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HI VISION Ascendus is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Trans-esophageal (Cardiac) - Adult/Pediatric, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal (Convent. / Superfic.), Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications.

The modes of operation of the HI VISION Ascendus are B mode, M mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Dual Doppler mode, CFI mode (Color Flow Image), Amplitude Dopper (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, Real-time Virtual Sonography, Real-time Tissue Elastography and Shear Wave Measurement.

An ultrasound diagnostic system with the following features:

• Ultrasound transducer(s) = to generate the transmitted ultrasound energy and detect the reflected echoes O
• O Ultrasound transducer accessories (standard and optional) - to maximize functional usage of transducer(s) in various modes of operation
• O A computer system - to control the transducer and analyze the signals resulting from the reflected echoes
• o A video monitor with optional image recorder - to display the computed image or derived Doppler data

The provided document is a 510(k) premarket notification for the Hitachi HI VISION Ascendus ultrasonic pulsed doppler imaging system. It establishes substantial equivalence to legally marketed predicate devices. The document does not contain acceptance criteria or a study proving the device meets acceptance criteria in the typical sense of a clinical trial evaluating performance against a predefined metric. Instead, it demonstrates substantial equivalence by comparing the device's features, intended use, and adherence to safety standards with those of predicate devices.

Here's a breakdown of the requested information based on the provided text:

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

The document does not specify quantitative acceptance criteria or a "reported device performance" in terms of clinical accuracy metrics (e.g., sensitivity, specificity, AUC) for the HI VISION Ascendus itself. Instead, the "performance" described is the system's array of features and its substantial equivalence to previously cleared devices.

Here’s a table summarizing the comparison to predicate devices, which serves as the basis for asserting safety and effectiveness:

The acceptance criteria for substantial equivalence are implied through the comparison: the subject device must demonstrate equivalent intended use, technological characteristics, safety, and effectiveness to its predicate devices. The document asserts that "The subject and predicate device(s) are both indicated for diagnostic ultrasound imaging and fluid flow analysis" and "The subject and predicate device(s) have the same gray scale and Doppler capabilities."

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: "Clinical testing: None required". This indicates that no clinical "test set" in the sense of patient data was used to prove performance against acceptance criteria for this 510(k) submission. The submission relies on non-clinical testing and substantial equivalence to predicate devices already on the market.

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 for this submission, there is no information provided regarding experts establishing ground truth for a test set.

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

As no clinical testing was performed, there is no adjudication method described for a test set.

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

The document does not mention any MRMC comparative effectiveness studies or any AI assistance. The device in question is an ultrasound imaging system, not an AI-based diagnostic tool.

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

This pertains to AI-based algorithms. The document does not describe the device as an AI-based algorithm, but rather an ultrasound imaging system. Therefore, no standalone algorithm performance study was reported.

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

Since no clinical testing data was reported as part of this submission, no type of ground truth for a test set is specified.

8. The sample size for the training set

This is relevant for machine learning models. The document does not indicate the use of such models or discuss a training set.

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

As no training set is discussed, the method for establishing its ground truth is not mentioned.

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