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The device is indicated for use in obtaining diagnostic images to aid the physician with diagnosis. The system can be used to perform radiographic imaging of various portions of the human body, including the skull, spinal column, extremities, chest, abdomen and other body parts. The device is not indicated for use in mammography

The DRX-Compass System is a general purpose x-ray system used for acquiring radiographic images of various portions of the human body. The system consists of a combination of components including various models of high voltage x-ray generators, control panels or workstation computers, various models of patient support tables, wall-mounted image receptors/detectors for upright imaging, various models of tube support devices, x-ray tube, and collimator (beam-limiting device). The DRX-Compass can be used with digital radiography (DR) and computed radiography (CR) receptors. Smart Features are added to the DRX-Compass system to provide remote capabilities for existing functions of the DRX-Compass system. These remote capabilities simplify exam set up and improve workflow for the operator while preparing for the patient exposure. The "smart features", described below, are designed to reduce the technologist's manual tasks and to speed up workflow for existing features of the system. These improvements are referred to as "smart features" in the product documentation. Implementation of these "smart features" does not change the intended use of the system.

The provided text does not contain detailed information about specific acceptance criteria and a study that comprehensively proves the device meets those criteria for the DRX-Compass system. The document is a 510(k) summary for the FDA, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive efficacy study for new features.

However, based on the information provided, I can extract the relevant details that are present and explain why some requested information is not available in this document.

Here's a breakdown of what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that "Predefined acceptance criteria were met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device." However, the specific acceptance criteria themselves (e.g., specific thresholds for DQE/MTF, or performance metrics for the "smart features") are not explicitly detailed in this 510(k) summary. Similarly, the reported device performance values against those specific criteria are also not provided.

The closest information related to performance is:

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

This information is not provided in the 510(k) summary. The document states "Non-clinical testing such as standards testing are the same as that of the predicate. The verification and validation testing of the modified device demonstrates that the modified device performs as well as the predicate and is substantially equivalent." without detailing the specific sample sizes or data provenance for these tests. For imaging performance, it mentions DQE/MTF data for detectors, but not the sample size of images or patients used for performance evaluation of the overall system or its new "smart features."

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the 510(k) summary. The document focuses on technical verification and validation, and comparison to a predicate device, rather than a clinical study requiring expert consensus on ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. Given the absence of specific clinical study details or expert ground truth establishment, no adjudication method would be mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study is not mentioned in this document. The submission's focus is on demonstrating substantial equivalence through technical testing and compliance with recognized standards, particularly for the "smart features" which are described as workflow enhancements rather than diagnostic AI tools requiring reader performance studies. There is no mention of AI assistance for human readers or associated effect sizes.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study of an algorithm without human-in-the-loop is not explicitly mentioned in this document. The "smart features" are described as functionalities to assist the operator, implying human-in-the-loop operation, rather than a standalone diagnostic algorithm. The document mentions "Flat panel detector DQE/MTF data shows that the additional detectors supported by the modified device (DRX-Compass) are equivalent in image quality to that of the DRX Plus detectors cleared with the predicate," which is a technical performance metric for the detector component, not an algorithm's diagnostic performance.

7. Type of Ground Truth Used

The type of ground truth used for any performance evaluation is not explicitly stated. For the detector performance, DQE/MTF data refers to physical image quality metrics rather than a diagnostic ground truth (like pathology or clinical outcomes). For the "smart features," their evaluation appears to be based on functional verification and validation of their workflow enhancement capabilities, rather than comparison to a ground truth for diagnostic accuracy.

8. Sample Size for the Training Set

This information is not provided in the 510(k) summary. The document does not describe the use of machine learning algorithms that would typically require a training set. The "smart features" appear to be rule-based or real-time processing functionalities rather than learning algorithms.

9. How Ground Truth for the Training Set Was Established

Since there is no mention of a training set or machine learning, details on establishing its ground truth are not provided.

In summary, the 510(k) submission for the DRX-Compass focuses on demonstrating substantial equivalence to a predicate device by:

• Ensuring the modified device's indications for use are identical.
• Confirming compliance with recognized electrical safety and performance standards (AAMI ES60601-1, IEC 60601-1-6, IEC 60601-1-3, IEC 60601-2-54, IEC 62366).
• Applying risk management (ISO 14971) to ensure no new risks are introduced.
• Showing that new components (e.g., additional detectors) maintain equivalent image quality (e.g., DQE/MTF data).
• Asserting that new "smart features" improve workflow without changing the device's intended use or safety profile.

The document does not provide the kind of detailed clinical study data often found for AI/ML-based diagnostic devices, including specific acceptance criteria values, sample sizes for test or training sets, expert qualifications, or adjudication methods, as these may not be typically required for modifications to a stationary X-ray system primarily focused on workflow enhancements and component upgrades.

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The device is indicated for use in obtaining diagnostic images to aid the physician with diagnosis. The system can be used to perform radiographic imaging of various portions of the human body, including the skull, spinal column, extremities, chest, abdomen and other body parts. The device is not indicated for use in mammography.

The DRX-Compass System is a general purpose x-ray system used for acquiring radiographic images of various portions of the human body. The system consists of a combination of components including various models of high voltage x-ray generators, control panels or workstation computers, various models of patient support tables, wallmounted image receptors/detectors for upright imaging, a ceiling mounted tube support, x-ray tube, and collimator (beam-limiting device).

The DRX-Compass can be used with digital radiography (DR) and computed radiography (CR) receptors. Systems equipped with DR or CR receptors can also be configured to include a workstation computer that is fully integrated with the x-ray generator.

The modified (subject) device, DRX-Compass, is the previously cleared Q-Rad System stationary x-ray system which has been modified as follows:

• New marketing names DRX-Compass and DR-Fit will be used depending upon regional marketing strategies.
• Implementation of a new wall stand that provides options for automated vertical motion and vertical to horizontal manual tilt (90 degrees).
• Implementation of a different Overhead Tube Crane (OTC): This OTC is ceiling suspended and provides x-y movement capability for the tube head with respect to the detector. The tube head is capable of three options for alignment with the image acquisition device (detector) as follows: 1) manual alignment by moving the x-ray tube support, 2) manual alignment using the "tube-up/tube-down" switch on the tube support, or 3) automatic alignment using the "Auto Position" switch to activate motors on the tube support in x, y, z, and alpha directions
• Focus 35C and Focus 43C Detectors are added as additional optional detector selections for customers ordering a DRX-Compass system.
• X-Ray Generator: Several Carestream designed generators are available with the system depending on power requirements and regional configurations. These generators are functionally identical to the generators currently offered for sale with the Q-Rad System.

This looks like a 510(k) summary for a medical device called DRX-Compass, an X-ray system. The document does not contain the acceptance criteria or results of a study (like an AI model performance study) that would typically involve statistical metrics, ground truth establishment, or expert reviews.

Instead, this document describes:

• Device Name: DRX-Compass
• Regulatory Information: Product Code, Regulation Number, Class, etc.
• Predicate Device: Q-Rad System (K193574)
• Device Description: Components of the DRX-Compass system, including generator models, patient support tables, wall-mounted receptors, ceiling-mounted tube support, X-ray tube, and collimator. It also mentions the new additions/modifications compared to the predicate device (new marketing names, new wall stand, different Overhead Tube Crane (OTC), added detectors, and available generators).
• Indications for Use: Obtaining diagnostic images for various body parts.
• Substantial Equivalence: The primary claim is that the DRX-Compass is substantially equivalent to the predicate Q-Rad System, stating that modifications do not raise new issues of safety and effectiveness.
• Discussion of Testing: It briefly mentions "non-clinical (bench) testing" to evaluate performance, workflow, function, verification, and validation, and that "Predefined acceptance criteria were met." However, it does not specify what those acceptance criteria were or how they were met in terms of specific performance metrics. It's focused on demonstrating equivalence to the predicate device, not on proving performance against a detailed set of criteria that would typically be described for an AI/CAD device.

Therefore, based only on the provided text, I cannot extract the detailed information requested in the prompt. The document is a regulatory submission summary, not a clinical or performance study report.

If this were a submission for an AI/CAD device, the "Discussion of Testing" section would typically elaborate on a clinical study including:

1. A table of acceptance criteria and the reported device performance: This would list metrics like sensitivity, specificity, AUC, etc., and the target performance values.
2. Sample size used for the test set and the data provenance: Details on number of cases, patient demographics, and origin of data.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Information about the radiologists/pathologists.
4. Adjudication method: How disagreements among experts were resolved.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: If conducted, the effect size (e.g., improvement in reader performance with AI).
6. Standalone performance: The algorithmic performance without human intervention.
7. Type of ground truth used: e.g., pathology, clinical follow-up.
8. Sample size for the training set: Number of cases used for model development.
9. How the ground truth for the training set was established: Similar to the test set, but for the training data.

In summary, the provided document does not contain the information requested because it pertains to a traditional X-ray system's substantial equivalence claim, not the performance evaluation of an AI/CAD (Computer-Aided Detection/Diagnosis) algorithm.

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