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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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