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The NUSONO Handheld Ultrasound Scanner is a portable and software-based ultrasound imaging system, indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:

NUSONO-C35

Fetal, Abdominal, Pediatric, Urology, Gynecology, Lung

NUSONO-L75

Pediatric, Small Organ (Thyroid, Prostate, Scrotum, Breast), Musculoskeletal (Superficial and Conventional), Peripheral Vessel, Others (Carotid), Lung

NUSONO-P25

Fetal, Abdominal, Pediatric, Urology, Gynecology, Cardiac (adult and pediatric), Lung

The system provides diagnostic ultrasound imaging in B mode, M mode, Color Doppler mode, Power Doppler mode and combine mode (B+M. B+CD. B+PD), intended for use in environments where healthcare is provided by trained healthcare professionals. The environments where the system can be used include physician offices, clinics, hospitals, and clinical point of care for diagnosis of patients except environments where intensity of electromagnetic disturbances is high.

The NUSONO Handheld Ultrasound Scanner is a portable, software-controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through an off-the-self (OTS) iOS 14, 15 and Android 12 or higher versions based mobile device. The system consists of a series of wireless transducers employing Wi-Fi-based technology to communicate with the NUSONO App on traditional smartphone/tablet devices via direct Wi-Fi. The NUSONO App provides the interface for mode/setting control and image display, acquisition, and storage functions. The 128-channel beamformer and image signal processing technology maximize the utility of all imaging transducer elements to enhance the diagnostic utility and confidence provided by the system.

The provided document describes the regulatory submission for the NUSONO Handheld Ultrasound Scanner, not a study evaluating its acceptance criteria. Therefore, most of the requested information cannot be extracted from the provided text.

Specifically:

• Acceptance Criteria and Reported Device Performance: The document does not list specific clinical acceptance criteria (e.g., sensitivity, specificity, accuracy for a particular diagnostic task) or the device's measured performance against such criteria. It notes non-clinical performance tests for compliance with general medical device standards.
• Sample size and data provenance for the test set: Not applicable as a clinical study proving acceptance criteria is not detailed.
• Number of experts and qualifications for ground truth: Not applicable.
• Adjudication method for the test set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
• Standalone (algorithm only) performance: Not explicitly discussed in terms of a clinical study.
• Type of ground truth: Not applicable as no clinical study is presented.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

The document focuses on demonstrating substantial equivalence to predicate devices through a comparison of intended use, technological characteristics, and compliance with non-clinical performance standards (electrical safety, EMC, software, biocompatibility, etc.). It explicitly states: "The NUSONO Handheld Ultrasound Scanner did not require clinical testing to establish substantial equivalence."

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The EdgeLife Handheld Wireless Ultrasound System is a general-purpose, handheld, wireless, portable softwarecontrolled ultrasonic diagnostic system that uses pulsed-echo technology to acquire and display ultrasound data in B-Mode, M-Mode, Color Doppler, and Pulse-Wave Doppler (PW) modes. The EdgeLife Handheld Wireless Ultrasound System is intended for diagnostic ultrasound echo imaging, measurement, and fluid flow analysis of the human body for the following clinical applications.

The specific clinical applications and exam types for the linear transducer include vascular, musculoskeletal (conventional and superficial), small organs, thoracic/lung, abdominal, intraoperative (excluding neurological, central nervous system, non-central cardiovascular system), urology, gynecology, pediatric, fetal, peripheral vessel, carotid, interventional and procedure guidance of needles into the body.

The specific clinical applications and exam types for the convex transducer include: abdominal, pulmonary, thoracic, intra-operative (abdominal organs & vascular), pediatric, small organ, urology, obstetrics, musculoskeletal (conventional and superficial), vascular, carotid, and cardiac (adult and pediatric).

The specific clinical applications and exam types for the Endocavitary transducer include gynecology, obstetrics, urology, transvaginal, transrectal, and interventional procedures.

The system is a portable ultrasound system intended for use in environments where is provided by trained healthcare professionals.

The EdgeLife Handheld Wireless Ultrasound System is a general-purpose, handheld, wireless, portable software-controlled ultrasonic diagnostic system that uses pulsed-echo technology to acquire and display ultrasound data in B-Mode, M-Mode, Color Doppler, and Pulse-Wave Doppler (PW) modes.

The EdgeLife Ultrasound Scanner receives instructions from and transmits images to the EdgeLife Ultrasound App running on a paired mobile device that utilizes the iOS operating system via wireless Wi-Fi communication.

The system is a transportable ultrasound system intended for use in environments where healthcare is provided.

The EdgeLife Handheld Wireless Ultrasound System consists of:

• EdgeLife Handheld Ultrasound Scanner:
  • o Model E8200 with convex and linear transducers
  • o Model E8220 with convex and endocavitary transducers
• EdgeLife Ultrasound App .
• Standard off-the-shelf Wireless Qi charger (not a medical device) ●

The provided text is a 510(k) summary for the EdgeLife Handheld Wireless Ultrasound System (models E8200 and E8220). This document describes the device, its intended use, and a comparison to a predicate device, along with non-clinical performance testing. It does not contain information about a study proving the device meets acceptance criteria related to its human-in-the-loop performance or algorithm-only performance for diagnostic tasks, as would be expected for a device incorporating AI for clinical decision support. Instead, the document focuses on the hardware and basic functional safety and effectiveness of the ultrasound system itself.

Therefore, many of the requested items (e.g., expert ground truth, adjudication, MRMC studies, effect size of AI assistance, standalone algorithm performance, training set details) are not present in the provided text. The document primarily describes the device's technical specifications and compliance with general medical device standards.

Here's a breakdown of what information is available based on the provided text, and what is missing:

Acceptance Criteria and Reported Device Performance

The document describes non-clinical performance testing to support the substantial equivalence of the device to its predicate. These are predominantly engineering and safety acceptance criteria, not diagnostic performance criteria for an AI or imaging algorithm.

Table of Acceptance Criteria (from Non-Clinical Performance Testing):

Study Details (based on available information):

1. Sample sizes used for the test set and the data provenance:

   • The document mentions "internal test methods" for measurement accuracy but does not provide specific sample sizes (e.g., number of measurements, phantoms, or clinical cases) or data provenance (country of origin, retrospective/prospective).
   • No clinical study with a "test set" in the context of diagnostic accuracy for an AI component is described. The "performance data" mentioned refers to non-clinical verification.

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

   • Not applicable as no diagnostic performance study involving expert ground truth is described.

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

   • Not applicable.

4. 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 or any study involving human readers with AI assistance is mentioned. The device is described as an "ultrasonic diagnostic system" to acquire and display data, not one with AI-driven diagnostic assistance.

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

   • No standalone algorithm performance study is mentioned. The device is an ultrasound system, not an AI diagnostic algorithm.

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

   • Not applicable, as no diagnostic performance validation is described. The "ground truth" for the non-clinical tests would be defined by the standards and phantoms used (e.g., known dimensions for measurement accuracy).

7. The sample size for the training set:

   • Not applicable, as no AI model requiring a training set is described within the scope of this FDA submission summary. The software validation is generic.

8. How the ground truth for the training set was established:

   • Not applicable.

Conclusion based on the provided text:

The provided 510(k) summary focuses on demonstrating the substantial equivalence of the EdgeLife Handheld Wireless Ultrasound System to a predicate device based on its technical specifications, intended use, and compliance with general medical device safety and performance standards (biocompatibility, electrical safety, EMC, acoustic output, cleaning/disinfection, and basic software/measurement validation). It does not describe any AI-related diagnostic function or a clinical study that evaluates the improvement of human readers with AI assistance, or the performance of an AI algorithm in a standalone capacity. Therefore, the specific criteria and study details requested for AI-driven devices are not present in this document.

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The Vave Wireless Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body.

The Vave Wireless Ultrasound System is intended to be used by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training.

The Vave Wireless Ultrasound System is a transportable system that is intended for use in environments where healthcare is provided by trained healthcare professionals (e.g., Hospital, clinic, medical office), home environment, roadlair ambulance and other environments where is provided. The Vave Charger is to be used in a stationary setting.

It is indicated for diagnostic ultrasound imaging in the following applications: Ophthalmic, Fetall Obstetrics, Abdominal (includes Gynecology, Renal, and Urology), Pediatric, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Small Organ (includes Breast, Thyroid, and Scrotum), Thoracic/Pleural, Cardiac Adult, Cardiac Pediatric, Peripheral Vessel and procedural guidance of needles into the body. The operating modes are B mode, M mode, B+M, B+C, CD mode.

The Vave Wireless Ultrasound System is a handheld ultrasound imaging system consisting of the following components: Ultrasound Probe, Display Application, Battery, and Batterv Charger.

The ultrasound probe (Model VA-0192), including its embedded software, is designed to acquire ultrasound image data and to wirelessly transmit the data to the display application software. The display application software runs on a commercial off-the-shelf mobile device. The operating system of the mobile device can be either iOS or Android. The ultrasound probe is completely wireless and is powered by a removable Li-ion battery (Model VA-0175). The battery is charged with a proprietary charging system (Model VCG).

The provided text describes the Vave Wireless Ultrasound System, its intended use, and a comparison to predicate devices, along with non-clinical testing conducted. However, it explicitly states that no clinical testing was done because the device introduces "no new indications for use, modes, features or technologies relative to the predicate device that require clinical testing."

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of clinical performance, as such a study was not conducted or reported for this submission. The information provided is primarily focused on demonstrating substantial equivalence through non-clinical testing and comparison to existing devices.

To address the prompt as much as possible with the provided information, I will focus on what was done (non-clinical testing) and explicitly state what was not done (clinical study to prove acceptance criteria).

Based on the provided FDA 510(k) summary (K241051), there was no clinical study conducted to prove the device meets acceptance criteria. The submission focuses on demonstrating substantial equivalence to predicate devices through a comparison of intended use, technological characteristics, and non-clinical testing.

The summary explicitly states: "The Vave Wireless Ultrasound system introduces no new indications for use, modes, features or technologies relative to the predicate device that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices."

Therefore, many of the requested details regarding a clinical study (e.g., sample size, ground truth establishment, expert qualifications, MRMC study, effect size) are not applicable or provided in this document.

Below, I will outline what is available regarding non-clinical acceptance criteria and testing, and explicitly mention where clinical information is not provided.

Acceptance Criteria and Device Performance (Non-Clinical)

The acceptance criteria for this device, as implied by the non-clinical testing section, are based on compliance with various international and national standards related to medical electrical equipment, electromagnetic compatibility, usability, battery safety, software life cycle, and biocompatibility. The "reported device performance" in this context is the successful demonstration of compliance with these standards.

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Compliance)

Information Not Available (Due to No Clinical Study Conducted)

1. Sample sizes used for the test set and the data provenance: Not applicable, as no clinical test set was used for performance evaluation (only non-clinical compliance testing).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method for the test set: Not applicable.
4. 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 an ultrasound system, and the submission does not mention any AI assistance features or human-in-the-loop performance studies.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is not an algorithm for performance evaluation.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
7. The sample size for the training set: Not applicable, as no clinical training set was mentioned or implied for performance evaluation of a clinical algorithm.
8. How the ground truth for the training set was established: Not applicable.

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The Leltek Ultrasound Imaging System (Model: LU700 Series) is a software-based imaging system and accessories intended for use by qualified physicians and healthcare professionals who has the ability to conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow analysis of the human body.

The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients

The modes of operation include B mode, PWD mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode (B+M, B+CD, B+PWD). Specific clinical applications and exam types including: LU700C General abdominal imaging, musculoskeletal (conventional), musculoskeletal (superficial), peripheral vessel and OB/Gyn. LU700L General abdominal imagine, small organ (breast, thyroid), musculoskeletal (superficial) and peripheral vessel. LU710C Fetal, abdominal, pediatric, small organ (thyroid, prostate, scrotum, breast), musculoskeletal (conventional), urology, gynecology, cardiac adult, cardiac pediatric and peripheral vessel. LU710M Fetal, abdominal, pediatric, small organ (thyroid, prostate, scrotum, breast), musculoskeletal (conventional), urology, gynecology, cardiac adult, cardiac pediatric and peripheral vessel. LU710PA Fetal, abdominal, pediatric, cardiac adult, cardiac pediatric. LU710E Fetal, abdominal, small organ (thyroid, prostate, scrotum, breast), trans-vaginal, urology, gynecology.

The Leltek Ultrasound Imaging System (Model: LU700 Series) is a portable, software controlled, handheld ultrasound system used to acquire and display hi-resolution, real-time ultrasound data through a commercial off-the-shelf (COTS) mobile device.

• l. The imaging system software runs as an app on a mobile device.
• II. The imaging system software can be download to a commercial off-the-shelf (COTS) mobile device and utilizes an icon touch-based user interface.
• III. The imaging system consists of a series of wireless transducers employing Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range portable personal device.
• IV. The imaging system houses a built-in battery, multichannel beamformer, prescan converter and Wi-Fi components

The device is intended for use in environments where healthcare is provided by trained healthcare professionals, but not intended for use in emergency medical service, ambulance, or aircraft.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K210432) is a 510(k) summary for premarket notification of a medical device (Leltek Ultrasound Imaging System). It focuses on establishing substantial equivalence to predicate devices rather than defining and meeting specific analytical or clinical performance acceptance criteria in the traditional sense of a clinical trial.

Therefore, the "acceptance criteria" here are compliance with recognized safety and performance standards and demonstrating similar performance characteristics to the predicate devices. The "reported device performance" is the system's demonstrated compliance with these standards and its functional equivalence.

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

The document does not provide details on specific sample sizes for a "test set" in the context of clinical performance or image-based evaluation.

Instead, the submission relies on:

• Compliance with recognized performance and safety standards: This implicitly means testing against defined criteria within those standards.
• Bench testing and engineering verification: "Acoustic output, biocompatibility, cleaning, and disinfection effectiveness as well as wireless, thermal, electromagnetic and mechanical safety" were evaluated by tests, but specific sample sizes for these tests are not mentioned.
• Substantial equivalence argument: The core of the 510(k) relies on demonstrating that the new device performs as safely and effectively as a legally marketed predicate device (K191235) and a reference device (K192107).

The data provenance is related to the testing performed to ensure compliance with the listed standards. This would typically be internal testing by the manufacturer (LELTEK, Inc. in Taiwan) as part of their design, manufacturing, and quality control processes. The document does not indicate the use of external or clinical data for the performance evaluation in the way a clinical trial would. It states, "The Leltek Ultrasound Imaging System did not require clinical testing to establish substantial equivalence." (K210432, page 10).

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

Since the document explicitly states that clinical testing was not required, there was no "test set" in the clinical sense that would require expert-established ground truth for diagnostic accuracy. The evaluation focused on engineering, safety, and performance characteristics against established standards.

4. Adjudication Method for the Test Set

Not applicable, as a clinical "test set" requiring adjudication for diagnostic accuracy as described in the prompt was not part of this 510(k) submission.

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

No, an MRMC comparative effectiveness study was not done. The document states, "The Leltek Ultrasound Imaging System did not require clinical testing to establish substantial equivalence." (K210432, page 10). The submission is based on demonstrating technical and safety equivalence to predicate devices, not on a clinical comparison of diagnostic efficacy with human readers.

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

This question is not directly applicable in the context of this device. The Leltek Ultrasound Imaging System is an ultrasound imaging device, not an AI algorithm intended for automated diagnosis or interpretation. The "software" aspect refers to the app running on a mobile device and controlling the ultrasound hardware, not a standalone diagnostic algorithm. Therefore, "standalone" performance for an algorithm is not a relevant concept for this type of device based on the provided information.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Given that clinical testing for diagnostic performance was not required, there was no "ground truth" of the type typically used for evaluating diagnostic accuracy (e.g., pathology, surgical findings, long-term outcomes, expert consensus on images). The ground truth for this submission was based on:

• Engineering specifications and measurements: To ensure parameters like acoustic output, image quality (implied by functional equivalence), and electrical safety met defined standards.
• Biocompatibility testing results: Against ISO 10993 standards.
• Compliance with cleaning/disinfection protocols.

8. The Sample Size for the Training Set

Not applicable. This device is an ultrasound imaging system, and the submission does not describe it as an AI/ML-based diagnostic algorithm that would require a "training set" of data in the sense used for machine learning. The "software" is for image acquisition, processing, and display, not for learning to diagnose from a dataset.

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

Not applicable, as there is no mention of a "training set" for an AI/ML algorithm in this 510(k) submission.

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The Apache Ultrasound System is intended for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Abdominal, Fetal/Obstetric, Gynecological, Fetal Echo, Musculo-skeletal (conventional and superficial), Small Organ (including breast, scrotum, thyroid), Peripheral Vessel, Carotid, Urology, and Pediatric. The system provides diagnostic ultrasound imaging in B, Color Doppler, M, PW and Combined (B+M; B+CD) modes. The clinical environments where the system can be used include physician offices, clinics, and clinical point-of-care for diagnosis of patients except environments where intensity of electromagnetic disturbances is high. The Apache Ultrasound System is a portable ultrasound system intended for use in environments where is provided by trained healthcare professionals.

The Apache Ultrasound System is a portable color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications through wireless communication with an off-the-shelf (OTS) mobile device. This system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode, M-Mode, PW mode and Color Doppler or a combination of these modes.

The Apache Probe processes the ultrasound signal and transfers real-time scan image data to the Apache App through the wireless connection with the mobile device. The 64-channel beamforming architecture of the probe maximizes the utility of all imaging transducer elements to enhance the diagnostic utility and confidence provided by the system. The Apache App provides the interface for mode/setting control and image display, acquisition, and storage functions. The Apache App is compatible with Android and iOS based mobile devices. Verified devices include Samsung Galaxy Tab S6, Samsung Galaxy Tab S7, Samsung Galaxy S10, Samsung Galaxy S21, Google Pixel 4, HTC U11, LG G85 ThinQ, iPhone 11, iPhone 12, iPad Pro 11-inch (Gen2), and iPad Air (Gen4).

The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients except environments where intensity of electromagnetic disturbances is high.

The Apache Ultrasound System is a portable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals.

This FDA 510(k) summary for the Apache Ultrasound System does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving the device meets those criteria.

The document states that the Apache Ultrasound System is a "Track 3 system" and that its substantial equivalence is primarily determined by comparison to a predicate device (Clarius Ultrasound Scanner K192107), specifically focusing on non-clinical performance tests rather than clinical efficacy studies in the way you've outlined.

Here's a breakdown of what the document does provide, and what it lacks in relation to your specific questions:

Key Takeaways from the Document:

• Substantial Equivalence: The primary method for proving the device is acceptable is by demonstrating "substantial equivalence" to a legally marketed predicate device (Clarius Ultrasound Scanner K192107). This is a common pathway for medical devices where new clinical efficacy studies are not deemed necessary because the fundamental technology and intended use are similar to existing, cleared devices.
• Focus on Non-Clinical Tests: The document explicitly states: "Non-clinical performance tests include measurement accuracy, system sensitivity, thermal, mechanical, electrical safety, patient-contact materials, cleaning and disinfection, software and acoustic output. The non-clinical test results show the device is compliant with the following standards, and it is safe and effective for its intended use and performance."
• No New Indications/Technologies Requiring Clinical Testing: "Apache Ultrasound System introduces no new indications for use, modes, features, or technologies relative to the predicate devices (Clarius Scanner) that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices."

Addressing Your Specific Questions Based on the Provided Text:

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

   • Acceptance Criteria: The document lists standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, ISO 10993-1, IEC 62304, ISO 14971) that the device must comply with for non-clinical performance (electrical safety, EMC, usability, biological evaluation, software lifecycle, risk management). These standards implicitly define acceptance criteria in terms of meeting their requirements.
   • Reported Device Performance: The document states, "The non-clinical test results show the device is compliant with the following standards, and it is safe and effective for its intended use and performance." However, it does not provide a detailed table with specific numerical performance metrics (e.g., measurement accuracy values, sensitivity values) or thresholds for these non-clinical tests. It merely states compliance.

2. Sample sized used for the test set and the data provenance:

   • Not Applicable/Not Provided: Since the substantial equivalence is primarily based on non-clinical performance and a comparison to a predicate device without new clinical indications, there is no mention of a clinical test set sample size or data provenance (e.g., country of origin, retrospective/prospective clinical data). The testing described is laboratory-based non-clinical testing.

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

   • Not Applicable/Not Provided: This information pertains to studies involving human interpretation or ground truth establishment for diagnostic accuracy, which was explicitly not performed as a clinical study for this 510(k) submission.

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

   • Not Applicable/Not Provided: Same as above, not relevant for the type of submission described.

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: The document states, "Apache Ultrasound System introduces no new indications for use, modes, features, or technologies relative to the predicate devices (Clarius Scanner) that require clinical testing." This device is an ultrasound system itself, not an AI assisting human readers, and no MRMC study was performed as part of this 510(k) submission.

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

   • No: This device is a diagnostic ultrasound system, not an AI algorithm intended for standalone performance evaluation in the usual sense of algorithm-only accuracy. Its "performance" is in generating images and fluid flow analysis, and its safety and effectiveness are established through engineering and non-clinical tests to meet standards.

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

   • Not Applicable/Not Provided: For the non-clinical tests, "ground truth" would be defined by calibrated instruments, reference materials, and engineering specifications. It's not clinical "ground truth" (e.g., pathology, expert diagnosis).

8. The sample size for the training set:

   • Not Applicable/Not Provided: This refers to the training of an AI model. While the device (like any modern medical device) contains software, the 510(k) summary does not describe it as an AI/ML-driven device that underwent a training phase on a specific dataset for diagnostic interpretation. Its software lifecycle processes are governed by IEC 62304, which is about software engineering, not AI model training.

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

   • Not Applicable/Not Provided: Same as above.

In summary: The provided document is a 510(k) summary from the FDA, which outlines the basis for demonstrating "substantial equivalence" for a medical device. For the Apache Ultrasound System, this was primarily achieved through comparison to a predicate device and rigorous non-clinical testing against established safety and performance standards. It explicitly states that no new clinical efficacy testing was required because the device did not introduce new indications, modes, features, or technologies. Therefore, the detailed information about clinical studies, expert-derived ground truth, sample sizes for test/training sets, and AI-related performance metrics (like MRMC studies) you requested are not present in this type of submission for this particular device.

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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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