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The MEDISONO Ultrasonic Diagnostic Imaging System models P3 Plus, P9 Plus, P25 Expert, P12 Plus, P11 Plus, and MS55 plus are intended for diagnostic ultrasound imaging analysis of adults, pregnant women, pediatric patients in gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms. The system is intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus, Abdomen, Pediatrics, Small Organ, Neonatal Cephalic, Cardiology, Peripheral Vessel, Musculo-skeleton (both Conventional and Superficial), Urology (including prostate), Transrectal and Transvaginal.

The P3 Plus Ultrasound Diagnostic System is a portable digital B/W compact ultrasound system with diagnostic B/W image quality and PW Doppler capability, applied in ultrasound diagnostic examination of abdominal, Vascular, Small Parts, Musculoskeletal, Obstetrics and Gynecology applications. It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor. The resulting information is displayed in six display modes: B-Mode, B+B, 4B Mode, M-Mode, and PW. This system controlled by software employs an array of probes that include linear array, convex linear array, microconvex linear array, transrectal and transvaginal with a frequency range of approximately 2.5MHz- 11MHz. The system consists of a main unit, transducers, and other accessories.

The P9 Plus Ultrasound Diagnostic System is a portable digital compact ultrasound system with multiple imaging modes applied in ultrasound diagnostic examination of f Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testicle, thyroid); Cardiac (adult & pediatric); Peripheral Vascular; Musculo-skeletal Conventional & Superficial; Transrectal and Transvaginal applications. It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor, with multiple imaging modes: B-mode, C-mode, M-mode, CWmode, PW-mode, and PDI mode that employs an array of probes that include linear, Convex and Phase Array probes with a frequency range of approximately 2MHz- 11MHz. The system consists of a main unit, transducers, and other accessories.

The P11 Plus Portable Digital Color Doppler Ultrasound System is a portable ultrasound system with Cardiac measurements, 4D. Elastography and Stress Echo capabilities. It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor; with complete imaging modes: 2D with THI, Color M, CFM, PDI, PW, HPRF, CW. This system contains an array of probes that include full range of Linear, Convex, Phased Array, Endocavity, TEE, Volumetric, and Biplane TRT probes with high density broadband transducers with Frequency up to 16 MHz. The system consists of a main unit, a display and transducers.

The MS55 Plus Digital Color Doppler Ultrasound System is a diagnostic ultrasound system, which applies advanced ultrasonic Doppler technologies such as Harmonic Compound Imaging. Panoramic Imaging, and Spatial Compounding Imaging, with capabilities for applications in of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculoskeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph (Cardiac), Laparoscopic, OB/ Gyn and Urology. Various image parameter adjustments, 22-inch touchscreen and diverse probes are configured to provide clear and stable images. Its function is to acquire and display Ultrasound images in Micro F mode, CFM mode, PW mode, SR-Flow mode, PDI/DPDI mode, TDI mode. This system provides a series of probes that include phased array, convex array, and abdominal volume probe.

The P12 Plus Digital Color Doppler Ultrasound System is a diagnostic imaging system, which applies device advanced ultrasonic Doppler technologies such as Harmonic Compound Imaging. Panoramic Imaging, and Spatial Compounding Imaging, with capabilities for applications in Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology. Various image parameter adjustments. 22-inch touch screen and diverse probes are configured to provide clear and stable images. Its function is to acquire and display Ultrasound images in Micro F mode, CFM mode, PW mode, PDI/DPDI mode, TDI mode. This system provides a series of probes that include Linear, Convex, Phased Array, Endocavity, TEE, Intraoperative, Volumetric, and Biplane TRT probes, wide scanning Angle Endo-Cavity Probe with frequency ranges of 1.9 MHz to 17MHZ.

The P25 Expert Digital Color Doppler Ultrasound System is a diagnostic imaging system, which applies advanced ultrasonic Doppler technologies such as Harmonic Compound Imaging, Panoramic Imaging, and Spatial Compounding Imaging, with capabilities for applications in Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Transvaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology, Various image parameter adjustments, 22-inch LED, 13.3-inch touch screen and diverse probes are configured to provide clear and stable images. Its function is to acquire and display Ultrasound images in 2D with THI, Color M, CFM, PDI, PW, HPRF, CW, Contrast Imaging, Elastography, Stress Echo. This system provides a series of probes that include Linear, Convex, Phased Array, Endocavity, TEE, Intraoperative, Volumetric, and Biplane TRT probes, wide scanning Angle Endo-Cavity Probe probes, wide scanning Angle Endocavity Probe with frequency ranges of 1.9 MHz to 17MHZ.

The provided document describes Medisono's submission for 510(k) premarket notification for several digital color Doppler ultrasound systems. The submission asserts substantial equivalence to a set of predicate devices.

Here's an analysis of the acceptance criteria and the study information as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., target accuracy, sensitivity, or specificity metrics) that would typically be seen for AI-driven diagnostic devices. Instead, the performance demonstration focuses on showing equivalence to predicate devices through technical comparisons and non-clinical testing. The performance is assessed against the established safety and effectiveness of the 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)

The document does not specify details about a "test set" for performance evaluation in terms of patient data. The provided performance evaluation is primarily based on non-clinical testing on the devices themselves (e.g., measurement accuracy, acoustic properties, safety standards adherence) rather than clinical studies with patient data. Therefore, information about sample size, country of origin, or retrospective/prospective nature of a clinical test set is not present.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

As the performance evaluation relied on non-clinical testing and comparison to predicate devices' specifications, there is no information about a "ground truth" derived from expert review of patient data.

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

Since there is no mention of a test set with patient data requiring ground truth established by experts, there is no information on an adjudication method.

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 describe a multi-reader multi-case (MRMC) comparative effectiveness study involving human readers or AI assistance. The devices in question are diagnostic ultrasound systems, not AI algorithms designed to enhance human reader performance.

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

The document describes the Medisono devices as "Ultrasonic Diagnostic Imaging System models," which are hardware systems with integrated software for image acquisition, processing, and display. The software itself is considered "moderate level of concern" and underwent verification and validation. However, the submission does not detail a standalone "algorithm only" performance study in the context of an AI/ML algorithm separate from the device's inherent functioning. The performance tests are for the overall device's measurement accuracy, acoustic output, and other core technical functions.

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

For the "performance testing (Measurement Accuracy)," the ground truth would typically be established by known physical standards or phantoms with precise dimensions for distance and area measurements. For acoustic and EMC testing, it would be against defined regulatory standards (e.g., IEC standards). This is not human-derived ground truth from clinical data.

8. The sample size for the training set

The document does not mention a "training set" of data, as is common for AI/ML algorithms. The software verification and validation are for the device's operational software, not an AI model that learns from data.

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

As there is no mention of a training set, there is no information on how ground truth for a training set was established.

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