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The M9/M9CV/M9T Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, trans-esoph.(Cardiac), peripheral vessel , urology exams.

M9/M9T/M9CV is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, PW-Mode, PW-Mode, Color-Mode , Power/Dirpower Mode, THI, iScape mode, Color M, Elastography, LVO or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color). This system is a Track 3 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 3.0 MHz to 10.0 MHz.

The provided text describes a 510(k) summary for the Mindray M9/M9T/M9CV Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or extensive study results typical of novel AI/ML device submissions.

Therefore, much of the requested information (acceptance criteria, specific study results, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training) is not present in the provided document.

However, based on the non-clinical tests mentioned, we can infer the acceptance criteria for certain parameters, and the document explicitly states that clinical studies were not applicable.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for an ultrasound system demonstrating substantial equivalence to predicate devices, direct "acceptance criteria" and "reported device performance" in the context of a new algorithm's efficacy are not explicitly stated in a quantitative table format. Instead, the acceptance is implied by adherence to general safety and performance standards for ultrasound systems and comparable features to predicate devices.

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/Not provided. The submission explicitly states "Clinical Studies: Not applicable. The subject of this submission, M9/M9T/M9CV Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence." This means there was no test set of patient data in the context of demonstrating clinical efficacy for a new algorithm or diagnostic capability. The evaluation relied on non-clinical engineering and safety standards, and comparison of features to already cleared predicate devices.

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/Not provided. As no clinical studies or a test set requiring ground truth were conducted, this information is not relevant to this submission.

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

Not applicable/Not provided. No test set was used for clinical performance evaluation.

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/Not provided. This is a clearance for a diagnostic ultrasound system, not a specific AI-powered diagnostic algorithm requiring a comparative effectiveness study of human readers.

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

Not applicable/Not provided. This is not an AI/ML algorithm submission in that sense. The device is a diagnostic ultrasound system.

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

Not applicable/Not provided. No test set requiring ground truth was used for clinical performance evaluation. The "ground truth" for this submission largely refers to engineering specifications, safety standards, and functional equivalence to predicate devices.

8. The sample size for the training set

Not applicable/Not provided. There is no mention of an algorithm development or training phase with a specific training set to establish new diagnostic capabilities. The device's functionalities (e.g., iScape, Elastography) are listed as "identical" to or "similar" to those in predicate devices, implying their performance was established previously or is inherent to the system's design and physics.

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

Not applicable/Not provided. As there is no explicitly mentioned training set, there is no information on how its ground truth would have been established.

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