Search Results

Sono-Scan/Cardio-Scan™ is intended to acquire, store, retrieve and analyze digital ultrasound images and Color Doppler images for computerized 3-dimensional and 4dimensional (dynamic 3D) image processing.

Sono-Scan/Cardio-Scan™ 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 Sono Scan and Cardio Scan are combining 3D and 4D Acquisition 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 transdacers for the addition of 2 = "M" 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 Sono Scan™ is a software module for the high performance computer system Compact High or Professional based on Microsoft Windows 2000/XP™ operating system standards.

The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets them. It primarily focuses on the 510(k) summary for TomTec Sono-Scan, Sono-Scan Pro, and Cardio-Scan, outlining its intended use, technological characteristics comparison to a predicate device, and the regulatory approval process.

However, based on the limited information, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific quantifiable acceptance criteria: The document uses general statements like "satisfies design intent" and "conforms to system performance specifications" without providing measurable metrics (e.g., specific accuracy, processing speed, image quality standards).
• Quantifiable reported performance: No actual data or results are reported against any specific criteria.

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

The document mentions "Software testing and validation were done at the module and system level," but does not explicitly state the sample size of the test set (e.g., number of images, number of cases).

Missing Information:

• Sample size for the test set: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective). It is implied that the testing was internal to TomTec.

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

The document states, "Test results were reviewed by designated technical professionals."

Missing Information:

• Number of experts: Not specified.
• Qualifications of experts: Only generally referred to as "designated technical professionals." No specific medical or technical expertise (e.g., radiologist with X years of experience) is provided.

4. Adjudication method for the test set

The document states, "Test results were reviewed by designated technical professionals."

Missing Information:

• Adjudication method: Not specified (e.g., 2+1, 3+1 consensus). It only mentions a review.

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

No mention of a multi-reader multi-case (MRMC) comparative effectiveness study. The testing described appears to be internal software validation, not a clinical effectiveness study.

Missing Information:

• MRMC study: Not performed or not reported.
• Effect size of human reader improvement with AI: Not applicable as no MRMC study was reported.

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

The "Test Discussion" refers to "Software testing and validation at the module and system level," which implies standalone testing of the software's functionality. However, it's not explicitly stated that this was a "standalone performance" study in the context of diagnostic accuracy.

Missing Information:

• Explicit standalone performance study: While internal software testing was done, it's not detailed as a separate standalone diagnostic performance study with specific metrics.

7. The type of ground truth used

The document does not explicitly define the "ground truth" used for testing. Given the nature of the device (image acquisition and processing), the "ground truth" would likely involve the expected output or behavior of the software based on its design, rather than a clinical ground truth like pathology for diagnosis.

Missing Information:

• Type of ground truth: Not specified. It's likely based on internal software specifications and expected technical outputs.

8. The sample size for the training set

The document does not mention any "training set." This type of device, which focuses on image acquisition, storage, retrieval, and 3D/4D processing (rather than automated diagnosis), typically undergoes traditional software testing and validation rather than machine learning training.

Missing Information:

• Sample size for the training set: Not applicable based on the provided information, as there's no indication of machine learning.

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

Not applicable as no training set is mentioned or implied.

Missing Information:

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

Summary of Study Details:

Based on the provided text, the "study" was an internal software testing and validation process carried out by TomTec Imaging Systems GmbH.

• Acceptance Criteria: General statements about satisfying design intent and conforming to system specifications. Specific quantifiable criteria are not provided.
• Reported Device Performance: Conclusions state that performance "satisfies the design intent" and "conforms to the system performance specifications," without reporting specific data.
• Sample Size (Test Set): Not specified.
• Data Provenance (Test Set): Internal testing conducted by TomTec (implied to be in Germany given the company address). The nature (retrospective/prospective) is not specified.
• Number and Qualifications of Experts (Ground Truth): "Designated technical professionals" reviewed test results, but their number and specific qualifications are not detailed.
• Adjudication Method: Not specified beyond a general review.
• MRMC Study: No MRMC comparative effectiveness study was reported.
• Standalone Performance Study: Internal software testing was done, but not explicitly framed as a standalone diagnostic performance study.
• Type of Ground Truth: Most likely based on internal software specifications and expected technical outputs, not clinical ground truth like pathology.
• Training Set Sample Size: Not applicable/not mentioned, as the device's function suggests traditional software development rather than machine learning.
• Training Set Ground Truth: Not applicable/not mentioned.

Ask a specific question about this device