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510(k) Data Aggregation
(226 days)
SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System
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 Abdominal, Neonatal Cephalic, Adult Cephalic, Cardiac Adult, Cardiac Pediatric.
The Digital Color Doppler Palm Ultrasound System is intended for use in environments where is provided by healthcare professionals.
The SonoEye P3/ SonoEye V3/ SonoEye G3 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 SonoEye P3/ SonoEye V3/ SonoEye G3 Digital Color Doppler Palm Ultrasound System is a portable system facilitating point of care ultrasound applications. The SonoEye P3 Series 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 P3, SonoEye V3, SonoEye G3 Phase array USB transducer
The provided text does not include information about AI/ML models or clinical studies involving human readers and AI assistance. Instead, it describes a 510(k) Premarket Notification for a medical device (Digital Color Doppler Palm Ultrasound System) and demonstrates its substantial equivalence to predicate devices, primarily through non-clinical testing and comparison of technical specifications.
Therefore, many of the requested categories for AI/ML model acceptance criteria and study design cannot be filled from the provided document. The document explicitly states: "No clinical testing was required." This indicates that the FDA clearance for this device was based on demonstrating similar technical and safety characteristics to already approved devices, rather than a clinical effectiveness study involving human users or AI.
However, I can extract the information that is present according to the prompt's structure:
Device: SonoEye P3/ SonoEye V3/ SonoEye G3 Digital Color Doppler Palm Ultrasound System
1. A table of Acceptance Criteria and the Reported Device Performance
Based on the provided document, the acceptance criteria are adherence to recognized medical device safety and performance standards and demonstration of substantial equivalence to predicate devices. The "reported device performance" is primarily the statement of compliance with these standards and the comparison of specifications.
| Category | Acceptance Criteria (Stated Requirements/Standards Met) | Reported Device Performance (as stated in the 510(k) summary) |
|---|---|---|
| General Compliance | Substantial equivalence to legally marketed predicate devices. | Concluded as substantially equivalent to predicate devices (Lumify Diagnostic Ultrasound System K192226, Clarius Ultrasound System K192107, TE7 Diagnostic Ultrasound System K160381) with regard to safety and effectiveness. |
| Electrical Safety | Compliance with IEC 60601-1 (Medical Electrical Equipment - Part 1: General Requirements for Safety) and ANSI/AAMI ES60601-1:2005. Transducers to meet Type BF isolated applied part requirements. When used with IEC 60950-1 compliant COTS devices, the system meets IEC 60601-1 Class II requirements. | Transducer and software, with representative device, verified compliant with IEC 60601-1. Transducers meet Type BF isolated applied part requirements. When used with IEC 60950-1 compliant COTS devices, the system meets IEC 60601-1 requirements for Class II equipment. The subject device passed hardware test for voltage and complied with IEC60601-1 & IEC60601-2-37 requirements. Passed temperature test and complied with IEC60601-1 & IEC60601-2-37 requirements. Complied with humidity requirements (IEC60601-1 & IEC60601-2-37) and within normal range. |
| EMC | Compliance with IEC 60601-1-2: 2014 (Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests). Classified as Group 1, Class A equipment per CISPR 11 for radiated and conducted electromagnetic disturbances. When used with IEC 55032 compliant COTS devices, the system meets IEC 60601-1-2 requirements for Group 1, Class A. | Transducer and representative Android device classified as Group 1, Class A equipment in accordance with CISPR 11. When used with IEC 55032 compliant COTS devices, the system meets IEC 60601-1-2 requirements for Group 1, Class A equipment. |
| Biocompatibility | Compliance with ISO 10993-1:2009 (Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process) and FDA guidance "Use of International Standard ISO 10993-1..." | Device found to conform to applicable medical device safety standards in regards to biocompatibility, and conforms to ISO 10993-1. |
| Ultrasound Specific | Compliance with IEC 60601-2-37: 2007 (Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment) and FDA guidance "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers". Acoustic Output: Track 3; Ispta.3 ≤ 720 mW/cm², MI ≤ 1.9, TI ≤ 6.0. | Device found to conform to applicable medical device safety standards in regards to thermal and mechanical safety, and fulfills the requirement of IEC 60601-2-37. Acoustic output meets criteria (Track 3; Ispta.3 ≤ 720 mW/cm², MI ≤ 1.9, TI ≤ 6.0). |
| Software | Compliance with FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Moderate Level of Concern) and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices". COTS Android devices: output current ≥ 1.5A, output voltage 5V±5%, full compliance with USB 2.0 standard. Representative Android devices (Samsung Galaxy A70s, Huawei MatePad Pro) configured as specified (CPU, RAM, ROM, resolution, WLAN, OS, Bluetooth). | Software Documentation for a Moderate Level of Concern included. Representative Android devices meet specified current, voltage, and USB 2.0 compliance. Samsung Galaxy A70s and Huawei MatePad Pro configurations are detailed. |
Note: The performance metrics provided relate to the operational specifications of the device (e.g., depth range, shades of gray, gain, focus, measurement types, transducer types, acoustic output limits, power requirements) and were deemed "Same" or had "SE (Substantial Equivalence) Analysis" where differences were addressed and determined not to affect safety or effectiveness.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of this 510(k) summary, as it explicitly states "No clinical testing was required." The "testing" referred to is non-clinical verification of compliance with standards and comparison to predicate devices, not a study on a human patient population or a dataset for AI.
- Data Provenance: Not applicable, as there was no clinical test set data. The device itself is manufactured in China (CHISON Medical Technologies Co., Ltd., Wuxi, Jiangsu, China).
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 as "No clinical testing was required" and therefore no human expert-established ground truth was part of the submission for clinical performance. The ground truth for engineering/safety testing would be derived from standard test equipment and protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no clinical test set requiring adjudication was performed.
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 done. The document explicitly states "No clinical testing was required." This premarket notification is for a general diagnostic ultrasound system, not an AI-powered diagnostic aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone algorithm performance study was done. This device is a hardware ultrasound system with integrated software, not an AI algorithm intended for standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests conducted (electrical safety, EMC, biocompatibility, acoustic output), the "ground truth" would be the specifications and requirements defined by the international standards (IEC, ISO, ANSI/AAMI, CISPR) and FDA guidance documents. These are objective engineering and physical measurements. Clinical ground truth for diagnostic accuracy was not established or required for this 510(k) clearance.
8. The sample size for the training set
- Not applicable, as there is no mention of an AI/ML model for which a training set would be used.
9. How the ground truth for the training set was established
- Not applicable, as there is no mention of an AI/ML model requiring a training set.
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