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The Coronis 5MP Mammo SL (MDMG 6121) Display is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.

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This FDA 510(k) clearance letter for the Barco Coronis 5MP Mammo SL states that the device is intended for displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners. However, the provided document does not contain information about the acceptance criteria or a study proving the device meets those criteria.

The letter is a regulatory filing indicating substantial equivalence to a predicate device, which means it met the administrative requirements for marketing. It does not include performance data, study design, or any of the detailed information requested in the prompt regarding acceptance criteria and performance studies.

Therefore, I cannot provide the requested table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment based on the provided text.

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Ask a specific question about this device

The Voxar 3D product family is a suite of products that is intended to provide tools for the reading and review of a DICOM compliant series of medical images which can be interpreted as representing a volume of data. These tools are meant for the use of trained medical imaging professionals to aid in their reading and review of such data.

The Voxar 3D product family provides several levels of functionality:

• Basic analysis tools used on a daily basis, such as 2D review, orthogonal Multi Planar Reconstructions . (MPRs), oblique MPRs, curved/cross-curved MPRs, slab MPRs, AvelP, MIP, MinIP, measurements, annotations, reporting, and distribution.
• Tools for in-depth analysis, such as regional segmentation of anatomical structures within the image data. . endoscopic review, color volume rendering of finite thickness data cross-sections, 3D review of data volumes, path definition through vascular and other tubular structures and boundary detection.
• Specialist tools and workflow enhancements for specific clinical applications which provide directed workflows. custom User Interfaces, and special measurement and reporting functions optimized for the specific clinical applications. Specialized clinical applications include:
  • Colon Screening (which is intended for the screening of patients for colonic polyps, tumours and other o lesions using tomographic Colonography),
  • Vessel Analysis (which is intended for the qualitative and quantitative analysis of tomographic o angiographic studies to evaluate occlusive and aneurismal diseases and the effectiveness of stents and stent grafts)
  • Coronary Artery Analysis (which is intended for the qualitative and quantitative analysis of coronary o arteries to evaluate occlusive and aneurismal disease),
  • Functional Cardiac Analysis (which is intended to evaluate the functional characteristics of the heart), O
  • PET-CT Reading (which is intended for analysis of lesions using FDG imaging from hybrid PET-CT o scanners)

This 510(k) submission (K070831) for the Voxar 3D Enterprise with ColonMetrix and PET/CT Perfusion, a Picture Archiving and Communications System (PACS), does not contain the acceptance criteria or a detailed study proving the device meets acceptance criteria.

The document is a letter from the FDA to BarcoView MIS Edinburgh, confirming that their device is substantially equivalent to legally marketed predicate devices. It primarily focuses on regulatory compliance and the device's indications for use.

Therefore, I cannot provide the requested information from the provided text. The document is a regulatory approval letter, not an engineering or clinical study report.

Here's what each requested piece of information would require, and why it's not present in this document:

1. A table of acceptance criteria and the reported device performance: This would typically be found in a verification and validation (V&V) report, a clinical study report, or a comprehensive technical specification. This regulatory letter does not include such details.
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 would be specific to the testing performed to demonstrate device performance. It is not included in this FDA approval letter.
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 is a detail of ground truth establishment for a performance study, which is absent here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Another detail typically found in a study design section, not in a regulatory approval letter.
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: The document mentions "Specialist tools and workflow enhancements for specific clinical applications" including "Colon Screening" and "PET-CT Reading," which might suggest such studies were performed. However, the results, methods, and effect sizes of any MRMC studies are not provided in this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Similar to MRMC studies, the details of any standalone performance assessment are not available in this letter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This is study-specific information and is not included.
8. The sample size for the training set: This relates to the development of the device's algorithms, not its regulatory approval based on substantial equivalence. This information is not in the document.
9. How the ground truth for the training set was established: Again, this is a detail of algorithm development, not present in this regulatory letter.

In summary, the provided document is a notification of FDA clearance based on substantial equivalence to a predicate device. It does not contain the detailed technical or clinical study data that would describe acceptance criteria or prove device performance.

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The MDNC 3120 is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography. The MDNC 3120, which is part of the Nio Color 3MP system, will be marketed separately.

The Nio Color 3MP is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography. The Nio Color 3MP, containing the display MDNC 3120, the software MediCal QAWeb Agent and a graphic board, will be marketed as separate device.

MDNC 3120 is a 20.8" color LCD display for medical viewing. It is combined with MediCal QAWeb Agent, a user-friendly software that allows to optimize the display for DICOM-compliant viewing.

Nio Color 3MP is a display system for medical viewing. It consists of 3 components: MDNC 3120 is a 20.8" color LCD display. MediCal QAWeb Agent is a softcopy QA software application for local calibration and QA control. The system also contains a fast high-resolution display controller board that plugs into a PACS workstation computer. Standard the system is delivered with the MXRT 2100 board, but the user can opt for another type of display controller board (MXRT 5100 or MXRT 7100). The display system can be a single-head system or multi-head system. In the last case it contains multiple displays and display controller boards.

This document describes two similar devices, MDNC 3120 and Nio Color 3MP. Both are medical display systems. The provided text is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of filing does not typically include detailed studies proving performance against acceptance criteria in the way a new, novel device might. Instead, the focus is on a comparison to existing devices.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for this device is largely absent because it's not a requirement for a 510(k) substantial equivalence submission for a display system. The "study" here is essentially the comparison to a predicate device.

Here's a breakdown of what can be extracted or inferred from the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the 510(k) summary in terms of a formal “acceptance criteria” and “reported device performance” table for the new device. The acceptance criteria for a 510(k) for a display device are typically centered around demonstrating substantial equivalence to a predicate device, meaning it performs as safely and effectively.

The "performance" is implicitly deemed equivalent to the predicate device E-2320C (for MDNC 3120) and Color Nio 2MP (for Nio Color 3MP) because the manufacturer states: "The basic specifications and functions, however, are the same." and "Any difference between both devices does not affect safety or efficacy."

Key Specifications mentioned for the new devices:

• Resolution: 2048 x 1536 pixels
• Display type: 20.8" color LCD (MDNC 3120)
• Software: MediCal QAWeb Agent (optimizes for DICOM-compliant viewing, sets display function, test patterns, calibrates, views controller info).
• Display Controller (for Nio Color 3MP system): 3-megapixel flat panel display, 32-bit display controller, up to 64-bit color.

Comparison to Predicate:
The document states that the new devices have "a different LCD panel, other electronic and mechanical parts" and (for Nio Color 3MP) "The software is a new version." However, it asserts that "The basic specifications and functions of all the parts are the same" and "Any difference between both devices does not affect safety or efficacy." This forms the basis of their claim of substantial equivalence.

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

• Sample size: Not applicable. This is not a study involving patient data or images in the traditional sense for assessing diagnostic performance. The "test" for a display device in a 510(k) is usually a technical comparison to a predicate device, focusing on specifications and functionality.
• Data provenance: Not applicable. No clinical or image data is mentioned.

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

• Number of experts: Not applicable. Ground truth, in the context of diagnostic performance, is not established for this type of device submission. The device is a display, not an AI algorithm performing diagnosis.
• Qualifications of experts: Not applicable.

4. Adjudication method for the test set

• Adjudication method: 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

• MRMC study: No. This is a display device, not an AI-powered diagnostic tool. Such a study would not be applicable.

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

• Standalone study: No. This is not an algorithm.

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

• Type of ground truth: Not applicable.

8. The sample size for the training set

• Sample size: Not applicable. This device does not use a "training set" in the machine learning sense.

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

• Ground truth establishment: Not applicable.

In summary:

The provided document is a 510(k) premarket notification for medical display systems. The "study" for this type of device, as presented here, is a demonstration of substantial equivalence to existing predicate devices based on a comparison of technical specifications, intended use, and general functionality. It does not involve clinical performance studies with patient data, diagnostic accuracies, or expert-adjudicated ground truth, as those are typical for diagnostic imaging algorithms or novel clinical devices, not medical display systems. The acceptance criteria are implicitly met by demonstrating that the new devices' characteristics are "substantially equivalent" to the predicate devices and that any differences do not affect safety or efficacy.

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The Nio 5MP-21″ is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners. The Nio 5MP-21", containing the display MDNG-5121 CB, the software NioWatch and the graphic board BarcoMed Nio, will be marketed as separate device.

Nio 5MP-21" is a display system for medical viewing. It consists of 3 components: MDNG-5121 CB is a 21.3" grayscale LCD display. BarcoMed Nio is a fast high-resolution display controller board that plugs into a PACS workstation computer. NioWatch is a softcopy QA software application for local calibration and QA control. The display system can be a single-head system or multi-head system. In the last case it contains multiple displays and display controller boards.

This submission, K062621, describes the Barco Nio 5MP-21" display system, which is intended for displaying digital images, including digital mammography, for review and analysis by trained medical practitioners. The document states that the device is substantially equivalent to existing predicate devices (Coronis 5MP and MFGD 5421). The submission does not provide specific acceptance criteria or a study proving the device meets those criteria in the traditional sense of a clinical performance study for an AI/CADe device.

Instead, this 510(k) summary focuses on demonstrating that the new device has "substantially equivalent" technological characteristics, general function, application, and intended use as its predicate devices, and that any differences do not affect safety or efficacy. This is a common approach for display systems where the primary concern is the accurate and consistent rendering of medical images, rather than algorithmic detection or diagnosis.

Therefore, the requested information about acceptance criteria, reported performance, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI/CADe systems, is not applicable to this 510(k) submission for a medical display system. The "study" here is essentially a technical comparison and declaration of substantial equivalence to a legally marketed predicate device.

However, based on the information provided, here's how some of your questions can be addressed in the context of this submission:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit "acceptance criteria" and "reported device performance" in the context of clinical accuracy (like sensitivity, specificity, AUC) are not provided for this display system. The acceptance criteria for a display system are typically related to its technical specifications matching or being equivalent to the predicate, ensuring it accurately displays images without introducing errors.

• "The Barco MDNG-5121 CB is substantially equivalent to the predicate device, MFGD 5421."
• "The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use." |

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

• Not Applicable. This is a medical display system, not an AI/CADe device that processes patient data for diagnostic output requiring a "test set" of images or patient data. The "testing" involves technical verification against specifications and comparison to predicate devices, not a clinical data set.

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. See point 2. Ground truth establishment with experts is relevant for diagnostic or AI/CADe devices, not for a display system.

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

• Not Applicable. See point 2. No test set requiring expert adjudication 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 Applicable. This is a display system, not an AI-assisted diagnostic tool. No MRMC study was performed or is relevant for this type of device.

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

• Not Applicable. This device does not have an algorithm that performs a standalone diagnostic or assistive function in the absence of a human reader.

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

• Not Applicable. For a display system, the "ground truth" would relate to its technical performance (e.g., luminance, uniformity, resolution accuracy) against industry standards or the manufacturer's specifications, not clinical outcomes or pathology. This document does not detail specific technical performance testing, but rather relies on substantial equivalence.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

• Not Applicable. See point 8.

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The Nio Fusion 4MP is intended to be used in displaying and viewing digital images, for review and analysis by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

The Nio Fusion 4MP, containing the display MDNC 4130, the software MediCal QAWeb and the graphic board MXRT 2100, will be marketed as separate device.

"The MDNC 4130 is intended to be used in displaying and viewing digital images, for review and analysis by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

The MDNC 4130, which is part of the Nio Fusion 4MP system, will be marketed separately.

MDNC 4130 is a 30" color LCD display for medical viewing. It is combined with MediCal QAWeb, a user-friendly software that allows to optimize the display for DICOM-compliant viewing.

Nio Fusion 4MP is a display system for medical viewing. It consists of 3 components: MDNC 4130 is a 30" color LCD display. MXRT 2100 is a fast high-resolution display controller board that plugs into a PACS workstation computer. MediCal QAWeb is a softcopy OA software application for local calibration and QA control.

The provided text describes two medical display devices, the Barco MDNC 4130 and the Barco Nio Fusion 4MP, and their substantial equivalence to predicate devices. However, it does not include detailed acceptance criteria or a study that proves the device meets specific performance criteria.

The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed performance study against explicit acceptance criteria. The common strategy for imaging displays in 510(k) submissions is to demonstrate that the new device has comparable or superior technical characteristics to a previously cleared device, and that these differences do not raise new questions of safety or effectiveness.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample size, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies is not present in the provided document.

Here's an explanation based on the information available:

The submissions describe the intended use for both devices: "intended to be used in displaying and viewing digital images, for review and analysis by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography."

The core of both submissions is a comparison to a predicate device.

For the Barco MDNC 4130 (K062905):

• Predicate Device: E-2320 C (510(k) number: K052958)
• Key Differences: Uses a larger LCD panel and modified electric circuits.
• Conclusion: "The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use. Any difference between both devices does not affect safety or efficacy."

For the Barco Nio Fusion 4MP (K062905):

• Predicate Device: Color Nio 2MP (510(k) number: K052958)
• Key Differences: Uses a larger LCD panel and modified electric circuits for the display component (MDNC 4130), a different display controller board (MXRT 2100), and the accompanying software (MediCal QAWeb) has more advanced functionality.
• Conclusion: "The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use. Any difference between both devices does not affect safety or efficacy."

Regarding your specific questions:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence, not a direct performance study against pre-defined acceptance criteria. The information provided highlights technical characteristics like resolution (2560x1600 pixels) and functionality (Single View, DuoView, MediCal QAWeb for calibration and QA), and implies that these meet or exceed the predicate's performance.
2. Sample sized used for the test set and the data provenance: Not applicable as a formal performance study with a test set as you describe was not included. The evaluation is based on comparison to a predicate device.
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 medical display system, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a medical display system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of device submission.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) summaries demonstrate substantial equivalence by comparing technical specifications and intended use to predicate devices. They do not contain the type of detailed performance study data you've requested for a device that relies on explicit acceptance criteria and clinical validation data.

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The Nio 5MP-M-21″ is intended to be used in displaying digital images, including digital mammography, for review and analasys by trained medical practitioners.
The MDNG-5121 BB is intended to be used in displaying digital images, including digital mammography, for review and analasys by trained medical practitioners.

Nio 5MP-M-21" is a display system for medical viewing. It consists of 3 components: MDNG-5121 BB is a 21.3" grayscale LCD display. BarcoMed Nio is a fast high-resolution display controller board that plugs into a PACS workstation computer. NioWatch is a softcopy QA software application for local calibration and QA control. The display system can be a single-head system or multi-head system. In the last case it contains multiple displays and display controller boards.
The device consists of three components: One 5-megapixel flat panel display (MDNG-5121 BB). One 10-bit display controller (BarcoMed Nio board). NioWatch software. The flat panel display has a resolution of 2560x2048 pixels. It can be used in landscape and portrait mode. The BarcoMed Nio display controller board is an ultra-high speed board with a 8-bit in, 10-bit out lookup table, providing 256 simultaneous shades of gray. The NioWatch software allows to set the display function, display test patterns, calibrate the display and view additional display and display controller information.

The provided 510(k) summary for the Barco Nio 5MP-M-21" (K062131) does not include a study that proves the device meets specific acceptance criteria in the way a clinical performance study would for an AI/algorithm-based device.

This submission is for a medical display system, not an AI or diagnostic algorithm. The acceptance criteria and "study" described below are based on the information provided in the 510(k) where the manufacturer asserts substantial equivalence to a predicate device by comparing technical characteristics.

Here's the information structured to address your request, with clarifications where the information is not applicable or not present in a display system 510(k):

Acceptance Criteria and Device Performance (for a display system)

Study Information (as applicable to a medical display 510(k) for substantial equivalence):

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

   • Test Set Sample Size: Not applicable. This 510(k) is for a medical display system, not an AI/diagnostic algorithm that relies on a test set of patient data for performance evaluation. The "test" involves comparing the technical specifications and intended use of the new device against a legally marketed predicate device.
   • Data Provenance: Not applicable in the context of patient data. The provenance pertains to the technical specifications and operational performance metrics of the device itself and its predicate.

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

   • Not applicable. There is no "ground truth" derived from expert consensus on medical images in the context of this 510(k). The evaluation is based on engineering specifications and regulatory comparison.

3. Adjudication method for the test set:

   • Not applicable. No test set requiring adjudication of diagnostic outcomes was used.

4. 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 is not an AI-assisted diagnostic device. The submission is for a display system.

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

   • Not applicable. This device is a display system, not an algorithm.

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

   • Not applicable. The "ground truth" equivalent in this type of submission is the established technical specifications and regulatory compliance of the predicate device, against which the new device's characteristics are compared for substantial equivalence.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that would require a training set.

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

   • Not applicable. No training set was used.

Summary of the "Study" (Substantial Equivalence Justification):

The "study" presented in this 510(k) is a comparison of technical characteristics between the proposed device (Nio 5MP-M-21") and its predicate device (Coronis 5MP). The manufacturer asserts that the devices are substantially equivalent, meaning the new device is as safe and effective as the predicate.

• Methodology: The manufacturer lists the technical components and specifications of the Nio 5MP-M-21" and directly compares them to those of the Coronis 5MP.
• Key Finding: The report states: "The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use. Any difference between both devices does not affect safety or efficacy."
• Differences noted: The primary difference is the absence of a built-in front sensor (I-Guard) in the Nio 5MP-M-21" display and lower functionality in its accompanying software application compared to the predicate. However, the basic specifications and functions relevant to displaying medical images are deemed the same.

In essence, the "study" is a technical comparison intended to demonstrate that the new device does not raise new questions of safety or effectiveness compared to a device already cleared for market. This is the standard approach for a medical display system 510(k) rather than a clinical performance study involving patient data.

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The Coronis Color 3MP is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

The MDCC 3120-DL is intended to be used in displaying digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

Coronis Color 3MP is a display system for medical viewing. It consists of 3 components: MDCC 3120-DL is a 20.8" color LCD display. MXRT 5100 is a fast high-resolution display controller board that plugs into a PACS workstation computer. MediCal QAWeb Agent is a softcopy QA software application for local calibration and QA control.

The display system can be a single-head system or multi-head system. In the last case it ntains multiple displays and display controller boards.

The device consists of three components:

• . One 3-megapixel flat panel display (MDCC 3120-DL)
• . One 32-bit display controller (MXRT 5100 board)
• . MediCal QAWeb Agent software

The flat panel display has a resolution of 1536x2048 pixels. It can be used in landscape and portrait mode.

The MXRT 5100 display controller board is an ultra-high speed board with a 32-bit in, 32-bit out lookup table, providing up to 64 bit color.

The MediCal QAWeb Agent software allows to set the display function, display test patterns, calibrate the display and view additional display controller information.

This 510(k) summary does not contain the kind of detailed information about acceptance criteria and study results you are looking for.

This document is a 510(k) Summary which primarily focuses on demonstrating Substantial Equivalence (SE) to a previously cleared predicate device. For display systems like the Coronis Color 3MP, the SE process typically involves comparing technical specifications and intended use rather than performing extensive clinical studies as one might for a diagnostic AI algorithm.

Here's why the document doesn't have the information you're asking for:

• Device Type: This is a medical display system, not a diagnostic AI algorithm. The performance evaluation for a display focuses on technical characteristics (resolution, brightness, contrast, calibration) rather than diagnostic accuracy.
• 510(k) Process: The 510(k) pathway is for devices substantially equivalent to existing ones. It often doesn't require new clinical studies if the device's technical characteristics and intended use are similar enough to a predicate.
• Date: This document is from 2006. The standards and expectations for AI/ML performance evaluation in medical devices have evolved significantly since then.

Therefore, I cannot extract the information requested as it is not present in the provided text. The document clearly states: "The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use. Any difference between both devices does not affect safety or efficacy." This signifies that the primary "proof" relies on comparing the device's technical specifications to a cleared predicate rather than a separate clinical performance study with acceptance criteria.

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