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The Radiance Ultra 32" 4K ZeroWire Duo is a paired wireless video communication transmitter and receiver, intended for delivery of video signals from a source such as an endoscopy camera/processor, or other video source over a radiofrequency link to a ZeroWire Receiver for display of images during endoscopic and general surgical procedures. The Radiance Ultra 32" 4K ZeroWire Duo is a non-sterile reusable device not intended for use in the sterile field.

Radiance Ultra 32" 4K ZeroWire Duo is a medical LCD display designed to both wirelessly receive or transmit video signal with up to 4K resolution over a radio frequency link to a partner display.

This document describes acceptance criteria and performance data for the Radiance Ultra 32" 4K ZeroWire Duo, a wireless video communication transmitter and receiver intended for displaying images during endoscopic and general surgical procedures.

Important Note: The provided text is a 510(k) summary from the FDA, which focuses on demonstrating substantial equivalence to predicate devices. As such, it often refers to "design verification" and "design validation" studies without providing detailed methodologies or specific performance metrics from those studies. Therefore, some requested information may not be explicitly available in the given text, and conclusions will be drawn based on the information provided.

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

The document does not explicitly list "acceptance criteria" in a quantitative format with corresponding "reported device performance" in the way one might see for an AI algorithm's diagnostic accuracy. Instead, it compares the technical specifications and standards compliance of the proposed device against its predicate devices. The "performance" in this context refers to meeting these specifications and standards.

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

The document does not describe a "test set" in the context of clinical data or images. This device is a display/wireless transmission system, not a diagnostic AI device that processes patient data. The "design validation" mentioned in section N and O would refer to testing the hardware and software functionality against engineering specifications and relevant medical device standards, rather than a clinical study with patients or patient data. Therefore, information on data provenance or sample size for a test set of clinical cases is not applicable/provided.

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 applicable, as a test set for clinical ground truth is not detailed for this type of device. The "ground truth" for this device would relate to engineering specifications and performance standards (e.g., video resolution accuracy, signal latency, wireless range), which are evaluated through technical testing by qualified engineers.

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

Not applicable for the reasons stated above.

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 applicable. This device is a medical display and wireless video transmission system, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers assisting with AI is not relevant to its evaluation.

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

Not applicable, as this is hardware, not an algorithm. The "standalone" performance would be about its technical capabilities (e.g., video transmission quality, latency, resolution) which are assessed through engineering tests. The document states in section N and O: "The display has successfully passed design validation to further demonstrate its safety and effectiveness" and "Based upon results from the design verification, Radiance Ultra 32" 4K ZeroWire Duo display demonstrates performance, safety, and effectiveness that are equivalent to the predicate devices." This implies various engineering and performance tests were conducted to verify its operation according to specifications and standards.

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

The "ground truth" for this device would be established by industrial standards (e.g., IEC 60601 series, FCC Part 15), engineering specifications, and validated test methodologies. For example, video resolution is objectively measured against a known signal, latency is measured using precise timing equipment, and electromagnetic compatibility is tested according to regulatory standards to ensure it doesn't interfere with other devices and operates safely in its intended environment.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI algorithms.

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

Not applicable for the same reason mentioned above.

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The ZeroWire Mobile, Radiance Ultra series ZeroWire G2 are a paired video communication transmitter and receiver, intended for delivery of medical video signals from a source such as an endoscopy cameralprocessor, or other video source over a radio-frequency link to a video for review and analysis of medical images during endoscopic and general surgical procedures.

The ZeroWire Mobile, Radiance Ultra series, and ZeroWire G2 wireless video systems are non-sterile reusable devices not intended for use in the sterile field.

ZeroWire Mobile is a medical grade, battery powered pole stand that eliminates the need for a power cord. It will be used as an accessory, secondary monitor display in Endo/GI procedure rooms, surgical operating rooms, or other clinical settings. ZeroWire Mobile is a cordless stand with a wireless monitor solution that provides the procedure or operating room with a mobile second display monitor eliminating the risk of biohazard contamination of cords and cables, and cable/cord trip hazards. The ZeroWire Mobile is the second accessory to ZeroWire Duo Wireless HD Video Transfer System G2/ ZeroWire G2 Duo (K151609). The first accessory to be approved was the Radiance Ultra ZeroWire Embedded (Special K161228).

The ZeroWire Mobile consists of a 5-wheel mechanical stand to hold a display monitor, up to 32" in size and / or

The provided text describes a 510(k) premarket notification for the "ZeroWire Mobile" device, which is an accessory product. Therefore, the device itself doesn't have "acceptance criteria" in the traditional sense of a diagnostic or treatment device having performance metrics like sensitivity or specificity. Instead, the "acceptance criteria" for a 510(k) submission are typically related to demonstrating substantial equivalence to a predicate device, primarily through compliance with recognized performance standards and safety testing.

Here's an analysis of the provided information based on your request, understanding that the context is about an accessory device's compliance rather than a standalone diagnostic algorithm's performance:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device (ZeroWire Mobile), the "acceptance criteria" are compliance with various electrical, medical device, and electromagnetic compatibility (EMC) standards. The "reported device performance" is the successful passing of tests against these standards.

The overall study demonstrating safety and effectiveness is referred to as "design verification testing." It concluded that the ZeroWire Mobile accessory stand "demonstrates safety and effectiveness that is equivalent to the predicate devices."

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

This information is not provided in the document. The testing described is compliance testing against various standards for electrical and safety performance of the hardware components (ZeroWire Mobile stand, power module, charger, and embedded displays with the mobile unit). This type of testing typically involves physical samples of the device and its components, but not a "test set" of clinical data or images like an AI algorithm would use.

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

This information is not applicable and therefore not provided in the document. The device is hardware (a mobile stand and power system for a monitor) and does not involve interpretation of medical images or diagnostic decisions that would require human expert ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document. Adjudication methods are relevant for studies where there are multiple interpretations or classifications of data, such as in clinical trials or AI performance evaluations. The testing here is against technical standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

This information is not applicable and therefore not provided in the document. An MRMC study is relevant for evaluating the impact of a system (often AI) on human performance in diagnostic tasks. The ZeroWire Mobile is a hardware accessory; it does not involve human readers making diagnostic assessments.

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

This information is not applicable and therefore not provided in the document. This concept applies to AI algorithms. The ZeroWire Mobile is a physical device accessory, not an algorithm. The core functionality of wireless video transfer (K151609) and the embedded monitors (K161228), which this device is an accessory to, would have undergone their own standalone performance and safety testing.

7. The Type of Ground Truth Used

This information is not applicable in the context of clinical ground truth (like pathology or outcomes data). For this device, the "ground truth" or reference for its performance is defined by the technical specifications of the relevant regulatory standards (e.g., IEC 60601-1 for safety, EN 301 489 for EMC). The device's performance is measured against these established technical benchmarks.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided in the document. "Training set" refers to data used to train an AI algorithm. This device is hardware and does not involve machine learning or AI.

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

This information is not applicable and therefore not provided in the document, as there is no training set mentioned for this hardware device.

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The Radiance Ultra series ZeroWire G2 is a paired wireless video communication transmitter and receiver, intended for delivery of video signals from a source such as an endoscopy cameralprocessor, or other video source over a radio-frequency link to a ZeroWire Receiver for display of images during endoscopic and general surgical procedures. The Radiance Ultra series ZeroWire Embedded and ZeroWire G2 wireless video system is a non-sterile reusable device not intended for use in the sterile field

Radiance Ultra series ZeroWire Embedded monitors are designed with an integrated wireless video receiver module (Rx), enabling the reception of a video signal over a radio frequency link instead of a video cable. These monitors are designed for use in non-sterile healthcare environments. The Radiance Ultra series ZeroWire Embedded is a medical grade wireless video streaming device pair. The external transmitter (Tx) unit is designed to be mounted on a primary display, on an endoscopic cart, or any other elevated location in close vicinity to the video source. The Tx unit obtains its video input signal from either the loop through output of the primary display, or directly from the video source. The Tx unit will accept video in either HDMI/DVI or SDI formats up to 1920 x 1080p 60 Hz resolution. The Tx unit is powered by a NDS 12-24V DC-DC power converter while the Rx module shares the same 24V DC input of the display.

The provided text describes a medical device called "Radiance Ultra series ZeroWire Embedded" and its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or a detailed breakdown of performance metrics, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

The document is a 510(k) premarket notification letter from the FDA, along with the applicant's 510(k) summary. It primarily focuses on establishing substantial equivalence to a predicate device (K151609 model ZeroWire G2) based on technological characteristics and intended use.

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

Information that can be extracted from the provided text:

• Device Name: Radiance Ultra series ZeroWire Embedded (and ZeroWire G2 for the paired transmitter/receiver system).
• Intended Use: Delivery of video signals from a source (e.g., endoscopy camera/processor) over a radio-frequency link to a ZeroWire Receiver for display of images during endoscopic and general surgical procedures. It is a non-sterile reusable device not intended for use in the sterile field.
• Predicate Device: K151609 model ZeroWire G2.
• Performance Claim (General): The device "meet and exceed IEC 60601-1, ANSI/AAMI ES60601-1, IEC 60601-1-2 and FCC part 15." It also states, "The displays have successfully passed design validation to further demonstrate their safety and effectiveness."
• Conclusion: The device demonstrates performance, safety, and effectiveness that are equivalent to the predicate device.

Information that is missing from the provided text regarding acceptance criteria and studies:

• A table of acceptance criteria and the reported device performance: While general standards (IEC, FCC) are mentioned, specific measurable acceptance criteria (e.g., latency, signal integrity, resolution maintenance under specific conditions) and the corresponding device performance against these criteria are not provided.
• Sample size used for the test set and the data provenance: No information on any specific test set, its size, or the origin of data is present.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no mention of a test set requiring expert ground truth.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, the effect size: Not applicable, as this device is a video transmission system, not an AI diagnostic tool that would typically involve human readers.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, for the same reason as above.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable, as this is hardware for video transmission, not an AI algorithm requiring a training set.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a video display and transmission system. It focuses on compliance with general safety and electromagnetic compatibility standards and functional equivalence to a predicate device, rather than detailed performance metrics from a specific clinical or technical study against predefined acceptance criteria for a diagnostic or AI-driven device.

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The NDS ZeroWire G2 is a paired wireless video communication transmitter and receiver, intended for delivery of video signals from a source such as an endoscopy camera/processor, or other video source over a radio-frequency link to a ZeroWire Receiver for display of images during endoscopic and general surgical procedures. The ZeroWire G2 wireless video system is a non-sterile reusable device not intended for use in the sterile field.

Model Wu-vwx-yz, where u = R or T; v=P or M; w=1 to 4; x= 1 to 6; y= 0 to 2; z=1 to 3, the ZeroWire G2 wireless device is designed as a wireless transmitter and receiver pair which allows delivery of a video signal over a radio frequency link to video destination such as Radiance and EndoVue devices.

The provided text describes the ZeroWire Duo Wireless HD Video Transfer System G2 (or ZeroWire G2), a device intended for wireless transmission of video signals during endoscopic and general surgical procedures.

Here's an analysis of the acceptance criteria and the study information, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of quantitative acceptance criteria with corresponding performance results in numerical form (e.g., latency threshold vs. measured latency). Instead, it states that the device "meets and exceeds" certain standards and has undergone "design validation and clinical study to further demonstrate its safety and effectiveness."

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

The document mentions "test results in clinical environment" but does not specify a sample size for this test set.

The data provenance is presented as "clinical environment," implying prospective testing. However, details about the country of origin are not provided.

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

This information is not provided in the document. The nature of the device (wireless video transfer) suggests that "ground truth" might relate more to technical performance (e.g., signal quality, latency) rather than image-based diagnostic accuracy requiring expert interpretation.

4. Adjudication Method for the Test Set

This information is not provided in the document. As noted above, the assessment likely focuses on technical performance metrics rather than interpretative agreement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No MRMC comparative effectiveness study is mentioned. The device is a technology for video transfer, not an AI diagnostic tool requiring human-in-the-loop performance evaluation in the typical sense.

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

The document mentions "design validation and clinical study" and "test results in clinical environment." This implies standalone testing of the device's technical performance characteristics. The device itself (a wireless video transfer system) inherently operates "standalone" in its primary function of transmitting video. The "clinical study" likely evaluated its performance in a clinical setting independent of human interpretation improvements.

7. The Type of Ground Truth Used

The "ground truth" for this device likely refers to objective technical specifications and performance metrics related to video transmission, such as:

• Video quality: Resolution, color accuracy, absence of artifacts.
• Latency: Delay in video transmission.
• Signal integrity and robustness: Ability to maintain a stable connection and quality in varying environments, including the presence of interference.
• Compliance with electrical and electromagnetic compatibility (EMC) standards: As indicated by meeting IEC 60601-1, ANSI/AAMI ES60601-1, IEC 60601-1-2 and FCC part 15.

The document implicitly suggests that these technical characteristics were measured and compared to the predicate device and relevant standards.

8. The Sample Size for the Training Set

The concept of a "training set" is typically associated with machine learning or AI models. Since this device is a wireless video transfer system and not an AI algorithm, a training set in that context is not applicable or mentioned.

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

As the concept of a "training set" for an AI model is not applicable to this device, this question is also not relevant to the information provided.

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Dome Sx line, model Dome S6c is intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners.

Model Dome S6c is not intended for mammography use.

The Dome model S6c is a widescreen 30-inch 6 megapixel color monitor. Its sleek design, high brightness and bezel free separation between two 3MP displays makes Dome model S6c ideal for read of patient images acquired from multiple medical imaging modalities.

The provided text describes NDS Surgical Imaging's Dome® S6c color monitor, a 6-megapixel display intended for displaying and viewing medical images. The submission focuses on demonstrating substantial equivalence to a predicate device, the Dome model C3 color.

However, the document does not contain the following information regarding acceptance criteria and performance studies:

• A table of acceptance criteria and reported device performance (beyond basic specifications and regulatory compliance). The document primarily compares the technical specifications to a predicate device for the purpose of demonstrating substantial equivalence, not against specific performance acceptance criteria for diagnostic tasks.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size of human reader improvement with AI assistance. This device is a display monitor, not an AI-powered diagnostic tool.
• Whether a standalone performance study was done. This device is a display monitor, not an AI-powered diagnostic tool.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

The core of the submission is a comparison of technical specifications and regulatory compliance, and not a clinical performance study using patient data and expert ground truth.

Based on the provided text, here is what can be extracted:

The device is a medical display monitor, and the "acceptance criteria" discussed are primarily related to its technical specifications and compliance with safety and EMI standards, rather than diagnostic performance metrics. The study presented is a technical comparison for substantial equivalence.

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

The document doesn't explicitly state "acceptance criteria" in the context of a performance study with diagnostic outcomes. Instead, it compares the technical specifications and regulatory approvals of the Dome® S6c with a predicate device (K032638 Dome model C3 color). The argument for acceptance is based on demonstrating substantial equivalence in these technical and regulatory aspects.

2. Sample size used for the test set and the data provenance: Not applicable. This is a technical comparison for a display device, not a study of diagnostic performance using a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 applicable. This device is a display monitor, which does not incorporate AI or directly assist human readers in diagnostic interpretation in the manner of an AI algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a display device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this submission is adherence to technical specifications and regulatory standards.

8. The sample size for the training set: Not applicable. This is a display device, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

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The Model S10 is intended for use in displaying and viewing radiography images for review and analysis by trained medical practitioners, and for use in mammography display systems.

The Dome S10 is a widescreen 30-inch 10 megapixel grayscale diagnostic monitor. Its sleek design and high brightness makes the S10 ideal for viewing full field digital mammography and allow it to show two 5MP images for back-to-back chest wall reads.

The provided document is a 510(k) summary for the Dome S10 Color Monitor, a medical display device. It focuses on establishing substantial equivalence to a predicate device rather than presenting a study demonstrating the device's performance against specific acceptance criteria for diagnostic accuracy.

Therefore, the document does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 regarding a study proving the device meets acceptance criteria for diagnostic performance.

The document primarily states:

• Intended Use: The Model S10 is intended for use in displaying and viewing radiography images for review and analysis by trained medical practitioners, and for use in mammography display systems. (Page 1, Section L & Page 4)
• Substantial Equivalence: The Dome S10 is substantially equivalent to the predicate device K093197 Coronis Fusion 10MP (MDCG-10130). Both devices have the same indication for use with the same characteristics. Both devices use the same technology and use displays with the same resolution, same number of colors, same refresh rate, same maximum brightness, and the same pixel rise/fall times. (Page 0, Section J)
• Safety Standards: Based upon test results, the model S10 radiology display meets IEC/EN60601-1 and 60601-1-2 standards which establish its safe design and operation. (Page 1, Section N)

In summary, this submission is for a display monitor, and the "acceptance criteria" discussed are related to technical specifications and regulatory compliance for substantial equivalence to an existing monitor, not diagnostic performance of an AI algorithm.

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The NDSsi ZeroWire Duo Wireless HD Video Transfer System is a paired transmitter and receiver, intended for delivery of video signals over a radio-frequency link to a video display during endoscopic and general surgical procedures. The ZeroWire wireless device is a non-sterile reusable device not intended for use in the sterile field. It is intended for use by qualified physicians having complete knowledge of these surgical procedures.

Model Wu-vwx-yz, where u = R or T; v=P or M; w=1 to 3; x= 1 to 6; y= 0 to 2; z=1 to 3, the ZeroWire wireless device is designed as a wireless transmitter and receiver pair which allows delivery of a video signal over a radio frequency link to video destination such as Radiance and Endo Vue devices. The device can operate on up to 9 channels.

This submission (K131115) is for a firmware modification to the existing ZeroWire Duo Wireless HD Video Transfer System (predicate device K100195), increasing the number of available channels from 3 to 9. The document states that clinical data is not needed for this type of wireless device according to 510(k) submission guidance. However, the submission does include test results in a clinical environment to demonstrate substantial equivalence to the predicate device.

Given this context, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" will be interpreted based on the provided information, which focuses on demonstrating equivalence rather than establishing new performance criteria for a novel device. The "acceptance criteria" here would be the successful demonstration of performance, safety, and effectiveness equivalent to the predicate device, as claimed in the conclusion.

Here's the breakdown of the information 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

• Sample Size: The document does not specify a numerical sample size for the "test results in clinical environment." It simply states that such results were provided.
• Data Provenance: The document does not specify the country of origin. It does state that the test results were collected in a "clinical environment," implying a prospective or retrospective observational study or testing directly within a clinical setting. Given the context of showing equivalence for a firmware update, a prospective testing phase in a clinical environment is more likely.

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

• Number of Experts: This information is not provided in the document.
• Qualifications of Experts: This information is not provided in the document.

4. Adjudication Method for the Test Set

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

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

• No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence to a predicate device for a firmware update to a wireless video transfer system, not on assessing human reader performance.

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

• The device is a "wireless video transfer system." Its performance is inherently about the quality and reliability of video transmission, not an AI algorithm performing a diagnostic task. The "test results in clinical environment" would assess the device's ability to transmit video without degradation or interference, which is a standalone performance assessment of the device's hardware and firmware. Therefore, implicitly, yes, a standalone performance assessment of the wireless video transfer capabilities was done.

7. The Type of Ground Truth Used

• For a wireless video transfer system, the "ground truth" would likely involve objective measures of video quality, signal integrity, latency, and reliability of the wireless link, assessed against a "gold standard" or expected performance during endoscopic and general surgical procedures. While not explicitly defined as "ground truth" in the diagnostic sense, the clinical environment test results would have compared the device's video output/performance against a known good reference or accepted clinical standard. It is not expert consensus, pathology, or outcomes data in the typical sense; rather, it relates to the technical fidelity of video transmission during surgical procedures.

8. The Sample Size for the Training Set

• The document is about a firmware modification for an existing device. It does not mention any machine learning or AI components that would require a "training set" in the traditional sense of AI algorithm development. Therefore, the concept of a training set sample size is not applicable here.

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

• As a training set is not applicable, this information is not provided.

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The Dome® GX4MP Color Monitor is intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners.

The Dome® GX4MP Color Monitor is a 30-inch 4 megapixel Color flat-panel AMLCD-TFT monitor for use with IBM PC or PC compatible computers for widescreen imaging. The combination of high resolution and high contrast ratio allow the viewing of color and grayscale images simultaneously. Bezel-free framing of 4 megapixels of data is presented in a landscape resolution of 2560 x 1600 pixels. Gamma correction is achieved on this true color display from a palette of 1,786 near-gray values. The integrated Dome RightLight Controller monitors and stabilizes backlight luminance. The display unit includes a PCI Express graphics board to support the required duallink connectivity for the display.

The provided text is a 510(k) summary for a medical display monitor, the Dome® GX4MP Color Monitor. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study for acceptance criteria of an AI/algorithm-based device.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment is not available in the provided document, as it pertains to the regulatory submission for a display monitor, not an AI or algorithm.

However, I can extract the following relevant information from the document:

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

The document does not explicitly state "acceptance criteria" in the context of a performance study for an algorithm. Instead, it presents a comparison of technological characteristics between the new device (Dome GX4MP) and a predicate device (Dome E4c) to demonstrate substantial equivalence. The "performance" in this context refers to the specified features of the device:

The acceptance criterion, implicitly, is that the new device's key performance characteristics (display resolution, color depth, DICOM calibration, luminance, contrast, viewing angle, and intended use) are "unchanged" or demonstrably equivalent to the predicate device.

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

This information is not applicable and not provided in the document because it is for a display monitor, not an algorithm that processes data or images.

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)

This information is not applicable and not provided as there is no "test set" or "ground truth" in the context of an algorithmic performance study for this device.

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

This information is not applicable and not provided.

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

This information is not applicable and not provided. MRMC studies are used for evaluating the impact of AI on human reader performance, which is not relevant for a display monitor.

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

This information is not applicable and not provided. The device is a display monitor, not a standalone algorithm.

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

This information is not applicable and not provided.

8. The sample size for the training set

This information is not applicable and not provided. The device is hardware (a display monitor), not a machine learning model requiring a training set.

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

This information is not applicable and not provided.

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The NDSsi ZeroWire Duo Wireless HD Video Transfer System is a paired transmitter and receiver, intended for delivery of video signals over a radio-frequency link to a video display during endoscopic and general surgical procedures. The ZeroWire wireless device is a non-sterile reusable device not intended for use in the sterile field. It is intended for use by qualified physicians having complete knowledge of these surgical procedures.

The ZeroWire® wireless device is a wireless transmitter and receiver pair which allows delivery of a video signal over a radio frequency link to a video display such as Radiance and EndoVue LCD surgical monitors.

The provided text is a 510(k) summary for the NDSsi ZeroWire Duo Wireless HD Video Transfer System. It states that "Clinical data is not needed for this type of wireless device 510(k) submission." Therefore, it does not include a study proving the device meets specific acceptance criteria based on clinical performance metrics such as sensitivity, specificity, accuracy, or reader performance.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Stryker Vision Elect Wireless High Definition Television / K081995) through non-clinical tests and surgical-setting tests. The "acceptance criteria" can be inferred from the claims of equivalence and the characteristics described for the device, rather than explicit numerical performance targets.

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

1. Table of Acceptance Criteria and Reported Device Performance

Since clinical performance metrics (like sensitivity, specificity, or accuracy) are not provided, the "acceptance criteria" here relate to the functional and safety equivalence to the predicate device, and the "reported device performance" is a statement of that equivalence.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "surgical-setting test results" but does not detail the number of cases, participants, or specific parameters of these tests.
• Data Provenance: Not explicitly stated. The document describes "surgical-setting test results" but does not specify the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) summary focused on substantial equivalence through non-clinical and "surgical-setting tests" (likely functional testing in a surgical environment), it's improbable to be large-scale clinical trial data.

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

• This information is not provided as the submission states, "Clinical data is not needed for this type of wireless device 510(k) submission." Therefore, there's no mention of experts establishing ground truth in the context of diagnostic accuracy or similar clinical outcomes. The "ground truth" for the non-clinical and surgical-setting tests would likely be objective measurements of video signal quality, latency, interference resistance, and adherence to technical standards.

4. Adjudication Method for the Test Set

• This information is not provided for the same reasons as point 3.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states, "Clinical data is not needed for this type of wireless device 510(k) submission." The comparison is primarily technical and functional equivalence to a predicate device.

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

• The device is a hardware system (transmitter and receiver for video transfer), not an algorithm that produces interpretations or diagnoses. Therefore, the concept of "standalone performance" in the context of an algorithm's diagnostic accuracy is not applicable to this device. The "standalone" performance here would refer to its ability to transmit video signals effectively, which is covered by the non-clinical and surgical-setting tests.

7. The Type of Ground Truth Used

• As clinical data for diagnostic purposes was not required, the "ground truth" used would be based on technical specifications, objective measurements, and compliance with established standards (e.g., video resolution, latency measurements, signal strength, interference levels, adherence to EN 60601-1, EN 60601-1-2, and FCC Part 15).

8. The Sample Size for the Training Set

• This device is a hardware system; it does not involve a "training set" in the context of machine learning or AI algorithms. The system's design and engineering are based on established electronics and wireless communication principles.

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

• As there is no training set for an AI/ML algorithm, this question is not applicable.

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The PrimeVue 21 inch 3MP Radiological Medical Display is intended to be used to display and view digital images for review and analysis by trained medical practitioners. However, This device must not be used in primary image diagnosis in mammography.

The PrimeVue 21 inch 3MP Color Display is a diagnostic display. The PrimeVue 21 inch 3MP Display is a high-resolution Liquid Crystal Display (LCD) with electronic capabilities used for the review and analysis of high-resolution medical images by trained medical practitioners.

This document indicates that the PrimeVue 21" 3MP Color Display is a diagnostic display intended for review and analysis of digital images by trained medical practitioners. It explicitly states that it must not be used in primary image diagnosis in mammography. The document is a 510(k) summary for the device.

However, the provided text does not contain information about acceptance criteria, device performance, or any studies proving the device meets acceptance criteria. It is a regulatory submission for premarket notification, establishing substantial equivalence to predicate devices. It discusses:

• Manufacturer and device details: NDS Surgical Imaging, LLC, PrimeVue 21" 3MP Color Display.
• Intended Use: Display and view digital images for review and analysis by trained medical practitioners (excluding primary image diagnosis in mammography).
• Technological Characteristics: High-resolution Liquid Crystal Display (LCD) with electronic capabilities for review and analysis of high-resolution medical images.
• Substantial Equivalence: Listing predicate devices (Coronis, Mdnc 3120 (Barco) K061927; RadiForce R31-C (Eizo Nanao) K052344).
• Regulatory Classification: 21 CFR 892.2050/Procode 90LLZ (System, image processing, radiological).

Therefore, I cannot provide the requested information about acceptance criteria, device performance, or studies from the provided text. The document focuses on regulatory approval based on substantial equivalence, not on performance studies against specific acceptance criteria.

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