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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 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, testes, thvroid), heart soft tissue, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, and Ob/Gyn.

The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal/QB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Cardiac (adult & pediatric); Peripheral Vascular, Musculo-skeletal Conventional & Superficial, Transrectal and Transvaginal.

This device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen; Pediatric; Small Organ (breast, testes, thyroid); heart soft tissue; Peripheral Vascular; Musculo-skeletal; Ob/Gyn and Urology.

The device is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Abdomen, Cardlac, Small Organ (breast, thyroid), heart soft tissue, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, Ob/Gyn, Trans-rectal, Trans-vaginal, Urology.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organ (Breast, Thyroid, Testes), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Ob/GYN, Cardiac Adult, Cardiac Pediatric, Peripheral vessel.

The UP600 diagnostic doppler ultrasound system is a compact and portable diagnostic ultrasound device, have integrated preprogrammed color ultrasound imaging system, capable of producing a resolution intended for clinical diagnostic imaging applications. The user interface includes a specialized control kevboard and color 15-inch LCD display. The digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the in depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows system integration to a variety of upgrade-able options and features.

The provided text is a 510(k) Premarket Notification Summary for the BenQ Medical Technology UP600 Diagnostic Doppler Ultrasound System. This document does not describe specific acceptance criteria and a study proving the device meets those criteria in the typical format expected for AI/ML device evaluations. Instead, it focuses on demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway.

Therefore, many of the requested elements (sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable or extractable from this specific document, as it predates the widespread regulatory expectations for AI/ML device evaluations.

Here's a breakdown of what can be extracted, along with explanations for what cannot:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria (e.g., specific sensitivity, specificity, or image quality metrics) or report performance against such criteria. Instead, it relies on demonstrating comparable technological characteristics and intended uses to legally marketed predicate devices. The "performance" aspect is implicitly shown by comparison to these predicate devices rather than through specific quantitative metrics presented for the UP600 itself.

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

This information is not provided in the document. As a premarket notification for a general ultrasound system based on substantial equivalence, the submission primarily focuses on technical specifications, safety standards, and comparison to existing devices rather than clinical study data with specific test sets.

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)

This information is not provided in the document. No specific clinical test set requiring expert ground truth is described.

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

This information is not provided in the document. No specific clinical test set requiring adjudication is 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

A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it applicable for this type of device submission. The UP600 is a diagnostic ultrasound system, a hardware device, and does not incorporate AI/ML functionality that would assist human readers in image interpretation. Therefore, there is no "AI vs without AI assistance" comparison.

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

A standalone performance evaluation of an algorithm was not performed, nor is it applicable. The UP600 is a diagnostic ultrasound system, not an algorithm, and is intended for use by a qualified physician (human-in-the-loop).

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

This information is not provided in the document. No specific ground truth for performance evaluation is mentioned, as the focus is on substantial equivalence.

8. The sample size for the training set

This information is not provided in the document. This device is a hardware system, not an AI/ML algorithm that would typically have a training set.

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

This information is not provided in the document. Not applicable for this hardware device.

Summary of the Study (or lack thereof, in the context of AI/ML evaluation):

The BenQ Medical Technology UP600 Diagnostic Doppler Ultrasound System's acceptance was based on a demonstration of substantial equivalence to legally marketed predicate devices (BenQ Medical Technology UP600 K121983, GE Healthcare Voluson i K053435, and CGMC OPUS 5000 K102989). This is the primary "study" or justification presented in the 510(k) summary.

The document highlights the following to support substantial equivalence:

• Comparable Indications for Use: The UP600 and its transducers are intended for the same clinical applications as the predicate devices.
• Similar Technological Characteristics: The UP600 shares core operational principles (applying high voltage burst to piezoelectric material, detecting reflected echoes, constructing 2D B-mode, Doppler color, and Doppler spectrum images) and many features (display modes, measurements, transducer types) with the predicate devices. Some features, like the 128-channel digital beam former, are even identical to one predicate (GE Voluson I) and an improvement over another (CGMC OPUS 5000).
• Compliance with Safety Standards: The device meets recognized national and international safety standards (NEMA UD 2, NEMA UD 3, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 10993-1).
• Equivalent Acoustic Output: The acoustic output levels are identical to the predicate devices and stated to be below applicable FDA limits ("Track 3; MI, TIS, TIC, TIB. Derated Ispta: 720mW/cm2 maximum," etc.).
• Biocompatible Patient Contact Materials: Materials used for patient contact are compliant with ISO10993-5 (a standard for biological evaluation of medical devices).

The 510(k) summary concludes that "The UP600 is substantially equivalent in safety and effectiveness to the predicate systems." This implies that by meeting the technical and safety specifications and having comparable intended uses to already cleared devices, it is deemed safe and effective without the need for extensive clinical performance studies that would typically involve test sets, expert ground truth, or AI-specific evaluations.

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