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The Portable Digital Color Doppler Ultrasound System is intended for ultrasound imaging in B (2D), Color Doppler and Pulsed Wave imaging modes.

It is indicated for ultrasound imaging and fluid flow analysis in the following applications: Abdominal, Small Organ, Musculoskeletal, Peripheral Vessel, Urology, and Carotid.

The Portable Digital Color Doppler Ultrasound System is intended for use in environments where healthcare is provided by appropriately trained and qualified healthcare professionals.

The Portable Digital Color Doppler Ultrasound System is a portable, general-purpose, software-controlled ultrasound system. It consists of a handheld ultrasound main unit and software. The system is engineered to produce real-time ultrasound images, with an emphasis on capturing detailed anatomical structures and evaluating blood flow patterns using color Doppler technology. It includes features for measurements, image storage and review, as well as printing and recording capabilities. This portable system enables point-of-care ultrasound applications, providing healthcare professionals with a convenient way to visualize anatomical structures and assess blood flow dynamics.

This document is a 510(k) Pre-market Notification for a Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L). The information provided focuses on demonstrating substantial equivalence to already-cleared predicate devices, rather than presenting a standalone study with specific performance acceptance criteria and results.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth are not available within this document. The submission primarily relies on non-clinical testing to demonstrate safety and effectiveness.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not explicitly define acceptance criteria for specific performance metrics (e.g., sensitivity, specificity, accuracy) like you would find in a clinical study report for an AI/algorithm-driven device.

Instead, the "acceptance criteria" here are implied by compliance with recognized standards and the demonstration of equivalent technical and performance properties to predicate devices. The document essentially states that the device "passed testings according to" various standards (listed below) and that "the proposed devices are substantially equivalent to the predicate devices" because "the minor differences don't raise any additional questions on effectiveness."

Therefore, a table of specific acceptance criteria and reported device performance metrics (e.g., sensitivity, specificity) cannot be generated from the provided text. The document focuses on showing compliance with general safety and performance standards for ultrasound systems.

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

Not provided. This document details non-clinical testing for compliance with standards, not a clinical test set with specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective).

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

Not applicable. No ground truth establishment by experts for a test set is described in this document. The testing described is primarily non-clinical compliance testing.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method for a test set is described.

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. A MRMC comparative effectiveness study is not mentioned or implied. This device is an ultrasound system, not an AI or algorithm-assistance tool for human readers in the context of diagnostic interpretation.

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

Not applicable. This device is an ultrasound system, not a standalone algorithm/AI for diagnostic interpretation.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Not applicable. The document describes non-clinical testing against established engineering and safety standards for ultrasound devices, not against a clinical ground truth for diagnostic accuracy.

8. The Sample Size for the Training Set

Not applicable. No training set is mentioned as this device is an ultrasound imaging system, not an AI/algorithm that requires a training set.

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

Not applicable. As no training set is mentioned, the method for establishing ground truth for a training set is not applicable.

Summary of Available Information from the Document:

The document emphasizes non-clinical testing to demonstrate substantial equivalence to predicate devices, focusing on safety and general performance in accordance with recognized standards.

Non-clinical Testing Summary (from Section 5 of the 510(k) Summary):

The Portable Digital Color Doppler Ultrasound System has passed testing according to the following standards:

1. ANSI AAMI ES60601-1:2005/R12012 & A1:2010/R)2012 & A2:2010/RJ2012 (Cons. Text) Incl. AMD2:2021): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
2. IEC 60601-1-2 Editor 4.1 2020-09 CONSOLIDATED VERSION: Medical electrical equipment - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
3. IEC TR 60601-4-2 Editor 1.0 2016-05: Medical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity performance of medical electrical equipment and medical electrical systems.
4. IEC 60601-1-6 Editor 3.2 2020-07 CONSOLIDATED VERSION: Medical electrical equipment - Part 1-6: Safety and essential performance - Collateral standard: Usability.
5. IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION: Medical devices - Part 1: Application of usability engineering to medical devices.
6. IEC 60601-2-37 Edition 2.1 2015: Medical electrical equipment for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
7. IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION: Ultrasonics - Field characterization - Test methods for the measurement of mechanical indices related to medical diagnostic ultrasonic fields.
8. NEMA UD 3-2004 (R2009): Standard for Real-Time Display of Thermal and Mechanical Acoustic Output for Diagnostic Ultrasound Equipment.
9. IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION: Medical device software life cycle processes.

Conclusion stated: The non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate devices.

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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 SonoScape S8 Exp/S9 Pro system is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Muscular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.

This SonoScape S8 Exp/S9 Pro Portable 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 portable console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a portable, 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 subject of this submission is the addition of new probes to the legally marketed SonoScape S8 Exp/S9 Pro. Add 3C-A, 4P-A and 10l2 probes. New probes

This document is a 510(k) Pre-market Notification from SonoScape Medical Corp. to the FDA for their S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System. It is an application for substantial equivalence to a previously cleared device. Therefore, the "acceptance criteria" and "device performance" are established by comparing the new device against the predicate device.

Here's an analysis based on the provided document, addressing your specific points:

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

The acceptance criteria are implicitly met by demonstrating "substantial equivalence" to the predicate device. For ultrasound systems, this typically involves matching or demonstrating comparable performance in various imaging modes and across different clinical applications and transducers, while ensuring safety standards are met.

The reported device performance is presented as a comparison to the predicate device, asserting that the new device has "the same intended uses" and "the same basic and key technical features." For the newly added probes, specific demonstrations of their performance and clinical application being equivalent to existing cleared probes are given.

• 3C-A Curved Array: Performance and clinical application are the same as the C344 Curved Array. Both meet clinical use despite slight frequency differences.
• 4P-A Phased Array: Performance and clinical application are the same as the 3P1 Phased Array. Both meet clinical use despite slight frequency differences.
• 10L2 Linear Array: Frequency, performance, and clinical application are the same as the L741 Linear Array. |
  | Safety and Standards Compliance: Device meets applicable electrical, mechanical, thermal, electromagnetic compatibility, biocompatibility, and acoustic output safety standards. | Compliant: Evaluated for electrical, mechanical, thermal, and electromagnetic compatibility safety, biocompatibility, and acoustic output. Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5, ISO10993-10, UD2, and UD3. Acoustic output levels are consistent with predicate. No new risks raised. |

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 "No clinical testing was required" for this 510(k) submission. This means no patient test set was used for proving substantial equivalence in a clinical context. The evaluation was based on non-clinical (laboratory) tests and comparison to a predicate device.

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 required and no patient test set was used for establishing clinical performance, there were no experts used to establish ground truth from clinical data. The "ground truth" for proving substantial equivalence was implicitly based on the technical specifications and performance characteristics of the predicate device and the new device.

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

Not applicable, as no clinical test set was used.

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. This device is an ultrasound system, not an AI diagnostic aid. No MRMC study was mentioned or required for this submission.

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

Not applicable. This is a medical imaging device, not an algorithm being evaluated for standalone diagnostic performance. The performance evaluated is of the hardware and integrated software for acquiring and displaying ultrasound images.

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

The "ground truth" in this context is the established performance and safety of the previously cleared predicate device (SonoScape S8 Exp/S9 Pro, K142714). The assessment for the new device relied on:

• Established technical specifications and performance characteristics of both the predicate and the new device.
• Compliance with recognized industry standards (e.g., IEC 60601 series, ISO 10993 series).
• Laboratory (Phantom) tests to verify that the system met design specifications.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set of data for an algorithm.

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

Not applicable. As this is not an AI/ML device, there was no "training set" in the context of machine learning.

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The SonoScape S9 system is a 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), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.

This SonoScape S9 Portable 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 portable console with touch screen and keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a portable, 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 subject of this submission is the addition of new probes to legally marketed SonoScape S9.

The provided text is a 510(k) Summary for the SonoScape S9 Portable Digital Color Doppler Ultrasound System. It outlines the device's technical characteristics, intended use, and comparison to a predicate device to demonstrate substantial equivalence.

However, the document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML medical device. It is for an ultrasound system, not an AI/ML algorithm.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence to a predicate device (SonoScape S9 Portable Digital Color Doppler Ultrasound System K142710) based on similar intended uses, technical characteristics, and compliance with safety standards for an ultrasound machine and its transducers. It explicitly states: "No clinical testing was required." and "Laboratory tests (including Phantom tests) were conducted to verify that the S9 system met all design specifications and the S9 system conformed to applicable medical device standards." This indicates a traditional medical device clearance pathway, not one typically involving the robust performance validation studies seen with AI/ML devices.

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The SonoScape S8 Exp/S9 Pro system is a 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 Vascular, Muscular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.

The SonoScape S8 Exp/S9 Pro system is a general-purpose ultrasonic imaging instrument 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 Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.

This SonoScape S8 Exp/S9 Pro Portable 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 2.0 MHz to 15.0 MHz. This system consists of a portable console with keyboard control panel, power supply module, color LCD monitor and optional probes.

This system is a portable, 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 subject of this submission is the addition of new indications, new probes and special function to original SonoScape S8 Exp and the addition of SonoScape S9 Pro.

The provided document is a 510(k) premarket notification for the SonoScape S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with the detailed information requested.

Therefore, many of the requested categories cannot be directly extracted from this document, as it outlines a regulatory submission process based on comparison, not a direct performance study to meet new acceptance criteria for a novel device.

However, I can extract the following information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in the typical sense of a novel device's performance metrics. Instead, "acceptance" is implicitly tied to demonstrating substantial equivalence to existing predicate devices. Therefore, the "reported device performance" is primarily presented as its similarity and compliance with standards already met by predicate devices.

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

• Sample Size for Test Set: Not applicable. The document discusses non-clinical tests (laboratory tests, phantom tests) but does not refer to a "test set" of clinical cases or patient data with a defined sample size for performance evaluation in the context of a new acceptance criterion.
• Data Provenance: Not applicable in the context of a clinical test set. The non-clinical tests were conducted internally by SonoScape Company Limited.

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

• Not applicable. No clinical test set requiring expert ground truthing is described.

4. Adjudication method for the test set:

• Not applicable. No clinical test set requiring adjudication is described.

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 comparative effectiveness study was done or mentioned. This device is an ultrasound system, not an AI-assisted diagnostic tool in the sense of improving human reader performance.

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

• Not applicable. The document describes an ultrasound system, which is inherently a human-operated device. It's not an "algorithm only" device for standalone performance.

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

• For the non-clinical tests mentioned, the "ground truth" would be established by physical measurements and expected outcomes from phantom models and engineering specifications (e.g., accuracy and repeatability of strain-ratio measurement for Elastography).

8. The sample size for the training set:

• Not applicable. This document does not describe the development of an AI algorithm requiring a training set.

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

• Not applicable. This document does not describe the development of an AI algorithm requiring a training set.

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The SonoScape S9 system is a 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), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.

This SonoScape S9 Portable 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 2.0 MHz to 15.0 MHz. This system consists of a portable console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a portable, 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 subject of this submission is the addition of new indications, new probes and special function to original SonoScape S9.

The provided document is a 510(k) Premarket Notification from SonoScape Company Limited for their S9 Portable Digital Color Doppler Ultrasound System. It primarily focuses on establishing substantial equivalence to previously cleared predicate devices for various indications and transducers.

Within this document, there is no specific section or study described that details acceptance criteria and device performance results in a quantitative manner (e.g., sensitivity, specificity, accuracy, precision, etc.) for AI/algorithmic components. The document predates widespread AI-driven medical devices, and the "special function" of Elastography mentioned is typically a feature of the ultrasound itself, not necessarily an AI algorithm in the modern sense.

The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical tests (as described in section 7 of the 510(k) Summary) that verify the system meets design specifications and applicable medical device standards. These are typically engineering tests, phantom tests for features like elastography, and adherence to safety and compatibility standards.

Therefore, many of the requested details about acceptance criteria, test sets, ground truth, experts, and comparative effectiveness studies for AI performance are not available or applicable in this document.

However, I can extract the information that is present and indicate what is missing based on your request.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not present quantitative performance metrics (like sensitivity, specificity, or accuracy) against specific acceptance criteria for an AI algorithm. The document focuses on establishing substantial equivalence to predicate devices based on intended use, technical characteristics, and probe comparisons, along with adherence to recognized safety and performance standards.

The closest to "acceptance criteria" mentioned are:

• "met all design specifications"
• "conformed to applicable medical device standards" (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5, ISO10993-10, UD2, and UD3)
• "Elastography function was effective and Elastography performance met design specifications, including accuracy and repeatability of strain-ratio measurement and etc."

However, specific numerical performance outcomes for these are not provided in the document's summary.

Regarding the study that proves the device meets the acceptance criteria:

The study described is a series of non-clinical tests.

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

• Sample size for test set: Not specified. The document mentions "Laboratory tests" and "Phantom test" but does not give a sample size for these tests.
• Data provenance: Not explicitly stated, but typical for phantom tests and lab tests conducted by the manufacturer. No patient data provenance (country of origin, retrospective/prospective) is mentioned as it's not a clinical study.

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

• Not applicable as the tests described are technical and phantom-based, not reliant on expert review of clinical cases to establish ground truth for algorithm performance. Ground truth for phantom tests would be based on the known properties of the phantom.

4. Adjudication method for the test set:

• Not applicable for the types of non-clinical tests described.

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 comparative effectiveness study was done. This device is an ultrasound system with various imaging modes, not an AI-assisted diagnostic tool in the sense of a standalone algorithm for interpretation. The "special function" of Elastography is an imaging modality feature.

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

• No standalone algorithm performance study was described. The submission is for an ultrasound system, not a specific AI algorithm.

7. The type of ground truth used:

• For the non-clinical tests, the ground truth would be based on engineering specifications for electrical, mechanical, thermal, electromagnetic compatibility, acoustic output, and the known physical properties of phantoms used for testing features like elastography.

8. The sample size for the training set:

• Not applicable. This is not an AI algorithm submission based on machine learning from a training set of data.

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

• Not applicable.

Summary of Non-Clinical Testing (from Section 7):

• Tests Conducted: Electrical, mechanical, thermal, electromagnetic compatibility safety, biocompatibility, and acoustic output.
• Special Feature Test: Phantom test to verify strain Elastography function effectiveness and performance, including accuracy and repeatability of strain-ratio measurement.
• Standards Met: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5, ISO10993-10, UD2, and UD3.
• Conclusion: The S9 system met all design specifications and conformed to applicable medical device standards.

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The SonoScape S8 Exp device is a general-purpose ultrasonic imaging instrument 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 Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

The SonoScape S8 Exp Portable 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 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 SonoScape 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 SonoScape S8 Exp Portable Digital Color Doppler Ultrasound System is a general-purpose integrated, preprogrammed color ultrasound imaging system intended for diagnostic imaging.
The device's performance aligns with the predicate device, SonoScape S9 Portable Digital Color Doppler Ultrasound System (K131088).

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states that "No clinical testing was required." Therefore, there is no information on a test set, sample size, or data provenance from clinical data. The testing mentioned in the submission focuses on laboratory testing to verify design specifications and compliance with safety standards.

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

Since no clinical testing was required, there is no mention of experts being used to establish a ground truth for a test set.

4. Adjudication Method for the Test Set

As no clinical testing was required, there is no adjudication method described.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study was mentioned in this submission. The submission focuses on comparing the proposed device to a predicate device based on technical specifications and compliance with standards, not on human reader performance.

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

This device is an ultrasound system and not an AI algorithm. Therefore, the concept of standalone performance of an algorithm without human-in-the-loop is not applicable in the context of this submission. The performance assessment is related to the imaging capabilities of the hardware and software as a complete diagnostic tool used by a physician.

7. The Type of Ground Truth Used

Given that no clinical testing was required, the "ground truth" for demonstrating device performance relied on:

• Compliance with Industry Standards: NEMA UID 2: 2004, NEMA UD3: 2004, IEC 60601-1: 2005, IEC 60601-1-2: 2007, IEC 60601-2-37: 2008, ISO 10993-5, ISO 10993-10.
• Comparison to Predicate Device Specifications: The primary method for proving substantial equivalence was a direct comparison of technical specifications, intended use, and performance parameters (e.g., measurement accuracy, acoustic output) against the previously cleared predicate device (SonoScape S9, K131088).

8. The Sample Size for the Training Set

There is no mention of a "training set" in the context of this device, as it is a diagnostic ultrasound system and not an AI/machine learning algorithm requiring a training phase with a dataset.

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

Not applicable, as no training set for an AI/machine learning algorithm was involved.

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The SonoScape S9 device is a general-purpose ultrasonic imaging instrument 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 Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

The SonoScape S9 Portable 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 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 SonoScape 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 provided text describes a 510(k) summary for the SonoScape S9 Portable Digital Color Doppler Ultrasound System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria based on a clinical performance study with AI.

Therefore, many of the requested details about acceptance criteria driven by AI performance, sample sizes for test sets, ground truth establishment, expert adjudication, or MRMC studies, are not explicitly mentioned in this type of submission.

However, I can extract information related to the device's technical specifications and the type of non-clinical testing performed to establish safety and effectiveness for substantial equivalence.

Here's a breakdown of what can and cannot be answered based on the provided document:

What can be answered (related to substantial equivalence and non-clinical testing):

• Acceptance Criteria (Indirect): The acceptance criteria are implicitly conformance to recognized safety and performance standards for diagnostic ultrasound equipment, and having technological characteristics similar to the predicate device, demonstrating equivalent capability. The "reported device performance" is the confirmation that these standards were met.
• Sample Size for Test Set: Not applicable in the context of clinical performance evaluation for AI. The testing described is laboratory-based non-clinical testing for standards compliance.
• Data Provenance: Not applicable, as no clinical test set data from patients is described. The testing is laboratory (acoustic output, electrical, thermal, mechanical safety, biocompatibility).
• Number of Experts for Ground Truth & Qualifications: Not applicable. Ground truth for clinical performance is not established as this is a non-clinical submission.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: No. This is not a study involving human readers and AI assistance.
• Standalone (algorithm only) Performance: No, as there isn't an AI algorithm described that would operate in a standalone manner. The device is a diagnostic ultrasound system.
• Type of Ground Truth Used: Not applicable. The "ground truth" here is compliance with established engineering and safety standards, not clinical diagnostic accuracy.
• Sample Size for Training Set: Not applicable. This device does not inherently involve a "training set" in the context of an AI/ML algorithm.
• How Ground Truth for Training Set was Established: Not applicable.

Table of Acceptance Criteria and Reported Device Performance (based on regulatory compliance):

Study Proving Device Meets Acceptance Criteria:

The study described is a series of non-clinical laboratory tests designed to demonstrate compliance with recognized consensus standards and to show that the S9 Portable Digital Color Doppler Ultrasound System is substantially equivalent to a previously cleared predicate device (SonoScape Company Limited, Diagnostic Ultrasound System, Model S6, K112602).

• Nature of the Study: This was a non-clinical validation focused on safety, electromagnetic compatibility, acoustic output, and biocompatibility, rather than a clinical performance study involving patient data and diagnostic accuracy.
• Acceptance Criteria for the Study: The implicit acceptance criteria were successfully passing all relevant tests defined by the listed international and national standards (IEC, ISO, NEMA) and demonstrating that the device's technical specifications and performance characteristics align closely enough with the predicate device to warrant substantial equivalence.
• Sample Size Used for Test Set: This is not a "test set" in the context of clinical data for AI performance. The "test set" here refers to the device and its transducers undergoing various physical and electrical tests. No specific number of "tests" or "samples" (like patient cases) is provided, as it's a conformity assessment to standards.
• Data Provenance: The data provenance is laboratory testing conducted by the manufacturer, SonoScape Company Limited, for regulatory submission to the FDA. It is not retrospective or prospective clinical data from human patients/cases.
• Number of Experts Used to Establish Ground Truth & Qualifications: Not applicable. No human expert "ground truth" for diagnostic accuracy was established in this type of testing. The "ground truth" is adherence to the technical specifications of the standards.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This type of study is for evaluating human performance, often with or without AI assistance, which is not relevant to this submission.
• Standalone (Algorithm Only) Performance: Not applicable. The device is an ultrasound system, not an AI algorithm.
• Type of Ground Truth Used: Standards conformance and engineering specifications. The "ground truth" for this submission is that the device physically performs according to established industry safety and performance benchmarks. It is not based on expert consensus, pathology, or outcomes data from patient diagnoses.
• Sample Size for the Training Set: Not applicable. This device does not describe an AI or machine learning component that would require a training set.
• How the Ground Truth for the Training Set was Established: Not applicable.

In summary, the provided document is a regulatory submission for a medical device (ultrasound system) based on substantial equivalence, which primarily relies on non-clinical testing for safety and basic performance characteristics against established standards and a predicate device. It does not describe a clinical performance study, especially not one involving AI or detailed human reader evaluation.

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The SonoScape S2 device is a general-purpose ultrasonic imaging instrument 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 Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

The SonoScapeS2 Portable 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 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 SonoScape 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.

This document details the acceptance criteria for the SonoScape S2 Portable Digital Color Doppler Ultrasound System and the study supporting its compliance.

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against recognized medical device safety standards and acoustic output measurement standards to ensure substantial equivalence to its predicate device. The performance is documented through adherence to these standards rather than specific imaging metrics in this summary.

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

The provided document describes non-clinical laboratory testing to verify the device's conformance to safety and performance standards. It does not mention a clinical test set involving human patient data the way AI/CAD devices typically do. Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set is not applicable or provided in this summary.

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

As there is no mention of a human-read clinical test set being used to assess the device's diagnostic performance (as it is a imaging system and not an AI/CAD system evaluated on diagnostic accuracy against human experts), this information is not applicable and not provided in the document.

4. Adjudication Method for the Test Set

Given that performance was assessed against engineering and safety standards rather than humanexpert interpretations of clinical images, an adjudication method for a test set is not applicable and not described.

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

This device is an ultrasound imaging system, not an AI or CAD (Computer-Aided Detection/Diagnosis) system. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human reader improvement with or without AI assistance is not applicable to this submission and was not performed.

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

Again, this is an ultrasound imaging system, not an AI algorithm. A standalone performance evaluation in the context of an algorithm's diagnostic accuracy is not applicable here. The "standalone" performance for this device would be its ability to produce images and measurements according to its technical specifications, which was confirmed through laboratory testing against established standards.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for this device's acceptance criteria is defined by recognized international and national standards for medical electrical equipment safety, electromagnetic compatibility, ultrasonic medical diagnostic equipment, acoustic output measurement, and biocompatibility. The device's conformance to these engineering and safety standards serves as its "ground truth."

8. The Sample Size for the Training Set

Since this is not an AI/Machine Learning device, the concept of a "training set" is not applicable. The device's functionality is based on established physics principles and engineering design, not on learning from a dataset.

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

As there is no training set for this type of medical device, this information is not applicable.

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