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The products:

• Echo-View 5.x
• Easy-View 2.x
• Omni View 2.x
• Cardio-View 1.x
• LV Analysis 1.x
• Surgical View 1.x
  are intended to retrieve, analyze and store digital ultrasound images and Color Doppler images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing.

Echo-View 5.x , Easy-View 2.x, Omni-View 2.x, Cardio-View 1.x, LV Analysis 1.x and Surgical View 1.x can import certain digital 2D or 3D image file formats for 3D tomographic reconstructions and surface rendering. It is intended as a general purpose digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastro-enterology, urology, surgery, obstetrics and gynecology.

The Review Software products

• . Echo-View 5.x
• Easy-View 2.x ●
• Omni-View 2.x
• Cardio-View 1.x ●
• LV Analysis 1.x .
• Surgical View 1.x ●
  are software modules for high performance computer systems based on Microsoft Windows 2000/XP™ operating system standards. These Review Software products are proprietary software for the analysis, storage, retrieval and reconstruction of digitized ultrasound B-mode images and Color Doppler images. The data can be acquired by a TomTec acquisition station or by a 3D capable ultrasound system. The result of acquired images allows a 3-dimensional volume to be reconstructed by Echo-View. The digital 3D / 4D data set can be used for 2D and 3D measurements.

The provided document KD22824 (TomTec Echo-View 5.x and related products) offers a limited description of the testing and validation performed. It does not contain a detailed study proving the device meets specific acceptance criteria in the format requested.

Here's a breakdown of the information available and what is missing:

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

Missing information: The document does not explicitly list quantitative or qualitative acceptance criteria for specific functionalities such as image analysis accuracy, speed, measurement precision, or reliability. It only provides high-level statements about meeting design intent and system specifications.

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

• Sample Size for Test Set: Not specified.
• Data Provenance (e.g., country of origin, retrospective/prospective): Not specified.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

• Adjudication Method: Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• MRMC Study: No, there is no mention of an MRMC comparative effectiveness study involving human readers with or without AI assistance. The document predates widespread AI in medical imaging as we know it today (2002).

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

• Standalone Study: The document describes "Software testing and validation" and that "Test results were reviewed by designated technical professionals." This implies standalone testing of the software's functionality, but the nature and metrics of this 'performance' are not detailed. It's not a standalone AI algorithm in the modern sense.

7. The type of ground truth used

• Type of Ground Truth: Not specified. The document globally states "Test results support the conclusion that actual device performance satisfies the design intent" and "conforms to the system performance specifications," implying internal validation against expected outcomes or predefined standards, but the basis of these standards (e.g., expert consensus, pathology, other validated tools) is not mentioned.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/Not specified. This device (from 2002) is described as a "Digital Ultrasound Image Analysis System" and "image processing tool," implying rule-based or conventional algorithmic analysis rather than a machine learning/AI model that would require a distinct "training set."

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

• Ground Truth for Training Set: Not applicable/Not specified, as it's not an AI/ML device that would typically have a distinct training set with established ground truth in the current understanding.

Summary of what's provided by the document:

The document describes the device as a "Digital Ultrasound Image Analysis System" and outlines its intended use for retrieving, analyzing, and storing digital ultrasound images for 3D/4D processing. It states that "Testing was performed according to internal company procedures" and that "Software testing and validation were done at the module and system level according to written test protocols." The conclusion is that "actual device performance satisfies the design intent" and "conforms to the system performance specifications."

The main limitation is that this 510(k) summary provides a high-level overview and does not include the detailed technical report or study data that would contain the specific acceptance criteria, test methodologies, sample sizes, and expert qualifications required for a comprehensive answer to your questions. The technology described is from 2002 and predates the rigorous clinical validation studies typically associated with AI/ML-based medical devices today.

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