(85 days)
The Ultrasound System SONIMAGE HS1 and its transducers are products designed to collect ultrasonic image data of the human body for diagnostic purposes. The system employs the ultrasonic pulse-echo method to visualize the anatomic structures, characteristics, and dynamics of the human body, and using an image display, Doppler display and/or Doppler sound, offers a procedure applied to the human body for medical diagnosis or examination. The range of intended clinical applications is same as other conventional ultrasound imaging systems for general purpose, such as small parts, abdomen, obstetrics, gynecology, musculoskeletal (soft tissue), peripheral vascular, and Cardiac.
The Ultrasound System SONIMAGE HS1 is a portable ultrasound system for general purposes. The system provides ultrasound imaging information such as used for the purpose of diagnosing the human body, which visually represents the internal geometry, characteristics and dynamics of the human body, and transmits / receives ultrasound waves to obtain image data of the visual representation. This system provides ultrasound images in all its modes of B-mode, M-mode, Color Doppler-mode, PW Doppler-mode, and Elastography-mode. It is also capable with Anatomical M-mode, CW Doppler-mode and CF/PW-TDI-mode with Sector transducer. The optional items are available, such as a Pole Cart with storage basket, a power extension unit, and a foot switch with dual/triple pedals. The system can be connected to LAN through the wired Ethernet and, is also capable of wireless LAN with the OTS USB-WiFi adapter supporting security of WPA/WPA2 and WEP. This system conforms to Real Time Display of Thermal and Mechanical Output Indices on Diagnostic Ultrasound Equipment (Track 3). Transducers have their own characteristic applications, and are brought into contact with the body surface.
The provided text describes the Konica Minolta Ultrasound System SONIMAGE HS1 and focuses on demonstrating its substantial equivalence to previously cleared predicate devices, rather than a study proving the device meets specific acceptance criteria in a clinical setting. Therefore, many of the requested details about a study evaluating performance metrics (like sample size, data provenance, expert ground truth, adjudication, MRMC studies, or standalone performance) are not present in this document.
However, I can extract information related to the device's technical acceptance and the basis for its clearance.
Acceptance Criteria and Reported Device Performance
The document states that the system's geometric accuracy, elastography position, and the accuracy of position and velocity for various Doppler modes were tested. The "acceptance criteria" here refer to meeting the expectations for these technical characteristics, aligning with existing standards and predicate devices, rather than predefined clinical performance thresholds.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Geometric Accuracy (B-mode) | Comprehensively tested with successful results. |
| Elastography Position | Comprehensively tested with successful results. |
| Accuracy of Position & Velocity (Color Doppler, PW/CW Doppler, TDI) | Comprehensively tested with successful results. |
| Accuracy of Time (PW/CW Doppler, ECG trace) | Comprehensively tested with successful results. |
| Quantitative Doppler Sensitivity | Not applicable; the proposed system and predicate systems do not have quantitative claims of sensitivity regarding Color Doppler, TDI, and PW/CW Doppler modes. |
| Compliance with Standards | Conforms to AAMI/ANSI ES 60601-1, IEC 60601-1-6, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 10993-1, NEMA UD 2-2004, NEMA UD 3-2004, and displays thermal and mechanical output indices (Track 3) in real time. |
| Biocompatibility | All patient contact materials conform to ISO 10993 and are determined acceptable. Achieves the same acceptance level as predicate devices. |
| Risk Analysis | All verification activities as required by the risk analysis were performed, and predetermined acceptance criteria were met. |
Regarding a "study that proves the device meets the acceptance criteria":
The document explicitly states: "The clinical studies are not required to support substantial equivalence for these conventional ultrasound diagnostic equipment."
Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices through technological characteristic comparison and non-clinical testing. The "study" aspects mentioned are primarily non-clinical bench tests.
Here's what can be inferred about the "study" (non-clinical testing) from the provided text:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify a "sample size" for a test set in the context of clinical images or patient data. The evaluations were "bench-tests," implying controlled laboratory settings rather than patient data.
- Data provenance is not mentioned, but given it's a submission by KONICA MINOLTA, INC. from Japan, the testing would likely have been conducted internally or by relevant testing facilities. The tests are non-clinical, so "retrospective or prospective" is not applicable in the patient data sense.
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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. As the testing involved "geometric accuracy verification," "position for Elastography-mode," and "accuracy verification of the position and the velocity for Color Doppler-mode, PW/CW Doppler-mode and TDI-mode," the "ground truth" would be established by engineering specifications, calibrated phantoms, and measurement standards, not by human experts interpreting clinical images.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations of clinical data, which was not the nature of these non-clinical bench tests.
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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:
- No MRMC study was done. This is a conventional ultrasound system, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical imaging device operated by a human, not a standalone algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The ground truth for the non-clinical tests would be based on physical and engineering measurements against established standards and validated test methods (e.g., using phantoms for spatial accuracy, calibrated flow models for Doppler velocity accuracy).
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The sample size for the training set:
- Not applicable. This document describes a medical device clearance based on substantial equivalence and non-clinical engineering tests, not an AI/machine learning model that requires a training set.
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How the ground truth for the training set was established:
- Not applicable (see point 7).
In summary, the provided information outlines a regulatory submission where the Ultrasound System SONIMAGE HS1 demonstrated substantial equivalence to predicate devices through non-clinical bench testing, ensuring adherence to technical specifications, safety standards, and performance characteristics consistent with its intended use as a conventional ultrasound imaging system. Clinical studies were explicitly stated as not required.
§ 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.