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The Digital Color Doppler Palm Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), B/M, Color Doppler, Combined(B+Color), Pulsed Wave and Fusion Harmonic Imaging modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Pediatrics, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid.

The Digital Color Doppler Palm Ultrasound System is intended for use in environments where is provided by healthcare professionals.

The SonoEye P1/ SonoEye P1-G/ SonoEye V1-G/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System is a mobile, general purpose, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. The Digital Color Doppler Palm Ultrasound System is a portable system facilitating point of care ultrasound applications.

The 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 P1, SonoEye V1, SonoEye G1, SonoEye P1-G, SonoEye V1-G, SonoEye G1-G Linear array USB transducer.

The provided text is a 510(k) Summary for the CHISON Medical Technologies Co., Ltd. SonoEye P1/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study (or lack thereof) to prove the device meets these criteria, based only on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" in the format of specific performance metrics with target values. Instead, it demonstrates compliance by comparing the subject device's features and safety adherence to those of legally marketed predicate devices. The "acceptance criteria" are implied to be the standards and functionalities met by the predicate devices and general medical device regulations.

The provided comparison table shows similarities in various aspects between the subject device and the predicate devices. Below is a summarized table reflecting the reported device performance as per the comparison table, where "Same" indicates alignment with predicate devices, and specific values are given where differences are noted.

Table 1: Reported Device Performance vs. Implied Acceptance Criteria (via Predicate Comparison)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "No clinical testing was required." This indicates that there was no test set involving human subjects or clinical data for performance evaluation in the usual sense of a clinical study. The evaluation focused on non-clinical tests and comparisons to predicate devices. Therefore, information on sample size, data provenance, or retrospective/prospective nature of a clinical test set is not applicable.

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)

Since no clinical testing was performed, there was no "test set" in the context of clinical images requiring ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical testing and no clinical test set were 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

Not applicable. The device is a "Digital Color Doppler Palm Ultrasound System," which is a diagnostic imaging system, not an AI-assisted diagnostic tool for interpretation. The document does not mention any AI capabilities or MRMC studies.

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

Not applicable. The device is an ultrasound system with human-in-the-loop operation for image acquisition and interpretation. There's no "algorithm only" performance reported in the context of a diagnostic interpretation task. The non-clinical tests indicate standalone performance of the device in terms of safety and technical specifications, but not diagnostic accuracy of an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no clinical testing was performed for diagnostic accuracy. The ground truth for the non-clinical tests would be the established engineering and safety standards (e.g., IEC 60601-1, ISO 10993-1) against which the device's technical performance was measured.

8. The sample size for the training set

Not applicable. The document does not indicate the use of machine learning or AI models requiring a training set for diagnostic purposes. The software mentioned is a "CHISON Ultrasound software" running as an Android app, which enables the device's functionalities, not a learning algorithm.

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

Not applicable, as no training set for AI/ML was mentioned or implied.

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The Digital Color Doppler Palm Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), B/M, Color Doppler, Combined(B+Color), Pulsed Wave and Fusion Harmonic Imaging modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Pediatrics, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid.

The Digital Color Doppler Palm Ultrasound System is intended for use in environments where healthcare is provided by healthcare professionals.

The SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System is a mobile, general purpose, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. The SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System is a portable system facilitating point of care ultrasound applications. The 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 P2, SonoEye V2, SonoEye G2 Linear array USB transducer

The provided FDA 510(k) summary (K201967) for the CHISON SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System does not contain information regarding acceptance criteria or a study proving the device meets specific performance criteria for AI-assisted image analysis.

The document focuses on demonstrating substantial equivalence to predicate devices for its general diagnostic ultrasound imaging capabilities, particularly in B (2D), B/M, Color Doppler, Combined (B+Color), Pulsed Wave, and Fusion Harmonic Imaging modes. The non-clinical tests mentioned primarily relate to electrical, mechanical, thermal, electromagnetic compatibility, and biocompatibility safety, as well as acoustic output.

Specifically, the document states:

• "No clinical testing was required." This indicates that no clinical study was performed to assess the device's diagnostic performance, let alone an AI component.
• The "Comparison Analysis" and "Substantially Equivalent Conclusion" sections primarily compare the device's technical specifications and operating controls to predicate devices, noting differences in value ranges (e.g., depth, voltage, temperature, humidity) and confirming compliance with safety standards (IEC60601-1, IEC60601-1-2, IEC60601-2-37, ISO 10993-1).

Therefore, based on the provided text, I cannot extract the requested information about acceptance criteria and a study proving a device's performance, as such details are not present for an AI component. The device described appears to be a diagnostic ultrasound system whose substantial equivalence is established through engineering and safety comparisons, not performance metrics from a clinical or AI evaluation study.

If an AI component is implied, it is not explicitly detailed with performance metrics or studies in this document. The listed product codes (IYN, IYO, ITX) are for general ultrasonic imaging systems and transducers, not specifically for AI/CADx devices.

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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.

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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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 Cardiac, Abdomen. The Digital Color Doppler Palm Ultrasound System is intended for use in environments where healthcare is provided by healthcare professionals.

The SonoEye P6/SonoEye V6/SonoEye G6 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 P6/SonoEye V6/SonoEye G6 is a portable system facilitating point of care ultrasound applications. The 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 P6/SonoEye V6/SonoEye G6 support Convex array transducer.

This is a 510(k) summary for a medical device (SonoEye P6/SonoEye V6/SonoEye G6 Digital Color Doppler Palm Ultrasound System) and does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the way typically found for an AI/ML medical device.

The document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria for a novel AI function. As such, many of the requested fields cannot be filled.

Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:

1. A table of acceptance criteria and the reported device performance

The document does not present a table of specific quantitative acceptance criteria or reported performance for the SonoEye P6/SonoEye V6/SonoEye G6 Digital Color Doppler Palm Ultrasound System in terms of diagnostic accuracy (e.g., sensitivity, specificity for detecting particular conditions). Instead, it establishes substantial equivalence by comparing its features and compliance with safety standards to predicate devices.

The comparisons provided are primarily focused on:

• Indications for Use: The submitted device has a more limited set of indications (Cardiac, Abdomen) compared to the predicate devices, but these are "Same" as a subset of the predicate's indications.
• Design and Operating Controls: Features like color processing, Doppler processing, probe types, cine playback, image archiving, gain, focus, ROI adjustment, freeze control, and operation modes are largely deemed "Same" or comparable in design. Differences in value ranges for depth and power requirements are noted but considered substantially equivalent due to compliance with relevant electrical and medical standards.
• Safety Compliance: The device conforms to the same international safety standards (ANSI/AAMI ES60601-1, IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2, ISO 10993-1) as the predicate devices.
• Acoustic Output: All devices are Track 3 and have similar maximum ISPTA.3 (≤ 720 mW/cm²) and MI (≤ 1.9), and TI (≤ 6.0 in the submission device's case, continuously displayed for one predicate, but generally aligned within safety limits).

Since this is a substantial equivalence submission for a diagnostic ultrasound system (not an AI/ML algorithm with specific diagnostic performance tasks), direct quantitative "acceptance criteria" for diagnostic accuracy are not presented in this document. The "acceptance criteria" are implicitly the demonstration that the device's characteristics and performance are comparable to (substantially equivalent to) legally marketed predicate devices, particularly concerning safety and effectiveness according to established standards.

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

Not applicable. The document explicitly states: "No clinical testing was required." Therefore, there is no test set for clinical performance mentioned. The "tests" performed were non-clinical (electrical, mechanical, thermal, electromagnetic compatibility, biocompatibility, and acoustic output).

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

Not applicable, as no clinical testing was performed for this submission.

4. Adjudication method for the test set

Not applicable, as no clinical testing was performed for this submission.

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

Not applicable. This device is a Digital Color Doppler Palm Ultrasound System, not an AI-assisted diagnostic tool in the sense of an AI/ML algorithm for image interpretation that would enhance human reader performance. No MRMC study or AI assistance effect size is mentioned.

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

Not applicable. This device is a diagnostic ultrasound system, which inherently involves a human operator acquiring and interpreting images. It is not an "algorithm only" device within the context of AI/ML performance.

7. The type of ground truth used

Not applicable, as no clinical testing for diagnostic performance was conducted. The "ground truth" referenced in the provided text relates to compliance with engineering and safety standards, where the "truth" is whether the device meets the specified technical and safety requirements.

8. The sample size for the training set

Not applicable. This document does not describe the development or training of an AI/ML algorithm.

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

Not applicable. This document does not describe the development or training of an AI/ML algorithm.

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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 Fetal, Abdominal, OB/GYN, Urology, Cardiac.
The Digital Color Doppler Palm Ultrasound System is intended for use in environments where healthcare is provided by healthcare professionals.

The SonoEye P5/ SonoEye V5/ SonoEye G5 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 Digital Color Doppler Palm Ultrasound System is a portable system facilitating point of care ultrasound applications.
The SonoEye P5/ SonoEye V5/ SonoEye G5 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 P5/ SonoEye V5/ SonoEye G5 Convex array USB transducer

This is an FDA 510(k) summary for the SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System. It details the device's substantial equivalence to predicate devices, but it does not contain any information about acceptance criteria or a study proving the device meets those criteria, as it is not an AI/ML device needing such validation.

Here's a breakdown of why the requested information is not present and what is provided:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with general medical device safety standards. It does not provide specific performance metrics or acceptance criteria for an AI/ML component.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This premarket notification does not involve an AI/ML device that would require clinical validation with a test set of data.

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. Ground truth establishment for an AI/ML test set is not part of this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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: Not applicable. This device is not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no mention of a standalone algorithm for diagnostic performance.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable. There is no mention of an AI/ML component requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Information that is provided in the document:

The document outlines the submission for a Digital Color Doppler Palm Ultrasound System, which is a general diagnostic ultrasound system. It demonstrates substantial equivalence to predicate devices (Lumify Diagnostic Ultrasound System, Clarius Ultrasound System, TE7 Diagnostic Ultrasound System) by comparing:

• Indications for Use: The device has similar indications for use (Fetal, Abdominal, OB/GYN, Urology, Cardiac) as the predicate devices.
• Design: It uses similar autocorrelation for color processing and FFT for pulse Doppler processing, supporting convex probes, and features like cine playback and image archiving.
• Operating Controls: Similar controls such as TGC (STC), Depth Range, shades of gray, Gain, Focus, Color box size/position, Baseline, Cine control, and Freeze control. Some differences in value ranges for depth, gain, etc., are noted but deemed substantially equivalent.
• Safety Compliance: The device conforms to applicable medical device safety standards like ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993-1, which are the same standards adhered to by the predicate devices.
• Operation Modes: Similar modes including B mode, PW mode, B/M mode, CFM mode, and Fusion Harmonic Imaging (FHI).
• Measurements and Reporting: Similar measurement capabilities (2D distance, area, circumference, volume, M-mode, PW-mode measurements) and reporting packages (Vessel, Abdomen, Obstetrics, Cardiac reports, General report).
• Transducer Types: The submission device uses Convex Array USB interface, compared to various array types in the predicate devices.
• Users/Sites: Intended for use in hospitals and clinics, similar to predicates.
• Acoustic Output: Compliant with Track 3, Ispta.3 ≤ 720 mW/cm², MI ≤ 1.9, TI ≤ 6.0, consistent with predicate devices.
• Power Requirements: Differences in specific voltage, humidity, and temperature ranges are discussed, but the device passed relevant hardware tests and complies with safety standards, leading to a conclusion of substantial equivalence.

In summary, this FDA 510(k) submission establishes the safety and effectiveness of a conventional ultrasound system by demonstrating its substantial equivalence to already legally marketed devices, focusing on technical specifications, operational features, and compliance with general medical device safety standards, rather than AI/ML performance criteria.

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