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Echo-Scan™ 4.1 is intended to acquire, store, retrieve and analyze digital ultrasound images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing.

Echo-Scan™ 4.1 can import certain digital 2D or 3D image file formats for 3D tomographic reconstructions and surface rendering. It is intended as a general purpose image acquisition and digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastro-enterology, urology, surgery, obstetrics and gynecology.

The TomTec acquisition software products Echo-Scan and Easy-Scan are combining 3D and 4D Acquisition Software and Echo-View™ / Easy-View Review Software for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing. It is the appropriate Software solution for TomTec's add-on accessories for existing ultrasound imaging systems, and is intended to control position and movement of ultrasound transducers for the acquisition of 2 dimensional image slices throughout a volume of interest. The 4D Echo-Scan™ Software acquires sets of 2D images and stores them digitally in a special 3D image file format for subsequent 3D tomographic reconstruction and surface rendering.

The 4D Echo-Scan™ is a software module for the high performance computer system Compact High or Professional based on Microsoft Windows NT™ 4.0 operating system standards.

The TomTec Echo-Scan 4.x and Easy-Scan 1.x are digital ultrasound image analysis systems.

Here's an analysis of the provided text regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not provide any specific sample sizes for test sets (e.g., number of images, cases, or patients).

The data provenance is also not explicitly stated. Given that it's an internal test by TomTec Imaging Systems GmbH (based in Germany), it's likely the testing was conducted internally and may have involved retrospective or internally generated data. There's no mention of country of origin for any external datasets, nor whether the data was retrospective or prospective.

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

The document does not provide any information regarding the number of experts used, their qualifications, or how ground truth was established for any test set. The testing described is primarily focused on software functionality and conformance to specifications, not clinical performance metrics validated against expert interpretations.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method. The testing described is primarily about software validation and conformance to specifications, which typically involves internal technical review rather than expert adjudication of clinical outcomes.

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

The document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. There is no information about human readers, AI assistance, or an effect size of improvement. The device described, Echo-Scan and Easy-Scan, is a software for acquiring, storing, retrieving, and analyzing digital ultrasound images, and for 3D/4D image processing. It is not presented as an AI-assisted diagnostic tool that directly aids human interpretation in a comparative effectiveness study.

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

The document does not explicitly describe a standalone performance study in terms of accuracy or specific diagnostic metrics. The "Test Discussion" states that "Software testing and validation were done at the module and system level according to written test protocols." This implies testing of the algorithm's functionality and adherence to specifications (e.g., image acquisition, storage, processing, reconstruction, rendering) without necessarily evaluating its diagnostic accuracy against a ground truth dataset in a standalone manner. The focus is on the software's ability to perform its defined functions, not its ability to make diagnoses independently.

7. Type of Ground Truth Used

The document does not specify the type of ground truth used. As noted, the testing primarily focused on confirming the software's functional performance and adherence to design specifications, rather than evaluating its diagnostic accuracy against clinical ground truth (like pathology, outcomes data, or expert consensus).

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. The described devices are acquisition and processing software, not a machine learning model that would typically have a separate training set.

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

Since no training set is mentioned (as the device is not described as a machine learning model), there is no information on how ground truth for a training set would have been established.

Summary of Study Limitations (from the provided text):

The provided text describes a 510(k) submission for a modified ultrasound imaging software (Echo-Scan 4.x and Easy-Scan 1.x) that has been ported to a new operating system (Windows NT) with an improved graphic user interface. The testing discussed is primarily focused on software validation and verification to ensure that the modified software performs its intended functions (acquisition, storage, retrieval, 3D/4D processing, reconstruction, rendering) as designed and to the specified standards.

The document lacks details on clinical performance studies, diagnostic accuracy evaluations, expert reviews, or the methodologies typically associated with assessing the clinical effectiveness or diagnostic capabilities of AI-driven medical devices. The testing appears to confirm the software's internal operational correctness and adherence to technical specifications, rather than its performance in a clinical diagnostic context validated against external ground truth.

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