(169 days)
The Wireless Probe Type Ultrasound Scanner (Model: UProbe-C) (frequency: 3.5Hz, module: convex) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including obstetrics (OB), gynecology (GY) and general (abdominal) imaging.
The Wireless Probe Type Ultrasound Scanner (Model: UProbe-L) (frequency: 7.5Hz, module: linear) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including small organ and peripheral vessel imaging.
The Wireless Probe Type Ultrasound Scanner (Model: BProbe) is intended to project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the bladder and uses that image to calculate the bladder volume non-invasively. It is contraindicated for fetal use and for use on pregnant patients. And it should not be used by those who are allergic to coupling agent and who have abdomen wound and skin disease.
The Wireless Probe Type Ultrasound Scanner (Model: UProbe-C; UProbe-L; BProbe) is a wireless ultrasound system that uses pulsed-echo technology to transmit ultrasound images via wireless communication to a mobile device that utilizes the iOS operating system.
The mobile device for use with the Wireless Probe Type Ultrasound Scanner (Model: UProbe-C; UProbe-L; BProbe) are those that utilizes the iOS operating system, i.e. all series of iPad or iPhone from Apple Inc.
The Wireless Probe Type Ultrasound Scanner is a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) a commercial off-the-shelf iOS mobile device, (ii) the Wireless Probe Type Ultrasound Scanner software that runs as an app on the mobile device, (iii) the battery-operated, hand-held Wireless Probe Type Ultrasound Scanner transducer that communicates wirelessly with iOS mobile devices, and (iv) the instructions for use manual, USB Cable for Charging, wrist wrap.
The Wireless Probe Type Ultrasound Scanner utilizes pulsed-echo technology to determine the depth and location of tissue interfaces, and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. Ultrasound waves are emitted from the transducer, propagate through tissues, and return to the transducer as reflected echoes. The returned echoes are then converted into electrical impulses by transducer crystals and further processed in order to form the ultrasound image presented on the screen.
The device components are not supplied sterile and do not require sterilization prior to use.
The provided document is a 510(k) summary for the Wireless Probe Type Ultrasound Scanner (Models: UProbe-C, UProbe-L, BProbe). It establishes substantial equivalence to predicate devices rather than providing a study proving performance against acceptance criteria for an AI/ML device.
Therefore, most of the requested information regarding acceptance criteria, reported performance, sample sizes, ground truth, experts, adjudication, and MRMC studies for an AI/ML device is not available in the provided text. The document describes a traditional medical device (ultrasound scanner) and its non-clinical testing for safety and effectiveness to demonstrate equivalence to existing devices.
Here's what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance
This information is not directly provided in the context of device performance metrics against specific acceptance criteria. Instead, the document focuses on demonstrating that the device meets general safety and effectiveness standards comparable to predicate devices. The "reported device performance" is implicitly that it meets the requirements of the standards listed below.
| Category | Acceptance Criteria (Stated as adherence to standards) | Reported Device Performance (Stated as compliance) |
|---|---|---|
| Biocompatibility | AAMI / ANSI / ISO 10993-5:2009/(R)2014 | Evaluated and Complies |
| AAMI / ANSI / ISO 10993-10:2010/(R)2014 | Evaluated and Complies | |
| Electrical Safety | AAMI / ANSI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (IEC 60601-1:2005, Mod) | Evaluated and Complies |
| Electromagnetic Comp. | AAMI / ANSI / IEC 60601-1-2:2007/(R)2012 (Edition 3) | Evaluated and Complies |
| Performance Safety/Eff. | IEC 60601-2-37 Edition 2.0 2007 | Evaluated and Complies |
| FCC Radio Frequency | FCC CFR Title 47 Part 15 Subpart C Section 15.247 | Tested and Complies |
For the BProbe model, specific accuracy for bladder volume measurement is mentioned:
| Category | Acceptance Criteria (Predicate Device 3) | Reported Device Performance (BProbe) |
|---|---|---|
| Bladder Accuracy | ±25% (60ml≤ volume ≤ 150ml) | |
| ±15% (150ml |
§ 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.