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The system is a general-purpose ultrasonic intended for use by a qualified physician for ultrasound evaluation/clinical analysis etc. It can be used in non-intrusive applications, including Abdomen, Cardiology, Gynecology, Obstetric, Breast, Thyroid, Musculoskeletal, Venous, Arterial), Nerve, Renal, and Urology. The clinical environments where the system can be used include clinics, hospitals, and clinical point of care for diagnosis of patients.

The system is intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the system user information, and only for the purposes for which it was designed. The system should only be operated by someone who has received proper training in the use and operation of an ultrasound system. This system produces images derived from sound echoes; those images must be interpreted by a qualified medical professional. This system in no way interprets these images or provides a medical diagnosis of the patient being examined.

The BenQ Diagnostic Ultrasound System (hereinafter called "system") is an easy-to-use, portable ultrasound imaging instrument intended for use by a qualified operator for ultrasound evaluation and clinical analysis. The user interface is touch screen with 13.3" display. The all-digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.

The major features of the BenQ diagnostic ultrasound:

• Compact size with 1 transducer sockets. Convertible cart-based svstem design.
• . 2D (B&M mode) with harmonic imaging
• Color Flow Imaging, Pulsed Wave Spectral Doppler, Steerable Continuous Wave Doppler, Power Doppler
• 13.3″ LCD supporting wide-viewing angle with multi-touch
• Support 64 channels, support up to 128 elements probes, and easy maintenance.
• High density transducers with frequency range from 2 to 15 MHz
• Full patient database solutions: DICOM3.0, MP4 /PNG, USB3.0, SSD, PDF report, etc.

The provided document is a 510(k) Premarket Notification from the FDA for a diagnostic ultrasound system. It details the device's indications for use, comparison to a predicate device, and summarization of non-clinical tests.

The document explicitly states: "The subject of this premarket submission, T3300, is not required clinical studies to support substantial equivalence." This means that the device was not evaluated through clinical studies with human subjects, and therefore, it does not contain the information requested in points 1-7 and 9 of your prompt.

The acceptance criteria mentioned in the document are primarily related to non-clinical performance and safety standards, not diagnostic accuracy derived from a test set of patient data with expert ground truth.

Here's an attempt to answer your questions based on the available information:

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

Since this is a 510(k) submission and clinical studies were not required, the "acceptance criteria" are compliance with recognized safety and performance standards for medical electrical equipment and diagnostic ultrasound systems. The "reported device performance" is its demonstration of conformance to these standards.

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, as no clinical test set was required or used for this 510(k) substantial equivalence determination.

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.

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 a diagnostic ultrasound system itself, not an AI-assisted interpretation tool. The document explicitly states, "This system in no way interprets these images or provides a medical diagnosis of the patient being examined."

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

Not applicable. This is a medical device (ultrasound system), not a standalone algorithm.

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

Not applicable. The ground truth for this submission was based on engineering and safety standard compliance, not clinical diagnostic accuracy.

8. The sample size for the training set

Not applicable, as no clinical training set was used for this 510(k) submission. The "training" in this context would refer to the engineering and design validation process against specified requirements and standards.

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

Not applicable for a clinical training set. For the non-clinical and engineering validation, "ground truth" was established based on internationally recognized standards and specifications for medical device performance and safety (e.g., IEC standards, ISO standards, AIUM guidelines). The manufacturer's design, development, and quality processes (conforming to 21 CFR 820 and ISO 13485) ensure that the device meets these established engineering and safety "ground truths."

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