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Using the software listed to post-process images, various analysis and reconstruction can be initiated by the user to obtain clinically relevant information pertaining to cardiac and radiology. Additionally this information can be used in the detection of cardiovascular disease and radiology diagnosis and risk management. Support functions are:

• URSE-001A: Stress Echo analysis of the ultrasound diagnostic images. .

• URFR-001A: Three-dimensional image reconstruction from the ultrasound . diagnostic images for abdominal, small organs and peripheral vascular.

• URTQ-001A : Following analysis from the TDI (Tissue Doppler Image) from the . ultrasound diagnostic images.

• Gray scale (display of only black-and-white images)

• Velocity display (display of the velocity after angle correction and smoothing)

• Display of the velocity gradient based on the velocity image

• Display of the degree of myocardial strain based on the velocity image

• Display of the displacement based on the velocity image

• Display of the dyssynchrony imaging based on the above imaging methods

These software packages are to be applied to the imaging processing system Encompass from Agfa Corp. Using the software listed to post-process images, various analysis and reconstruction can be initiated by the user to obtain clinically relevant information pertaining to cardiac and radiology. Additionally this information can be used in the detection of cardiovascular disease and radiology diagnosis and risk management. Support functions are:

• URSE-001A: Stress Echo analysis of the ultrasound diagnostic images. .

• URFR-001A: Three-dimensional image reconstruction from the ultrasound . diagnostic images for abdominal, small organs and peripheral vascular.

• URTQ-001A : Following analysis from the TDI (Tissue Doppler Image) from the . ultrasound diagnostic images.

• Gray scale (display of only black-and-white images)

• Velocity display (display of the velocity after angle correction and smoothing)

• Display of the velocity gradient based on the velocity image

• Display of the degree of myocardial strain based on the velocity image

• Display of the displacement based on the velocity image

• Display of the dyssynchrony imaging based on the above imaging methods

The provided text is a 510(k) summary for the Toshiba America Medical Systems, Inc. Encompass Software Package (K053043). This document details the software's intended use, technological characteristics, and substantial equivalence to predicate devices. However, this specific document does not contain information about acceptance criteria, detailed study designs, performance metrics, sample sizes, or ground truth establishment that would typically be found in a performance study report.

The 510(k) process is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel performance based on rigorous clinical trials and statistical acceptance criteria. The document explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices."

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth, or MRMC studies, as this information is not present in the provided 510(k) summary. The summary focuses on comparing the new device's features and intended use to existing devices.

Below is a summary of what can be extracted from the provided text, while also noting the absence of the requested performance study details:

Summary of Device: Encompass Software Package (K053043)

1. Table of Acceptance Criteria and Reported Device Performance:

• No specific acceptance criteria or quantified performance metrics are reported in this 510(k) summary. The document focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics, rather than performance against defined criteria.

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

• Not applicable / Not provided. The 510(k) summary does not describe any specific test set or data used for a performance study.
• The comparison is made against predicate devices' known functionalities.

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

• Not applicable / Not provided. No ground truth establishment process involving experts for a test set is described.

4. Adjudication method for the test set:

• Not applicable / Not provided. No test set or adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not performed / Not described. This 510(k) summary does not mention an MRMC comparative effectiveness study. The device is software for post-processing images, not an AI for assisting human readers in diagnosis in the context of an MRMC study.

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

• Not applicable / Not described as a standalone study. The software itself performs analysis and reconstruction, but its "performance" is assessed in terms of its functions being similar to predicate devices, not through a standalone quantitative performance study described here.

7. The type of ground truth used:

• Not applicable / Not provided. No ground truth for a performance study is mentioned in this document. The basis for approval is substantial equivalence to legally marketed predicate devices and compliance with general controls.

8. The sample size for the training set:

• Not applicable / Not provided. No training set for an algorithm is mentioned in this document.

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

• Not applicable / Not provided. No training set or ground truth establishment for a training set is mentioned.

Explanation of Device and Substantial Equivalence (from the document):

This 510(k) submission is for software packages (URSE-001A, URFR-001A, URTQ-001A) designed to be applied to the Agfa Corp. Encompass imaging processing system. These software packages enable:

• URSE-001A: Stress Echo analysis of ultrasound diagnostic images.
• URFR-001A: Three-dimensional image reconstruction from ultrasound diagnostic images for abdominal, small organs, and peripheral vascular.
• URTQ-001A: Analysis from Tissue Doppler Imaging (TDI) from ultrasound diagnostic images, including display of velocity, velocity gradient, myocardial strain, displacement, and dyssynchrony imaging.

The device's substantial equivalence is claimed based on its similarity in uses and applications to the predicate devices:

• Agfa Corp. Encompass [K040896]
• Toshiba SSA-770A [K041499]
• General Electric Vivid 7 with TSI [K031663]

The FDA's determination of substantial equivalence (K053043) means the device can be legally marketed, as it has similar indications for use and technological characteristics to devices already on the market prior to May 28, 1976, or reclassified devices. This implies that the device is considered as safe and effective as the predicate devices, without requiring new clinical performance studies to prove novel performance or meet specific, quantifiable acceptance criteria.

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