Search Results

The SONON Ultrasound Imaging System (Model: SONON 300C) 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 system operating modes is B (Brightness), CF (color flow), PW (pulsed wave), M (motion). The intended to be used in a hospital or medical clinic is used by appropriately trained healthcare professionals, including radiologists, sonographers, technologists, and clinicians, in a medical facility.

The SONON Ultrasound Imaging System, Model: SONON 300C, is a wireless ultrasound system that uses pulsed-echo technology (frequency: 3.5 MHz; module: convex) to transmit ultrasound images via wireless communication to a mobile device that utilizes the iOS or Android, or PC that uses Windows operating system. The SONON Ultrasound Imaging System is a portable, general-purpose, softwarecontrolled, hand-held diagnostic ultrasound system that consists of (i) a commercial off-the-shelf iOS or Android mobile device, or Windows PC, (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, Android mobile device or Windows PC 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 PACS 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 B-Mode and Color Flow Doppler (CF Mode) Mode with 2-dimensional scan format. In addition, PW (pulsed wave) mode displays different wave velocities and directions in a spectrum. Moreover, in M mode (also known as "motion mode"), the changes over time on a line graph appears in a spectrum. All images and data collected are stored in the mobile app. If the app is removed and reinstalled, all stored information is lost and cannot be recovered. The SONON Ultrasound Imaging System 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 text does not contain information about acceptance criteria and the study proving the device meets them in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating substantial equivalence to a predicate device through engineering changes and performance tests related to safety, electrical, mechanical, and software aspects.

The document discusses the following types of performance criteria and tests, but not diagnostic performance criteria:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Diagnostic):

Missing Information (based on the provided text):

The document explicitly states:

• No clinical test nor animal study was performed to support substantial equivalence. Therefore, no information is available regarding:
  • Diagnostic performance acceptance criteria (e.g., sensitivity, specificity, accuracy).
  • Sample size used for a test set for diagnostic performance.
  • Data provenance for diagnostic performance.
  • Number of experts used to establish ground truth.
  • Adjudication method.
  • Multi Reader Multi Case (MRMC) comparative effectiveness study.
  • Standalone algorithm performance (as there's no diagnostic algorithm described for evaluation).
  • Type of diagnostic ground truth used.
  • Sample size for training set (as there's no mention of a training set for a diagnostic algorithm).
  • How ground truth for a training set was established.

The submission focuses entirely on bench testing and verification/validation of engineering changes compared to a predicate device, rather than a de novo clinical performance study of the device's diagnostic capabilities. The substantial equivalence argument relies on the fact that existing predicate devices have established safety and effectiveness for similar intended uses and the changes to the current device do not introduce new questions of safety or effectiveness.

Ask a specific question about this device

The SONON Ultrasound Imaging System (Model: SONON 500L) 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 thorax (thoracic/pleural motion and fluid detection imaging).

SONON 500L provides 4 modes: B (2D) mode, CF (Color Flow) mode, PW (Pulsed Wave) mode, M (Motion) mode.

SONON 500L is suitable for use in professional healthcare environment (hospital, clinic and medical office settings) by appropriately trained healthcare professional.

The SONON Ultrasound Imaging System, Model: SONON 500L, is a wireless ultrasound system that uses pulsed-echo / Doppler technology (Color Flow Doppler (CF Mode) / Brightness mode(2D B Mode) / Pulsed wave mode(PW Mode) / Motion mode(M mode); frequency: 4 MHz – 13MHz; module: linear; depth max: 6 cm) to transmit ultrasound images via wireless communication to a mobile device that utilizes the iOS or Android, or PC that uses Windows operating system.

The minimum requirements for the mobile devices that utilize the iOS, Android or Windows operating system for use with the SONON Ultrasound Imaging System, Model: SONON 500L are as follows:

Operating system versions

• iOS: iOS 11.0 or later
• Android: Android 5.0 (Lollipop) or later
• Windows (UWP): Windows 10 (64-bit) or later

Minimum specifications for mobile devices

• CPU: 1.7GHz
• Core: 8 cores
• RAM: 4GB
• Resolution: 2560 X 1600 (287ppi)

The SONON Ultrasound Imaging System is a TRACK 3, portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of
(i) a commercial off-the-shelf iOS or Android mobile device or Windows PC
(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 or Windows PC and
(iv) the instructions for use manual, battery, charger, and power cords.

The mobile application of SONON 500L, which controls the probe, imaging capabilities and functionalities, can be downloaded to an iOS, Android mobile device or Windows PC 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, and image annotation, as well as storage and PACS 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 B-Mode with 2-dimensional scan format. The software also allows the user to save / edit patient and diagnosis information. An identification and password are required for accessing the SONON 500L app via the mobile device or PC. All information captured is saved in the app. If the app is removed and reinstalled, all stored information is lost and cannot be recovered.

The SONON ultrasound device utilizes pulsed-echo technology to determine the depth and location of tissue interfaces. Ultrasound imaging requires mechanical oscillation of crystals excited by electrical pulses, generating a piezoelectric effect. A number of these crystals make up a transducer, which converts one type of energy into another. Using pulse-echo transformation by the piezoelectric crystals, an ultrasound transducer converts electricity into sound.

The SONON ultrasound device measures the duration of an acoustic pulse travelling from the transmitter to the tissue interface and back to the receiver. Ultrasound waves emitted from the transducer propagate through various tissues and return to the transducer as reflected echoes. These echoes are then converted into high-frequency electrical signals by the crystals in the transducer. Next, the signals are amplified and further processed by several analog and digital circuits and software filters to adjust the frequency and time response, in order to finally generate a series of digital images.

The device components are not supplied sterile and do not require sterilization prior to use.

Here's a breakdown of the acceptance criteria and the study information for the SONON Ultrasound Imaging System (Model: SONON 500L), based on the provided FDA 510(k) Clearance Letter.

Disclaimer: This document is a 510(k) summary, which generally provides limited detail on specific performance acceptance criteria and study methodologies compared to a full submission. Therefore, some information might be missing or generalized. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a novel device's performance against clinical endpoints.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list specific quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity values) or detailed reported device performance against such metrics. Instead, it relies on demonstrating compliance with recognized standards and established engineering practices, as well as showing substantial equivalence to predicate devices.

The acceptance criteria are generally framed around compliance with safety and performance standards and equivalency to predicate devices.

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

The document does not describe a "test set" in the context of clinical image data for evaluating diagnostic performance (e.g., sensitivity, specificity). The studies mentioned are primarily engineering verification and validation tests and compliance with standards.

• Sample Size for performance evaluation: Not applicable in the context of a diagnostic performance test set composed of patient data. Performance tests were bench tests using unspecified samples/units of the device.
• Data Provenance: Not applicable as no clinical image data set for diagnostic performance evaluation is described. The document indicates that no clinical studies or animal studies were conducted to support substantial equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. As noted above, no clinical studies with a diagnostic "test set" requiring expert-established ground truth were conducted.

4. Adjudication Method for the Test Set

Not applicable. No diagnostic test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "The subject of this premarket submission, SONON Ultrasound Imaging System (Model: SONON 500L), requires no clinical studies to support substantial equivalence." This implies there was no study comparing human readers with and without AI assistance for improved effectiveness.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. The SONON Ultrasound Imaging System is a hardware/software medical device that produces images for human interpretation. It is not an AI algorithm that provides a standalone diagnostic output. Therefore, an "algorithm only" performance would not be relevant in this context.

7. The Type of Ground Truth Used

For the engineering and safety tests, the "ground truth" was based on:

• Established standard requirements (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical and ultrasound safety, FDA acoustic output limits).
• Design specifications and functional requirements of the device itself (for "basic performance and the output of the ultrasound equipment").

No pathology, expert consensus on clinical images, or outcomes data were used as ground truth, as no clinical studies were performed.

8. The Sample Size for the Training Set

Not applicable. This device is an ultrasound imaging system, not an AI model that requires a "training set" of data for learning a diagnostic task. The software validation mentioned refers to the development and testing of the device's operating software, not an AI inference model.

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

Not applicable, as there is no "training set" for an AI model described. The software validation ensures that the device's software functions as intended and meets its specifications, rather than learning from data.

Ask a specific question about this device

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

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.

Ask a specific question about this device

The SONON Ultrasound Imaging System (Model: SONON 300C) 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 SONON Ultrasound Imaging System, Model: SONON 300C, is a wireless ultrasound system that uses pulsed-echo technology (frequency: 3.5 MHz; module: convex) 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, brightness, contrast, linear/elliptical measurement, 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 B-Mode. 2dimensional scan format. All images and data collected are stored in the mobile app. If the app is removed and reinstalled, all stored information is lost and cannot be recovered.

The SONON Ultrasound Imaging System 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 describes a 510(k) submission for the Healcerion Co., Ltd. SONON Ultrasound Imaging System (Model: SONON 300C). This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a dedicated study with performance metrics like accuracy, sensitivity, or specificity.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and ground truth establishment are not explicitly provided in this type of regulatory submission. This document highlights compliance with general safety and performance standards for ultrasound devices, but not the kind of detailed performance validation typically seen for AI/software-based diagnostics.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic task. Instead, it demonstrates compliance with recognized safety and performance standards relevant to ultrasound imaging systems.

• Results (Convex only transducer):
  • Ispta.3: 0.0627[W/cm2]
  • TIS: 0.2535
  • MI: 0.7861
  • Ipa.3@MImax: 11.6369[W/cm2]
• Conclusion: Below Track 3 FDA limits in accordance with Sept. 2008 ultrasound systems guidance document. |
  | Clinical Measurement Range and Accuracies | - Test: Used a phantom with vertical, dead zone, horizontal, and linear groups.
• Evaluation: Length and vertical/horizontal resolutions.
• Conclusion: Results met performance criteria (specific criteria not detailed). |
  | Display Performance | - Test: Assessed using various mobile devices.
• Conclusion: Test results demonstrate that the device meets performance specifications (specific specifications not detailed). Display ranges from 4 to 10 inches, similar to predicate devices. |
  | Electrical Safety, EMC, RF Wireless | - Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62359.
• Conclusion: Device complies with these international standards. |
  | Usability | - Process: Usability engineering process conducted to assess and mitigate risks from usability problems and user errors.
• Conclusion: Test results demonstrate the product is reasonably safe and effective for intended users, uses, and environments. |
  | Failure Mode and Risk Analyses | - Standard: ISO 14971.
• Process: FMEA and risk analysis performed. Hazards identified, risks estimated, and procedures implemented for control.
• Conclusion: All identified hazards were reduced to acceptable levels. |
  | Biocompatibility | - Standard: ISO 10993-1.
• Test: Patient-contacting surfaces (probe nosepiece and lens) evaluated for cytotoxicity, skin irritation, and skin sensitization.
• Conclusion: Test results demonstrate biocompatibility. |
  | Software Evaluation & Cybersecurity | - Standard: IEC 62304.
• Process: Validation and verification activities, cybersecurity evaluation.
• Conclusion: Software passed performance requirements and met specifications. |

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified for any clinical performance evaluation, as clinical tests were not conducted. For non-clinical tests like acoustic output or phantom studies, specific sample sizes (e.g., number of measurements or phantoms) are not provided.
• Data Provenance: Not applicable as clinical data was not used for the primary demonstration of substantial equivalence. The non-clinical tests would have been performed by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not provided. No clinical "ground truth" was established for a test set, as no clinical studies were performed (see "Clinical tests and animal studies - not conducted" under section 7 of the 510(k) Summary).

4. Adjudication method for the test set

• Not applicable, as no clinical test set requiring expert adjudication was used.

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

• No MRMC study was performed. The device is an ultrasound imaging system, and the submission focuses on its equivalence to existing ultrasound systems, not on its role as an AI-powered diagnostic aid for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• No standalone algorithm performance study was done for diagnostic accuracy. The "algorithm" here refers to the software controlling the ultrasound device and image display, not a diagnostic AI algorithm.

7. The type of ground truth used

• For the non-clinical performance evaluations (acoustic output, measurement accuracy, display performance), the "ground truth" would be established by the physical properties of the testing equipment, phantoms, and calibrated measurement devices, according to the specified standards (e.g., NEMA UD2-2004 for acoustic output). There is no "ground truth" in terms of expert consensus, pathology, or outcomes data mentioned, as no clinical studies were conducted.

8. The sample size for the training set

• Not applicable. This device is an ultrasound imaging system, not a machine learning model that would require a "training set" for diagnostic algorithm development. The software development follows a software life-cycle process (IEC 62304) and includes verification and validation activities, but this is distinct from training a machine learning model.

9. How the ground truth for the training set was established

• Not applicable, as no training set for a machine learning model was used.

Ask a specific question about this device