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The ATAL 8 and ATAL 8c is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding fluoroscopic, angiographic, and mammographic applications.

Device Description

The ATAL 8 and ATAL 8C are flat-panel type digital X-ray detectors that capture radiographic images in digital format within seconds, eliminating the need for an entire X-ray film or an image plate as an image capture medium. The ATAL 8 and ATAL 8C device differs from traditional X-ray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, a device called a Detector Panel is used to capture the image in electronic form. Once the system captures a radiographic image and subsequently displays and stores an image, radiologists or physicians can adjust the image electronically to optimize the view of the desired anatomy at a workstation. The system enables a user to duplicate images without having to take additional exposures so that the user can easily transmit a duplicate to the second physician who needs the duplicate image through the network. The ATAL 8 and ATAL 8C differ only in the enclosure type. They have identical technological characteristics.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Equivalence or superiority to the predicate device in diagnostic quality of clinical images.	"a board certified Radiologist reviewed the images and declared the new panel to be equivalent or better than the predicate device, and that the images are of diagnostic quality."
Device produces images suitable for "general radiographic images of human anatomy" and can "replace radiographic film/screen systems in all general-purpose diagnostic procedures."	The clinical evaluation concluded the device provides images of diagnostic quality, indirectly confirming suitability for its intended use. The conclusion of substantial equivalence also supports this, implying it meets the requirements for general radiography.
Compliance with non-clinical performance standards (MTF, DQE, Quantum Limited Performance, Effects of Aliasing, Output Signal Level and Linearity, Lag).	"Non-clinical testing included performance tests, EMC tests, Electrical Safety and software validation tests. The performance testing was based on the requirements of the FDA Guidance Document for Solid State Imaging Devices and included tests for MTF, DQE, Quantum Limited Performance, Effects of Aliasing, Output Signal Level and Linearity, and Lag or residual signal level from prior exposure." Results are implied to be satisfactory as per the substantial equivalence conclusion.

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

Sample Size for Test Set: 30 pairs of clinical images (30 images from the ATAL 8/8C and 30 corresponding images from the predicate device).
Data Provenance: Not explicitly stated, but based on the nature of clinical image acquisition, it would be prospective for the purposes of this equivalency study, as these images were specifically obtained for the comparison. The country of origin is not specified.

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

Number of Experts: One
Qualifications of Experts: "a board certified Radiologist"

4. Adjudication Method for the Test Set

Adjudication Method: None explicitly mentioned beyond a single radiologist's review. The radiologist "declared the new panel to be equivalent or better than the predicate device, and that the images are of diagnostic quality." This suggests a direct comparison and qualitative assessment by a single expert, without a formal adjudication process involving multiple readers.

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 explicitly described. The study involved a single radiologist's assessment of paired images.
Effect Size: Not applicable, as an MRMC study was not performed.

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

Standalone Performance: Not applicable/not explicitly stated in the context of this device. The ATAL 8 and ATAL 8C are digital X-ray detectors, not an AI algorithm. Their performance is inherently tied to producing images for human interpretation. The clinical study assessed the diagnostic quality of the images produced by the device, which are then interpreted by a human (the radiologist). Therefore, the concept of a "standalone" algorithmic performance isn't directly relevant in the same way it would be for an AI-powered diagnostic tool.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for the clinical comparison was based on expert consensus (or in this case, expert declaration by a single board-certified radiologist) that the images were of diagnostic quality and equivalent or better than those from the predicate device. This is a form of expert review for diagnostic suitability.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. The document describes a medical device (digital X-ray detector), not an AI algorithm that requires a training set. The "development" of the device would involve engineering and physical testing, not machine learning training.

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

Ground Truth for Training Set: Not applicable, as this device does not involve an AI algorithm with a training set. The "ground truth" for non-clinical development would be established through physical and engineering specifications, validation against known standards, and performance test results (e.g., MTF, DQE).

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