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510(k) Data Aggregation
(198 days)
Digital Color Doppler Ultrasound System (P60 Series)
The Digital Color Doppler Ultrasound System is a general-purpose ultrasonic imaging instrument intended for use by appropriately trained healthcare professionals in hospital for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vasculoskeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph (Cardiac), Laparoscopic, OB/Gyn and Urology.
This SonoScape P60 Series 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 phased array and etc.
This system consists of a mobile console with touch screen and 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, Power Doppler, Direct Power Doppler, or the combination of these modes, Compound, 3D/4D, Elastography and Contrast.
Here's a breakdown of the acceptance criteria and the study details for the S-FetusAI feature of the Sonoscape Digital Color Doppler Ultrasound System (P60 Series), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| S-Fetus-Recognition | Accuracy: Not less than 85%. | 90.01% |
| S-Fetus-Measure | Accuracy: Not less than 80%. | 85% |
Clinical Performance:
| Evaluation Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Identification Precision of the 14 Standard Sections (Primary Evaluation Indicator) | Non-inferiority design: The lower limit of the 95% CI for the difference of Identification Precision must be greater than -10% (S-FetusAI compared to manual recognition). | The recognition precision of the standard sections of S-FetusAI was not inferior to that of the manual scan. |
| Measurement Error of Growth Parameters (Secondary Evaluation Indicator) | - Relative errors of measurement for 11 Growth Parameters. |
- Precision of Sp (spinal cord cone end positioning). | S-FetusAI has a good consistency with the manual measurement.
The Sp (spinal cone end positioning) precision was basically equal between the trial group and control group. |
2. Sample Size Used for the Test Set and Data Provenance
- S-Fetus-Recognition Test Set:
- More than 200 images for each of the 14 standard sections.
- Total: 3717 images.
- S-Fetus-Measure Test Set:
- More than 250 images for each of the 9 standard sections.
- Total: 2929 images.
- Data Provenance: A mix of retrospective and prospective data collection in clinical practice. The test sets were collected at three hospitals in China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Initial Ground Truth Drawing: Five OB/GYN experts with more than 3 years' experience.
- Cross-checking: Two experts with more than 20 years' experience.
- Re-checking: Four experts with more than 30 years' experience.
- Clinical Performance Study (Adjudication of results): Two Readers from an independent evaluation group, consisting of qualified professionals (senior experts who had been involved in prenatal ultrasound examination).
4. Adjudication Method for the Test Set
The ground truth was established through a multi-level expert consensus process:
- Initial Drawing: 5 OB/GYN experts.
- Cross-checking: 2 senior experts.
- Re-checking: 4 very senior experts.
This indicates a robust, multi-stage consensus-based adjudication, effectively a form of "expert consensus with multiple layers of review."
For the clinical performance testing, a separate "independent evaluation group" with 2 senior experts evaluated the section recognition results and precision of Sp from both the trial (AI-assisted) and contrast (manual) groups.
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
- A clinical performance testing was conducted, which involved comparing the S-FetusAI function (Trial group) with manual recognition and measurement by investigators (Contrast group). This can be considered a comparative effectiveness study.
- Research Group Composition (Contrast Group): Investigators (physicians with more than 3 years of specialized training in obstetric ultrasound examination; total 7 investigators) performing manual recognition and measurement.
- Effect Size: The study focused on demonstrating non-inferiority rather than a specific improvement percentage for human readers with AI assistance. The conclusion states that "the recognition precision of the standard sections of S-FetusAI was not inferior to that of the manual scan." This implies that the AI-assisted system performs at least as well as, or comparably to, manual recognition. It does not explicitly quantify how much human readers improve when using AI, but rather that the AI's standalone performance (for recognition) and consistency/precision (for measurement) are comparable to manual methods.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance testing was done for the S-FetusAI feature for both S-Fetus-Recognition and S-Fetus-Measure. The results (90.01% accuracy for recognition and 85% accuracy for measurement) are reported as entirely algorithmic performance against established ground truth.
7. The Type of Ground Truth Used
The ground truth used was expert consensus. It was established by multiple OB/GYN experts with varying levels of experience, going through a process of initial drawing, cross-checking, and re-checking. Any images not meeting inclusion/exclusion criteria were excluded from the ground truth set.
8. The Sample Size for the Training Set
The document explicitly states: "The test set used to test the standalone performance of S-FetusAI are independent of the training data set and tuning data set". However, the sample size for the training set is not provided in the given text.
9. How the Ground Truth for the Training Set Was Established
While the document implies that training and tuning datasets were used, the specific method for establishing their ground truth is not mentioned in the provided text. It only details the ground truth establishment for the test set.
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(146 days)
Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)
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:
- 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.
- IEC 60601-1-2 Editor 4.1 2020-09 CONSOLIDATED VERSION: Medical electrical equipment - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
- 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.
- IEC 60601-1-6 Editor 3.2 2020-07 CONSOLIDATED VERSION: Medical electrical equipment - Part 1-6: Safety and essential performance - Collateral standard: Usability.
- IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION: Medical devices - Part 1: Application of usability engineering to medical devices.
- 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.
- 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.
- NEMA UD 3-2004 (R2009): Standard for Real-Time Display of Thermal and Mechanical Acoustic Output for Diagnostic Ultrasound Equipment.
- 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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(266 days)
SonoMax Series Digital Color Doppler Ultrasound System
The SonoMax Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B(2D/3D/4D), B/M, M, B+CFM, B+CPA(PD), B+DPD, B+PW, B+CW, B+CFM+D(PW)/CW, B+CPA(PD)+D(PW)/CW, TDI and Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic imaging instrument intended for use by appropriately-trained qualified healthcare professionals for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Cardiac (adult, pediatric), Musculoskeletal (Conventional, Superficial), Peripheral Vascular, Trans-esophageal, Trans-vaginal, OB/GYN and Urology, which is intended to be used in a hospital or medical clinic.
The SonoMax Series Digital Doppler Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array.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 echo data and to display the image in B(2D/3D/4D), B/M, M, B+CFM, B+CPA(PD), B+DPD, B+PW, B+CW, B+CFM+D(PW)/CW, B+CPA(PD)+D(PW)/CW, TDI, Fusion Harmonic lmaging modes or a combination of these mode.
The FDA 510(k) summary for the SonoMax Series Digital Color Doppler Ultrasound System (K233697) indicates that no clinical testing was required to demonstrate substantial equivalence. Therefore, the document does not contain information about acceptance criteria or a study proving the device meets performance criteria beyond non-clinical testing and comparison to a predicate device.
Specifically, under "7. Clinical Test:" on page 6, it explicitly states: "No clinical testing was required."
Given this, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or ground truth for the training set from the provided text for this cleared device. The substantial equivalence determination was based on non-clinical tests (electrical, mechanical, thermal, electromagnetic compatibility, biocompatibility, and acoustic output) and a comparison of the device's technical specifications and indications for use to those of a predicate device (XBit 90 Digital Color Doppler Ultrasound System, K200780).
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(253 days)
MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color Doppler Ultrasound
System (P25 Expert); P12 Plus Digital Color Doppler Ultrasound System (P12 Plus); P11 Plus Portable
Digital Color Doppler Ultrasound System (P11 Plus); P9 Plus Ultrasound Diagnostic System (P9 Plus); P3
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.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety and Effectiveness Equivalence to Predicate Devices | Affirmed: Non-clinical product evaluation (software verification and validation, performance testing (measurement accuracy), acoustic testing, EMC, doppler sensitivity, and safety testing per IEC standards) demonstrates the Medisono devices perform comparably and are as safe and effective as the predicate devices. |
| Software Functionality | Confirmed: Software verification and validation conducted; documentation provided per FDA guidance. Software considered "moderate level of concern." |
| Measurement Accuracy | Confirmed: Performance Testing included measurement accuracy for various distance and area measurements. |
| Acoustic Output and Electrical Safety | Confirmed: Acoustic output testing per IEC 60601-2-37, and safety testing per IEC 60601-1 and IEC 60601-1-2 standards were performed. |
| EMC (Electromagnetic Compatibility) | Confirmed: EMC measurements were performed. |
| Doppler Sensitivity | Confirmed: Doppler sensitivity measurements were performed. |
| Technical Characteristics Equivalence (e.g., display modes, gray scale, storage, cine review, depth adjustment, image conversion, annotations, body mark, USB port, display, operating voltage/frequency, capacity, battery life, dimensions) | Confirmed: Detailed comparison tables (pp. 9-20) show nearly identical or equivalent technical specifications and features for each Medisono device compared to its respective predicate device. The only noted difference is the absence of network connectivity for Medisono devices. |
| Intended Use Equivalence | Affirmed: The intended uses of the Medisono devices are similar to those of the predicate devices for diagnostic ultrasound imaging of various body parts and patient populations in a clinical setting. |
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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(122 days)
SonoAir Series Digital Color Doppler Ultrasound System
The SonoAir Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B(2D),B/M,M,B+CFM,B+CPA (PD),B+DPD,B+PW,B+CFM + D (PW),B+CPA(PD) + D (PW), Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic intended for use by an appropriatelytrained qualified clinician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid, testes ), Adult Cephalic, Cardiac Adult. Musculo-skeletal(Conventional, Superficial).Peripheral Vascular, Trans-vaginal and Urology,which is intended to be used in a hospital or medical clinic.
The SonoAir Series Digital Doppler Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array.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 echo data and to display the image B-Mode (2D), Fusion Harmonic Imaging, M-Mode, Pulsed Doppler (PW) Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode or a combination of these mode.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SonoAir Series Digital Color Doppler Ultrasound System, structured to answer your questions:
Important Note: The provided document is a 510(k) Summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission generally relies on demonstrating that the new device is as safe and effective as existing devices, often without requiring new large-scale clinical trials measuring specific performance metrics against pre-defined acceptance criteria in the way a novel AI algorithm might.
1. A table of acceptance criteria and the reported device performance
The document does not provide explicit acceptance criteria and corresponding performance metrics for the SonoAir Series Digital Color Doppler Ultrasound System in terms of diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing technical specifications, safety standards, and intended uses.
The "acceptance criteria" in this context are broadly related to meeting established medical device safety and performance standards, and having comparable features and indications for use as the predicate device. The "reported device performance" is essentially that it complies with these standards and operates similarly to the predicate.
Here's a table based on the provided information, focusing on the comparisons made for substantial equivalence, rather than specific performance metrics against diagnostic acceptance criteria:
| Acceptance Criterion (Implicit) | Reported Device Performance (SonoAir Series) |
|---|---|
| Indications for Use (Substantially Equivalent to Predicate) | Comparable to predicate devices (EBit 90 & XBit 90) with minor differences. Differences analyzed and deemed not to raise new safety/effectiveness concerns. |
| Design | Same autocorrelation for color processing, FFT for pulse/CW Doppler, supporting linear, curve, phase array probes, Cine playback, image archive. |
| Operational Controls | Same design as predicate. Minor differences in setting ranges (e.g., depth range, color wall filter, color baseline, PW sweeping speed, PW sample volume, PW angle correction, baseline) exist but comply with standards and meet clinical requirements. |
| Safety Compliance | Complies with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993 (various parts). |
| Operational Modes | Comparable operational modes (B mode, M mode, CFM, PW, CPA(PD), DPD, Triplex, HPRF, FHI, etc.) to predicate devices. |
| Measurements | Similar 2D, M-mode, and Doppler measurements to predicate devices. |
| Transducer Types & Connectors | Convex Array, Phased Array, Linear Array, 4 ports. Considered similar to predicate (differing slightly in volume probe and number of ports). |
| Users / Sites | Hospitals, clinics usage (same as predicate). |
| Acoustic Output | Track 3; MI, TIS, TIC, TIB (Derated Ispta: 720mW/cm² max, TIS/TIB/TIC: 0.1-4.0 Range, Mechanical Index: 1.9 Max, Derated Isppa: 190 W/cm² max) - same as predicate. |
| Power Requirements | Power requirements: AC: 100V-240V, Freq: 50-60Hz; Operating temp: 10-38°C; relative humidity 30-75%; Barometric pressure: 700 to 1060hPa. Operating temperature is within the scope of the predicate. |
| Software Documentation (Moderate Level of Concern) | Included and reviewed per FDA guidance. |
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." This means there was no specific clinical test set used to evaluate the device against diagnostic performance metrics. The evaluation was based on non-clinical tests demonstrating compliance with recognized standards and a comparison of technical specifications with predicate devices.
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, there were no "experts" in the context of establishing ground truth for a diagnostic test set. The evaluation relied on regulatory compliance and engineering comparisons.
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 is a general diagnostic ultrasound system, not an AI-assisted diagnostic device, and no clinical studies of this nature were conducted or required for this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a general diagnostic ultrasound system, not an AI-driven algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this 510(k), the "ground truth" for demonstrating substantial equivalence was adherence to recognized medical device standards and the technical specifications and operational characteristics of the legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This is a general diagnostic ultrasound system; there is no mention of an AI component or a training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable, as no training set was identified.
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(168 days)
S90 Exp Series Digital Color Doppler Ultrasound System
The S90 Exp Series Digital Color Doppler Ultrasound System (S90 Exp, S80 Exp, S80 Exp, S80 Plus, S80 Elite, S80 Senior, S80 Super, S70i, S100 Exp, P90i, P80, P80 Exp, P80 Plus, P80 Elite, P80 Senior, P80 Super, P70i, I80-Endo, I80-Surg, 175-Endo, 170-Endo) is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician or sonographer with sufficient clinical ultrasound training for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic. The system is applicable for people who need clinical ultrasound examination.
The system is intended for use in the following clinical applications: Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esophageal (Cardiac), Laparoscopic, OB/Gyn and Urology.
Modes of operation include: B, M, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Power Doppler, Directional Power Doppler, Tissue Harmonic Imaging, Tissue Doppler Imaging, 3D/4D Imaging mode, Strain Elastography, Shear Wave Elastography, Contrast and Combined modes: B/M, B/PWD, B/THI, M/Color M, B/Color Doppler, B/Color Doppler/PWD, B/Power Doppler/PWD.
This SonoScape S90 Exp Series 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.
This system consists of a mobile console with touch screen and 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, Power Doppler and Directional Power Doppler Imaging, or the combination of these modes, Contrast Imaging, Strain Elastography, Shear Wave Elastography (S-SWE, P-SWE), SonoFusion, 3D/4D.
The provided text describes the Sonoscape Medical Corp.'s S90 Exp Series Digital Color Doppler Ultrasound System and its substantial equivalence to predicate devices, but does not contain information about specific acceptance criteria related to a performance study for the device's clinical or algorithmic performance, nor does it detail a study that proves the device meets such criteria.
The document primarily focuses on:
- Indications for Use: What the device is intended for (various clinical applications and modes of operation).
- Comparison to Predicate Devices: Explaining how the S90 Exp Series is similar to previously cleared devices in terms of intended use, regulations, safety standards, acoustic output, probes, biopsy brackets, and technical characteristics.
- Non-Clinical Tests: Listing compliance with electrical safety, EMC, acoustic, and software verification standards.
Therefore, I cannot provide the requested information. The text explicitly states:
"No clinical testing was required."
This indicates that, for the purpose of this 510(k) submission, a clinical study demonstrating the device's performance against specific clinical acceptance criteria was not performed or submitted. The substantial equivalence argument is based on the device's similarity to predicate devices and compliance with non-clinical technical standards.
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(155 days)
P12 Elite Series Digital Color Doppler Ultrasound System
The P12 Elite Series Digital Color Doppler Utrasound System (P12 Exp, P12 Elite, P12 Pro, R12, P12N, P11 Exp, P11 Elite, P11 Pro, R11, P11N, P10 Eirte, P10N, R10, P9 Eirte, M11,R9) is a general-purpose ultrasonic imaging instrument intended for use by a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic. The system is applicable for people who need clinical ultrasound examination. Age, weight, health condition and race are unlimited. The system is intended for use in the following clinical applications: 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 (pediatric and adult), Trans-esoph (Cardiac), Laparoscopic, OB/ Gyn and Urology.
This SonoScape P12 Elite Series 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.
This system consists of a mobile console with touch screen and 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, Power Doppler and Directional Power Doppler Imaging, or the combination of these modes, Contrast Imaging, Elastography, 3D/4D.
The provided text details the P12 Elite Series Digital Color Doppler Ultrasound System and its substantial equivalence to predicate devices, but it does not include a study that proves the device meets specific performance acceptance criteria related to efficacy beyond general safety and electrical standards. The document states "No clinical testing was required" (Section 8).
Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and comparative/standalone effectiveness studies is not available in the provided text.
However, the document does list non-clinical performance test results:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Electrical safety testing | IEC 60601-1:2005+A1:2012 | Passed |
| EMC testing | IEC 60601-1-2:2014 | Passed |
| Acoustic testing | IEC 60601-2-37:2007+A1:2015; AIUM/NEMA UD 2:2004 (R2009) | Passed |
| Software Verification and Validation | IEC 62304:2006 +A1:2015 | Passed |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable/not specified for performance criteria beyond standards compliance. The document explicitly states "No clinical testing was required." The "test set" in this context refers to the device and its components undergoing engineering and safety evaluations rather than a clinical dataset.
- Data Provenance: Not specified, but likely internal laboratory testing by Sonoscape Medical Corp. (manufacturer's non-clinical testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/not specified, as no clinical ground truth was established from expert consensus for device performance. The "ground truth" for the non-clinical tests was the compliance with established engineering and safety standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/not specified, as individual case-level adjudication by experts was not performed for these non-clinical tests. Compliance was assessed against defined technical standards.
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 "No clinical testing was required." The device is a general-purpose ultrasound system, not an AI-assisted diagnostic tool discussed in the context of improving human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. The device is a diagnostic ultrasound system, not an algorithm being tested in a standalone capacity without a human operator. Its performance is assessed through its ability to provide images and measurements for human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests described, the "ground truth" was compliance with established international and national engineering, electrical, electromagnetic, acoustic output, software, and biocompatibility standards (e.g., IEC 60601 series, ISO 10993, AIUM/NEMA UD 2).
8. The sample size for the training set:
- Not applicable. This document describes the regulatory clearance of a medical device (ultrasound system), not the development or validation of a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, this document does not concern a machine learning model with a training set.
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(147 days)
P20 Elite Series Digital Color Doppler Ultrasound System
The P20 Elite Series Digital Color Doppler Ultrasound System (P25 Exp, P20 Exp, P20 Elite, P22 Elite, P22 Exp, P15 Exp and P15 Elite) is a general-purpose ultrasonic imaging instrument intended for use by a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital clinic. The system is applicable for people who need clinical ultrasound examination. Age, weight, health condition and race are unlimited.
The system is intended for use in the following clinical applications: 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 (pediatric and adult), Trans-esoph (Cardiac), Laparoscopic, OB/ Gyn and Urology.
Modes of operation include: B, M, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Directional Power Doppler, Tissue Harmonic Imaging, Tissue Doppler Imaging mode, Elastography, Contrast and Combined modes: B/M, B/PWD, B/THI, M/Color Doppler, B/Color Doppler/PWD, B/Power Doppler/PWD.
This SonoScape P20 Elite Series 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.
This system consists of a mobile console with touch screen and 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, Power Doppler and Directional Power Doppler Imaging, or the combination of these modes, Contrast Imaging, Elastography, 3D/4D.
The provided FDA 510(k) summary (K221140) describes the Sonoscape P20 Elite Series Digital Color Doppler Ultrasound System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for software performance and acceptance criteria for an AI/ML powered device.
Therefore, the information required to answer your request (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth details, and training set information) is not available in the provided text.
The document discusses general performance tests related to electrical safety, EMC, acoustic testing, and software verification/validation, but these are for the overall ultrasound system's hardware and embedded software, not for an AI/ML algorithm within the system.
The "P20 Elite Series" system includes some "newly added features in Function" such as "contrast imaging, Color 3D, S-Live/S-Live Silhouette/S-Live Contour, S-Depth, STIC, 3D/4D HyCoSy, SPI, Micro F, SR Flow, Auto Face, VCI and etc." and "new features (Measurement Items), including AVC Follicle, Auto OB, Auto NT, Auto EF, Auto bladder, Auto IMT and etc."
For these new functions, the summary states:
- They are "the same as or similar with the imaging functions of the reference device S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System (K201059)" for imaging functions.
- They are "the same as or equivalent with the measurement functions of the reference S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System (K201059)" for measurement items.
- "The differences in function and measurement items will not raise new risk and different questions of safety and effectiveness."
- "The end user can edit, accept, or reject the measurements and can modify the measurement results at any point. The final output and its accuracy is controlled by the end user."
This indicates that these functions are either manual or assisted measurement tools where the final decision rests with the user, and their performance is deemed similar to existing cleared devices, not necessarily validated through specific AI/ML performance studies with acceptance criteria as you've requested.
Conclusion: The provided text does not contain the detailed information regarding acceptance criteria and performance studies for an AI/ML powered device as outlined in your request. The submission focuses on demonstrating substantial equivalence of a general-purpose ultrasound system to a predicate device based on technical characteristics and safety standards.
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(133 days)
XBit Series Digital Color Doppler Ultrasound System
The XBit Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B (2D/3D/4D),B/M,M,B+CFM,B+CPA (PD),B+DPD,B+PW,B+CW,B+CFM +D (PW)/CW, B+ CPA(PD) + D (PW)/CW, TDI and Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified clinician for evaluation of Fetal ,Abdominal,Pediatric,Small Organ (breast, thyroid,testes ), Neonatal Cephalic , Adult Cephalic, Cardiac (adult , pediatric), Musculo-skeletal (Conventional , Superficial) , Peripheral Vascular, Transesophageal, Trans-rectal, Trans-vaginal, OB/GYN and Urology.
The XBit Series Digital Color Doppler Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array. This system consists of a mobile console with keyboard control panel, power supply module, color LED monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display the image B-Mode (including Fusion Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes, Elastography, contrast imaging, 3D/4D. Auto Follicle, SonoBeam, SonoColor, and SonoFusion, these four features are all semi-automated functions, they need to be modified during processing.
The provided text is a 510(k) Summary for the CHISON XBit Series Digital Color Doppler Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results designed to prove device performance against specific acceptance criteria.
Therefore, the document does not contain the acceptance criteria or a detailed study proving the device meets those criteria in the way typically expected for a novel AI/ML device. The focus here is on the similarity of the new device to existing, already cleared ultrasound systems.
Specifically, the document states:
- "7. Clinical Test: No clinical testing was required." This explicitly indicates that no clinical study was conducted for this submission.
Given this, I cannot extract the information required for accepting a device, particularly regarding a study that proves the device meets specific performance acceptance criteria related to AI/ML features. The "Acceptance Criteria" in this context would likely refer to the FDA's requirements for demonstrating substantial equivalence (e.g., similar indications for use, technological characteristics, and safety/performance as a legally marketed predicate device).
However, I can extract information related to the device's assessment of its substantially equivalent nature, which includes functional comparisons. The "SE Analysis" sections do describe what the device's "semi-automated functions" do and compare them to predicate features. These comparisons serve as the basis for the declaration of substantial equivalence, which is the "acceptance" in a 510(k) context.
Let's break down what can and cannot be answered based on the provided text, assuming the "AI" features refer to the "semi-automated functions" mentioned in section 4 and detailed in the SE Analyses (e.g., Auto Follicle, SonoBeam, SonoColor, SonoFusion).
Summary of what can be extracted from the document:
The document describes the XBit Series Digital Color Doppler Ultrasound System, which includes "semi-automated functions" like Auto Follicle, SonoBeam, SonoColor, and SonoFusion. For a 510(k) submission, the "acceptance criteria" revolve around demonstrating substantial equivalence to legally marketed predicate devices rather than proving performance against novel, quantitatively defined acceptance metrics. Indeed, the document explicitly states: "No clinical testing was required."
However, the "SE Analysis" sections serve as the basis for demonstrating that these "semi-automated functions" are substantially equivalent to features found in predicate devices. This is the closest the document comes to describing how the device "meets acceptance criteria" for these features.
1. A table of acceptance criteria and the reported device performance:
Since "No clinical testing was required," there are no explicit quantitative acceptance criteria or reported device performance metrics in the traditional sense (e.g., sensitivity, specificity, accuracy). Instead, substantial equivalence is claimed based on functional similarity.
Here's how the document frames the comparison for the "semi-automated functions":
| Feature (Subject Device) | Claimed Functionality (Subject Device) | Predicate Device Analogue(s) | Predicate Functionality | Basis for Equivalence (Implicit Acceptance Criteria) |
|---|---|---|---|---|
| Auto Follicle | Automatically identifies, traces, and calculates area and circumference of follicles after user positions ROI. Output values can be modified (semi-automated). | Acuson x700 Diagnostic Ultrasound System (synqo® Auto Follicle measurement option) | Automated measurement technique for fast, accurate assessment of multiple follicles. Measurement methods supported: Distance, 2Dist + Avg, 3Dist + Avg, 2Dist Avg, 3Dist Avg, Area, Volume, Circumference. | Both can get area and circumference of follicles. The semi-automated nature of the subject device is noted but doesn't affect substantial equivalence. |
| SonoFusion | (Implied: Makes real-time ultrasound image match with CT/MR image.) | Resona 7 Diagnostic Ultrasound System (Fusion Imaging) | (Implied: Makes real-time ultrasound image match with CT/MR image.) | Both improve diagnostic efficiency by matching images (despite differences in "navigation device and navigation bracket"). |
| SonoColor | Recognizes vessel angle automatically. | Resona 7 Diagnostic Ultrasound System (Color Vol) | (Implied: Requires user control for vessel angle recognition.) | Both can get point velocity and meet clinical requirements, despite differences in automation level for angle acquisition. |
| SonoBeam | Improved version of Q-beam, multi-beam blood flow high frame rate function based on traditional dual beamformer principle. Improves processing speed, increases frame rate, reduces noise. | CBit 9 Digital Color Doppler Ultrasound System (Q-beam) | Q-beam is implied to be a less advanced multi-beam technology for blood flow. | Both improve image quality. The subject device's improvement is noted but does not invalidate substantial equivalence. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The document states "No clinical testing was required." The "test set" for demonstrating substantial equivalence is the comparison of functional specifications and safety data to predicate devices.
- Data Provenance: Not applicable for a clinical test set. The regulatory submission data provenance is CHISON Medical Technologies Co., Ltd. from China. The comparison is based on the declared specifications and previously cleared status of predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical testing with ground truth establishment was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical testing was performed for which adjudication would be relevant.
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 "No clinical testing was required." Therefore, no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. No standalone performance evaluation for these "semi-automated functions" is mentioned or appears to have been required. The functions are described as "semi-automated," implying a human-in-the-loop is always present.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. As no clinical testing was performed, no ground truth needed to be established for performance evaluation. Ground truth for the predicate devices' original clearances would have been established, but this document does not detail that.
8. The sample size for the training set:
- Not applicable. The document does not provide information on the training set for the "semi-automated functions" (AI/ML components). This level of detail is typically not required for a 510(k) submission unless the AI/ML algorithm represents a significant change in technology or indications from the predicate.
9. How the ground truth for the training set was established:
- Not applicable. As no information on the training set is provided, how its ground truth was established is also not detailed.
In conclusion, this 510(k) summary for an ultrasound system relies on demonstrating substantial equivalence to predicate devices, and explicitly states that no clinical testing was required. Therefore, the detailed and quantitative information typically sought for AI/ML device acceptance criteria and performance studies (sample sizes, expert ground truth, MRMC studies, etc.) is not present in this document. The "acceptance" of this device is based on its similarity to already cleared devices in terms of indications, technology, and safety/performance characteristics.
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(100 days)
S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System
The Digital Color Doppler Ultrasound System is a general-purpose ultrasonic 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 (pediatric and adult), Trans-esoph (Cardiac), Laparoscopic, OB/Gyn and Urology. The Modes of Operation include B, M, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Tissue Harmonic Imaging, Power Doppler Imaging, Directional Power Doppler Imaging, Tissues Doppler Imaging, Pulse Inversion Harmonic Imaging, 3D/4D Imaging mode, Elastography Imaging, Contrast imaging, Panoramic Imaging, Trapezoid Imaging and their combination modes, and the system is intended to be used in a hospital or medical clinic.
This SonoScape S60 Elite Series 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. This system consists of a mobile console with touch screen and 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, Power Doppler and Directional Power Doppler Imaging, or the combination of these modes, Contrast lmaging, Elastography, 3D/4D.
The medical device in question is the Sonoscape S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System (K201059).
Based on the provided document, here's the information regarding its acceptance criteria and supporting study:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Standard/Test Name | Device Performance (Result) | Details / Remarks |
|---|---|---|---|
| Electrical Safety | IEC 60601-1:2005+A1:2012 | Passed | Met General requirements for basic safety and essential performance. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2014 | Passed | Met requirements for electromagnetic disturbances. |
| Acoustic Safety | IEC 60601-2-37:2015 | Passed | Met particular requirements for basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. Acoustic Output Limits: Derated ISPTA: 720mW/cm2 maximum, TIS/TIB/TIC: 6.0 maximum, MI: 1.9 maximum for all listed probes (3C-A, C1-6A, C1-6, C2-9, C322, 6CT-A, 6CI-A, 12L-A, 12L-B, 9L-A, L3-9, L741, L742, 10I2, 12LT-A, 12LI-A, 4P-A, 3P-A, S1-5, VE9-5, 6V1, 6V3, 6V7). |
| AIUM/NEMA UD 2:2004 (R2009) | Passed | Met acoustic output measurement standard for diagnostic ultrasound equipment. | |
| Biocompatibility | ISO 10993-5:2009 | Conformed | Met tests for in vitro cytotoxicity. |
| ISO 10993-10:2010 | Conformed | Met tests for irritation and skin sensitization. | |
| Software Verification and Validation | IEC 62304:2006 +A1:2015 | Passed | |
| Functional Equivalence to Predicate Device | Comparison to SonoScape S60 Series (K172082) & Philips EPIQ 5/7 (K172607) & SonoScape P10 Series (K173058) | Substantially Equivalent | Demonstrated similar intended uses, compliance with regulations, consistent acoustic output, and similar probes and technical characteristics. Differences in frequency, operation modes (DPDI vs PDI), and functions are deemed not to raise new risks according to the SE Analyses (5, 6, 7). |
2. Sample Size Used for the Test Set and Data Provenance:
- The document states that non-clinical tests (electrical safety, EMC, acoustic, biocompatibility, software verification/validation) were performed.
- No clinical testing was required for this 510(k) submission.
- Therefore, there is no specific "test set" in terms of patient data for an AI algorithm as typically understood in such studies. The evaluation focused on engineering and performance parameters against established standards.
- Data provenance: Not applicable as no clinical data test set was used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. Since no clinical test set was utilized and no AI algorithm with independent ground truth establishment was conducted, there were no experts needed to establish ground truth for a clinical test set. The device is an ultrasound system, not an AI diagnostic tool requiring clinical ground truth for performance evaluation in this submission.
4. Adjudication Method for the Test Set:
- Not applicable. No clinical test set or subjective interpretations requiring adjudication were part of this 510(k) 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. An MRMC comparative effectiveness study was not performed. This submission is for a general-purpose ultrasound system, not an AI-assisted diagnostic tool that would typically undergo such a study to evaluate reader performance with and without AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No. This is not an AI algorithm. It is a digital color Doppler ultrasound system. The evaluation was of the system's compliance with safety and performance standards.
7. The Type of Ground Truth Used:
- For the non-clinical tests, the "ground truth" was based on the requirements and methodologies outlined in the specified international medical device standards (IEC, ISO, AIUM/NEMA). These standards define objective parameters and testing procedures for assessing the safety and performance of ultrasound systems.
8. The Sample Size for the Training Set:
- Not applicable. This submission does not pertain to an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no AI algorithm training set, no ground truth needed to be established for it.
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