(71 days)
Readius L15/ Readius P8/ Readius C6 Digital Color Doppler Ultrasound Imaging System is a general purpose diagnostic ultrasound system intended to be used by a trained qualified physician in a hospital or clinical setting for ultrasound evaluation of abdominal, small organ (thyroid, testes, breast), and peripheral vascular applications in B-Mode, M-mode, Color Flow Map (CFM), Vector Space Flow (VS Flow), Color Power Angio (CPA), Pulsed Wave (PW) and Panoscope.
Readius L15/ Readius P8/ Readius V6/ Readius C6 Digital Color Doppler Ultrasound Imaging System is a general purpose diagnostic ultrasound system intended to be used by a trained/qualified physician in a hospital or clinical setting for ultrasound evaluation of abdominal, small organs (thyroid, testes, breast), and peripheral vascular applications in B-Mode, M-mode, Color Flow Map (CFM), Vector Space Flow (VS Flow), Color Power Angio (CPA), Pulsed Wave (PW) and Panoscope.
The system is designed for use in linear, convex, phased array scanning modes and supports linear, convex and phased array transducers. The system has cine review, image zoom, measurements and calculations, image storage, review and recording capabilities.
This system is a Track 3 device and the software used in Readius L15/ Readius P8/ Readius V6/ Readius C6 Digital Color Ultrasound Imaging System is Ultrasound Software developed by SIUI and is based on the predicate device. The software documentation level is Basic Documentation Level.
The provided text does not contain information about acceptance criteria or a study proving the device meets specific performance criteria. Instead, it is an FDA 510(k) summary for a "Digital Color Doppler Ultrasound Imaging System" (Readius series), arguing for substantial equivalence to a predicate device (Apogee 2300).
Therefore, I cannot provide the requested information about acceptance criteria, reported performance, sample sizes, ground truth establishment, expert adjudication, or MRMC studies.
The document states:
- "Clinical testing is not necessary for the Readius L15/ Readius P8/ Readius V6/ Readius C6 Digital Color Doppler Ultrasound Imaging System in order to demonstrate substantial equivalence to the predicate device." This explicitly indicates that no clinical study was conducted to establish new performance metrics for this device.
- The non-clinical testing focused on compliance with various international standards (e.g., IEC 60601-1, ISO 14971, IEC 62304) to demonstrate safety and effectiveness as well as the predicate device, rather than proving specific performance against acceptance criteria for an AI algorithm.
Summary of what can be extracted, related but not directly answering the prompt:
- Device Name: Digital Color Doppler Ultrasound Imaging System (Readius L15, Readius P8, Readius V6, Readius C6)
- Intended Use: General purpose diagnostic ultrasound system for ultrasound evaluation of abdominal, small organ (thyroid, testes, breast), and peripheral vascular applications in B-Mode, M-mode, Color Flow Map (CFM), Vector Space Flow (VS Flow), Color Power Angio (CPA), Pulsed Wave (PW) and Panoscope.
- Predicate Device: Apogee 2300 Digital Color Doppler Ultrasound Imaging System (K173000) by SIUI.
- Basis for Clearance: Substantial equivalence to the predicate device, not new performance demonstration against specific acceptance criteria.
- Non-clinical Testing: Compliance with various safety, EMC, software lifecycle, usability, and risk management international standards (listed in the document).
- Clinical Testing: Not conducted as it was deemed "not necessary... to demonstrate substantial equivalence."
- AI/Algorithm Performance: The document mentions "Ultrasound Software developed by SIUI" and designates it as a "Track 3 device" with "Basic Documentation Level," but does not provide details on specific AI algorithms or their performance metrics. The comparison focuses on hardware similarity, imaging principles, and modes, but notes the current device uses WiFi for image transmission to handheld devices, unlike the predicate.
This 510(k) summary is typical for devices seeking clearance based on substantial equivalence to an already legally marketed device, often without new clinical performance studies.
§ 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.