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The Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type CT, Type CL) 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 part of this device to contact with the patient is the probe head.

The Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) 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 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.

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 provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria, as it relates to AI performance metrics. This document is a 510(k) summary for a medical device (Wireless Probe Type Ultrasound Scanner) seeking market clearance from the FDA.

The summary focuses on demonstrating substantial equivalence to existing predicate devices based on:

• Intended Use: The device has the same diagnostic ultrasound echo imaging, measurement, and analysis indications for general clinical applications (OB, GY, abdominal imaging) as the primary predicate device.
• Technological Characteristics: The device employs the same basic operating principles (pulsed-echo ultrasound, B, BM, Color Doppler, PDI, PW modes) and similar features (biopsy guideline, harmonic function) as the predicate devices. Differences mentioned (e.g., image display unit size, specific frequency ranges) are deemed not to affect core usage or substantial equivalence.
• Safety and Effectiveness: Compliance with recognized international standards for biocompatibility (ISO 10993), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance safety (IEC 60601-2-37), as well as FCC radio frequency testing.

Crucially, the document explicitly states: "Clinical testing was not performed for Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) as part of the submission." This means there is no performance study evaluating the device's diagnostic accuracy or comparing it with other methods (human readers, AI assistance, etc.) presented in this document.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, test set details, expert ground truth adjudication, MRMC studies, standalone performance, or training set details as these are not discussed in the provided text.

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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.

For the BProbe model, specific accuracy for bladder volume measurement is mentioned:

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C5 Diagnostic Ultrasound System is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

The C5 Diagnostic Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. This system is a Track 3 device that employs a series of probes that include linear array (frequency: 7.5 MHz), convex array (frequency: 3.5 MHz), trans-vaginal (also belong to the category of "linear array") (frequency: 6.5 MHz), micro-convex array (frequency: 5.0 MHz). This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode , M-Mode, Color-Flow Doppler, Pulsed Wave Doppler and Power Doppler, or the combination of these modes (i.e. "B-Mode + Color-Flow Doppler", "B-Mode + Color-Flow Doppler + Pulsed Wave Doppler" and "B-Mode + M-Mode").

This FDA 510(k) premarket notification for the C5 Diagnostic Ultrasound System is for a general-purpose ultrasound device. It is a comparison to a predicate device, not an AI/ML medical device. Therefore, much of the requested information regarding AI/ML study design is not applicable.

Here's the relevant information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not specify numerical performance acceptance criteria for diagnostic accuracy. Instead, substantial equivalence is claimed based on meeting various safety and performance standards. The "device performance" in this context refers to its ability to meet these general standards.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "Clinical testing was not performed for C5 Diagnostic Ultrasound System as part of the submission." Therefore, there is no test set of patient data, no sample size for such a set, and no data provenance from patients mentioned. Technical performance tests were conducted on the device itself.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable, as no clinical testing with patient data or ground truth established by experts was performed for this submission.

4. Adjudication Method

Not applicable, as no clinical testing with patient data was performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable, as this is a general-purpose ultrasound system and not an AI-assisted device. The submission explicitly states, "Clinical testing was not performed."

6. Standalone (Algorithm Only) Performance Study

Not applicable, as this is a physical diagnostic ultrasound system, not a standalone algorithm. The submission explicitly states, "Clinical testing was not performed."

7. Type of Ground Truth Used

Not applicable, as no clinical testing with patient data requiring ground truth was performed. Performance was evaluated against recognized industry standards for safety and technical performance.

8. Sample Size for the Training Set

Not applicable, as no AI/ML algorithm requiring a training set is mentioned or evaluated in this submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no AI/ML algorithm or training set is mentioned.

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