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Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating Tomographic images. Revolution XR/d Digital Radiographic Imaging System is not intended for mammographic applications.

The Revolution XR/d with Tomosynthesis is a radiographic x-ray system intended for examinations using digital Tomosynthesis acquisition techniques. Tomosynthesis is a hardware & software option to the Revolution XR/d Digital Radiography System. The Revolution XR/d with Tomosynthesis consists of a elevating radiographic table with integrated digital detector, a radiographic wall stand with integrated digital detector, and an x-ray tube hanger, Overhead Tube Crane or Floor Mounted Tube Stand.

The provided documents, K051967, contain limited information about the acceptance criteria and study details. Based on the "Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c)," here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Implied Criteria: The document explicitly states the goal of the clinical tests was to show the tomosynthesis diagnostic capability is "as good as" the predicate device and that key features are "consistent." While no specific quantitative metrics or thresholds are provided as acceptance criteria, these qualitative statements serve as the basis for the reported performance.

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

• Sample Size: The document does not specify the sample size used for the clinical tests.
• Data Provenance: The document does not provide information on the country of origin of the data or whether the study was retrospective or prospective. It only states, "Clinical Tests: Clinical tests under the authority of an IRB..."

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

• The document does not provide any information regarding the number of experts used or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set

• The document does not mention any adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• The document does not indicate that a multi-reader, multi-case (MRMC) comparative effectiveness study was performed or provide any effect size information. The clinical tests simply aimed to compare the diagnostic capability to a predicate device.

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

• This device is a "Digital Radiographic Imaging System with Tomosynthesis," implying it's an imaging hardware and software system, not solely an algorithm. The clinical tests assessed its "diagnostic capability," which inherently involves the output of the system that would then be interpreted by a human. Therefore, a standalone algorithm-only performance assessment in the modern sense (e.g., AI output without human interpretation) is not explicitly described or implied in this context, given the 2005 date of the submission. The "Tomosynthesis" part is described as an "acquisition technique" and a "software option."

7. The Type of Ground Truth Used

• The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). The comparison is made against the "Tomo-link linear tomographic device," suggesting the predicate device's diagnostic performance served as the benchmark.

8. The Sample Size for the Training Set

• The document refers to a "Revolution XR/d with Tomosynthesis" which is described as a "hardware & software option." Given the 2005 date, it is highly unlikely that "training set" in the context of modern machine learning was applicable in the same way. The document does not mention any training set or data used for algorithm development or machine learning.

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

• As no "training set" for an AI algorithm is mentioned or implied, there is no information on how its ground truth would have been established.

Summary of the Study:

The provided 510(k) summary for the Revolution XR/d Digital Radiographic Imaging System with Tomosynthesis (K051967) indicates that clinical tests were conducted under the authority of an Institutional Review Board (IRB). The primary finding of these tests was that the "Tomosynthesis diagnostic capability is as good as the Tomo-link linear tomographic device" (K944967), which was the predicate device. Additionally, it was concluded that the device's "key features are consistent with traditional clinical procedures."

It's important to note that this submission dates back to 2005. The level of detail regarding clinical study design, acceptance criteria, and AI-specific performance metrics has evolved significantly in regulatory submissions since then. The information provided in this document is much less detailed than what would typically be required for a modern AI/ML-enabled device submission.

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Revolution XR/d Digital Radiographic Imaging System with Image Pasting and Autopositioning is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.

The Revolution XR/d with Image Pasting and Autopositioning is the latest version of the Revolution XR/d digital radiographic x-ray system. It includes features and functions that have been developed since the introduction of the original XRd in 2001. Auto image pasting enables the operator to electronically join several sequentially acquired radiographs into a single image (such as spine images). Autopositioning offers improved end user workflow by minimizing the number of steps needed to set up and initiate imaging.

The provided documentation for the Revolution XR/d Digital Radiographic Imaging System with Image Pasting and Autopositioning (K050704) does not contain information about acceptance criteria or a study proving that the device meets such criteria.

Instead, the document primarily focuses on establishing substantial equivalence to a predicate device based on its intended use and fundamental scientific technology.

Here's why the requested information cannot be extracted from the provided text:

• No mention of specific performance metrics: The document does not define any quantitative or qualitative metrics that would serve as acceptance criteria (e.g., image quality scores, diagnostic accuracy, efficiency improvements, specific error rates).
• No detailed study report: The "Summary of Studies" section only states that the device was evaluated for electrical and radiation safety and conforms to applicable medical device safety standards. It does not describe any performance-based study methodology, results, or statistical analysis.
• "Clinical Tests: None required.": This explicit statement indicates that no clinical performance study was conducted or deemed necessary for this 510(k) submission.

Therefore, I cannot populate the requested table or provide details on the study design elements (sample size, data provenance, expert qualifications, adjudication, MRMC, standalone performance, ground truth types and establishment methods) as this information is absent from the provided text.

The key takeaway from the document regarding acceptance criteria and performance is that the device was considered substantially equivalent to a predicate device (Revolution XR/d with image pasting application, K042602) because its new features (Image Pasting and Autopositioning) primarily offered improved workflow and ease-of-use without altering the intended use or fundamental scientific technology of the device.

If acceptance criteria and a corresponding study were conducted, they would typically be detailed in a separate, more comprehensive study report submitted as part of the 510(k) application, or summarized with specific performance metrics within the "Summary of Safety and Effectiveness" document. This particular document serves as a high-level summary that doesn't delve into that level of detail.

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Image Pasting Application for Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.

Image pasting allows the operator to generate 2 to 5 sequential radiographic images and electronically join them to create a single electronic mage.

This submission for the GE Medical Systems' Image Pasting application for the Revolution XR/d Digital Radiographic Imaging System (K042602) does not provide explicit acceptance criteria or a detailed study proving the device meets specific performance metrics.

The submission focuses primarily on demonstrating substantial equivalence to a predicate device (Revolution XR/d without image pasting) based on the device's technical specifications, intended use, and adherence to quality standards, rather than direct performance testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable. No dedicated "test set" or clinical study data is described for evaluating the image pasting functionality.
• Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No ground truth establishment activity for a test set is described. The submission relies on the established clinical practice for radiography and the predicate device's performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. No test set or adjudication process is 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:

• No MRMC study was done. This device is an image processing application, not an AI-assisted diagnostic tool, and the submission explicitly states "Clinical Tests: None required."

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

• The performance described is inherently "standalone" in terms of the image pasting function's ability to combine images. However, this is a technical function, not a diagnostic algorithm where standalone accuracy would be measured against ground truth. The primary evaluation appears to be technical functionality and safety rather than a diagnostic performance study.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable. No formal ground truth was established for the image pasting functionality, as it's presented as a technical enhancement that mimics existing clinical practice (using oversized film or multiple overlapping exposures). The "ground truth" for the overall system's radiographic image generation would be expert interpretation of the radiographs themselves, but this specific submission focuses on the image manipulation feature.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that would require a "training set" in the conventional sense. The image pasting logic would be based on image processing algorithms.

9. How the ground truth for the training set was established:

• Not applicable, as there is no training set mentioned.

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The Revolution XR/d Digital Radiographic X-ray System is indicated for use in generating radiographic images of human anatomy. It is intended for use in replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.

The Revolution XR/d Digital Radiographic Imaging System is designed to perform radiographic x-ray examinations. The detector is comprised of amorphous silicon with a cesium iodide scintillator. The resulting digital image can be sent through a DICOM network for applications such as printing, viewing, and storage. The Revolution XR/d Digital Radiographic Imaging System consists of an elevating radiographic table with integrated digital detector, x-ray tube, x-ray tube hanger, collimator, system controller, generator, and tilting radiographic wall stand with integrated digital detector. The configuration can consist of digital table and digital wall stand, digital table only, or digital wall stand only.

This document is a 510(k) summary for the GE Medical Systems Revolution XR/d Digital Radiographic Imaging System. It describes the device, its intended use, and its substantial equivalence to a previously cleared device. Due to the nature of this document (a 510(k) summary focused on substantial equivalence), it does not contain the detailed clinical study information typically found in a full clinical trial report or a more extensive submission for novel devices.

Here's the breakdown of the requested information based solely on the provided text, with explicit notes about what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

This document describes the device as being "substantially equivalent" to a previously cleared device (K992066). For devices seeking 510(k) clearance based on substantial equivalence, the primary "acceptance criterion" is often that the new device performs as safely and effectively as the predicate device, or that any differences do not raise new questions of safety or effectiveness. Specific quantitative performance metrics (e.g., sensitivity, specificity, image quality scores) and their associated acceptance thresholds are not provided in this 510(k) summary.

The document states:

• "The Revolution XR/d Digital Radiographic Imaging System is substantially equivalent to the presently marketed Revolution XR/D Digital Radiographic Imaging System (K992066)."
• "The Revolution XR/d Digital Radiographic Imaging System does not include any new indications for use, nor does use of this device result in any new potential hazards."

Therefore, the reported device performance is implicitly considered to be equivalent to the predicate device.

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

This information is not provided in the 510(k) summary. Given that it's a submission for substantial equivalence to an existing device, it's possible that no new clinical data or a specific "test set" of patient images was explicitly used in the public summary. The focus is on demonstrating that the technical modifications (e.g., new SSXI - presumably a detector technology from the FDA letter) do not alter the fundamental safety and effectiveness of the existing device.

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

This information is not provided in the 510(k) summary.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary.

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

An MRMC study is not mentioned in this 510(k) summary. This device is an X-ray imaging system, not an AI-powered diagnostic aid meant to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not discussed.

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

This device is an imaging system, not a standalone algorithm. Therefore, "standalone" algorithm performance is not applicable and not discussed.

7. The Type of Ground Truth Used

This information is not provided in the 510(k) summary. For a general radiographic system, the "ground truth" would typically refer to the clinical utility of the images produced for diagnostic purposes, which is often inferred from successful use of predicate devices, rather than a specific "ground truth" established for this submission.

8. The Sample Size for the Training Set

This information is not provided in the 510(k) summary. The document does not describe a machine learning algorithm or a "training set" in the context of this device's submission.

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

This information is not provided in the 510(k) summary as there is no mention of a training set or ground truth for such in this document.

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