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The M9/M9CV/M9T/M8 Elite Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-reginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, trans-esoph.(Cardiac), peripheral vessel , urology exams.

M9/M9T/M9CV/M8 Elite Diagnostic Ultrasound System is a general purpose, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, THI, iScape mode, TDI mode, Color M, Elastography, 3D/4D mode, Contrast imaging (Contrast agent for Liver), 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, convex array and phased array.

The provided text is a 510(k) summary for the Shenzhen Mindray Bio-Medical Electronics Co., Ltd.'s M9/M9CV/M9T/M8 Elite Diagnostic Ultrasound System. It describes the device, its intended use, modifications from a previously cleared device, and a comparison with predicate devices.

However, it does not contain acceptance criteria for specific device performance metrics or a study explicitly proving the device meets quantitative acceptance criteria. Instead, it states that the device was evaluated for certain aspects and conforms to applicable medical safety standards, which forms the basis for its substantial equivalence to predicate devices already on the market.

Here's an attempt to answer your questions based on the provided text, recognizing that much of the specific performance data against acceptance criteria is not detailed.

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

The document does not explicitly state quantitative acceptance criteria for device performance and specific reported performance values against them. Instead, it relies on the concept of "substantial equivalence" to previously cleared devices (K152543, K170277, K162267). The general statement is that "M9/M9T/M9CV/M8 Elite has the same performance specification as the predicate device M9/M9T/M9CV (K152543) except adding 4D Function, Smart 3D, Smart Volume, iPage and Contrast imaging (Contrast agent for Liver). New added functions are substantial equivalent with the predicates DC-8 (K170277)."

The core "acceptance criteria" appear to be compliance with various recognized medical safety standards and being "substantially equivalent" to predicate devices for its intended uses and performance.

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 states: "Not applicable. The subject of this submission, M9/M9T/M9CV/M8 Elite Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence." This implies no specific clinical "test set" in the sense of patient data was used for a new clinical study to demonstrate performance. The evaluation was based on non-clinical tests and comparison to predicate devices. Therefore, there's no information on sample size, country of origin, or retrospective/prospective nature of a clinical data set.

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)

Given the statement that "clinical studies" were "Not applicable," there's no information about experts used to establish ground truth from a clinical test set. The assessment relied on engineering and quality control evaluations, and comparison to already approved devices.

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

As no specific clinical test set was used, there is no adjudication method mentioned.

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 conducted or mentioned. The device described is a diagnostic ultrasound system, which produces images and calculations, but the document does not indicate it incorporates AI for interpretation or reader assistance. Therefore, there's no information on human reader improvement with/without AI assistance.

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

The device is an ultrasound system. While it has computation features, these are integrated into the diagnostic workflow rather than being a standalone algorithm for independent diagnosis. The document does not describe any standalone algorithm performance testing in the absence of a human operator.

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

For the non-clinical tests performed (acoustic output, biocompatibility, electrical safety, etc.), the "ground truth" would be established by compliance with recognized standards and regulatory limits. For the "substantial equivalence" argument, the ground truth is implicitly the established safety and effectiveness of the predicate devices. There's no mention of pathology or outcomes data from new studies.

8. The sample size for the training set

No training set is mentioned as no new clinical study or AI algorithm requiring specific training data is described in the provided document. The device is evaluated for substantial equivalence to existing predicate devices.

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

As no training set is mentioned, this information is not applicable/provided.

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