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The multifunctional ultrasound scanner is used to collect, display, and analyze ultrasound images during ultrasound imaging procedures in combination with supported echographic probes.

Main applications

• Cardiac
  • Districts: Cardiac Adult, Cardiac Pediatric (including newborns)
  • Invasive access: Transesophageal
• Vascular
  • Districts: Neonatal, Adult Cephalic, Vascular
  • Invasive access: Not applicable
• General Imaging
  • Districts: Abdominal, Musculo-skeletal, Neonatal, Pediatric, Small Organ (Testicles, Breast, Thyroid), Urologic
  • Invasive access: Intraoperative (Abdominal), Laparoscopic, Transrectal
• Women Health
  • Districts: OB/Fetal, Gynecology
  • Invasive access: Transrectal, Transvaginal

The primary modes of operation are: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler (both PW and CW), Color Flow Mapping (CFM), Power Doppler, Tissue Velocity Mapping (TVM), Combined modes, Elastosonography, 3D/4D and CnTI.

The ultrasound scanner is suitable for use in health institutions and is designed for ultrasound practitioners.

7600 Ultrasound System is a portable based ultrasound device used to perform diagnostic general ultrasound studies.

7600 Ultrasound System is equipped with two LCD Color Displays. The first LCD Color Display is the main output device used to display the acquisition image, the acquisition configuration and the exam results. The second LCD is provided with Touch panel and is used as a flexible input control device because its easy configurability.

The device uses the physical properties of the ultrasound (i.e. sound waves with frequency above 20 kHz and that are not audible to the human ear) for the visualization of deep structures of the body by recording the reflections or echoes of ultrasonic pulses directed into the tissues and of the Doppler effect, i.e. the frequency-shifted ultrasound reflections produced by moving targets (usually red blood cells) in the bloodstream, to determine both direction and velocity of blood flow in the target organs.

The primary modes of operation are: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler (both PW and CW), Color Flow Mapping (CFM), Power Doppler, Tissue Velocity Mapping (TVM), Combined modes. 7600 Ultrasound System also manages Elastosonography, 3D/4D and CnTI.

Several types of probes are used to cover different needs in terms of geometrical shape and frequency range.

7600 Ultrasound System can drive Phased array, Convex array, Linear array, Doppler probes and Volumetric probes (Bi-Scan probes).

7600 Ultrasound System is equipped with wireless capability.

7600 Ultrasound System will be available on the market in two models with the following commercial names: MyLabC25, MyLabC30.

The difference between MyLabC25 and MyLabC30 models is only in the licenses configuration.

7600 Ultrasound System, defined herein, is a new portable version of the cart-based 6600 Ultrasound System previously cleared under K243253.

The proposed 7600 Ultrasound System includes a new software version that combines features FDA-cleared and already available in the predicate and reference devices (K243253 and K241671). No new functionalities have been introduced in the current software release compared to the version previously cleared.

7600 Ultrasound System employs the same fundamental technological characteristics as its predicate device cleared via K243253.

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The device is a general purpose ultrasound system intended for use by qualified and trained healthcare professionals. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Vascular; Transvaginal (including GYN); Transrectal

Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/ PWD, B/Elastography. The Voluson™ Expert 18, Voluson™ Expert 20, Voluson™ Expert 22 is intended to be used in a hospital or medical clinic.

The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide highly accurate real-time three-dimensional imaging supporting all standard acquisition modes.

The following probes are the same as the predicate: RIC5-9-D, IC5-9-D, RIC6-12-D, 9L-D, 11L-D, ML6-15-D, RAB6-D, C1-6-D, C2-9-D, M5Sc-D, RM7C, eM6CG3, RSP6-16-D , RIC10-D, 6S-D and L18-18iD, RIC12-D.

The existing cleared Probe C1-6-D is being added to previously cleared SW- AI Feature Sonolyst 1st Trimester.

The provided text describes the FDA 510(k) clearance for the Voluson Expert Series ultrasound systems, specifically focusing on the AI feature "Sonolyst 1st Trimester" and the addition of the C1-6-D transducer to this feature.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Additional Performance Data (Mean values across transabdominal and transvaginal scans):

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

• SonoLyst 1st Trim IR: 7970 images

• SonoLyst 1st Trim X: 4931 images

• SonoLyst 1st Trim Live: 9111 images

• SonoBiometry CRL: 243 images

• Specific to Probegroup CL2 (which includes C1-6-D Probe): Data was collected from 396 patients.

• Data Provenance: Data was collected from multiple geographical sites including the UK, Austria, India, and USA. The data was collected using different systems (GE Voluson V730, P8, S6/S8, E6, E8, E10, Expert 22, Philips Epiq 7G).

• Retrospective/Prospective: The document does not explicitly state whether the test data was retrospective or prospective. However, the mention of "data acquired with transabdominal vs transvaginal probes" and "patients within the dataset includes pregnancies between 11 and 14 weeks of gestation, with no known fetal abnormalities at the time of imaging" suggests that the images were pre-existing or collected specifically for this evaluation, implying a retrospective or a pre-defined prospective collection for the study.

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

• Initial Curation: A single sonographer curated (sorted and graded) the images initially.
• Review Panel for Graded Images: Where the system's grading differed from the initial ground truth, the images were reviewed by a 5-sonographer review panel to determine the grading accuracy of the system.
• Qualifications: The document identifies them as "sonographers." Specific years of experience or expertise in fetal ultrasound are not provided, other than their role in image curation and review.

4. Adjudication Method for the Test Set

• Initial Sorting and Grading: Images were initially curated (sorted and graded) by a single sonographer.
• Reclassification during Sorting: The SonoLyst IR/X First Trimester process resulted in some images being reclassified during sorting based on the majority view of the panel (after the step where the system had sorted them).
• Grading Accuracy Review: For graded images where the initial single sonographer's ground truth differed from the system, a 5-sonographer review panel was used to determine the accuracy. This suggests an adjudication process where the panel formed a consensus or majority opinion to establish the final ground truth when discrepancies arose. The exact method (e.g., simple majority, weighted vote) is not specified beyond "majority view of the panel."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to evaluate how much human readers improve with AI vs. without AI assistance. The testing focused on the standalone performance of the AI algorithm against a ground truth established by sonographers.
• The verification of SonoLystLive 1st Trim Trimester features was based on the "average agreement between a sonographer panel and the output of the algorithm regarding Traffic light quality," which involves human readers assessing traffic light quality in relation to the algorithm's output, but it's not a study designed to measure human improvement with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, a standalone performance evaluation was conducted. The performance metrics (SonoLystIR, SonoLystX, SonoLystLive, SonoBiometry CRL success rate) are reported as the accuracy of the algorithm comparing its output directly against the established ground truth. This is a measure of the algorithm's ability to perform its specified functions independently.

7. The Type of Ground Truth Used

• The ground truth was established through expert consensus/review by sonographers.
  • Initial curation by a single sonographer.
  • Review and reclassification during sorting based on the "majority view of the panel."
  • A 5-sonographer review panel was used to determine grading accuracy for discrepancies.
• The ground truth also adhered to standardized imaging protocols based on internationally recognized guidelines (AIUM Practice Parameter, AIUM Detailed Protocol, ISUOG Practice Guidelines, ISUOG Detailed Protocol, and the study by Yimei Liao et al.) which informed the quality and consistency of the expert review.

8. The Sample Size for the Training Set

• 122,711 labelled source images from 35,861 patients were used for training.

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

• The document states that "Data used for both training and validation has been collected across multiple geographical sites using different systems to represent the variations in target population."
• While the specific method for establishing ground truth for the training set is not explicitly detailed in the same way as the test set, it can be inferred that similar expert labeling and curation processes would have been applied given the emphasis on "labelled source images." The document focuses on the test set truthing process as part of verification, implying that the training data would have undergone a robust labeling process to ensure quality for machine learning.

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ACUSON Maple
The ACUSON Maple ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Abdominal, Obstetrics, Gynecology, Small Parts, Pediatric, Neonatal, Vascular, Urology, Echocardiography, Musculoskeletal, and Intraoperative applications using different ultrasound transducers for different applications. The system supports the Ultrasound-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult patients with hepatic steatosis. The system also provides the ability to measure anatomical structures and provides analysis packages that provide information used by a physician for clinical diagnostic purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding the state of their cardiovascular system.

ACUSON Maple Select
The ACUSON Maple Select ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Abdominal, Obstetrics, Gynecology, Small Parts, Pediatric, Vascular, Urology, Echocardiography, and Musculoskeletal applications using different ultrasound transducers for different applications. The system also provides the ability to measure anatomical structures and provides analysis packages that provide information used by a physician for clinical diagnostic purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding the state of their cardiovascular system.

The ACUSON Maple Diagnostic Ultrasound System and ACUSON Maple Select Diagnostic Ultrasound System are multi-purpose, mobile, software-controlled, diagnostic ultrasound systems with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Their function is to acquire harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Doppler Tissue Image mode, Amplitude Doppler Mode, combination modes, Harmonic Imaging and 3D Imaging modes, or Harmonic Imaging and 4D imaging modes on a flat panel display for diagnostic ultrasound imaging.

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The ACUSON Juniper ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Abdominal, Obstetrics, Gynecology, Small Parts, Pediatric, Neonatal, Vascular, Urology, Echocardiography, Musculoskeletal, and Intraoperative applications using different ultrasound transducers for different applications.

The system supports the Ultrasound-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult patients with hepatic steatosis.

The system also provides the ability to measure anatomical structures and provides analysis packages that provide information used by a physician for clinical diagnostic purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding the state of their cardiovascular system.

ACUSON Juniper Select

The ACUSON Juniper Select ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Abdominal, Obstetrics, Gynecology, Small Parts, Pediatric, Vascular, Urology, Echocardiography, and Musculoskeletal applications using different ultrasound transducers for different applications.

The system also provides the ability to measure anatomical structures and provides analysis packages that provide information used by a physician for clinical diagnostic purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding the state of their cardiovascular system.

The ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System are multi-purpose, mobile, software-controlled, diagnostic ultrasound systems with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Their function is to acquire harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Doppler Tissue Image mode, Amplitude Doppler Mode, combination modes, Harmonic Imaging and 3D Imaging modes, or Harmonic Imaging and 4D imaging modes on a flat panel display for diagnostic ultrasound imaging.

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The Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal (superficial), thoracic/ pleural, cardiac adult, cardiac pediatric, peripheral vessel and urology, intra-operative (abdominal, thoracic, and vascular) exams.

This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals 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.

Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined mode (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape View, TDI, Color M, Smart 3D, 4D(Real-time 3D), Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).

The Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images.

Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined mode (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape View, TDI, Color M, Smart 3D, 4D(Real-time 3D), Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).

The Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.

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The Sonosite MT Ultrasound System is a general-purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:

• Abdominal
• Adult Cephalic
• Cardiac Adult
• Cardiac Pediatric
• Fetal-OB/GYN
• Musculo-skeletal (Conventional)
• Musculo-skeletal (Superficial)
• Ophthalmic
• Pediatric
• Peripheral Vessel
• Small Organ (breast, thyroid, testicles, prostate)
• Transvaginal
• Needle Guidance

Modes of operation include: B Mode (B), M-Mode (M) (including simultaneous M-mode and anatomical M Mode), PW Doppler (PWD) (including High Pulse Repetition Frequency (HPRF) and simultaneous PWD for certain exam types), Tissue Doppler Imaging (TDI), Continuous Wave Doppler (CWD), Color Power Doppler, Velocity Color Doppler, Color Variance, Tissue Harmonic Imaging (THI), Multi-beam imaging, Steep Needle Profiling, Trapezoid, and combined modes, including duplex and triplex imaging: B+M, B+PWD, B+CWD, B+C, (B+C)+PWD, (B+C)+CWD.

This device is indicated for Prescription Use Only.

The Sonosite MT Ultrasound System is intended to be used in medical practices, clinical environments, including Healthcare facilities, Hospitals, Clinics and clinical point-of-care for diagnosis of patients.

The system is used with a transducer attached and is powered either by battery or by AC electrical power. The clinician is positioned next to the patient and places the transducer onto the patient's body where needed to obtain the desired ultrasound image.

The Sonosite MT is a high-resolution, portable and versatile ultrasound system designed for use on a stand and easy grab-and-go deployment. It is a fully featured, general purpose, software controlled, diagnostic ultrasound system using all digital architecture.

The system is used to acquire and display high-resolution, real-time ultrasound data in B Mode (B), M-Mode (M) (including simultaneous M-mode and anatomical M-Mode), PW Doppler (PWD) (including High Pulse Repetition Frequency (HPRF) and simultaneous PWD for certain exam types), Tissue Doppler Imaging (TDI), Continuous Wave Doppler (CWD), Color Power Doppler, Velocity Color Doppler, Color Variance, Tissue Harmonic Imaging (THI), Multi-beam imaging, Steep Needle Profiling, Trapezoid, and combined modes, including duplex and triplex imaging.

The system includes a variety of accessories including needle guide starter kits (optional). The system also includes an ECG-specific port to support the ECG feature. The non-diagnostic ECG module provides ECG tracing of the cardiac signal synchronized with the ultrasound image. ECG is available only with cardiac exam types with the P5-1 transducer. Sonosite MT also features a Triple Transducer Connect (TTC) that allows simultaneous connection of three transducers to the system. The system also includes an I/O hub to facilitate connection to a network using an Ethernet connection. The I/O hub includes three USB 2.0 ports to connect with the accessories and one USB 3.0 plug to connect the module with the system. Sonosite MT system features a battery charge indicator presented by four LED lights and a scan time remaining display that indicates the battery charge level.

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The Diagnostic Ultrasound System Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, and Aplio i700 Model TUS-AI700 are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs (thyroid, breast and testicle), trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial), laparoscopic and thoracic/pleural. This system provides high-quality ultrasound images in the following modes: B mode, M mode, Continuous Wave, Color Doppler, Pulsed Wave Doppler, Power Doppler and Combination Doppler, as well as Speckle-tracking, Tissue Harmonic Imaging, Combined Modes, Shear wave, Elastography, and Acoustic attenuation mapping. This system is suitable for use in hospital and clinical settings by physicians or appropriately trained healthcare professionals.

In addition to the aforementioned indications for use, when EUS transducer GF-UCT180 and BF-UC190F are connected, Aplio i800 Model TUS-AI800/E3 provides image information for diagnosis of the upper gastrointestinal tract and surrounding organs, airways, tracheobronchial tree and esophagus.

The Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800 and Aplio i700 Model TUS-AI700, V9.0 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex, and sector array with frequency ranges between approximately 2MHz to 33MHz.

This FDA 510(k) clearance letter details the substantial equivalence of the Aplio i900, Aplio i800, and Aplio i700 Software V9.0 Diagnostic Ultrasound System to its predicate device. The information provided specifically focuses on the validation of new and improved features, with particular attention to the 3rd Harmonic Imaging (3-HI), a new deep learning (DL) enabled filtering process.

Acceptance Criteria and Device Performance for 3rd Harmonic Imaging (3-HI)

Detailed Study Information

1. Acceptance Criteria and Reported Device Performance

(See table above)

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

• 3rd Harmonic Imaging (3-HI) Clinical Evaluation:
  • Sample Size: 30 patients.
  • Data Provenance: Previously acquired data from a U.S. clinical site (retrospective). Patients were selected to ensure diverse demographic characteristics representative of the intended U.S. patient population, including a wide range of body mass indices (18.5-36.3 kg/m²), roughly equivalent numbers of males and females, and ages ranging from 23-89 years old.
• 3rd Harmonic Imaging (3-HI) Phantom Study:
  • Sample Size: Five abdominal phantoms.
  • Data Provenance: Phantom data.

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

• 3rd Harmonic Imaging (3-HI) Clinical Evaluation:
  • Number of Experts: Three (3).
  • Qualifications: U.S. board-certified radiologists.

4. Adjudication Method for the Test Set

• 3rd Harmonic Imaging (3-HI) Clinical Evaluation:
  • Adjudication Method: Blinded observer study. The three radiologists compared images with 3-HI to images without 3-HI (predicate functionality) using a 5-point ordinal scale. The median score was then compared with the middle score of 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Yes, a MRMC-like comparative effectiveness study was done for 3-HI's clinical evaluation.
• Effect Size: The statistical analysis demonstrated that scores for 3-HI were higher than the middle score of 3 for spatial resolution, contrast resolution, and artifact suppression. This indicates that human readers (radiologists) rated images with 3-HI as improved compared to those without.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

• Yes, a standalone study was performed for 3-HI in the phantom study. The phantom studies objectively examined lateral and axial resolution, slice resolution, contrast-to-noise ratio (CNR), reverberation artifact suppression, and frequency spectra without human interpretation.

7. The Type of Ground Truth Used

• 3rd Harmonic Imaging (3-HI) Clinical Evaluation:
  • Type of Ground Truth: Expert consensus (from the three board-certified radiologists) on image quality metrics (spatial resolution, contrast resolution, artifact suppression) through a blinded comparison against predicate functionality. The initial selection of patient images included "representative focal pathologies" suggesting clinical relevance in the images themselves.
• 3rd Harmonic Imaging (3-HI) Phantom Study:
  • Type of Ground Truth: Objective measurements against known physical properties and targets within the phantoms.

8. The Sample Size for the Training Set (for 3-HI)

• The document explicitly states that the "The validation data set [30 patients] was entirely independent of the data set used to train the algorithm during its development." However, the actual sample size for the training set is not provided in the given text.

9. How the Ground Truth for the Training Set Was Established (for 3-HI)

• This information is not provided in the given text, beyond the statement that the algorithm was "locked upon completion of development" and had "no post-market, continuous learning capability."

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LOGIQ E10 is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic, Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal; Tranesophageal and Intraoperative (Abdominal and Vascular).

Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD.

The LOGIQ E10 is intended to be used in a hospital or medical clinic.

The LOGIQ E10 is a full featured, Track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 585 mm wide (keyboard), 991 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 12-inch high-resolution color touch screen and 23.8-inch High Contrast LED LCD monitor.

Here's an analysis of the acceptance criteria and supporting studies for the LOGIQ E10 ultrasound system, derived from the provided FDA 510(k) Clearance Letter:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Auto Abdominal Color Assistant 2.0:
  • Test Set Sample Size: 49 individual subjects, 1186 annotation images.
  • Data Provenance: Retrospective, all data from the USA.
• Auto Aorta Measure Assistant:
  • Test Set Sample Size:
    • Long View Aorta: 36 subjects (11 Male, 25 Female).
    • Short View Aorta: 35 subjects (11 Male, 24 Female).
  • Data Provenance: Retrospective, from Japan (15-16 subjects) and USA (20 subjects).
• Auto Common Bile Duct (CBD) Measure Assistant:
  • Test Set Sample Size: 25 subjects (11 Male, 14 Female).
  • Data Provenance: Retrospective, from USA (40%) and Japan (60%).
• Ultrasound Guided Fat Fraction (UGFF):
  • Test Set Sample Size (Primary Study): 582 participants.
  • Data Provenance (Primary Study): Retrospective, Japan.
  • Test Set Sample Size (Confirmatory Study 1): 15 US patients + 5 EU patients (total 20).
  • Data Provenance (Confirmatory Study 1): Retrospective, USA and EU.
  • Test Set Sample Size (Confirmatory Study 2): 24 EU patients.
  • Data Provenance (Confirmatory Study 2): Retrospective, EU.

3. Number of Experts and Qualifications for Ground Truth

• Auto Abdominal Color Assistant 2.0: Not explicitly stated, but implies multiple "readers" to ground truth anatomical visibility. No specific qualifications are mentioned beyond "readers."
• Auto Aorta Measure Assistant: Not explicitly stated, but implies multiple "readers" for measurements and an "arbitrator" to select the most accurate measurement. No specific qualifications are mentioned beyond "readers" and "arbitrator."
• Auto Common Bile Duct (CBD) Measure Assistant: Not explicitly stated, but implies multiple "readers" for measurements and an "arbitrator" to select the most accurate measurement. No specific qualifications are mentioned beyond "readers" and "arbitrator."
• Ultrasound Guided Fat Fraction (UGFF): Ground truth for the primary study was MRI Proton Density Fat Fraction (MRI-PDFF %). No human experts were involved in establishing the ground truth for UGFF, as it relies on MRI-PDFF as the reference. The correlation between UGFF and UDFF also used UDFF as a reference, not human experts.

4. Adjudication Method for the Test Set

• Auto Abdominal Color Assistant 2.0: Not explicitly mentioned, however, the process described as "Readers to ground truth the 'anatomy' visible in static B-Mode image. (Before running AI)" and then comparing to AI predictions does not suggest an adjudication process for the ground truth generation itself beyond initial reader input. Confusion matrices were generated later.
• Auto Aorta Measure Assistant: An "Arbitrator" was used to "select most accurate measurement among all readers" for the initial ground truth, which was then compared to AI baseline. This implies a 1 (arbitrator) + N (readers) adjudication method for measurement accuracy. For keystroke comparison, readers measured with and without AI.
• Auto Common Bile Duct (CBD) Measure Assistant: An "Arbitrator" was used to "select most accurate measurement among all readers" for the initial ground truth, which was then compared to AI baseline. This implies a 1 (arbitrator) + N (readers) adjudication method for measurement accuracy. For keystroke comparison, readers measured with and without AI.
• Ultrasound Guided Fat Fraction (UGFF): Ground truth was established by MRI-PDFF or comparison to UDFF. No human adjudication method was described for these.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Auto Aorta Measure Assistant: Yes, a comparative study was performed by comparing keystroke counts with and without AI assistance for human readers.
  • Effect Size:
    • Long View Aorta AP Measurement: Average reduction from $4.132 \pm 0.291$ keystrokes (without AI) to $1.236 \pm 0.340$ keystrokes (with AI).
    • Short View Aorta AP and Trans Measurement: Average reduction from $7.05 \pm 0.158$ keystrokes (without AI) to $2.307 \pm 1.0678$ keystrokes (with AI).
• Auto Common Bile Duct (CBD) Measure Assistant: Yes, a comparative study was performed by comparing keystroke counts with and without AI assistance for human readers.
  • Effect Size: Average reduction of $1.62 \pm 0.375$ keystrokes (mean and standard deviation) from manual to AI-assisted measurements.
• Other features (Auto Abdominal Color Assistant 2.0, UGFF): The documentation does not describe a MRMC study for improved human reader performance with AI assistance for these features.

6. Standalone (Algorithm Only) Performance Study

• Auto Abdominal Color Assistant 2.0: Yes, the model's accuracy (detection accuracy, sensitivity, specificity, DICE score) was evaluated in a standalone manner against the human-annotated ground truth.
• Ultrasound Guided Fat Fraction (UGFF): Yes, the correlation and agreement of the UGFF algorithm's values were tested directly against an established reference standard (MRI-PDFF) and another device's derived fat fraction (UDFF).

7. Type of Ground Truth Used

• Auto Abdominal Color Assistant 2.0: Expert consensus/annotations on B-Mode images, followed by comparison to AI predictions.
• Auto Aorta Measure Assistant: Expert consensus on measurements (human readers with arbitrator selection) and keystroke counts from these manual measurements and AI-assisted measurements.
• Auto Common Bile Duct (CBD) Measure Assistant: Expert consensus on measurements (human readers with arbitrator selection) and keystroke counts from these manual measurements and AI-assisted measurements.
• Ultrasound Guided Fat Fraction (UGFF): Established clinical reference standard: MRI Proton Density Fat Fraction (MRI-PDFF %). For one confirmatory study, another cleared device's derived fat fraction (UDFF) was used as a comparative reference.

8. Sample Size for the Training Set

• The document states that "The exams used for test/training validation purpose are separated from the ones used during training process" but does not provide the sample size for the training set itself for any of the AI features.

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

• The document implies that the ground truth for training data would have been established similarly to the test data ground truth (e.g., expert annotation for Auto Abdominal Color Assistant, expert measurements for Auto Aorta/CBD Measure Assistants). However, the specific methodology for the training set's ground truth establishment (e.g., number of experts, adjudication, qualifications) is not detailed in the provided text. It only explicitly states that "Before the process of data annotation, all information displayed on the device is removed and performed on information extracted purely from Ultrasound B-mode images" for annotation. Independence of test and training data by exam site origin or overall separation is mentioned, but not the process for creating the training set ground truth.

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The LOGIQ E10s is intended for use by a qualified physician for ultrasound evaluation.

Specific clinical applications and exam types include: Fetal / Obstetrics; Abdominal (including Renal, Gynecology / Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (Abdominal and Vascular).

Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD.

The LOGIQ E10s is intended to be used in a hospital or medical clinic.

The LOGIQ E10s is a full featured, Track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 585 mm wide (keyboard), 991 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 12-inch high-resolution color touch screen and 23.8-inch High Contrast LED LCD monitor.

The provided text describes three AI features: Auto Abdominal Color Assistant 2.0, Auto Aorta Measure Assistant, and Auto Common Bile Duct (CBD) Measure Assistant, along with a UGFF Clinical Study.

Here's an analysis of the acceptance criteria and study details for each, where available:

1. Table of Acceptance Criteria and Reported Device Performance

For Auto Abdominal Color Assistant 2.0

For Auto Aorta Measure Assistant

For Auto Common Bile Duct (CBD) Measure Assistant

For UGFF Clinical Study

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

Auto Abdominal Color Assistant 2.0:

• Sample Size: 49 individual subjects (1186 annotation images)
• Data Provenance: Retrospective, from the USA (100%).

Auto Aorta Measure Assistant:

• Sample Size:
  • Long View Aorta: 36 subjects
  • Short View Aorta: 35 subjects
• Data Provenance: Retrospective, from Japan and USA.

Auto Common Bile Duct (CBD) Measure Assistant:

• Sample Size: 25 subjects
• Data Provenance: Retrospective, from USA (40%) and Japan (60%).

UGFF Clinical Study:

• Sample Size:
  • Original study: 582 participants
  • Confirmatory study (US/EU): 15 US patients and 5 EU patients (total 20)
  • Confirmatory study (UGFF vs UDFF): 24 EU patients
• Data Provenance: Retrospective and Prospective implicitly (clinical study implies data collection).
  • Original Study: Japan (Asian population)
  • Confirmatory Study (US/EU): US and EU (demographic info unavailable for EU patients, US patients: BMI 21.0-37.5, SCD 13.9-26.9)
  • Confirmatory Study (UGFF vs UDFF): EU

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

Auto Abdominal Color Assistant 2.0:

• Number of Experts: Not specified. The text mentions "Readers to ground truth the 'anatomy'".
• Qualifications of Experts: Not specified.

Auto Aorta Measure Assistant:

• Number of Experts: Not specified. The text mentions "Readers to ground truth the AP measurement..." and an "Arbitrator to select most accurate measurement among all readers." This implies multiple readers and a single arbitrator.
• Qualifications of Experts: Not specified.

Auto Common Bile Duct (CBD) Measure Assistant:

• Number of Experts: Not specified. The text mentions "Readers to ground truth the diameter..." and an "Arbitrator to select most accurate measurement among all readers." This implies multiple readers and a single arbitrator.
• Qualifications of Experts: Not specified.

UGFF Clinical Study:

• Number of Experts: Not applicable, as ground truth was established by MRI-PDFF measurements, not expert consensus on images.

4. Adjudication method for the test set

Auto Abdominal Color Assistant 2.0:

• Adjudication Method: Not explicitly described as a specific method (e.g., 2+1). The process mentions "Readers to ground truth" and then comparison to AI predictions, but no specific adjudication among multiple readers' initial ground truths.

Auto Aorta Measure Assistant:

• Adjudication Method: Implies an arbitrator-based method. "Arbitrator to select most accurate measurement among all readers." This suggests multiple readers provide measurements, and a single arbitrator makes the final ground truth selection.

Auto Common Bile Duct (CBD) Measure Assistant:

• Adjudication Method: Implies an arbitrator-based method. "Arbitrator to select most accurate measurement among all readers." Similar to the Aorta assistant.

UGFF Clinical Study:

• Adjudication Method: Not applicable. Ground truth was established by MRI-PDFF measurements.

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

Auto Abdominal Color Assistant 2.0:

• MRMC Study: Not explicitly stated as a comparative effectiveness study showing human improvement. The study focuses on the algorithm's performance against ground truth.
• Effect Size (Human Improvement with AI): Not reported.

Auto Aorta Measure Assistant:

• MRMC Study: Yes, an implicit MRMC study comparing human performance with and without AI. Readers performed measurements with and without AI assistance.
• Effect Size (Human Improvement with AI):
  • Long View Aorta (Keystrokes): Average keystrokes reduced from 4.132 (without AI) to 1.236 (with AI).
  • Short View Aorta (Keystrokes): Average keystrokes reduced from 7.05 (without AI) to 2.307 (with AI).
  • (No specific improvement in diagnostic accuracy for human readers with AI is stated, primarily focuses on efficiency via keystrokes).

Auto Common Bile Duct (CBD) Measure Assistant:

• MRMC Study: Yes, an implicit MRMC study comparing human performance with and without AI. Readers performed measurements with and without AI assistance.
• Effect Size (Human Improvement with AI):
  • Porta Hepatis CBD (Keystrokes): Average reduction in keystrokes for measurements with AI vs. manually is 1.62 +/- 0.375.
  • (No specific improvement in diagnostic accuracy for human readers with AI is stated, primarily focuses on efficiency via keystrokes).

UGFF Clinical Study:

• MRMC Study: No, this was a standalone algorithm performance study compared to a reference standard (MRI-PDFF) and a predicate device (UDFF). It did not involve human readers using the AI tool.

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

Auto Abdominal Color Assistant 2.0:

• Standalone Performance: Yes. The reported accuracy, sensitivity, specificity, and DICE score are for the algorithm's performance.

Auto Aorta Measure Assistant:

• Standalone Performance: Yes, implicitly. The "AI baseline measurement" was compared for accuracy against the arbitrator-selected ground truth. While keystrokes involved human interaction to use the AI, the measurement accuracy is an algorithm output.

Auto Common Bile Duct (CBD) Measure Assistant:

• Standalone Performance: Yes, implicitly. The "AI baseline measurement" was compared for accuracy against the arbitrator-selected ground truth.

UGFF Clinical Study:

• Standalone Performance: Yes. The study directly assesses the correlation and agreement of the UGFF algorithm's output with MRI-PDFF and another ultrasound-derived fat fraction algorithm.

7. The type of ground truth used

Auto Abdominal Color Assistant 2.0:

• Ground Truth Type: Expert consensus for anatomical visibility ("Readers to ground truth the 'anatomy' visible in static B-Mode image.")

Auto Aorta Measure Assistant:

• Ground Truth Type: Expert consensus from multiple readers, adjudicated by an arbitrator, for specific measurements ("Arbitrator to select most accurate measurement among all readers.")

Auto Common Bile Duct (CBD) Measure Assistant:

• Ground Truth Type: Expert consensus from multiple readers, adjudicated by an arbitrator, for specific measurements ("Arbitrator to select most accurate measurement among all readers.")

UGFF Clinical Study:

• Ground Truth Type: Outcomes data / Quantitative Reference Standard: MRI Proton Density Fat Fraction (MRI-PDFF %).

8. The sample size for the training set

Auto Abdominal Color Assistant 2.0:

• Training Set Sample Size: Not specified beyond "The exams used for test/training validation purpose are separated from the ones used during training process".

Auto Aorta Measure Assistant:

• Training Set Sample Size: Not specified beyond "The exams used for regulatory validation purpose are separated from the ones used during model development process".

Auto Common Bile Duct (CBD) Measure Assistant:

• Training Set Sample Size: Not specified beyond "The exams used for regulatory validation purpose are separated from the ones used during model development process".

UGFF Clinical Study:

• Training Set Sample Size: Not specified. The study describes validation but not the training phase.

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

Auto Abdominal Color Assistant 2.0:

• Training Set Ground Truth: Not explicitly detailed, but implied to be similar to the test set ground truthing process: "Information extracted purely from Ultrasound B-mode images" and "Readers to ground truth the 'anatomy'".

Auto Aorta Measure Assistant:

• Training Set Ground Truth: Not explicitly detailed, but implied to be similar to the test set ground truthing process: "Information extracted purely from Ultrasound B-mode images" and "Readers to ground truth the AP measurement...".

Auto Common Bile Duct (CBD) Measure Assistant:

• Training Set Ground Truth: Not explicitly detailed, but implied to be similar to the test set ground truthing process: "Information extracted purely from Ultrasound B-mode images" and "Readers to ground truth the diameter...".

UGFF Clinical Study:

• Training Set Ground Truth: Not specified for the training set, but for the validation set, the ground truth was MRI-PDFF measurements.

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The X9 Ultrasound System is intended for ultrasound imaging of validated vascular accesses for hemodialysis during the preliminary stage of a cannulation procedure, prior to inserting the needle. The device is intended to be used by qualified healthcare professionals in a medical setting. The device is not intended to be used to diagnose the position of the vascular access without confirming position per standard of care. The X9 Ultrasound System is not for use in pediatric patients.

The X9 Ultrasound System is intended for guidance in accessing arteriovenous fistulas and grafts (AVF/G). The X9 Ultrasound System consists of a Handpiece and Software. The Handpiece is a handheld device with an ultrasound transducer and is attached via a cable to a user-supplied Computer. The Handpiece is covered by a compatible probe cover and is placed on the patient's limb and positioned (translated/rotated) by the user to align with the AVF/G. The Handpiece contains a physical button for the user to activate/deactivate the system and an alignment marking to assist the user with positioning the Handpiece over the vessel. The software, which runs on a standard operating system platform installed on the Computer, provides the Graphical User Interface (GUI). The GUI will indicate when the Handpiece is aligned with the AVF/G. The information given from the system is intended to guide the user so that they can efficiently proceed with the standard of care assessment prior to cannulation.

Here's a detailed breakdown of the acceptance criteria and the study that proves the X9 Ultrasound System meets those criteria, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Note: The FDA 510(k) summary explicitly states that the Machine Learning Model (and therefore the X9 Ultrasound System) met the ML Model Validation acceptance criteria for the primary analyses.

Study Details

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

• Sample Size for Test Set: 378 B-mode ultrasound images collected from 63 participants.
• Data Provenance: The study involved participants known to have an arteriovenous fistula or graft (AVF/G). Clinic locations for ML model validation were selected to obtain a sample of participants. The patient demographics provided (31 females, 32 males, 34 Black/African American, 27 White, 1 Asian, 1 Unknown/Not Reported, 4 Hispanic or Latino, and 59 Not Hispanic or Latino, aged 18 to 75+ years old) suggest a diverse, likely multi-center, prospective collection of data within a clinical setting, although specific countries are not mentioned. Given the FDA submission, the data is most likely from the United States or a country adhering to similar clinical trial standards.

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

• Number of Experts: Three (3) independent sonographers.
• Qualifications of Experts: The document states they used their "clinical expertise" to determine if an access vessel was visible and to annotate its location. This implies they are trained and experienced medical professionals in ultrasound imaging, specifically sonographers.

4. Adjudication Method for the Test Set

• The ground truth for Access Presence was established when the "majority of independent reviewers determined that an access vessel was present in the image." This indicates a 2 out of 3 consensus (or "2+1") method for access presence.
• For the True Location of the access vessel, it was established by calculating the average of the locations annotated by each of the independent reviewers. This is an averaging adjudication method for continuous metrics.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a MRMC comparative effectiveness study was not explicitly done or reported. The study focused on the standalone performance of the machine learning model against expert-annotated ground truth. There is no mention of comparing human readers with AI assistance versus human readers without AI assistance, nor any effect sizes of human reader improvement.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance study was done. The "Machine Learning Model Validation" directly assesses the performance of the algorithm (X9 Ultrasound System's ML model) in determining access vessel presence and location against expert-established ground truth. The reported metrics (Access Presence Sensitivity, Average Lateral Error, and Average Dice Similarity Coefficient) are all measures of the algorithm's performance alone.

7. Type of Ground Truth Used

• The ground truth used was expert consensus and expert annotation.
  • For "Access Presence," it was based on the majority decision of three independent sonographers.
  • For the "True Location" of the access vessel, it was the average of the locations annotated by the three independent sonographers.

8. Sample Size for the Training Set

• The document states, "The training dataset was collected at dialysis clinics not included in the ML model validation and was used exclusively for model training." However, the specific sample size (number of images or participants) for the training set is not provided in this document.

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

• The document states, "Separate test datasets were reserved for performance validation against expert-annotated ground truth." This implies that the training data also likely utilized expert-annotated ground truth, similar to the test set, but this is not explicitly detailed for the training set. It's standard practice for machine learning models to be trained on data with established ground truth, often through expert labeling or external verified sources.

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