXDI-11 is indicated for use in generating radiographic Images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.

CANON X-RAY DIGITAL CAMERA CXDI-11 provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.

CANON X-RAY DIGITAL CAMERA CXDI-11 is used to directly capture and convert conventional projection X-ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations. CANON X-RAY DIGITAL CAMERA CXDI-11 differs from traditional X-ray systems in that instead of exposing a film for subsequent wet chemical processing to create a hardcopy image, a device is used to capture the image in electronic form. The digital data are then used to produce diagnostic hardcopy and reference-softcopy images.

Here's a breakdown of the acceptance criteria and the study details for the Canon X-Ray Digital Camera CXDI-11, based on the provided text:

Acceptance Criteria and Device Performance

The provided document doesn't explicitly state "acceptance criteria" in a numerical or percentage format typically seen. Instead, the study's goal was to demonstrate that the image quality of the Canon Digital Radiography System (CXDI-11) was substantially equivalent to conventional x-ray film. This qualitative assessment of "substantial equivalence" is the de-facto acceptance criteria.

Additional Performance Metrics (not explicitly linked to "acceptance criteria" but included in comparison):

Study Details

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

   • Sample Size: Not explicitly stated as a number of cases or images. The document mentions "various inpatient cases."
   • Data Provenance: Not specified, but given the context of a 510(k) summary for a US market application, it's reasonable to infer that the data was likely from a US (or generally Western) clinical setting. It is a retrospective study as it involved evaluating "analog films... read twice."

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

   • Number of Experts: Not specified. The document states "Qualified readers evaluated both digital and analog films."
   • Qualifications of Experts: Not explicitly stated, beyond being "Qualified readers." Typically, for imaging studies, these would be radiologists, but their specific experience level is not provided.

3. Adjudication Method for the Test Set:

   • Not explicitly stated. The study involved "Qualified readers evaluated both digital and analog films." There's no mention of multiple readers reaching a consensus or any formal adjudication process beyond individual readers' assessments. The mention of readers reading analog films twice to assess consistency suggests individual reader scoring rather than a consensus approach for the primary equivalency comparison.

4. 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, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI assistance.
   • This study was a comparison between a new digital radiography system (CXDI-11) and a conventional film/screen system, not an AI-assisted interpretation study. The CXDI-11 device is a capture device, not an AI interpretation tool.

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

   • Yes, in essence, a comparison of the "standalone" performance of the imaging systems was done. The study's primary objective was to evaluate the image quality of films generated by the CXDI-11 compared to conventional film, as assessed by human readers. While human readers were involved in the assessment, the focus was on the inherent quality of the image produced by the device, not the reader's diagnostic performance with or without the device (beyond assessing image quality).

6. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

   • The "ground truth" for the comparison of image quality was based on expert subjective assessment by "qualified readers." They evaluated the images for "overall image quality, as well as for image quality with respect to specific anatomical areas." There's no mention of objective pathology or outcomes data being used to establish a 'true' diagnosis or lesion presence for the purpose of image quality assessment. The "ground truth" here is the perceived quality by experts.

7. The Sample Size for the Training Set:

   • Not applicable / Not mentioned. The CXDI-11 is an X-ray digital camera, a hardware device for capturing images. It's not an AI algorithm that learns from a training set of data. The document describes a clinical evaluation study for image quality, not the development or training of an AI model.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable / Not mentioned. As explained above, there is no AI algorithm training set for this device.

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The Direct Radiography™ device provides a digital image capture capability for conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications). The device has application wherever conventional screen-film systems are currently used.

The Sterling Diagnostic Imaging Direct RadiographyTM device is used to directly capture and convert conventional projection X-ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a digital network for diagnostic viewing and printing. The device provides digital image capture for conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications). The Direct RadiographyTM device differs from traditional X-ray systems in that instead of exposing a film for subsequent wet chemical processing to create a hardcopy image, a device called a digital array is used to capture the image in electronic form. The digital data are then used to produce hardcopy and softcopy images.

The provided document is a 510(k) summary for the "Sterling Diagnostic Imaging Direct Radiography™" device. This device is described as a system to directly capture and convert conventional projection X-ray images to digital images.

However, the document does not contain information regarding detailed acceptance criteria, specific device performance metrics, or any studies demonstrating that the device meets such criteria.

The document primarily focuses on:

• Device Description: What the device is and how it works (digital image capture instead of film).
• Intended Use: For conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications) wherever screen-film systems are currently used.
• Predicate Device Comparison: It compares the digital nature of the Sterling device to the analog nature and chemical processing of traditional screen-film systems, concluding substantial equivalence for conventional radiographic examinations.
• FDA Clearance Letter: A letter from the FDA stating that the device is substantially equivalent to the predicate and can be marketed.

Since the document is a 510(k) summary, it aims to establish substantial equivalence to a predicate device rather than providing extensive performance studies with detailed acceptance criteria typically found in clinical trial reports or technical specifications for newer, novel devices. The determination of "substantially equivalent" implies that the new device is as safe and effective as a legally marketed predicate device, and thus, extensive de novo performance studies with separate acceptance criteria might not have been required or documented in this specific submission summary.

Therefore, I cannot provide the requested information from the given text.

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