Search Results

While the PSH-25GT and PSF-37FT mainly differ in their indications for use (transcranial doppler vs cardiac, respectively), the PSH-25GT and P3-2 probes are intended for transcranial doppler applications.

The PSH-25GT, when used with the SSH-140A diagnostic ultrasound system, utilizes high frequency sound waves, beyond the range of human hearing, to perform diagnostic examinations. These sound waves are a form of non-ionizing radiation which can be used to demonstrate anatomical structures. Ultrasonic waves are easily focussed for the examination of small quantities of material and short time span phenomena. Additionally, ultrasound is especially beneficial in the examination of soft tissues. Doppler imaging permits investigation of vascular flow via the use of non-ionizing energy, rather than requiring the employment of ionizing radiation.

This document is a 510(k) summary for a medical device (Toshiba PSH-25GT Transcranial Doppler Transducer). It focuses on regulatory compliance and substantial equivalence to existing devices, rather than presenting a study with specific acceptance criteria and performance metrics in the way a clinical trial for a new AI diagnostic device would.

Therefore, many of the requested sections about acceptance criteria, study design, and performance metrics are not present or not applicable in this type of regulatory submission. The document outlines compliance with various performance standards and guidances but does not detail a specific study with defined acceptance criteria and performance results in the context of diagnostic accuracy.

Here's an attempt to answer the questions based only on the provided text, indicating where information is missing:

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

This document does not provide a table of acceptance criteria paired with specific device performance metrics in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, it states compliance with various regulatory and voluntary standards.

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

This information is not provided in the document. The submission focuses on regulatory compliance and substantial equivalence rather than a new clinical study.

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 information is not provided in the document.

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

This information is not provided in the document.

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

An MRMC study is not mentioned and is not applicable here as the device is an ultrasound transducer, not an AI diagnostic algorithm.

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

This is not applicable. The device is an ultrasound transducer, which is a physical component of a diagnostic system, not a standalone algorithm.

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

This information is not provided as there is no mention of a specific diagnostic accuracy study with a "ground truth" in the traditional sense for an AI device. The "ground truth" for this device's performance would be its adherence to established electrical, acoustic, and safety standards.

8. The sample size for the training set

This information is not provided and is not applicable for a hardware device like an ultrasound transducer.

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

This information is not provided and is not applicable for a hardware device like an ultrasound transducer.

Ask a specific question about this device