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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 application:

• Cardiac
  Districts: Cardiac Adult, Cardiac Pediatric
  Invasive access: Transesophageal

• Vascular
  Districts: Neonatal, Adult Cephalic, Vascular
  Invasive access: Not applicable

• General Imaging
  Districts: Abdominal, Breast, Musculoskeletal, Neonatal, Pediatric, Small Organs (Testicles), Thyroid, Urological
  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 Pulsed Wave (PW) and Continuous Wave (CW)), Color Flow Mapping (CFM), Power Doppler, Tissue Velocity Mapping (TVM), Combined modes, Elastosonography, 3D/4D and CnTI.

The ultrasound scanner is suitable to be installed in professional healthcare facility environment and is designed for ultrasound practitioners.

6600 Ultrasound System is a general-purpose diagnostic ultrasound system, based on a mainframe platform that can be easily moved thanks to four swivelling wheels.

6600 Ultrasound System consists of a control panel assembly with LCD monitor and a console with the device electronics and connectors, housed in an ergonomic cart designed to be both highly mobile and adjustable for a range of users and operating conditions.

6600 Ultrasound System use 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. 6600 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.

6600 Ultrasound System can drive Phased Array, Convex Array, Linear Array, Doppler probes and Volumetric probes (Bi-Scan probes). The control panel is equipped with a pull out Qwerty alphanumeric keyboard that allows data entry. The touchscreen has an emulation of the Qwerty keyboard that allows data entry and has additional controls and mode-depending keys, integrated in the touchscreen.

6600 Ultrasound System is equipped with wireless capability.

6600 Ultrasound System will be available on the market in two models with the following commercial names: MyLabA50, MyLabA70. The difference between MyLabA50 and MyLabA70 models is only in the licenses configuration.

6600 Ultrasound System, defined herein, introduces new features and accessories listed below:

1. AutoOB: AutoOB (Automatic Obstetric Biometric Measurement) is a tool based on A.I. algorithms that supports the clinician in performing the Obstetric Biometric Measurements during an Obstetric ultrasound examination.

2. AutoCM: AutoCM (Automatic Cardiac Measurement), is a tool based on A.I. algorithm that supports the clinician in performing the Cardiac Measurements during a Cardiac ultrasound examination.

3. XStrain RV: XStrain allows clinicians to quantify endocardial velocities of contraction and relaxation and local deformation of the heart (Strain/Strain rate). XStrain RV is an advanced processing package for the Right Ventricle analysis.

4. New probes: C 1-8E, L 3-15E and P 1-5E, available for MyLabA50 model.

5. New probes: C 1-8A and P 1-5A available for MyLabA70 model.

6600 Ultrasound System employs the same fundamental technological characteristics as its predicate device cleared via K230179.

The document describes the FDA 510(k) clearance for the Esaote 6600 Ultrasound System, specifically highlighting the AI-powered features: AutoOB (Automatic Obstetric Biometric Measurement) and AutoCM (Automatic Cardiac Measurement). The study performed aimed to demonstrate the statistical equivalence between the AI-powered automatic measurements and manual measurements.

Here's a breakdown of the acceptance criteria and the study details for the AI functionalities:

AutoOB (Automatic Obstetric Biometric Measurements) Feature AI-powered

Acceptance Criteria and Reported Device Performance

For Scan Plane Classification Algorithm:

For Automatic Measurement Algorithm:

Note: The document states "All test results are in line with the acceptance criteria" for both algorithms, indicating that the reported performance met the acceptance criteria.

Study Details for AutoOB

1. Sample sizes used for the test set and the data provenance:

   • Scan plane classification algorithm: 265 images (test dataset)
   • Automatic measure algorithm: 521 images (test dataset)
   • Data Provenance: Based on female, pregnant, Caucasian patients. The document does not explicitly state the country of origin but implies data was collected by Esaote (an Italian company) and its predicate device users. The information available suggests it's retrospective data, as images were "saved during the examinations."

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

   • Number of Experts: Two experts established the ground truth for both training and test datasets.
   • Qualifications: Clinicians specialized in Radiology with 30 and 24 years of experience in Ob-fetal ultrasound imaging.

3. Adjudication method for the test set:

   • Method: Consensus reading. Each expert contributed to the annotation, then reviewed the annotations of the other. A consensus reading was done whereby the two radiologists discussed if they agreed on or not.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study comparing human readers with and without AI assistance was not reported for AutoOB. The study focused on the equivalence between manual and AI measurements, rather than human reader performance improvement.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the study evaluates the performance of the algorithm in classifying scan planes and performing measurements automatically, comparing them to expert-derived ground truth. This is a standalone evaluation of the algorithm's accuracy.

6. The type of ground truth used: Expert consensus by a panel of two radiologists.

7. The sample size for the training set:

   • Scan plane classification algorithm: 25597 images
   • Automatic measure algorithm: 11698 images

8. How the ground truth for the training set was established: The consensus of the same expert panel (two radiologists with 30 and 24 years of experience) was used as ground truth for the training datasets, following the same adjudication method.

AutoCM (Automatic Cardiac Measurements) Feature AI-powered

Acceptance Criteria and Reported Device Performance

For Segmentation and Measurement Algorithm:

Note: The document states "All test results are in line with the acceptance criteria," indicating that the reported performance met the acceptance criteria.

Study Details for AutoCM

1. Sample sizes used for the test set and the data provenance:

   • Test set sample size: 100 images
   • Data Provenance: Based on both female and male Caucasian adult patients. The test dataset was "acquired and labelled in a different medical center" than where the training data experts established ground truth, implying prospective or at least independently collected retrospective data. The country of origin is not explicitly stated.

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

   • Number of Experts for Test Set Ground Truth: One expert.
   • Qualifications for Test Set Ground Truth: Clinician specialized in Cardiology with 36 years of experience.
   • (For training set ground truth, two cardiologists with 30 and 24 years of experience were used).

3. Adjudication method for the test set:

   • Method: The test dataset was labelled by a single clinician. Therefore, no formal adjudication of multiple readers on the test set is reported for the AutoCM feature. (For the training set, a consensus reading of two cardiologists was performed).

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study comparing human readers with and without AI assistance was not reported for AutoCM. The study focused on the equivalence between manual and AI measurements.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the study evaluates the performance of the algorithm in performing cardiac measurements automatically, comparing them to expert-derived ground truth. This is a standalone evaluation of the algorithm's accuracy.

6. The type of ground truth used: Expert ground truth. For the training set, it was expert consensus (two cardiologists). For the test set, it was established by a single expert.

7. The sample size for the training set: 2011 images

8. How the ground truth for the training set was established: The consensus of an expert panel consisting of two clinicians specialized in Cardiology with 30 and 24 years of experience was used. Each contributed to the annotation and then reviewed the annotations of the other, with a consensus reading to resolve disagreements.

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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 application: Cardiac, Vascular, General Imaging, Women Health. Districts: Cardiac Adult, Cardiac Pediatric, Neonatal, Adult Cephalic, Vascular, Abdominal, Breast, Musculoskeletal, Neonatal, Pediatric, Small Organs (Testicles), Thyroid, Urological, OB/Fetal, Gynecology. Invasive access: Transesophageal, Not applicable, Intraoperative (Abdominal), Laparoscopic, Transrectal, Transvaginal.

Virtual Navigator option supports a radiological clinical ultrasound examination (first modality) by providing additional image information from a second imaging modality. As second imaging modality it is intended any image coming from CT, MR, US, PET, XA and NM.
The second modality provides additional security in assessing the morphology of the real time ultrasound image.

The primary modes of operation are: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler (both Pulsed Wave (PW) and Continuous Wave (CW)), Color Flow Mapping (CFM), Power Doppler, Tissue Velocity Mapping (TVM), Combined modes, Elastosonography, 3D/4D and CnTI.
The ultrasound scanner is suitable to be installed in professional healthcare facility environment and is designed for ultrasound practitioners.

6450 Ultrasound System is a general-purpose diagnostic ultrasound system, based on a mainframe platform that can be easily moved thanks to four swivelling wheels.
6450 Ultrasound System consists of a control panel assembly with LCD monitor and a console with the device electronics and connectors, housed in an ergonomic cart designed to be both highly mobile and adjustable for a range of users and operating conditions.
6450 Ultrasound System use 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. 6450 Ultrasound System also manages Elastosonography (ElaXto, QElaXto, QElaXto 2D), 3D/4D and CnTI.
Several types of probes are used to cover different needs in terms of geometrical shape and frequency range.
6450 Ultrasound System can drive Phased Array, Convex Array, Linear Array, Doppler probes and Volumetric probes (Bi-Scan probes).
The control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry. The touchscreen has an emulation of the Qwerty keyboard that allows data entry and has additional controls and mode-depending keys, integrated in the touchscreen.
6450 Ultrasound System is equipped with wireless capability.
6450 Ultrasound System will be available on the market in two models with the following commercial names: MyLabE80, MyLabE85.
The difference between MyLabE80 and MyLabE85 models is only in the licenses configuration.
For both models, there is the ETC (Easy To Clean) version, having a keyboard with special controls and material, compatible with disinfection procedures.
6450 Ultrasound System, defined herein, introduces new features and accessories listed below:

1. XStrain LA: XStrain allows clinicians to quantify endocardial velocities of contraction and relaxation and local deformation of the heart (Strain/Strain rate). XStrain LA is an advanced processing package for the Left Atrium analysis.
2. New probe: IHX 6-25
   6450 Ultrasound System employs the same fundamental technological characteristics as its predicate device cleared via K192157.

The provided FDA clearance letter (K241671) describes a 510(k) submission for the Esaote 6450 Ultrasound System (MyLabE80/E85). While it states that "The proposed device did not require clinical studies to support substantial equivalence," it does detail non-clinical testing, specifically for a new feature called "XStrain LA." This section will focus on the acceptance criteria and study proving the device meets these criteria for the XStrain LA feature, as it's the only performance validation detail provided.

Note: The document is primarily a 510(k) clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical performance studies often seen with novel high-risk devices or completely new AI functionalities. The XStrain LA validation described appears to be a non-clinical performance test against a reference software, not a separate clinical study with human readers.

Acceptance Criteria and Reported Device Performance

The acceptance criterion for the XStrain LA feature is based on the Intraclass Correlation Coefficient (ICC) when comparing its results (LASr, LAScd, LASct) to a recognized reference software (TomTec AutoSTRAIN). The specific acceptance thresholds are not explicitly stated as numerical values in the document but are implied by the reported results being "valid." Given the context of a 510(k) summary, these would typically be pre-defined thresholds considered adequate for clinical equivalence or sufficient performance.

Here's a table summarizing the acceptance criteria (implied by the study design) and the reported performance for the XStrain LA feature:

Study Details for XStrain LA Feature Validation

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

   • Sample Size: Undisclosed, but described as "five batches of image data." The exact number of patients or images within these batches is not specified.
   • Data Provenance: The data comes from various sources, indicating a retrospective collection:
     • Batch 1: Acquired using an Esaote MyLab Alpha system in a multi-vendor strain comparison study (Farsalinos, Daraban, Ünlü, & Thomas, 2015).
     • Batch 2: Acquired using an Esaote MyLab Alpha system in another multi-vendor strain comparison study (Mirea, et al., 2018).
     • Batch 3: Acquired at the cardiology department of the Amsterdam Medical Center.
     • Batch 4: Acquired at the cardiology department of Auxologico hospital Milan.
     • Retrospective/Prospective: All described data acquisition appears to be retrospective, utilizing existing datasets from previous studies or clinical archives.

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

   • The "ground truth" for the test set is established by the TomTec AutoSTRAIN software (part of TomTec Arena TTA2 LOT 42.0), which is used as the "prior reference" or "reference software."
   • For the data acquisition from the Amsterdam Medical Center and Auxologico hospital Milan, the images were acquired by "experienced cardiographers." This refers to the acquisition of the images themselves, not the establishment of the "ground truth" for the strain analysis. The document does not specify human experts involved in manually adjudicating or segmenting images solely for the purpose of establishing ground truth for this particular validation study's comparison to the reference software.

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

   • No human adjudication method is described for the test set's ground truth. The comparison is directly between the Esaote 6450 Ultrasound System's XStrain LA results and the results from the TomTec reference software.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC comparative effectiveness study was performed as described in this document. The validation focuses on the performance of the XStrain LA feature (an advanced processing package) itself against a reference software, not on human reader improvement with or without this feature.

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

   • Yes, the validation of XStrain LA against the TomTec reference software can be considered a form of standalone performance assessment, as it evaluates the algorithm's output directly against a computational reference, rather than its impact on a human reader's diagnostic accuracy. The process described is: "A strain analysis is done for one complete heart cycle on each of the image runs... The LASr, LAScd and LASct results for each image run are compared to the corresponding TomTec reference." This is a direct comparison of algorithmic output.

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

   • The ground truth is established by a reference software/algorithm: TomTec AutoSTRAIN. This is a computational ground truth, specifically a widely used and validated commercial software for cardiac strain analysis.
   • The initial contouring and frame index used for the Esaote system's analysis were set to be "equal to the ones used during the creation of the TomTec references," indicating consistency in the input conditions for comparison.

7. The sample size for the training set:

   • The document does not provide any information regarding the training set sample size for the XStrain LA feature. This is typical for a 510(k) summary that focuses on validation of a specific feature rather than the entire development lifecycle of a complex AI model.

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

   • The document does not provide any information regarding how the ground truth for the training set was established.

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The general-purpose magnetic resonance imaging (MRI) device is designed to scan any targeted area of the body, to collect, display and analyze MR images and other real-time imaging procedures.

Imaging portions of calf, knee, ankle, foot, thigh, hand, wrist, forearm, elbow, arm, shoulder, hip, lumbar column, sacral column, cervical column, thoracic spine, pelvis, temporomandibular joint (included only for "Open" configuration), head (included only for "Open" configuration).

MRI provides better soft tissue contrast than CT and can differentiate better between fat, water, muscle, and other soft tissue than CT (CT is usually better at images provide information to physicians and can be useful in diagnosing a wide variety of diseases and conditions.

The new Magnifico EVO 23 employs the same fundamental scientific technology as its predicate device, the first version of Esaote Magnifico, cleared via K212419.

The modifications, do not affect the intended use or alter the fundamental scientific technology of the device.

The software, used on the proposed Magnifico system has been modified, from EVO 21 to include the

• LSDWI sequence for brain examination

• · MR Angiography
  · Maximum Intensity Projection (MIP)

• and to support:
  · Additional multi-channel technology coil for body

• · Enhancement of PC board with new processor
  Maqnifico keeps all the other technological characteristics of the first cleared, version, as the 0.4T permanent Magnet, based on NdFeB (neodymium), C-shape.

The provided text indicates that the device in question is the Magnifico Open (100009900) and Magnifico MSK (100009910) MRI systems, specifically focusing on the new EVO 23 software release.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it describes general categories of testing and qualitative conclusions. The reported device performance is described as meeting these criteria.

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

The document does not specify a numerical sample size for the test set. It mentions "Sample clinical images for the new features were reviewed."

The data provenance (country of origin, retrospective/prospective) is not specified in the provided text.

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

• Number of Experts: One expert.
• Qualifications: An "ACR registered radiologist." The document does not specify their years of experience.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly stated as a formal process like 2+1 or 3+1. Given that only one expert (an ACR registered radiologist) reviewed the sample clinical images for new features, it appears to be a single-reader review rather than a consensus or adjudicated process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not mentioned in the provided text. The study focuses on the substantial equivalence of the device itself and the diagnostic quality of its output.

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

The device is an MRI system, not an AI algorithm performing diagnostic tasks independently. The "software" modifications refer to new sequences (LSDWI, MR Angiography) and features (MIP), which are integrated into the MRI system to produce images, and these images are then assessed by a human expert. Therefore, a standalone algorithm-only performance study in the context of diagnostic AI is not applicable here. The software verification and validation, along with image quality tests, implicitly evaluate the system's standalone performance in generating medically relevant images.

7. The Type of Ground Truth Used

The ground truth for evaluating the "diagnostic quality" of the sample clinical images for new features was expert consensus/opinion. Specifically, it was the opinion of a single "ACR registered radiologist."

8. The Sample Size for the Training Set

The document does not provide any information about a training set since the device is an MRI system with new imaging sequences and features, not a machine learning model that requires a distinct training phase. The software changes involve implementation of established imaging techniques and display methods.

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

As no training set is mentioned or applicable in the context of the described device and its modifications, this information is not provided.

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The multifunctional ultrasound scanner MyLabX90 is used to collect, display, and analyze ultrasound images during ultrasound imaging procedures in combination with supported echographic probes.

Virtual Navigator option supports a radiological clinical ultrasound examination (first modality) by providing additional image information from a second imaging modality. As second imaging modality it is intended any image coming from CT, MR, US, PET,XA and NM. The second modality provides additional security in assessing the morphology of the real time ultrasound image.

The upgraded 6440 systems, MyLabX90 is a mainframe systems equipped with wheels allowing to move the system.

MyLabX90 scanners are based on a mainframe easily movable platform.

MyLabX90 scanners have four swiveling wheels. they have a range of height adjustments for onetime installation, the main screen can be easily moved due to an optional articulated arm. Due to their small footprint they can fit in any real-world clinical environment.

The possibility to adjust both the main screen. control panel and touchscreen brightness enables the use of MyLab in any environment even with really different lighting conditions:

from the really bright scenario of the operative room, to the dark scenario of the examination room, passing through the medium-light environment of the bed-side examination setting.

The primary modes of operation are for both models: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D. Model 6440 manages Qualitative Elastosonography (ElaXto).

Model 6440 can drive Phased array, Convex array, Linear array, Doppler probes and Volumetric probes (Bi-Scan probes). The control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry.

Model 6440 has the Virtual Navigator software option integrated, designed to support a radiological clinical ultrasound examination (first modality) and follow a percutaneous procedure providing additional image information from a 2nd imaging modality (CT, MR, US and PET). The user is helped in assessing the patient anatomy by displaying the image generated by the 2nd modality.

Model 6440 is equipped with wireless capability.

Model 6440 is already cleared via K173291.

The marketing name for new devices of Model 6440 will be:

MyLabX90 ●

MyLabX90, defined herein, combines the cleared features of 6440 system with new capabilities, listed below:

• 1. Cardio Package with new AUTO E.F. The AutoEF, based on Artificial Intelligence, detects and track, automatically, the LV endocardial border to calculate LV Volumes (Diastolic Volume - Systolic Volume) and EF (Ejection Fraction). The software module (powered with A.I.) is registered by Pie Medical Imaging B.V. as Caas Qardia (K212376)
• 2. eDetect for Breast Lesions contouring function supports the operator by detecting the lesion contour (with A.I. algorithm) in Breast measurements, after that the operator has identified the region, with suspicious lesions, and applied the ROI marker. At the end of the detection the operator can confirm/edit the proposed contour or redraw it completely. In addition, several morphologic parameters (following Bi-Rads : shape, orientation and circumscribed) are automatically proposed to the customer and upon validation is inserted in the final report. The tool is available in Breast application.
• 3. XStrain allows clinicians to quantify endocardial velocities of contraction and relaxation and local deformation of the heart (Strain rate). Based on 2D speckle tracking technology with Angle-independent technology. A.I. Powered for auto border detection of left ventricle (LV).
• 4. The QAI (Quality Attenuation Imaging) application allows to perform a Colored Quantitative Attenuation analysis of tissues in Real-time. Based on the attenuation analysis along the ROI. In QAI attenuation parameter values are converted and color coded and displayed inside the Region Of Interest (ROI). A different set of palettes is available, with dynamic control and transparency.
• The Prostate Biopsy Stepper is enabling the compatibility with CIVCO Classic and GfM 5. MST50 steppers displaying a Grid Template overlays for precise guided-biopsies. The Stepper help stabilizes and follows accurate needle path during transperineal procedure. Stepper functionality is available in Fusion imaging / UroFusion environment.
• HyperDoppler, based on Color Doppler Flow Mapping (CDFM) technology, provides different 6. map representation to highlight the intracardiac flow properties
• 7. Transducer Element Check
• 8. New transducers 2CWL, 5CWL, CX 1-8, LX 3-15, LMX 4-20, PX 1-5 and TE 3-8
• 9. New biopsy kits JSM-198 and JSM-113.

Here's a breakdown of the acceptance criteria and study details for the "eDetect for Breast Lesions contouring" and "Endocardium border segmentation" AI features, based on the provided document:

eDetect for Breast Lesions Contouring

1. Table of Acceptance Criteria and Reported Device Performance

*Note: The document provides example values for "Absolute Difference [mm²]" and "Absolute Difference [mm]" for the image contouring, which are then converted to "Percentage Error (%)". The "Average Error 0.9 | 0.95 |
| Standard Deviation | 20 years of experience and one clinical researcher with >5 years of experience mentioned in the "Truthing" process).

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The general-purpose magnetic resonance imaging (MRI) system is designed to scan any targeted area of the body, to collect, display and analyse MR images and other real-time imaging procedures. Imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip, imaging the temporomandibular joint and imaging the cervical, the thoracic, the lumbar and the sacral sections as portions of the spinal column, imaging the pelvis and imaging the head. Outcomes related to diagnosis Magnifico is a Magnetic Resonance (MR) system that produces cross-section images of the limbs, joints, spinal column, pelvis and head. MRI provides better soft tissue contrast than CT and can differentiate better between fat, water, muscle, and other soft tissue than CT (CT is usually better at imaging bones). These images provide information to physicians and can be useful in diagnosing a wide variety of diseases and conditions.

Magnifico is a Magnetic Resonance (MR) system with two configurations: 1. Magnifico Open, "Whole body" configuration (all above listed, in intended use, anatomical regions) 2. Magnifico MSK, musculoskeletal configuration (all above listed anatomical regions, excluded head and pelvis) which produces images of the internal structures of the patient's limbs, joints and spinal column. The system comprises four main parts: - Patient Table - . Magnetic Unit, containing a permanent magnet - Console, comprising a PC, keyboard, mouse, monitor and operating table - Electronic box Magnifico has an open magnet that makes comfortable MRI exam for all patients, including claustrophobic patients, in particular children. Additionally, Magnifico comes with a transparent headcoil for enhanced patient comfort.

The provided text is a 510(k) summary for the Esaote Magnifico MRI system. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document focuses on regulatory compliance, technological characteristics, and safety standards for the MRI system itself, rather than the performance of an AI/ML powered device.

Therefore, based on the provided text, I cannot answer the specific questions about acceptance criteria and study details for an AI/ML powered device. The document describes image quality being "of good diagnostic quality by the board-certified radiologist, Dr. Mark Awh," but this is a general statement about the MRI system's output and does not constitute a detailed study validating an AI/ML algorithm's performance against specific acceptance criteria.

The questions you've asked are typically relevant for AI/ML-driven diagnostic or prognostic devices that analyze medical images. The Magnifico, as described, is the imaging hardware.

If there were an AI/ML component for analysis within the Magnifico system, or integrated with it, that information is not detailed in this 510(k) summary.

In summary, the provided document does not contain the information required to answer your questions regarding acceptance criteria and the study that proves an AI/ML powered device meets those criteria.

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The multifunctional ultrasound scanner MyLabX75 Family is used to collect, display, and analyze ultrasound images during ultrasound imaging procedures in combination with supported echographic probes
-Cardiac [Adult and Pediatric]
-Vascular [Neonatal, Adult Cephalic, Vascular generic] -General Imaging [Abdominal, Breast, Musculo-skeletal, Neonatal, Pediatric, Small Organs (Testicles), Thyroid, Urological ] with invasive access Intraoperative (Abdominal), Laparoscopic, Transrectal. -Women Health [OB/Fetal, Gynecology with invasive access (Transrectal, Transvaginal)]
The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. The ultrasonic medical diagnostic equipment is intended to mechanical and electronic ultrasound probes (convex array, linear array and phased array) and Doppler probes.
The Fiber Guidance option assists ultrasound guidance in the phases of insertion and positioning of the introducer needle and optical fiber and procedure monitoring.

Model 6430, commercial names MyLabX75 and MyLab XPro75, is a mainframe ultrasound system used to perform diagnostic general ultrasound studies. The primary modes of operation are: B-Mode, Tissue Enhancement Imaging (TEI), M-Mode, Multi View (MView), Doppler (both PW and CW), Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D, Qualitative Elastosonography (ElaXto) and Quantitative Elastosonography (QElaXto).
Model 6430 has a software option integrated, called PLA, designed to support a radiological clinical ultrasound examination (first modality) and follow a percutaneous procedure providing additional image information from a second imaging modality (CT, MR, US and PET). The user is helped in assessing the patient anatomy by displaying the image generated by the 2nd modality.
Model 6430 is equipped with a LCD color display where acquired images and advanced image features are shown. Model 6430 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry. The touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry and has additional controls and mode-depending keys, integrated in the touchscreen.
Model 6430 can drive Phased Array (PA), Convex Array (LA), Linear Array (LA), Doppler and Volumetric probes.
Model 6430 is equipped with an internal Hard Disk Drive. Data can also be stored directly to external archiving media (Hard-Disk, PC, on server) via a LAN/USB port.
6430 project is mainly design change of 6450 devoted to reducing cost and to differentiate design and performances, 6430 will introduce in the Esaote's Mid-ultrasound tier functionalities that, at the moment are present only in our High -End Ultrasound tier, such as 2D Shear Wave Elastography (2D-SWE) and Virtual Navigator.
The marketing names for Model 6430 will be MyLabX75 and MyLab XPro75.
The difference between MyLab XPro75 is only in the licenses configuration: on MyLab XPro75 all the options are included while in the MyLabX75 some licenses can be ordered by customer.

The provided text is a 510(k) summary for the Esaote MyLabX75 and MyLab XPro75 ultrasound systems. It explicitly states that no clinical tests were performed to demonstrate that the device meets acceptance criteria. The submission relies entirely on non-clinical data and equivalence to a predicate device.

Therefore, many of the requested details about acceptance criteria and study design are not applicable or cannot be extracted from this document.

Here's what can be extracted based on the information provided:

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

The document does not specify quantitative acceptance criteria for performance; rather, it focuses on safety and technological equivalence.

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

• Not Applicable. No clinical test set was used as "No clinical tests were performed." The submission relies on non-clinical data, typically engineering verification and validation.

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

• Not Applicable. No clinical test set was used, and thus no expert ground truth establishment for a clinical study.

4. Adjudication method for the test set

• Not Applicable. 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. No clinical effectiveness study, and specifically no MRMC study, was performed. This device is an ultrasound system, not an AI-assisted diagnostic tool in the context of human reader improvement.

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

• Not Applicable. This is an ultrasound imaging system, not a standalone diagnostic algorithm. The performance evaluation was based on non-clinical engineering tests and comparison to a predicate device's technological characteristics and safety standards.

7. The type of ground truth used

• Not Applicable. As no clinical studies were performed, there was no ground truth for patient outcomes or expert consensus on diagnostic accuracy required in this submission. The "ground truth" for the non-clinical tests would be the compliance with engineering specifications and safety standards.

8. The sample size for the training set

• Not Applicable. This document does not describe the development or training of any machine learning algorithms. It is a traditional 510(k) for an ultrasound imaging system.

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

• Not Applicable. As no machine learning training set is mentioned.

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Esaote's Model 6450, commercial names MyLabX8 and MyLabX8 eXP, is intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organ, Neonatal, Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Urological, Cardiovascular Pediatric, Transesophageal (cardiac), Peripheral Vessel.

The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculosketal applications. The ultrasonic medical diagnostic equipment is intended to be connected to mechanical and electronic ultrasound probes (convex array, linear array and phased array) and Doppler probes.

The Virtual Navigator software option for Esaote 6450 system is intended to support a radiological clinical ultrasound examination (first modality) and follow percutaneous procedures or surgical operations providing additional image information from a second imaging modality (CT, MR, US and PET). The second modality provides additional security in assessing the morphology of the ultrasound image.

Virtual Navigator can be used in the following application: Abdominal, Gynecological, Musculoskeletal, Obstetrics, Pediatric, Urologic, Small Organs, Peripheral Vascular and Transcranial for radiological examinations only.

The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information.

The Virtual Navigator tracking system is contraindicated for patients, personnel and other people who use an electronic life support device (such as a cardiac pacemaker or defibrillator).

Model 6450, commercial names MyLabX8 and MyLabX8 eXP, is a mainframe ultrasound system used to perform diagnostic general ultrasound studies. The primary modes of operation are: B-Mode, Tissue Enhancement Imaging (TEI), M-Mode, Multi View (MView), Doppler (both PW and CW), Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D, Qualitative Elastosonography (ElaXto) and Quantitative Elastosonography (QElaXto).

Model 6450 has the Virtual Navigator software option integrated, designed to support a radiological clinical ultrasound examination (first modality) and follow a percutaneous procedure providing additional image information from a second imaging modality (CT, MR, US and PET). The user is helped in assessing the patient anatomy by displaying the image generated by the 2nd modality.

Model 6450 is equipped with a LCD color display where acquired images and advanced image features are shown. Model 6450 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry. The touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry and has additional controls and mode-depending keys, integrated in the touchscreen.

Model 6450 can drive Phased Array (PA), Convex Array (LA), Linear Array (LA), Doppler and Volumetric probes.

Model 6450 is equipped with an internal Hard Disk Drive. Data can also be stored directly to external archiving media (Hard-Disk, PC, server) via a LAN/USB port.

The marketing names for Model 6450 will be MyLabX8 and MyLabX8 eXP.

The provided text does not contain specific acceptance criteria, reported device performance metrics, or detailed study information for the 6450 Ultrasound System. It is a 510(k) summary and clearance letter for a medical device, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria.

Therefore, most of the requested information cannot be extracted from this document, as no formal clinical study with performance criteria was conducted for this submission.

Here's a breakdown of what can be inferred or directly stated:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document explicitly states "No clinical tests were performed." The submission relies on demonstrating substantial equivalence to a predicate device (Esaote 6440 - MyLab9 eXP, K173291), not on meeting specific performance acceptance criteria through a clinical study for this 510(k). The non-clinical tests (acoustic output, biocompatibility, cleaning/disinfection, thermal, electromagnetic, and mechanical safety) are stated to conform to relevant standards but no specific acceptance criteria or performance metrics are detailed in the text.

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

Not applicable. No clinical test set was used as "No clinical tests were performed."

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

Not applicable. No clinical test set was used, and therefore, no expert-established ground truth for such a set was required or reported.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set was used.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No. The document states "No clinical tests were performed," so an MRMC comparative effectiveness study was not conducted.

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

Not applicable. The device is an ultrasound system with a software option (Virtual Navigator). While software verification and validation were performed, this is not a standalone algorithm performance study as typically understood for AI/ML devices. The Virtual Navigator software option is intended to support a radiological clinical ultrasound examination, implying a human (radiologist) in the loop.

7. The Type of Ground Truth Used

Not applicable in the context of a clinical performance study. For the non-clinical tests performed (acoustic output, safety, etc.), the "ground truth" is adherence to established engineering and medical device safety standards (e.g., IEC 60601-1, NEMA UD-2).

8. The Sample Size for the Training Set

Not applicable. This submission does not describe an AI/ML algorithm that would undergo training with a dataset in the typical sense. The Virtual Navigator software option is a feature for image guidance using information from a second modality, implying image registration and fusion, but not a trainable algorithm with a distinct training set.

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

Not applicable. As no training set is described, no ground truth establishment for a training set is mentioned.

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MyLabSigma is intended to perform diagnostic general ultrasound studies including:

Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organs, Neonatal,

Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional),

Musculoskeletal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric,

Transoesophageal (cardiac), Peripheral Vessel.

The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

The ultrasonic medical diagnostic equipment is intended to mechanical and electronic ultrasound probes (convex array, linear array and phase array) and Doppler probes.

The upgraded 7410 system (MyLabSigma), is a portable system equipped with a handle. The system sizes and weights allow them to be carried using its handle. The primary modes of operation are: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D.

Model 7410 is equipped with a LCD color display where acquired images and advanced image features are shown. Model 7410 can drive Phased array. Linear array. Doppler probes and Volumetric probes (Bi-Scan probes). The control panel is equipped with a touchscreen that has an emulation of the Qwerty alphanumeric keyboard that allows data entry.

Model 7410 is equipped with wireless capability.

Model 7410 is already cleared via K161359.

The marketing name for new devices of Model 7410 will be:

• MyLabSigma ●
  MyLabSigma, defined herein. combine the cleared features of 7410 system with new capabilities, listed below:

• Addition of Auto NT (Automatic Nuchal Translucency) option, allows to automatically capture Nuchal Translucency measurement.

• Addition of Auto EF (Automatic Ejection Fraction) option, allows to automatically capture Ejection Fraction measurement.

• . Management of probes L3-11, L4-15, mC 3-11 and P2 3-11.

• . Full screen option.

• . Windows 10 Operative System.

The 7410 new version is manufactured under a quality system compliance with 21CFR 820 requirements and certified according to ISO 9001:2015 and ISO 13485:2016.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, using the specified format. It's important to note that this document is a 510(k) summary for a medical device (ultrasound system), and therefore, the "study" described is a demonstration of substantial equivalence rather than a traditional clinical trial proving specific performance metrics beyond those of predicate devices.

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

The document does not explicitly present a quantitative table of acceptance criteria and reported device performance in the way a clinical study might for specific diagnostic metrics. Instead, it asserts substantial equivalence to predicate devices (K161359, K183191, K173291) by demonstrating that:

• The fundamental technological characteristics are the same.
• Clinical uses have not changed or are equivalent to those of previously cleared devices.
• Added options (Auto NT, Auto EF, certain probe management, capacitive touchscreen, full screen mode, Windows 10 OS) are identical or equivalent to features cleared on other Esaote models.
• The device conforms to relevant safety standards.
• Performance (Ergonomics, General Usability, and Image Quality) is in line with predicate and reference devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states, "No clinical tests were performed." Therefore, there is no specific patient-based test set or data provenance to report in this context. The evaluation was based on non-clinical tests (safety, software validation, performance characteristic comparisons).

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)

Not applicable, as no clinical tests were performed and thus no "ground truth" was established from patient data. The ground truth for engineering and system performance would be defined by the relevant standards and specifications.

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

Not applicable, as no clinical tests were performed.

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 submission is for an ultrasound system, not an AI-assisted diagnostic device, and no MRMC study was mentioned or performed.

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

Not applicable. This is not an algorithm-only device. The submission focuses on the ultrasound system and its integrated features.

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

The "ground truth" for this submission is based on adherence to recognized medical device safety standards (e.g., IEC, NEMA, ETSI standards) and the established performance and safety profiles of the predicate devices. For features like "Auto NT" and "Auto EF," the ground truth is their functional equivalence to previously cleared implementations on other Esaote models.

8. The sample size for the training set

Not applicable, as this is not a machine learning device that requires a training set in the typical sense. The software validation was performed as a part of a system function test.

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

Not applicable, as no training set for a machine learning model was used. Software validation involved testing functions and confirming their operation with traceability of anomalies, likely against predefined functional specifications and requirements.

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MyLabX6 and MyLabX7 are intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organs, Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional), Musculosketal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric, Transoesophageal (cardiac), Peripheral Vessel.

The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

The ultrasonic medical diagnostic equipment is intended to mechanical and electronic ultrasound probes (convex array, linear array and phased array) and Doppler probes.

The upgraded 6400 systems, (MyLabX6 and MyLabX7), are a mainframe systems equipped with wheels allowing to move the system. The primary modes of operation are for both models: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D. Model 6400 manages Qualitative Elastosonography (ElaXto).

Model 6400 is equipped with a LCD color display where acquired images and advanced image features are shown. Model 6400 can drive Phased array, Linear array, Linear array, Doppler probes and Volumetric probes (Bi-Scan probes). The control panel is equipped with a pull-out Owerty alphanumeric keyboard that allows data entry.

Model 6400 is equipped with wireless capability.

Model 6400 is already cleared via K161359.

The marketing name for new devices of Model 6400 will be:

• MyLabX6
• . MyLabX7

MyLabX6 and MyLabX7, defined herein, combine the cleared features of 6400 system with new capabilities, listed below:

• 1. Addition of Auto NT (Automatic Nuchal Translucency) option, allows to automatically capture Nuchal Translucency measurement.
• 2. MicroV option, only for MyLabX7, recognizes the lowest speeds with ultra-sensitivity for small vessels and slow flow detection.
• 3. QPack option (Quantification Curves), only for MyLabX7, provides capabilities to evaluate time/intensity curves of Doppler or CnTI signals within the organ under examination.
• 4. 4D STIC option, only for MyLabX7, allows Time/Intensity analysis.
• 5. Management of probes L3-11, L4-15, mC 3-11, P 1-5, P 2-9 and P2 5-13. P 1-5, P 2-9 and mc 3-11 are available only for MyLabX7.
• 6. Full screen option.
• 7. Windows 10 Operative System.

The 6400 new version is manufactured under a quality system compliance with 21CFR 820 requirements and certified according to ISO 9001:2015 and ISO 13485:2016.

This FDA 510(k) summary for the Esaote 6400 Ultrasound System (MyLabX6, MyLabX7) does not contain detailed information about specific acceptance criteria for image quality or clinical performance and the results of a study proving those criteria are met. The document focuses on establishing substantial equivalence to previously cleared predicate devices based on technological characteristics and adherence to safety standards.

Here's a breakdown of the requested information based on the provided text, and what is explicitly stated as not applicable or not provided:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document for specific image quality or clinical performance metrics. The submission focuses on substantial equivalence based on overall indications for use and technological similarity to cleared predicate devices, rather than a new performance study with specific acceptance criteria that are numerically defined. The clinical applications listed represent the intended use and are not acceptance criteria for a performance study.

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

Not applicable/Not provided. No specific clinical test set or data provenance is mentioned as this was not a clinical performance study. The submission relies on the established performance 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/Not provided. No specific test set with ground truth established by experts is mentioned.

4. Adjudication method for the test set

Not applicable/Not provided. No specific test set or adjudication method is mentioned.

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/Not provided. The document does not describe any AI component or MRMC study. The device is an ultrasound system, not an AI-powered diagnostic tool.

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

Not applicable/Not provided. The device is an ultrasound system, not a standalone algorithm.

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

Not applicable/Not provided. No specific ground truth methodology is mentioned as this was not a clinical performance study for image accuracy or diagnostic efficacy.

8. The sample size for the training set

Not applicable/Not provided. This document describes an ultrasound system, not a device trained on a dataset.

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

Not applicable/Not provided. This document describes an ultrasound system, not a device trained on a dataset.

Summary of what is provided from the text:

The submission for the Esaote 6400 Ultrasound System (MyLabX6, MyLabX7) is a 510(k) Premarket Notification, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This type of submission generally relies on demonstrating similar technological characteristics and indications for use, and adherence to recognized performance and safety standards, rather than conducting new, elaborate clinical performance studies with specific acceptance criteria and ground truth validation for novel claims.

The document explicitly states: "No clinical tests were performed." This clarifies that the submission did not include studies with acceptance criteria related to clinical performance, a test set, expert ground truth, or MRMC studies.

The justification for substantial equivalence relies on:

• Predicate Devices: Primary predicate K161359 (6400 – MyLabSeven), and reference predicates K183191 (6420 - MyLabX5) and K173291 (6440 – MyLab9).
• Technological Characteristics: The updated devices (MyLabX6 and MyLabX7) employ the "same fundamental technological characteristics" as the predicate device (Esaote 6400 model cleared via K142008 and K161359). New capabilities (Auto NT, MicroV, QPack, 4D STIC, management of new probes, full screen option, Windows 10 OS) are stated to be "identical" to those already cleared in other Esaote models (6440 and 6420 via K173291 and K183191).
• Non-Clinical Tests: Evaluation for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety, conforming to standards such as IEC 60601-1, IEC 60601-2-37, NEMA UD-2, and NEMA UD-3, among others.
• Indications for Use: The indications for use are consistent with those of previously cleared devices.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are interpreted as the regulatory requirement to demonstrate substantial equivalence to legally marketed predicate devices, primarily through engineering and safety testing, and showing that any new features are identical to those already cleared.

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Esaote 7400, MyLabOmega, is a compact portable system intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organs, Neonatal, Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric, Transoesophageal (cardiac), Peripheral Vessel.

The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular, or other anatomical structures, as well as peripheral nerve blocks in Musculoskeletal applications.

The ultrasonic medical diagnostic equipment is intended to be connected to mechanical and electronic ultrasound probes (convex array, linear array and phased array) and Doppler probes.

The upgraded 7400 system (MyLabOmega) is portable systems equipped with a handle. The system sizes and weights allow them to be carried using its handle. The primary modes of operation are for both models: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D. Model 7400 manages Qualitative Elastosonography. 7400 is equipped with a LCD color display where acquired images and advanced image features are shown. 7400 can drive Phased, Convex, Linear array, Doppler probes and Volumetric probes (Bi-Scan probes). On both models the touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry. 7400 model is equipped with wireless capability and has been designed to be powered by battery.

The upgraded 7400 system, defined herein, combines the cleared features of both the 6440 and 7400 systems with new capabilities, listed below:

• 1. Addition of Auto NT option.
• 2. Addition of MicroV option.
• 3. Addition of Qpack option.
• 4. Management of probe P 1-5.
• 5. Management of probe L 4-15
• 6. Addition of 4D Stic option.
• 7. Addition of Full screen option.
• 8. Operative system Windows 10

The provided text details a 510(k) premarket notification for the Esaote 7400 Ultrasound System, not an AI/ML medical device. Therefore, the traditional acceptance criteria and study designs typically associated with proving the performance of AI/ML devices (e.g., specific metrics like sensitivity/specificity, sample sizes for test/training sets, expert ground truth establishment, MRMC studies) are not applicable here.

The 510(k) submission for the Esaote 7400 Ultrasound System (K190447) focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through technological characteristics and adherence to established medical device safety and performance standards.

Here's how the provided information relates to the request, reinterpreting "acceptance criteria" and "study" in the context of a traditional medical device 510(k):

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

In the context of a 510(k) for a conventional ultrasound system, the "acceptance criteria" are compliance with relevant safety and performance standards, and demonstrating that the new device's technological characteristics are substantially equivalent to the predicate. Device performance is typically proven through a suite of non-clinical tests.

• Acoustic output
• Biocompatibility
• Cleaning and disinfection effectiveness
• Thermal, electrical, electromagnetic, and mechanical safety
  And found to conform to:
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-2-37
• NEMA UD-3 (Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment)
• NEMA UD-2 (Acoustic Output Measurement Standard for Diagnostic Ultrasound) |
  | Technological Equivalence to Predicate Devices: | The 7400 upgrade employs the same fundamental technological characteristics as its predicate devices.
• The upgraded system is substantially equivalent to Esaote 7400 (cleared via K111302 and K161359).
• Clinical uses from Esaote 7400 (K142008) and Esaote 6440 (K173291) are unchanged.
• Specific new features (Auto NT, Auto EF, Qpack, probes L 4-15 and P 1-5 management, Full screen mode, Windows 10 OS) are identical to those already cleared on the Esaote 6440 (K173291). |
  | Manufacturing Quality System: | The 7400 new version is manufactured under an ISO 9001 and ISO 13485 certified quality system. |

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

For this type of device (ultrasound system), the "test set" is not a dataset of images for an algorithm, but rather the device itself undergoing a series of engineering and performance verification tests. The document does not specify a "sample size" in the conventional sense of patient data.

• Test Sample Size: Not applicable in the context of an AI/ML algorithm. The "sample" is the physical device being tested against engineering specifications and regulatory standards.
• Data Provenance: Not applicable for an AI/ML algorithm test set. The data presented are engineering test results and compliance assessments. The document mentions previous clearances (K111302, K132231, K132466, K142008, K161359, K173291), indicating an iterative development and clearance process, but not specifically data provenance for an algorithm. This is a submission for a hardware system update.

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

• Number of Experts/Qualifications for Ground Truth: Not applicable. Ground truth, in the context of AI/ML, refers to expert-labeled data used to train and validate models. For a conventional ultrasound system, performance is assessed through objective engineering measurements and compliance testing, not through expert reading of images in a studies designed for AI model evaluation.

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

• Adjudication Method: Not applicable. This concept belongs to the evaluation of AI/ML algorithms where multiple readers might disagree on a diagnosis, requiring an adjudication process to establish definitive ground truth. For an ultrasound system, performance is assessed against technical specifications and established standards, which don't typically involve reader adjudication.

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:

• MRMC Study: No, an MRMC study was not done, and it's not relevant for this type of device submission. This study design is specifically for evaluating the impact of AI on human reader performance. This submission is for the ultrasound system itself, not an integrated AI-powered diagnostic tool requiring such a study for its regulatory clearance.

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

• Standalone Performance: Not applicable. The device is an ultrasound system, which is inherently a human-in-the-loop diagnostic tool. The document does not describe any "algorithm only" component being evaluated in a standalone manner. The "options" mentioned (Auto NT, MicroV, Qpack, 4D Stic) are features of the ultrasound system, not independent AI algorithms with their own performance metrics being evaluated in isolation.

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

• Type of Ground Truth: Not applicable in the AI/ML sense. The "ground truth" for this device's performance is compliance with international and national safety and performance standards (e.g., IEC, NEMA) and demonstrating that its technological changes do not raise new questions of safety or effectiveness compared to predicate devices. This involves objective engineering measurements and verification, not diagnostic ground truth from medical cases.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This refers to the data used to train an AI/ML model, which is not the subject of this 510(k) submission.

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

• Training Set Ground Truth Establishment: Not applicable, as there is no mention of an AI/ML training set in the provided document.

In summary: The provided document is a 510(k) premarket notification for a diagnostic ultrasound system, not an AI/ML medical device. Therefore, the criteria and study types requested in the prompt, which are standard for AI/ML device evaluations (e.g., test sets, training sets, ground truth, MRMC studies), are not present or applicable here. The focus of this 510(k) is on demonstrating substantial equivalence to predicate devices and adherence to established safety and performance standards for ultrasound equipment through non-clinical (engineering) testing.

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