(275 days)
The SONON Ultrasound Imaging System (Model: 300L) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including musculoskeletal (MSK), vascular, small parts (breast, thyroid), and thoracic/pleural motion and fluid detection imaging.
The SONON Ultrasound Imaging System, Model: 300L, is a wireless ultrasound system that uses pulsed-echo/Doppler technology (Color Flow Doppler (CF Mode)/B Mode (2D): frequency: 5 MHz/7.5 MHz/10 MHz; module: linear; depth max: 10 cm) to transmit ultrasound images via wireless communication to a mobile device that utilizes the iOS or Android operating system.
The SONON Ultrasound Imaging System is a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) a commercial off-the-shelf iOS or Android mobile device, (ii) the SONON Ultrasound Imaging System software that runs as an app on the mobile device, (iii) the battery-operated, hand-held SONON Ultrasound Imaging System transducer that communicates wirelessly with iOS or Android mobile devices, and (iv) the instructions for use manual, battery, charger, and power cords.
The SONON software can be downloaded to an iOS or Android mobile device and utilizes an icon touch-based user interface. The software enables ultrasound image capture and review, controls for time gain, dynamic range, display of mirror image, focal length, depth, brightness, contrast, linear/elliptical measurement, color flow, and image annotation, as well as storage and email transmission of images and videos. The SONON Ultrasound Imaging System allows the user to image in real time and review cine or freeze-frame images on the screen in a Color Flow Doppler/B-Mode, 2-dimensional scan format.
The SONON Ultrasound Imaging System utilizes pulsed-echo/Doppler 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.
This document is a 510(k) Summary of Safety and Effectiveness for the Healcerion Co., Ltd. SONON Ultrasound Imaging System, Model: 300L. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study proving the device meets specific acceptance criteria with quantifiable metrics. Therefore, several aspects of your request (e.g., sample sizes for test and training sets, number and qualifications of experts, adjudication methods, MRMC study results, specific ground truth types) cannot be fully extracted from this document, as they pertain to clinical efficacy studies which were not conducted for this submission (as stated on page 10-11).
However, I can extract the acceptance criteria based on compliance with various international standards and reported performance in certain non-clinical tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criterion (Standard/Test) | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1 (Basic Safety and Essential Performance) | Complies with the standard. |
| Usability | IEC 60601-1-6 (Usability – Collateral Standard) & IEC 62366 (Application of Usability Engineering) | Complies with the standard. The usability engineering process demonstrated the product is "reasonably safe and effective for the intended users, intended uses, and intended use environments." |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 (EMC – Collateral Standard) | Complies with the standard. |
| Ultrasound Safety (Acoustic Output) | IEC 60601-2-37 (Particular requirements for ultrasonic equipment) & IEC 62359 (Field Characterization) & NEMA UD3 (Acoustic Output Measurement Standard) | Complies with standards. Acoustic output exposure levels were measured and calculated following NEMA UD3 and "met FDA levels." |
| Clinical Measurement Range & Accuracy | Internal "performance criteria" (tested with a phantom) | Resolutions were evaluated, and "results met performance criteria." (Specific range/accuracy values not provided) |
| Display Performance | Internal "performance specifications" (assessed with various mobile devices) | Test results "demonstrate that the device meets performance specifications." (Specific metrics/values not provided) The display ranges from 4 to 10 inches, similar to predicate devices. |
| Failure Mode & Risk Analyses | ISO 14971 (Application of Risk Management to Medical Devices) | Conducted FMEA and risk analysis. "All identified hazards were reduced to acceptable levels." |
| Biocompatibility | ISO 10993-1 (Biological Evaluation of Medical Devices) | Patient-contacting surfaces (probe nosepiece and lens) evaluated for cytotoxicity, skin irritation, and skin sensitization. Test results "demonstrate that the patient-contacting surfaces of the probe are biocompatible." These are identical to the predicate device 300C. |
| Software Evaluation & Cybersecurity | IEC 62304 (Medical Device Software Life-Cycle Processes) | Validation and verification activities were conducted. Cybersecurity evaluation was done. "The software passed its performance requirements and met specifications." |
| Other Standards Compliance | ISO 15223-1 (Symbols for Medical Device Labels) | Ensured compliance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: This document explicitly states, "Clinical tests and animal studies - not conducted" on page 10 and 11. Therefore, there is no clinical test set of patients or medical images that would have a sample size for evaluating the AI component (if any) or reader performance. The non-clinical tests predominantly used phantoms or focused on technical compliance.
- Data Provenance: Not applicable, as no clinical data for a "test set" was used for performance evaluation. The compliance tests were conducted on the device hardware and software.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts & Qualifications: Not applicable. Since no clinical tests were conducted and no patient data was used to establish a 'ground truth' for diagnostic performance, no experts were needed for this purpose.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable, as no clinical test set requiring expert adjudication for ground truth establishment was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The document states, "The Healcerion SONON Ultrasound Imaging System ultrasound system does not introduce new indications for use, modes, features, or technologies relative to the predicate devices that would require evaluation through clinical or animal testing." This implies no human-in-the-loop performance evaluation against a baseline or with AI assistance was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: The document does not describe a standalone algorithm performance study for diagnostic accuracy using patient data. The device is an ultrasound imaging system, and the "software" referenced runs as an app providing image capture, review, and display functionalities for a human user, not an autonomous diagnostic algorithm. Its performance evaluation was based on meeting technical specifications, not diagnostic accuracy.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the non-clinical performance tests mentioned (e.g., Clinical Measurement Range and Accuracies), the "ground truth" would be established by the known physical properties of the phantom used for testing or the defined parameters of the technical standards (e.g., known acoustic output levels, specified electrical safety limits). No clinical ground truth (e.g., pathology, outcomes data, expert consensus on patient images) was used for performance validation in this submission.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The document describes a medical device (ultrasound system) that relies on established ultrasound physics and engineering principles, with software providing image display and control. It does not mention any machine learning or AI models that would require a "training set" of data for development.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as no training set was used.
§ 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.