(777 days)
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.
| Acceptance Criterion (as implied by regulatory compliance) | Reported Device Performance |
|---|---|
| Compliance with 21 CFR 1010 (Performance Standards for Electronic Products) | Complies |
| Compliance with CDRH guidances ("Revised 510(k) Diagnostic Ultrasound Guidance for 1993" and "510(k) Guide for Measuring and Reporting Acoustic Output of Diagnostic Ultrasound Medical Devices") | Complies |
| Compliance with Japanese (JIS) voluntary standards | Complies |
| Compliance with European (IEC-601-1) voluntary standards | Complies |
| Compliance with ISO-9001 manufacturing standard | Complies |
| Software safety features prevent acoustic intensities from exceeding Pre-enactment guidelines | Software safety features employed |
| Electrical safety assured through proper grounding/certification | Assured/Certified |
| Thermal and mechanical safety aspects comply with IEC-601-1 standard | Complies |
| Substantial Equivalence to PSF-37FT and P3-2 Transcranial Doppler transducer (ATL) | Claimed substantially equivalent |
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.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.