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The DRX-Evolution Plus is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging. This device is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging. This device also supports Dual Energy chest imaging. The Dual Energy feature is not to be used for imaging pediatric patients.

The DRX-Evolution Plus 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). In addition to general radiography applications, the system also includes the optional Dual Energy functionality. The DRX-Evolution Plus can be used with digital radiography (DR) and computed radiography (CR) receptors. "Smart" Features are added to the DRX-Evolution Plus system to provide remote exam set-up capabilities for existing functions of the DRX-Evolution Plus 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. Implementation of these features does not change the intended use of the system and does not affect the Dual Energy functionality.

The provided FDA 510(k) document for the Carestream Health, Inc. DRX-Evolution Plus System (K233381) does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria, specifically regarding AI/algorithm performance.

The document discusses the substantial equivalence of the DRX-Evolution Plus system to a predicate device (K190330), focusing on hardware components, new integrated detectors, and workflow enhancements referred to as "Smart" features (Real-time Video Assistance, Long Length Imaging, Collimation from User Interface, Patient Picture).

The "Smart" features described are workflow improvements that seem to involve remote control and visualization, not an AI/algorithm that performs diagnostic or detection tasks requiring rigorous performance criteria and clinical validation studies per the questions asked. The document explicitly states: "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. Implementation of these features does not change the intended use of the system and does not affect the Dual Energy functionality."

Therefore, I cannot extract the information requested about acceptance criteria for an AI/algorithm's diagnostic performance, sample sizes used for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance from this specific document.

The document indicates:

• Non-clinical testing was performed for the "Smart" Feature user options, and these tests "indicated that the subject device as described in this submission meets the predetermined safety and effectiveness criteria." However, it does not specify what those criteria were for these workflow enhancements beyond general safety and effectiveness.
• Detector integration testing involved "functional testing, installation testing, media verification tests, performance tests, regression tests, risk mitigation testing, and serviceability testing." For the Lux 35 detector, "comprehensive image quality tests, vacuum testing to validate its liquid ingress (IP57) requirement, and Dual Energy functionality and performance testing" were done.

Given the nature of the device (a general diagnostic X-ray system with workflow enhancements), it's highly probable that the acceptance criteria and validation studies are related to hardware performance, image quality, electrical safety, usability, and compliance with recognized standards (IEC, ISO), rather than the diagnostic accuracy of an AI algorithm.

In summary, the provided text does not contain the information requested to answer the questions about AI/algorithm acceptance criteria and performance studies because the "Smart" features described are workflow enhancements, not diagnostic AI algorithms.

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The device is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging including tomography. This device also supports digital tomosynthesis. The tomography and digital tomosynthesis features are not to be used for imaging pediatric patients.

Carestream Digital Tomosynthesis (DT) is a limited "sweep" imaging technique that generates multiple two-dimensional (2D) coronal slices (i.e. planes) from a series of low dose x-ray images of the same anatomy taken at the same exposure but at different angles. During a tomosynthesis acquisition the detector will be stationary while the tube head travels (sweeps) in a straight path (i.e. focal spot travel path). For each exposure, the tube will be angled toward the center of the detector. The Carestream Digital Tomosynthesis contains 3 options: Sweep angle option is to provide the desired slice thickness. The number of images per degree of sweep angle. The Projection Image Resolution allows for the selection of speed of capture versus image resolution.

The Carestream Digital Tomosynthesis (DT) system was evaluated through non-clinical (bench) testing and a clinical reader study to demonstrate its diagnostic image quality and equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Clinical Images: 17 Digital Tomosynthesis image cases from adult human subjects (patients). Each case included a thoracic digital radiograph (PA and lateral chest exposure) and a DT exam (scout PA chest image and DT exposures).
  • Phantom Images: 11 Digital Tomosynthesis phantom exams and corresponding Linear Tomography exams.
• Data Provenance: Clinical study conducted at Toronto General Hospital located in Toronto, Ontario, Canada (prospective). Phantom studies were also conducted.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Seven (7) board certified radiologists.
• Qualifications: "general varying reading experience." (No further specific details on years of experience were provided in the text).

4. Adjudication Method for the Test Set

The text indicates that seven radiologists performed an evaluation, but it does not specify an adjudication method (e.g., 2+1, 3+1 consensus). It only states they used a "graduated 4-point RadLex rating scale" and the mean rating was calculated from their assessments.

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

A clinical reader study was performed. The study involved seven radiologists evaluating images from the investigational device, a reference comparison (standard of care PA and lateral chest x-rays), and the predicate device (Linear Tomography phantom studies). The "statistical test results demonstrate the Carestream Digital Tomosynthesis delivers quality imaging performance that is equivalent or better in diagnostic quality compared to images obtained using commercially available predicate and reference devices."

• Effect Size: The document does not provide a specific quantitative effect size of how much human readers improved with AI (Digital Tomosynthesis) vs. without AI assistance. It states the DT system was found to be "equivalent or better" in diagnostic quality.

6. Standalone (Algorithm Only) Performance

The document describes the "Carestream Digital Tomosynthesis reconstruction software leverages algorithms that are the same in principle to those applied in computed tomography (CT), such as filtered back projection or iterative reconstruction etc." While it implies algorithm processing, the overall evaluation was of the imaging system producing the images for radiologist interpretation. The reader study assessed the diagnostic image quality facilitated by the DT feature. It is not explicitly stated whether a standalone algorithm-only performance assessment without human-in-the-loop was conducted. The focus was on the diagnostic utility of the images produced by the device.

7. Type of Ground Truth Used for the Test Set

The ground truth for the clinical cases was based on the diagnostic image quality ratings by board-certified radiologists using a RadLex scale. For the phantom studies, the ground truth would inherently be known from the phantom's construction and expected imaging characteristics, used for comparison with Linear Tomography.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set of any AI or reconstruction algorithms.

9. How Ground Truth for the Training Set Was Established

The document does not provide information on how ground truth was established for the training set. It focuses on the validation of the device performance.

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The device is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging including tomography. This device also supports dual energy chest imaging. The tomography and dual energy features are not to be used for imaging pediatric patients.

The modified Carestream DRX-Evolution/Plus is a stationary x-ray system with expanded capability to be used for Dual Energy adult chest radiographs. The only hardware change to the system to incorporate the Dual Energy functionality is a change to the existing collimator filter wheel. The previously cleared x-ray system contains a collimator filter wheel with multiple filters. For the Dual Energy Feature, a 0.5mm silver (Ag) filter was added to the 1mm aluminum (Al) filter location. This modified collimator filter wheel can be used for both general radiography and Dual Energy examinations.

The Dual Energy Feature is an imaging technique that takes advantage of the differential, energy-dependent absorption properties of bone and soft tissue structures in human anatomy. The operation consist of capturing two radiographic images of a patient in rapid succession, one at a relatively lower energy X-ray exposure compared to the second at a relatively higher energy exposure. These images are then subject to a weighted subtraction that can remove structures and produce three processed images, a Standard-of-Care image, a bone image, and a soft tissue image.

The Dual Energy Feature software includes a motion compensation option to suppress artifact due to involuntary patient motion that can occur between image acquisitions.

The DRX-Evolution/Plus system was cleared for use with tomography in a previous submission.

The Carestream Health, Inc. DRX-Evolution/Plus with Dual Energy device was evaluated through non-clinical (bench) testing and a clinical reader study to demonstrate its performance and safety.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: 120 Dual Energy studies.
• Data Provenance: Not explicitly stated, but the "clinical reader study" implies human patient data. It is not specified if the data was retrospective or prospective, nor the country of origin.

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

• Number of Experts: Three (3).
• Qualifications of Experts: Board-certified radiologists. No specific years of experience are mentioned.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly detailed as a formal adjudication process. The radiologists evaluated images using a graduated 4-point RadLex rating scale. It's implied that individual ratings contributed to the overall finding that the imaging performance was diagnostic or better, but a method like 2+1 or 3+1 for resolving disagreements is not described.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human readers with and without AI assistance was not explicitly described or performed. The clinical reader study focused on evaluating the diagnostic image quality of the Dual Energy software itself, with and without its own patient motion artifact reduction feature, rather than comparing human reader performance with and without AI assistance for diagnosis.

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

• Standalone Performance: The study primarily evaluated the imaging performance of the Dual Energy software, including its ability to produce diagnostic quality images and its motion artifact reduction feature. While the software processes images without human intervention, the ultimate "diagnostic image quality" was assessed by human radiologists. Therefore, a purely standalone diagnostic performance without any human interpretation is not the focus of the reported study.

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

• Type of Ground Truth: The ground truth for the clinical reader study was based on the expert opinion/ratings of three board-certified radiologists. They rated the "diagnostic image quality" on a 4-point RadLex scale. There is no mention of pathology, clinical outcomes, or other objective ground truth used to determine the accuracy of diagnoses made from these images.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not provided. The document describes tests and a clinical reader study used for evaluation and validation, but it does not specify the size or nature of any dataset used to train the Dual Energy software's algorithms (e.g., for image processing or motion compensation).

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

• Training Set Ground Truth Establishment: Not provided, as the training set details are not mentioned in the submission.

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The device is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients.

permanently installed diagnostic x-ray system for general radiographic x-ray imaging including tomography

The provided document is a 510(k) clearance letter for the Carestream DRX-Evolution, a stationary x-ray system. It does not contain any information regarding acceptance criteria, device performance, or any studies conducted on the device.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval and general information required for marketing the device.

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The device is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients.

The DRX-Evolution is a diagnostic x-ray system utilizing digital radiography (DR) technology. The DRX-Evolution is designed for horizontal and upright projection exams. The system consists of a high voltage x-ray generator, overhead tube crane with x-ray tube assembly, radiographic table with detector tray, Bucky image receptor on an upright wall stand, and x-ray controls containing a power distribution unit and operator PC (user interface).

This document describes the Carestream DRX-Evolution, a diagnostic x-ray system. The modifications to the device include firmware and mechanical changes to facilitate linear tomography exams, the addition of a new generator option, and software updates such as Bone Suppression and Pneumothorax Visualization.

Here's an analysis of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Linear Tomography Accuracy (Bench Testing):
  • Sample Size: Not explicitly stated, but it involved "a tool phantom" and "four different anthropomorphic phantoms (chest, hand, knee and pelvis)."
  • Data Provenance: Bench testing, likely conducted internally by Carestream Health, Inc. The country of origin is not specified but the company is based in Rochester, New York, USA. This is retrospective for the purpose of regulatory submission.
• Detector Image Quality (Clinical Studies - DRX 2530C and DRX-1C):
  • Sample Size: Not explicitly stated in this document ("Results of these studies demonstrated..."). These studies refer to K130464 for DRX 2530C and K120062 for DRX-1C, where detailed sample sizes would be found.
  • Data Provenance: Clinical studies, in accordance with FDA guidance. Prospective studies are typical for such evaluations. The country of origin is not specified.
• DR Long Length Imaging Software Diagnostic Capability (Clinical Study):
  • Sample Size: Not explicitly stated in this document ("Results of the DR Long Length Imaging study demonstrated..."). It refers to K130567 for more details.
  • Data Provenance: Clinical study, likely prospective. The country of origin is not specified.
• Bone Suppression Software Effectiveness (Clinical Study):
  • Sample Size: Not explicitly stated in this document ("Results of the Bone Suppression clinical study demonstrated..."). It refers to K133442 for more details.
  • Data Provenance: Clinical study, likely prospective. The country of origin is not specified.

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

• Linear Tomography Diagnostic Quality (Bench Testing):

  • Number of Experts: A single expert ("evaluated by a board-certified radiologist").
  • Qualifications: "board-certified radiologist."

• For other clinical studies (Detectors, LLI, Bone Suppression): The number and qualifications of experts are not detailed in this summary; they would be in the referenced 510(k) documents (K130464, K120062, K130567, K133442).

4. Adjudication Method for the Test Set

• Linear Tomography Diagnostic Quality: No formal adjudication method is described beyond a single board-certified radiologist's evaluation.
• For other clinical studies (Detectors, LLI, Bone Suppression): Adjudication methods are not detailed in this summary; they would be in the referenced 510(k) documents.

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

• No explicit MRMC comparative effectiveness study involving AI assistance for human readers is described in this document. The clinical studies mentioned for Bone Suppression and DR Long Length Imaging software compare the investigational software/images to a predicate or standard-of-care, but they don't explicitly state an "AI vs without AI assistance" MRMC study for improved human reader performance with an effect size.
  • The Bone Suppression study mentions a "companion image that, when presented to the physician along with the standard-of-care image, is rated substantially equivalent or improved." This implies a reader study where human performance (or perception of image utility) is assessed with and without the software-generated companion image, but it does not specify an MRMC design or quantify an "effect size" in terms of improved diagnostic accuracy for human readers.

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

• Yes, standalone performance was evaluated for certain aspects:
  • Linear Tomography Accuracy: The initial bench testing using a "tool phantom" evaluated the mechanical accuracy of the device's linear tomography function in a standalone manner (without human diagnostic interpretation), confirming "accuracy of the tube head movement."
  • Image Quality Metrics: The statement that DRX-1C and DRX 2530C detectors "provide equal or superior image quality with respect to noise and spatial resolution at equivalent doses" suggests that standalone technical image quality metrics were assessed, and these would be algorithm-only or device-only measurements.

7. The Type of Ground Truth Used

• Linear Tomography Accuracy: The ground truth for mechanical accuracy was based on the "expected" results from a "tool phantom," implying known physical measurements or standards.
• Linear Tomography Diagnostic Quality: The ground truth was based on expert consensus/opinion by a "board-certified radiologist" regarding "acceptable diagnostic quality" of anthropomorphic phantom images.
• Detector Image Quality, DR Long Length Imaging Software, Bone Suppression Software: For these, the ground truth was generally based on comparison to a predicate device or standard-of-care, with evaluation typically performed by qualified experts (e.g., physicians for diagnostic capability). While not explicitly stated as "ground truth," the predicate/standard-of-care serves as the reference for equivalence or improvement claims.

8. The Sample Size for the Training Set

• The document does not explicitly state the sample size for any training sets.
• The software features (Bone Suppression, Pneumothorax Visualization) likely involved machine learning/AI models that would require training data. However, this information is not provided in the 510(k) summary. References to K133442 (Bone Suppression) might contain this information.

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

• The document does not provide details on how ground truth for any training sets was established. Since training set details are absent, the method for establishing their ground truth is also not mentioned.

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The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.

The DRX-Evolution is a diagnostic x-ray system utilizing digital radiography (DR) technology. The DRX-Evolution is designed for horizontal and upright projections. It consists of a high frequency x-ray generator, overhead tube crane (with x-ray tube assembly), elevating 4-way float radiographic table with detector tray, tilting Bucky receptor on an upright Wall Stand, and x-ray controls containing a power distribution unit and operator PC.

Due to the nature of the submitted document, which is a 510(k) summary for a diagnostic X-ray system, the information typically found in a study demonstrating how a device meets acceptance criteria for an AI/CADe (Computer-Aided Detection/Diagnosis) system is not present.

This document describes a conventional diagnostic X-ray system (DRX-Evolution) and its substantial equivalence to predicate devices, focusing on hardware components and intended use. It is not an AI/CADe device, and therefore, the concepts of "acceptance criteria" and a "study to prove the device meets acceptance criteria" as defined in the prompt for AI/CADe are not applicable here.

The "Discussion of Testing" mentions "Predefined acceptance criteria was met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device." However, these acceptance criteria relate to the performance of an X-ray system (e.g., image quality, radiation output, mechanical safety, software functionality), not the diagnostic performance of an AI algorithm based on sensitivity, specificity, or other metrics typically used for AI/CADe.

Therefore, I cannot provide the requested information regarding AI/CADe specific acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as this device does not appear to incorporate such AI technology requiring these types of evaluations.

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