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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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The Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley are general purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vasculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gvn and Urology.

The P11 Portable Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. 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 P1 Portable Diagnostic Ultrasound system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D.

The P11 EXPERT Portable Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. 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. This P11 Expert Portable system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D.

The P12 Trolley Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. 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 P12 Trolley Digital Color Doppler Ultrasound System is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 4D.

The P12 Expert Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array with a frequency range of 1.0 MHz to 15.0 MHz. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. The system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, 3D/4D.

The P25 Trolley Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. 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. This system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D.

The P25 Expert Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array with a frequency range of 2.0 MHz to 15.0 MHz. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, 3D/4D.

This document describes the 510(k) premarket notification for the MEDISONO Color Doppler Ultrasound System, comprising models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley.

Here's a breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the device's conformance to established industry standards and substantial equivalence to legally marketed predicate devices. The reported device performance is indicated by its ability to meet these standards and achieve the same intended uses as the predicates.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Clinical testing is not required." This indicates that no separate "test set" in the sense of patient data was used for a clinical study to prove efficacy, but rather, performance was established through non-clinical testing and comparison to predicate devices. Therefore, there is no information on sample size or data provenance from a new clinical test set.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Since clinical testing was not required and no new "test set" from patient data was analyzed by experts for ground truth, this information is not applicable and not provided in the document.

4. Adjudication Method for the Test Set

As no clinical test set requiring expert adjudication was conducted, this information is not applicable and not provided.

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 study, nor does it describe any "AI" or human-in-the-loop performance evaluation. The device is a diagnostic ultrasound system, which typically involves direct use by a qualified physician, not an AI assistance evaluation.

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

This information is not applicable as the device is a diagnostic ultrasound system, not an AI algorithm. Its performance is inherent to its imaging capabilities, which are evaluated through technical standards and comparison to predicate devices, not as a standalone algorithm without human interaction.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical testing, the "ground truth" implicitly refers to the established specifications and performance parameters as defined by the mentioned standards (NEMA, IEC, ISO). For the substantial equivalence determination, the "ground truth" is the established safety and effectiveness of the legally marketed predicate devices.

8. The Sample Size for the Training Set

As this is not an AI/machine learning device, there is no concept of a "training set" for an algorithm. Therefore, this information is not applicable.

9. How the Ground Truth for the Training Set Was Established

Since there is no training set mentioned, this information is not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The device's acceptance is based on demonstrating substantial equivalence to existing legally marketed predicate devices. The study proving this involved:

• Non-clinical testing: The device was tested to ensure it conforms to applicable acoustic output, electrical safety, and biocompatibility medical device standards. These standards (NEMA UD 2: 2004, NEMA UD3: 2004, IEC 60601-1:2012 A(2), IEC 60601-1-1, IEC 60601-1-2:2007, IEC 60601-2-37:2007, ISO 10993-5:2009, and ISO 10993-10:2010) represent the acceptance criteria for the technical performance and safety aspects of the device.
• Comparison to Predicate Devices: The submission highlights that the Medisono Color Doppler Ultrasound System (P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley models) incorporates the "same fundamental technology" as its respective predicate devices (Sonoscape S6, S8 Exp Portable, S11, S12, S20, and S22 ultrasound systems). It asserts that the subject device has similar technology characteristics, the same intended use, same design principle, same electrical classification, and same accuracy as the predicate devices. The conclusion drawn is that "There are no differences between the devices that affect the usage, safety and effectiveness, thus no new question is raised regarding the safety and effectiveness."

In essence, the "study" is a demonstration of conformance to regulatory standards and a thorough comparison to already cleared devices, rather than a novel clinical trial.

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The MEDISONO Ultraonic Diagnostic Imaging System models P1, P3 and P10, are intended for diagnostic ultrasound imaging analysis of adults, pregnant women, pediatic 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), Transrecta and Transvagina.

The P1 model is a portable digital ultrasonic diagnostic system applied in ultrasound diagnostic examination of abdominal, obstetrical, small parts, gynecological, orthopedic, cardiac, and urological 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 five display modes: B-Mode, 2B3-Mode, M-Mode, B+M Mode, B+M Mode. This system controlled by software is a Track 1 device that employs an array of probes that include linear array, convex linear array, microconvex linear array, transrectal and transvaginal with a frequency range of approximately 2.0MHz- 10.0MHz. The system consists of a main unit, transducers and other accessories.

The P3 model is a portable digital ultrasonic diagnostic system applied in ultrasound diagnostic examination of abdominal, obstetrical, small parts, gynecological, orthopedic, cardiac, and urological 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 the following display modes: B-Mode, B+M Mode and PW Mode. This system controlled by software is a Track 3 device that employs an array of probes that include linear array, convex linear array, microconvex linear array, transrectal and transvaginal with a frequency range of approximately 2.0MHz-10.0MHz. The system consists of a main unit, a display and transducers.

The P10 model is a portable Diagnostic Ultrasound System, which applies device advanced technologies such as Phased Inversion Harmonic Compound Imaging (eHCl), Multi-Beam-Forming (mBeam), Speckle Resistance Imaging (eSRI), and Spatial Compounding Imaging, etc. Various image parameter adjustments, 12.1 inch LCD and diverse probes are configured to provide clear and stable images. Its function is to acquire and display Ultrasound images in Bmode, M-mode, PW-mode, Color-mode, PDI/DPDI mode. This system provides a series of probes that include linear array, convex array, micro-convex array with a frequency range of approximately 2.5 MHz to 11 MHz.

The provided text is a 510(k) premarket notification for a medical device (MEDISONO Ultrasonic Diagnostic Imaging System). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through clinical studies in the way a novel AI/ML device might.

Therefore, the document explicitly states that clinical testing is not required (Page 32). This means there is no study described that involves patients, human readers, or an AI algorithm's diagnostic performance for the purposes of this submission. The "acceptance criteria" discussed are related to technical performance and safety standards, not clinical efficacy or diagnostic accuracy.

Based on the provided document, I cannot fulfill most of your request as it pertains to clinical performance and AI/ML evaluation metrics. The document is for an ultrasound imaging system, which is a hardware device for image acquisition, not an AI/ML diagnostic aid.

However, I can extract information related to the acceptance criteria for non-clinical performance and the testing done to meet them.

Here's what can be extracted from the document:

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

Based on the "Non-clinical Test" section (Page 32), the acceptance criteria appear to be compliance with specific international and FDA guidance standards for safety and performance of ultrasonic medical devices. The document states that these tests were conducted, implying the device met the requirements of these standards.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable. Non-clinical testing of compliance with standards typically does not involve "samples" in the sense of patient data sets. It refers to testing the physical device and its compliance with engineering and safety specifications.
• Data Provenance: Not applicable. No clinical data is referenced in this section.

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

• Not applicable. No "ground truth" in a clinical diagnostic sense is established or mentioned for this type of device submission. The tests are engineering and safety compliance tests, not diagnostic performance evaluations.

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

• Not applicable. Adjudication methods are relevant for human interpretation or AI performance studies, which were not required for this submission.

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. The document explicitly states "Clinical Test: Clinical testing is not required." Therefore, no MRMC study, AI assistance, or effect size comparison was performed or reported for this submission.

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

• No. This is an ultrasound imaging system, not an AI algorithm for diagnosis.

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

• Not applicable. The ground truth for this submission relates to the device meeting technical and safety specifications rather than diagnostic accuracy against a clinical reference standard.

8. The sample size for the training set:

• Not applicable. There is no mention of a training set as this is not an AI/ML device that learns from data.

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

• Not applicable. No training set is mentioned.

In summary, the provided document is a 510(k) premarket notification for a traditional ultrasonic diagnostic imaging system. It demonstrates substantial equivalence to predicate devices primarily through compliance with recognized performance and safety standards, rather than complex clinical performance studies involving AI/ML components.

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