(128 days)
The HD60 Series Ultrasound Diagnostic System is a general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment.
The systems support the following clinical applications:
The HD60 series Diagnostic Ultrasound System is applicable for adults, pregnant woments and neonates. It is intended for use in fetal, abdominal, pediatric, small organ, neonatal and adult cephalic, trans-rectal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vessel, and urology exams.
Modes of operation include: 3D/4D Imaging mode. B. M. PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/Color/PWD or CWD, B/Power/PWD.
The HD60 Series consists of a mobile console with a height-adjustable control panel, color LCD touch panel, LCD display monitor and optional image storage and printing device. It includes a variety of electronic array transducers operating in linear, curved, sector/phase array, and real time 3D transducer. HD60 series is a Track 3 diagnostic ultrasound system. The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, hard copy printing, and network access to the facility through LAN or Wireless with WIFI adapter module.
The provided text is a 510(k) summary for the Qingdao Hisense Medical Equipment Co., Ltd's HD60 Series Ultrasound Diagnostic System. It outlines the device's technical specifications, indications for use, and a comparison with a predicate device to demonstrate substantial equivalence.
However, the document explicitly states: "The subject of this premarket submission, did not require clinical studies to support substantial equivalence."
This means that the submission for the HD60 Series Ultrasound Diagnostic System does not contain information about acceptance criteria for device performance based on clinical studies, nor does it provide details of a study (clinical or otherwise with human data) that proves the device meets such criteria.
The basis for substantial equivalence is primarily through demonstrating that the new device has "the same intended use, and similar physical characteristics" and "employs the same fundamental scientific technology" as its predicate device. Any new functions or changes are argued to have "no impact on safety or effectiveness" because they are either:
- Equivalent to features found on other already-cleared reference devices.
- New, but their performance "meets the requirements" and does not raise new risks.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets them, because this specific 510(k) summary states that no clinical studies were required or conducted for this submission.
To directly answer your numbered points based only on the provided text's stated approach for this 510(k) submission:
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A table of acceptance criteria and the reported device performance: Not applicable. The document does not describe specific acceptance criteria for performance based on user studies or clinical trials, nor does it report device performance data from such studies. The acceptance is based on substantial equivalence to a predicate device and adherence to regulatory standards for safety and non-clinical performance (e.g., electrical, acoustic, biocompatibility).
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Sample sizes used for the test set and the data provenance: Not applicable. No clinical or human-data based performance test set is described.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring ground truth establishment by experts is described.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication is described.
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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 an ultrasound diagnostic system, not an AI-assisted diagnostic tool for which MRMC studies are typically conducted. No MRMC study is mentioned.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a complete ultrasound system, not a standalone algorithm. Performance is assessed through compliance with general safety and performance standards for ultrasound equipment.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No explicit "ground truth" as typically understood in performance studies for diagnostic accuracy is mentioned, as no such studies were required or presented.
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The sample size for the training set: Not applicable. This is not an AI/ML device that would undergo a training phase on a dataset.
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How the ground truth for the training set was established: Not applicable. No training set is described.
§ 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.