(15 days)
The Power Vision 8000 is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transesophageal, peripheral vascular, and musculo-skeletal (both conventional and superficial).
The PowerVision 8000 Ultrasound System is a mobile system. This system is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 10 MHz.
The provided document is a 510(k) Summary for the Toshiba SSA-390A/PowerVision 8000 Ultrasound Imaging System. This document focuses on demonstrating substantial equivalence to predicate devices, primarily by comparing intended use, technological characteristics, and safety considerations. It does not contain information about a study proving the device meets specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy) using a test set with ground truth established by experts.
The core of this submission is to confirm that the new device does not raise new questions of safety or effectiveness compared to previously cleared devices. It relies on the predicate devices' prior approvals and compliance with general safety standards.
Therefore, many of the requested details about acceptance criteria and a performance study demonstrating those criteria cannot be extracted from this document, as such a study is not presented.
Here's a breakdown of what can be inferred or directly stated from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This table cannot be fully completed from the provided document as specific diagnostic performance acceptance criteria (e.g., sensitivity, specificity, or accuracy thresholds) and corresponding reported performance are not included. The "acceptance criteria" here relate to demonstrating substantial equivalence based on technical specifications and indications of use, rather than a clinical performance study.
| Acceptance Criterion Type | Acceptance Criterion (Threshold) | Reported Device Performance |
|---|---|---|
| Safety Compliance | Compliance with Quality System Regulation, IEC 60601 (applicable portions), AIUM-NEMA UD2, AIUM-NEMA UD3 | Device is designed and manufactured in conjunction with these standards. Engineering assessments identify no new issues of risk or safety compared to the predicate device. |
| Substantial Equivalence | Device is substantially equivalent to a legally marketed predicate device (SSA-380A/PowerVision 7000 and associated transducers). | FDA determined the device is substantially equivalent to the predicate devices for the stated indications for use. |
| Intended Use | Intended uses are consistent with predicate devices and accepted clinical applications for diagnostic ultrasound. | The device is intended for Fetal, Abdominal, Intraoperative, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Cardiac, Transrectal, Transesophageal, Peripheral Vascular, and Musculo-skeletal (conventional and superficial) studies. No new indications for in vitro fertilization or percutaneous umbilical blood sampling are permitted. |
| Technological Characteristics | Wide array of probes: flat linear, convex linear, sector array; Frequency range: 2 MHz to 10 MHz. | Device employs a wide array of probes including flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 10 MHz. |
| Post-Clearance Acoustic Output | Submit a post-clearance special report with complete information, including acoustic output measurement based on production line devices, requested in Appendix G of "Information for Manufacturer's Seeking Marketing Clearance of Diagnostic Ultrasound System and Transducers." | A condition of clearance is to submit this report. No performance data is reported here, only the requirement. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No diagnostic performance study with a test set is described. The submission relies on establishing substantial equivalence to a predicate device, which usually involves demonstrating similar technical specifications and safety profiles rather than a clinical study comparing diagnostic outputs.
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)
Not applicable. No diagnostic performance study with a test set and ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No diagnostic performance study with a test set 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 applicable. This is a 1999 submission for a diagnostic ultrasound system, not an AI-assisted device. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a diagnostic ultrasound system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No diagnostic performance study with ground truth is described. The "ground truth" in this context is the FDA's existing clearance for the predicate device and its established safety and effectiveness.
8. The sample size for the training set
Not applicable. This is a diagnostic ultrasound system, not an AI/ML device that undergoes training.
9. How the ground truth for the training set was established
Not applicable. This is a diagnostic ultrasound system, not an AI/ML device that undergoes training.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.