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The Digital Color Doppler Palm Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), B/M, CFM, Combined(B+CFM), Pulsed Wave and Fusion Harmonic Imaging modes. It is indicated for Fetal, Abdominal, OB/GYN, Urology, Cardiac.
The Digital Color Doppler Palm Ultrasound System is intended for use in environments where healthcare is provided by healthcare professionals.

The SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System is a mobile, general purpose, softwarecontrolled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. The Digital Color Doppler Palm Ultrasound System is a portable system facilitating point of care ultrasound applications.
The SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System includes:

• · A commercial off-the-shelf (COTS) Android mobile device
• CHISON Ultrasound software is running as an app (Android ) on the COTS device
• The SonoEye P5/ SonoEye V5/ SonoEye G5 Convex array USB transducer

This is an FDA 510(k) summary for the SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System. It details the device's substantial equivalence to predicate devices, but it does not contain any information about acceptance criteria or a study proving the device meets those criteria, as it is not an AI/ML device needing such validation.

Here's a breakdown of why the requested information is not present and what is provided:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with general medical device safety standards. It does not provide specific performance metrics or acceptance criteria for an AI/ML component.

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. This premarket notification does not involve an AI/ML device that would require clinical validation with a test set of data.

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. Ground truth establishment for an AI/ML test set is not part of this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 device is not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no mention of a standalone algorithm for diagnostic performance.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable. There is no mention of an AI/ML component requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Information that is provided in the document:

The document outlines the submission for a Digital Color Doppler Palm Ultrasound System, which is a general diagnostic ultrasound system. It demonstrates substantial equivalence to predicate devices (Lumify Diagnostic Ultrasound System, Clarius Ultrasound System, TE7 Diagnostic Ultrasound System) by comparing:

• Indications for Use: The device has similar indications for use (Fetal, Abdominal, OB/GYN, Urology, Cardiac) as the predicate devices.
• Design: It uses similar autocorrelation for color processing and FFT for pulse Doppler processing, supporting convex probes, and features like cine playback and image archiving.
• Operating Controls: Similar controls such as TGC (STC), Depth Range, shades of gray, Gain, Focus, Color box size/position, Baseline, Cine control, and Freeze control. Some differences in value ranges for depth, gain, etc., are noted but deemed substantially equivalent.
• Safety Compliance: The device conforms to applicable medical device safety standards like ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993-1, which are the same standards adhered to by the predicate devices.
• Operation Modes: Similar modes including B mode, PW mode, B/M mode, CFM mode, and Fusion Harmonic Imaging (FHI).
• Measurements and Reporting: Similar measurement capabilities (2D distance, area, circumference, volume, M-mode, PW-mode measurements) and reporting packages (Vessel, Abdomen, Obstetrics, Cardiac reports, General report).
• Transducer Types: The submission device uses Convex Array USB interface, compared to various array types in the predicate devices.
• Users/Sites: Intended for use in hospitals and clinics, similar to predicates.
• Acoustic Output: Compliant with Track 3, Ispta.3 ≤ 720 mW/cm², MI ≤ 1.9, TI ≤ 6.0, consistent with predicate devices.
• Power Requirements: Differences in specific voltage, humidity, and temperature ranges are discussed, but the device passed relevant hardware tests and complies with safety standards, leading to a conclusion of substantial equivalence.

In summary, this FDA 510(k) submission establishes the safety and effectiveness of a conventional ultrasound system by demonstrating its substantial equivalence to already legally marketed devices, focusing on technical specifications, operational features, and compliance with general medical device safety standards, rather than AI/ML performance criteria.

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