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Intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion DR + Wireless allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.

The ViZion DR + Wireless system represents the straightforward integration of a modified digital x-ray receptor panel and our previously cleared software. This is a MODIFICATION of our clearance K152279 wherein we have changed the panel scintillator to Cesium Iodide in addition to having the GOS scintillator available. Changing the scintillator is the only modification.

ViZion DR + Wireless is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD). ViZion DR + Wireless is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the Viztek PACS and the new receptor panel were not changed.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vizion DR + Wireless device, presented in the requested format:

1. A table of acceptance criteria and the reported device performance

The document describes a modification to an existing device (K152279) where the scintillator material was changed from Gadolinium Oxysulfide (GOS) to Cesium Iodide (CSI). The primary acceptance criteria for equivalence appear to be related to imaging performance metrics (MTF and DQE) and clinical image quality.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not explicitly stated for either the quantitative (MTF/DQE) or clinical image evaluation. For the clinical images, it states "Clinical images were acquired," implying a set of images, but no number is given.
• Data Provenance: Not explicitly stated. The document is from the US FDA, and the company address is in North Carolina, USA, suggesting the study was likely conducted in the USA, but this is not confirmed. It is implied to be prospective or specifically acquired for this evaluation, as it mentions "Clinical images were acquired and evaluated..."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: One
• Qualifications of Experts: "a board certified radiologist" (no mention of years of experience).

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

• Adjudication Method: None. A single board-certified radiologist performed the evaluation.

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. The study described is a comparison of two imaging technologies (different scintillators), not an AI-assisted reading study. The device is a digital X-ray receptor, not an AI diagnostic tool.

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

• Standalone Performance: Not applicable. This device is an imaging acquisition system, not an AI algorithm. The performance evaluation focuses on the image quality produced by the system itself before interpretation. The quantitative metrics (MTF, DQE) are "standalone" in the sense that they measure the physical performance of the sensor, but this is not an AI algorithm.

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

• Type of Ground Truth:
  • For MTF and DQE: These are objective physical measurements of image quality, not dependent on a "ground truth" derived from patient data in the same way clinical diagnostics are. They are measured against known physical standards.
  • For Clinical Image Quality: The "ground truth" for clinical image quality comparison was the subjective opinion of a board-certified radiologist, who evaluated whether images from the modified panel were "as good as or better than" images from the predicate panel. This is a form of expert opinion/subjective evaluation rather than an objective clinical endpoint like pathology.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. The Vizion DR + Wireless is a hardware device (digital X-ray detector) and associated software, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "software" was previously cleared and confirmation testing was performed after the hardware modification.

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

• Ground Truth for Training Set: Not applicable, as there is no "training set" for this type of device.

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Intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion DR + Wireless allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.

The ViZion DR + Wireless system represents the straightforward integration of a modified digital x-ray receptor panel and our previously cleared software. This is a MODIFICATION of our clearance K123644 wherein we have changed panel to a wireless version of the previously cleared panel/software combination. Going wireless (with batterv operation possible) are the ONLY modifications.

ViZion DR + Wireless is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD). ViZion DR + Wireless is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the Viztek PACS and the new receptor panel were not changed. Our predicate is ViZion DR +, K123644. We do not supply the router, but any router meeting the IEEE 802.11 a/b/g/n specifications will work. With the advent of AED (automatic exposure detection) by the panel, integration with or connection to specific generators is no longer required. If the user decides NOT to use AED, wired synchronization with Sedecal Series SHF generators is known to work.

Here's a breakdown of the acceptance criteria and study information for the Viztek ViZion DR + Wireless device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provided does not explicitly state formal "acceptance criteria" in a quantitative, measurable sense for the device, beyond equivalence to a predicate device. Instead, it focuses on demonstrating substantial equivalence through a comparison of technical specifications and performance characteristics, some of which could be considered de-facto acceptance criteria derived from the predicate's performance.

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

• Sample Size for Test Set: The document simply states "Clinical images were acquired" and "bench, and test laboratory results." It does not specify the number of clinical images or cases used for evaluation.
• Data Provenance: The document does not explicitly state the country of origin. Given the submission is to the U.S. FDA, it is likely that the clinical image acquisition was performed in the U.S. The study appears to be prospective in the sense that new images were acquired specifically for this evaluation.

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

• Number of Experts: One board-certified radiologist.
• Qualifications: "board certified radiologist." No specific tenure or experience level is mentioned beyond board certification.

4. Adjudication Method for the Test Set

• Adjudication Method: None mentioned. A single radiologist evaluated the images.

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

• No, a MRMC comparative effectiveness study was not done. The evaluation was based on a single radiologist's assessment of clinical images from the new panel compared to the predicate, and bench testing.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable / not a software-only algorithm. The device is a digital X-ray receptor panel (hardware) with associated software. The "performance" being evaluated is of the integrated system and its ability to produce diagnostic images. The comparison focuses on the image quality produced by the device, which is inherently designed for human interpretation.

7. Type of Ground Truth Used

• Expert Consensus / Expert Interpretation: The ground truth for image quality was established by the interpretation of a single board-certified radiologist. There is no mention of pathology, outcomes data, or other objective measures for ground truth.

8. Sample Size for the Training Set

• Not applicable / Not explicitly a machine learning model requiring a training set. The device is primarily a hardware modification (wireless panel) to an existing cleared system. While there's "software," the document states "Since no software modifications were required, confirmation testing was performed." This suggests the software itself was not re-trained or developed with a new dataset for this specific submission, but rather integrated with the new wireless panel.

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

• Not applicable. As stated above, a distinct "training set" for a machine learning model isn't indicated as part of this device's submission or the testing described.

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ViZion + DR is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion + allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.

The ViZion + DR system represents the straightforward integration of a new digital x-ray receptor panel and our previously cleared software. This is a MODIFICATION of our clearance K112661 wherein we have changed the supplier of the panel. ViZion + DR is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) ViZion + is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the Viztek PACS and the new receptor panel were not changed. Our main predicate is ViZion DR, K112661, wherein we combined our OPAL-RAD software with a new digital panel. We now also offer two sizes of panels: 14" x 17" and 17" x 17" panels.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Viztek ViZion + DR device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary (K123644) does not outline specific numerical acceptance criteria for image quality metrics. Instead, it relies on a qualitative assessment for substantial equivalence.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "Clinical images were acquired," implying a set of images, but the exact number is not provided.
• Data Provenance: The document does not specify the country of origin of the data. It is implied to be retrospective or a limited prospective acquisition for the purpose of the 510(k) submission, as it involves comparison to existing predicate devices. The study is described as a clinical image evaluation, not a large-scale clinical trial.

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

• Number of Experts: "a board certified radiologist" (singular).
• Qualifications: "board certified radiologist." No further details on years of experience are provided.

4. Adjudication Method for the Test Set

• Adjudication Method: "a board certified radiologist who concluded the images from the new panel are as good as or better than the images acquired with the predicate panel." This indicates a single reader assessment, not a multi-reader adjudication method (like 2+1 or 3+1).

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 done. The evaluation was performed by a single board-certified radiologist.
• Effect Size: Not applicable, as no MRMC study was conducted.

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

• This device is a digital flat panel X-ray detector system, not an AI algorithm. Therefore, a standalone performance study in the context of an AI algorithm is not applicable. The device itself is the imaging system, and its performance is assessed directly (both technically and clinically).

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the clinical image evaluation was expert opinion/consensus, specifically the judgment of a single board-certified radiologist comparing the new panel's images to those from predicate panels. There is no mention of pathology or outcomes data for establishing ground truth in this submission.

8. The Sample Size for the Training Set

• This submission describes a hardware modification (a new digital panel combined with existing software) and its equivalence to predicate devices, not the development or training of a new AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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

• Not applicable, as there is no training set for an AI algorithm.

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ViZion DR is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.

The ViZion DR system represents the straightforward integration of two cleared devices: ViZion DR, K102123 and K102587, the Samsung Digital Flat Panel. ViZion DR is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) (K102587, Samsung Flat-Panel X-Ray Detector), made by Samsung Mobile Display Co., Ltd. (this is the 510(k) for the flat panel detector) and Viztek's proprietary OPAL-RAD PACS image viewing and acquire interface software technology, (K063337) which incorporates state of the art object-oriented software and connectivity. ViZion is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a film less. environment and improves cost effectiveness. The major functions and principle of operation of the Viztek PACS and Samsung FPD were not changed.

This is a 510(k) premarket notification for a new version of the Viztek ViZion DR, a Digital Radiography (DR) system. The submission focuses on replacing the digital flat panel detector (FPD) with a new model while maintaining the existing software and overall functionality. As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed in terms of demonstrating substantial equivalence to a predicate device, rather than proving a specific diagnostic accuracy against a clinical ground truth.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the demonstration of substantial equivalence to the predicate device, specifically regarding safety and effectiveness, and the absence of new indications for use or technological differences that would raise new questions of safety or effectiveness. The reported performance is a comparison to the predicate.

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

The document states: "Clinical images collected demonstrate equal or better image quality as compared to our predicates." However, it does not specify the sample size for this clinical image inspection, nor does it provide details about the data provenance (e.g., country of origin, retrospective or prospective nature). Given the nature of a 510(k) for a component change (the FPD), this might have been a limited comparative study rather than a large-scale clinical trial.

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

The document mentions "clinical image inspection" but does not provide any information on the number of experts involved in this inspection or their qualifications.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method. It only mentions "clinical image inspection."

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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is a digital X-ray detector system, not an AI-assisted diagnostic tool. The comparison is between the new detector and a previous detector system, with the focus on image quality and equivalence, not reader performance improvement with AI.

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

This refers to an algorithm's performance without human intervention. Since the device is a digital X-ray detector system (hardware), not a diagnostic algorithm, this concept does not apply. The "standalone performance" for this device would relate to its hardware specifications and image acquisition capabilities, which are covered by bench and laboratory testing.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The available information suggests that the "ground truth" for the comparison was based on "clinical image inspection" and possibly "bench, and test laboratory" results, comparing the image quality of the new device to that of the predicate device. This implies a subjective assessment of image quality by potentially experts, but the specifics are not detailed. It is unlikely to involve pathology or outcomes data for this type of 510(k) submission.

8. The Sample Size for the Training Set

This submission is for a digital X-ray detector system, not an AI algorithm that requires a training set. Therefore, there is no training set in the context of this device.

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

As there is no training set for this hardware device, this question is not applicable.

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ViZion DR is intended for digital image capture use in general radiographic examinations for adult and pediattic, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis and extremities.

The ViZion DR system represents the straightforward intearation of two cleared devices. ViZion DR is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) K090742 (Samsung Flat-Panel X-Ray Detector), Samsung Mobile Display Co., Ltd. (this is the 510(k) for the flat panel detector) and Viztek's proprietary OPAL-RAD PACS image viewing and acquire interface software technology, (K063337) which incorporates state of the art object-oriented software and connectivity. ViZion is designed to perform digital radiographic examinations in replacement for conventional film. This integrated platform provides the benefits of PACS with the with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the Viztek PACS and Samsung FPD were not changed.

The provided text is a 510(k) summary for the Viztek ViZion DR, a digital flat panel X-Ray detector system. It describes the device, its intended use, and states that bench and test laboratory results indicate the new device is as safe and effective as predicate devices, with clinical images demonstrating equal or better image quality.

However, the document does not contain specific acceptance criteria, detailed study results, sample sizes for test or training sets, ground truth establishment methods, information about expert involvement, adjudication methods, or MRMC study details. The 510(k) summary is a high-level comparison to predicate devices, focusing on substantial equivalence rather than a detailed performance study with quantifiable acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or stated based on the text provided:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): Not specified. The document only states "Clinical images collected."
• Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or from which country.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not specified. The document does not mention the involvement of experts in establishing ground truth or evaluating the clinical images.

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

• Not specified. No adjudication method is mentioned.

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

• Not specified. The document does not mention an MRMC study or any AI assistance. The device is a digital X-ray detector system, not an AI-powered analysis tool.

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

• Not applicable/Not specified. The device is a digital X-ray detector system, not an algorithm, so the concept of "standalone" performance for an algorithm isn't directly relevant in the context of this document. The document focuses on the image quality produced by the detector.

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

• Not specified. The document only states "Clinical images collected demonstrate equal or better image quality." It does not elaborate on how "image quality" was objectively assessed or against what ground truth.

8. The sample size for the training set

• Not applicable/Not specified. This device is an imaging hardware system. It does not appear to involve machine learning models that would require a "training set" in the conventional sense. The "training" here would refer to engineering and calibration, not data-driven model training.

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

• Not applicable/Not specified. (See point 8).

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