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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 analyse MR images and other real-time imaging procedures.

The indications for use are the following: 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, hip, imaging the temporomandibular joint, imaging the cervical, the thoracic, the lumbar and the sacral sections as portions of the spinal column, and imaging the head.

The S-scan Open device is a Magnetic Resonance (MR) system that produces cross-section images of the internal structures of the body. Images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift. When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.

S-scan Open represents the evolution of its predicate device, the Esaote S-scan, cleared under K161973 (initial clearance K063207). Compared to the predicate device, the following modifications have been introduced:

• Changes to the external design and shape, and an update of the electronics.
• Integration of the new software version MRI EVOlution 25, which provides compatibility with updated electronics, improvements in cybersecurity management, bug fixing and optimization, and includes the following features: management of new coils, 3D viewer, prone patient positioning management, SPED sequence, updated operating system, new graphical user interface, flow compensation feature extension, operator-selectable gradients direction, DWI (Diffusion Weighted Imaging) sequence, 2D SST1 sequence, and HyperClarity. Note: the subject device integrates the AI-based algorithm HyperClarity (SwiftMR, K230854) without any modification. The algorithm is classified under a different regulation in its 510(K) and this is out-of-scope from the current submission of the subject device.
• Introduction of a patient alert system.
• Addition of new receiving Coils: XL flex L-Spine coil 10, Flex Coil 11, Knee Coil 21.

S-scan Open is substantially equivalent to the predicate device with respect to intended use, technical specifications, fundamental scientific technology and principle of operation.

The provided FDA 510(k) clearance letter for K260746, S-scan Open, does not contain detailed information about the acceptance criteria and a specific study proving the device meets those criteria, particularly for an AI-based algorithm. The letter explicitly states that the integrated AI-based algorithm, HyperClarity (SwiftMR, K230854), is out-of-scope for this particular submission and is classified under a different regulation in its own 510(k) (K230854).

Therefore, based solely on the provided text for K260746, I cannot provide the requested information regarding the acceptance criteria and study proving the device's performance related to the AI component.

However, I can extract information about the overall device's (S-scan Open) non-clinical testing and the lack of clinical studies for this submission:

Based on the provided K260746 submission, for the S-scan Open MRI system as a whole (excluding the detailed performance of the integrated AI component which is out-of-scope for this submission):

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific acceptance criteria or tabulated performance metrics for the S-scan Open device (beyond compliance with standards). It mentions that "predefined acceptance criteria were successfully met" through verification and validation activities, but these criteria themselves are not detailed.

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

• Sample Size: Not specified. The document states that "Sample clinical images acquired using the proposed updated device and reviewed by a U.S. board-certified radiologist have been included to demonstrate acceptable diagnostic image quality." However, the number of images or cases is not quantified.
• Data Provenance: The document does not specify the country of origin of the data. It mentions "clinical images acquired using the proposed updated device," implying they are retrospective or prospective images generated for the purpose of this submission, but does not clarify further.

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

• Number of Experts: "a U.S. board-certified radiologist" (singular).
• Qualifications: U.S. board-certified radiologist. No mention of years of experience.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable or specified for this submission, as only one radiologist was mentioned for review of sample images. There's no indication of a consensus or multiple-reader process.

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

• MRMC Study: No. The document does not mention an MRMC study comparing human readers with and without AI assistance. The AI component (HyperClarity) is explicitly stated as "out-of-scope" for this submission, suggesting its comparative effectiveness would have been established in its own K230854 filing.

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

• Standalone Study: Not addressed in this submission for the S-scan Open system itself. For the integrated AI algorithm (HyperClarity), such a study would likely have been part of its independent 510(k) (K230854), but details are not provided here.

7. Type of Ground Truth Used

• Ground Truth Type: For the "sample clinical images" reviewed, the ground truth appears to be based on the expert opinion/review of a U.S. board-certified radiologist assessing "acceptable diagnostic image quality" in accordance with FDA guidance. There is no mention of pathology or outcomes data for this specific review.

8. Sample Size for the Training Set

• Sample Size: Not applicable/not provided for the 510(k) submission of the S-scan Open system as a whole. This information would be relevant for the AI component (HyperClarity, K230854) if it were the subject of the submission. The S-scan Open is an MRI hardware and software system, not solely an AI algorithm.

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

• Ground Truth Establishment: Not applicable/not provided for the S-scan Open system as a whole. This information would be relevant for the AI component (HyperClarity, K230854) if it were the subject of the submission.

Crucially, to get the detailed acceptance criteria and study information for the AI component (HyperClarity/SwiftMR), you would need to consult the 510(k) submission K230854. The K260746 document only states the S-scan Open integrates this already-cleared AI algorithm without modification, thereby deferring its evaluation to its own separate clearance.

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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 analyse MR images and other real-time imaging procedures.

The indications for use are the following:

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) and upper abdomen (included only for "Open" configuration under option).

Magnifico device is a Magnetic Resonance (MR) system that produces cross-section images of the internal structures of the body. Images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift.

When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.

The updated Magnifico is the evolution of its predicate device, the Magnifico device cleared via K241133. Compared to the predicate device, the following modifications have been introduced:

• A new software version (MRI EVOlution 25), including:
  • The optional functionality "HyperClarity", an AI-based algorithm for MRI image enhancement (K230854), integrated without any modification. The algorithm is classified under a different regulation in its 510(K) and this is out-of-scope from the current submission of the subject device.
  • Abdominal Imaging package for abdomen examination, which delivers:
    • Patient's breathing management (including respiratory movement reduction techniques)
    • ROTAR sequences
    • 3D FSE sequences
• Introduction of a patient breathing detection device (Respiratory Gating System)
• Introduction of a support for spontaneous movements of the knee (flexion/extension)
• A modification of the maximum gradient intensity
• New receiving Coils: DPA Shoulder Coil, Flex Coil, 4 ch. Foot/Ankle coil

Magnifico is substantially equivalent to the predicate device with respect to the fundamental scientific technology, technological characteristics and the principle of operation. The core components remain unchanged and are identical to those of the cleared Magnifico device.

The provided FDA 510(k) clearance letter and summary for the Magnifico Open MRI System (K251901) describes an updated version of a previously cleared device. While it mentions the integration of an AI-based algorithm called "HyperClarity" for MRI image enhancement, the document explicitly states that this algorithm is "out-of-scope from the current submission of the subject device" as it was cleared under a separate 510(k) (K230854).

Therefore, the acceptance criteria and study details for the Magnifico Open MRI System itself primarily focus on demonstrating substantial equivalence to its predicate device (K241133) and the safety and effectiveness of its new features (abdominal imaging, breathing management, gradient intensity modification, new coils, etc.). The document indicates a "validation based on radiologists' expert opinions" for HyperClarity, but the specifics of that study are not included in this submission.

Based on the provided document, here's a breakdown of the requested information for the Magnifico Open MRI System (K251901) as a whole, with the caveat that the detailed study for HyperClarity is referenced but not fully described here:

Acceptance Criteria and Device Performance (Magnifico Open MRI System K251901)

The document does not explicitly present a table of quantitative acceptance criteria for the entire Magnifico Open MRI system in the same way one might find for a standalone algorithm. Instead, the acceptance is implied by meeting safety and performance standards and demonstrating diagnostic image quality.

Study Information (for Magnifico Open MRI System K251901)

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

   • Test Set Sample Size: Not explicitly stated as a numerical count of patients or images. The document mentions "Sample clinical images" and "A comparative evaluation."
   • Data Provenance: Not explicitly stated in terms of country of origin. The document refers to "clinical images acquired using the proposed updated device." It does not specify if the studies were retrospective or prospective, though the nature of acquiring "sample clinical images" suggests either freshly acquired images or a selection from an existing dataset.

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

   • Number of Experts: "a U.S. board-certified radiologist" (singular, for image quality review).
   • Qualifications of Experts: "U.S. board-certified radiologist." Specific years of experience are not mentioned.
   • For the HyperClarity feature, it mentions "radiologists' expert opinions" (plural), but further details are not provided within this document.

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

   • Not specified. For the general image quality review, a single radiologist is mentioned, suggesting "none" in the sense of consensus or arbitration.

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:

   • MRMC Study: Not explicitly mentioned for the Magnifico Open MRI System itself. The document refers to "A comparative evaluation of conventional images and images acquired using the Respiratory Gating System" to demonstrate clinical benefit, which likely involved comparison but not necessarily a formal MRMC study with AI assistance.
   • For the HyperClarity AI feature, the document mentions "validation based on radiologists' expert opinions," which could imply a comparative aspect (with and without the enhancement), but the details (including effect size or MRMC design) are not provided in this specific submission. Given HyperClarity is out-of-scope for this 510(k), that information would be in K230854.

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

   • The Magnifico Open MRI System is a hardware device (MRI scanner) with integrated software and features, not a standalone algorithm. Its performance is intrinsically tied to producing images for human interpretation.
   • For the HyperClarity AI feature, its performance as an image enhancement algorithm would be considered in a standalone context (algorithm output vs. original image), but the details are not part of this 510(k).

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

   • Expert Opinion/Clinical Review: For diagnostic image quality, the ground truth was established by the "U.S. board-certified radiologist's" review of the images.
   • For respiratory motion artifact reduction, the clinical benefit was demonstrated through "comparative evaluation," implying expert assessment of artifact presence.
   • For the HyperClarity feature, it refers to "radiologists' expert opinions."

7. The sample size for the training set:

   • The document describes the Magnifico Open MRI System (K251901), an MRI scanner, not a machine learning algorithm that undergoes a "training set" in the conventional sense. The "training set" concept would apply to the HyperClarity AI algorithm (K230854), but that information is not part of this submission.

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

   • This question is not applicable to the Magnifico Open MRI System itself, as it's a hardware device. For the HyperClarity AI algorithm, this information would be detailed in its own 510(k) submission (K230854).

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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.

N/A

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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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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's 6420 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 be connected to mechanical and electronic ultrasound probes (convex array, linear array and phase array) and Doppler probes.

The upgraded 6420 system (MyLabX5) is compact mainframe system equipped with wheels allowing to move the system. The system sizes and weights allow them to be carried using the handle.

The primary modes of operation are: 2D, M-Mode, Continuous Wave Doppler (CW), Tisue Enhancement Imaging (TEI), Multi View (MView), Doppler, Pulse Wave (PW) Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D.

6420 is equipped with a LCD color display where acquired images and advanced image features are shown. 6420 can drive Phased array, Convex array, Linear array, Doppler probes and Volumetric probes (Bi-Scan probes). Model 6420 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry.

6420 is equipped with wireless capability.

Model 6420 was previously cleared via K161168.

The upgraded 6420 system, defined herein, combines the cleared features of both the 6440 and 6420 systems with new capabilities, listed below:

• 1. Management of Strain 2D.
• 2. Addition of Auto NT option.
• 3. Addition Auto EF option
• 4. Management of probe L 4-15.
• 5. Addition of Full screen option.
• 6. Operative system Windows 10

The 6420 new version is manufactured under an ISO 9001 and ISO 13485 certified quality system.

The provided document is a 510(k) summary for the Esaote 6420 Ultrasound System. It details an upgrade to an existing device, establishing substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present acceptance criteria in terms of quantitative performance metrics, such as sensitivity, specificity, or accuracy, for the device's diagnostic capabilities. Instead, the "acceptance criteria" are implied through establishing substantial equivalence to predicate devices and conformance to recognized safety standards. The reported device performance is therefore based on its similarity to the cleared predicates and its adherence to non-clinical safety requirements.

Acceptance Criteria (Implied by Substantial Equivalence and Standards Conformance)

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

The document explicitly states: "No clinical tests were performed." Therefore, there is no sample size for a test set and no data provenance from clinical studies. The demonstration of performance relies on substantial equivalence to existing devices and non-clinical evaluations.

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

Since "No clinical tests were performed," there were no experts used to establish ground truth for a clinical test set.

4. Adjudication Method 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, as "No clinical tests were performed" and this device is an ultrasound system, not an AI-assisted diagnostic tool as described. The document does not mention any AI components or human-in-the-loop performance studies.

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

Not applicable, as this is an ultrasound imaging system, not a standalone algorithm. The performance evaluation is based on the characteristics of the hardware and software features being substantially equivalent to predicates.

7. The type of ground truth used:

Given the statement "No clinical tests were performed," there was no clinical ground truth established through expert consensus, pathology, or outcomes data. The "ground truth" for this 510(k) submission is effectively the established performance and safety profiles of the predicate devices. The submission asserts that the upgraded device's features and overall performance are analogous to these already cleared devices, and non-clinical testing confirms adherence to relevant technical standards.

8. The sample size for the training set:

Not applicable. As "No clinical tests were performed" and the device is not an AI/ML algorithm that requires a training set in the conventional sense, there is no mention of a training set or its size. The upgrades primarily involve hardware and software features already present in other cleared devices.

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

Not applicable for the same reasons as #8.

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G-scan Brio is a Magnetic Resonance (MR) system that produces transversal, sagittal, coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for 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 and the lumbosacral sections as portions of the spinal column.

G-scan Brio images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.

The changes performed to G-scan Brio, with respect to the cleared version – G-scan Brio K133490 – are due to the improvement of the system performance. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following:

• A new Bilateral TMJ Coil
• Introduction of the DPA Lumbar spine coil n° 10 with a new extra-large flexible section
• Introduction of the thoracic spine section examination
• A new software version including the following features:
  • o Customization of Image Enhancement
  • o Overlay sending to PACS
  • o Isotropic 3D acquisition

The provided document is a 510(k) summary for the G-scan Brio, a Magnetic Resonance (MR) system. It describes modifications made to an already cleared device (K133490) to improve system performance.

Based on the content, the document explicitly states that "No clinical tests were performed." This means there is no study described within this document that demonstrates the device meets acceptance criteria through clinical performance.

Therefore, most of the requested information cannot be provided from this particular document.

Here's what can be inferred or stated based on the document:

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

• Acceptance Criteria: Not explicitly stated in terms of clinical performance metrics. The submission focuses on adherence to safety standards and technical characteristic equivalence.
• Reported Device Performance: No clinical performance metrics are reported as no clinical tests were performed. The device's "performance" is demonstrated through non-clinical testing for compliance with safety and performance standards.

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

• Not applicable, as no clinical tests were performed.

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.

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

• No MRMC study was done, as no clinical tests were performed. The device described is an MR system, not an AI-powered diagnostic tool.

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

• No standalone performance study was done, as no clinical tests were performed. The device is a diagnostic imaging system, designed to be interpreted by medical experts.

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

• Not applicable, as no clinical tests were performed.

8. The sample size for the training set

• Not applicable, as no clinical tests were performed.

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

• Not applicable, as no clinical tests were performed.

Summary of Non-Clinical Tests (as provided in the document):

The document details that the G-scan Brio was evaluated through non-clinical tests to demonstrate substantial equivalence to its predicate device. These tests focused on:

• Medical electrical equipment safety
• Risk management
• Software verification
• Image quality

The device was found to conform to the following medical device safety standards:

• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-2-33
• ISO 14971
• ISO 62304
• IEC 62366
• NEMA MS-1
• NEMA MS-3

The conclusion states that "The non-clinical testing demonstrates that the G-scan Brio is as safe, as effective, and performs as well as or better than the predicate. G-scan Brio is substantially equivalent to the legally marketed devices to applicable medical device safety and performance standards."

In essence, the device's acceptance criteria in this submission are met by demonstrating compliance with recognized safety and performance standards through non-clinical testing, rather than through a clinical performance study.

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Esaote's Model 7410 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transrectal, Pediatric and Other: Urologic. The 7410 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Model 7410 is a portable system equipped with a handle. The system size and weight allow it to be carried using its handle. The primary modes of operations 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. 7410 is equipped with a LCD color display where acquired images and advanced image features are shown. 7410 system can drive Phased, Convex, Linear array, Doppler probes and Volumetric probes (Bi-Scan probes). On 7410 system the touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry. 7410 system is equipped with wireless capability. Model 7410 has been designed to be powered by battery.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Esaote 7410 Ultrasound System, presented in the requested format:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary for an ultrasound system, which primarily demonstrates substantial equivalence to predicate devices rather than establishing novel performance acceptance criteria or conducting a dedicated performance study against new criteria. Therefore, the "acceptance criteria" here are implicitly the performance specifications and safety standards met by the predicate devices. The "reported device performance" is the assertion that the new device (7410 System) meets these same technological characteristics and standards.

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

The document explicitly states: "No clinical tests were performed." This is a 510(k) submission based on substantial equivalence to predicate devices and non-clinical engineering/safety testing, not a performance study involving a test set of patient data.

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

Not applicable, as no clinical tests were performed and thus no ground truth was established by experts for a test set.

4. Adjudication Method 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 is not an AI/CADe/CADx device and no MRMC study was conducted.

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 algorithm.

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

Not applicable, as no clinical performance study was conducted requiring ground truth. The basis for clearance is substantial equivalence to legally marketed predicate devices and conformity to recognized safety standards.

8. The sample size for the training set

Not applicable, as no algorithm requiring a training set was developed or evaluated.

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

Not applicable, as no algorithm requiring a training set was developed or evaluated.

Summary of the Document's Nature:

This document is a 510(k) Pre-market Notification for the Esaote 7410 Ultrasound System. Its primary purpose is to demonstrate substantial equivalence to already legally marketed predicate ultrasound devices (Esaote 7400 and Esaote Europe 6420). This means the new device shares the same intended use and fundamental technological characteristics, and any differences do not raise new questions of safety or effectiveness. The "studies" performed are non-clinical engineering and safety tests to ensure the device meets recognized industry standards for medical electrical equipment and diagnostic ultrasound. No new clinical performance studies were conducted to establish specific accuracy, sensitivity, or specificity metrics for diagnostic image interpretation by the device itself.

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S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for 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 of the temporomandibular joint and imaging the cervical spine and the lumbar spine sections as portions of the spinal column.

S-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.

The changes performed on the modified S-scan device, with respect to the cleared version - Sscan K121650 - are due to the improvement of the system performance. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following:

• 1. Upgrading of the electronics
• 2. Patient bed unlocking function
• 3. A new software version

This document is a 510(k) summary for the S-scan Magnetic Resonance (MR) system from Esaote S.p.A. It describes a modified version of the S-scan device compared to its cleared predicate (K121650).

Here's an analysis of the provided text regarding acceptance criteria and the study:

Important Note: The provided 510(k) summary is for a modified device, and the changes are described as "improvement of the system performance" due to "Upgrading of the electronics," "Patient bed unlocking function," and "A new software version." Crucially, it states that these modifications "do not affect the intended use or alter the fundamental scientific technology of the device." As a result, this 510(k) relies on the substantial equivalence to the predicate device (K121650) and does not describe a new study with explicit acceptance criteria for a novel AI/software feature with reported device performance results.

Therefore, I cannot directly extract "acceptance criteria and the study that proves the device meets the acceptance criteria" in the typical sense of a new AI algorithm's performance study from this particular document. The document essentially states that because the fundamental scientific technology and intended use are unchanged, a new major performance study against specific acceptance criteria for the new components is not required to demonstrate substantial equivalence for the overall device.

However, I can still extract information related to the device and its intended function, which would implicitly encompass its performance requirements.

1. Table of acceptance criteria and the reported device performance

Based on the provided text, there are no explicit acceptance criteria or reported device performance metrics stated for the modified S-scan's new software/electronics within this 510(k) summary. This is because the submission is a "Special 510(k)" relying on the fundamental equivalence to the predicate, K121650, where performance was presumably established. The modifications are described as improvements that do not alter the fundamental scientific technology or intended use.

The intended function of the device is to produce diagnostic MR images. Therefore, the implicit acceptance criterion is that the modified device must continue to produce diagnostically useful images of equivalent or improved quality compared to the predicate device, as determined by a medical expert.

Regarding the study proving the device meets acceptance criteria:

The document doesn't describe a specific clinical study for the modified S-scan to prove it meets new or modified acceptance criteria as if it were a novel AI algorithm. Instead, the "proof" is based on the argument of substantial equivalence to the predicate device (K121650). The modifications are considered "improvements" that do not alter the fundamental scientific technology. This type of submission (a Special 510(k)) typically relies on verification and validation of the engineering changes to ensure the device continues to meet its established performance specifications, rather than a full-scale clinical trial to re-establish diagnostic accuracy.

Therefore, for aspects 2-9, the answer is largely that this information is not applicable to this specific 510(k) summary because it doesn't describe a new performance study to establish primary diagnostic performance of a new algorithm but rather an upgrade to an existing MR imaging system.

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

• Not applicable. This 510(k) does not describe a new performance study with a test set of images for diagnostic evaluation by a new algorithm. The "test set" for the system itself would be part of the predicate device's original clearance (K121650) and internal engineering verification and validation testing for the upgrades.

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. See point 2.

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

• Not applicable. See point 2.

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 510(k) is for a conventional MR imaging system, not an AI-assisted diagnostic tool.

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

• Not applicable. This 510(k) is for an MR imaging system; it does not involve a standalone algorithm for diagnostic interpretation. The device's output (images) requires interpretation by a medical expert. ("When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.")

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

• Not applicable for this 510(k) submission. For the original predicate device (K121650), the ground truth for validating MR image quality would typically involve various phantoms, physical measurements, and potentially clinical correlation with other imaging modalities or pathologies if clinical validation was performed.

8. The sample size for the training set

• Not applicable. This device is an MR imaging system; it is not described as involving a machine learning algorithm with a "training set" in this context. The "new software version" likely refers to operational software for the MRI, not an AI diagnostic algorithm.

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

• Not applicable. See point 8.

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Esaote's Model 6400 is a mainframe ultrasound system diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric and Other: Urologic. The 6400 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Esaote's Model 7400 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric and Other: Urologic. The 7400 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Model 6400 is a mainframe system equipped with wheels allowing them to move the system. Model 7400 is a portable system equipped with a handle. The system size and weight allow it to be carried using its handle. The primary modes of operation are for both models: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD) and Tissue Velocity Mapping (TVM). Both 6400 and 7400 are equipped with a LCD color display where acquired images and advanced image features are shown. Both 6400 and 7400 can drive Phased, Convex, Linear array and Doppler probes. 6400 control panel is equipped with a pull-out qwerty alphanumeric keyboard that allows data entry. On 7400 model the touchscreen has an emulation of the qwerty alphanumeric keyboard that allows data entry. Both 6400 and 7400 models are equipped with wireless capability. Model 7400 was designed to be powered by battery.

Both 6400 and 7400 have been cleared via K111302.

6400 and 7400 Upgrade, defined herein, combine the cleared features of both 6400 and 7400 systems with other new software capabilities, listed below:

• 1. Management of motorized probes (Bi-Scan probes) that allow volumetric acquisition.
• 2. Management of 3D/4D mode of operation.
• 3. Management of the acquisition of consecutive ultrasound images on extended surface. The final image is composed of the consecutive frames placed side (Panoramic View or VPan).

The 6400 and 7400 Upgrades are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

This 510(k) summary for the Esaote 6400 and 7400 Ultrasound Systems (K132231) indicates that no clinical tests were performed to establish acceptance criteria or demonstrate device performance.

Instead, the submission relies on demonstrating substantial equivalence to previously cleared predicate devices and conformity to applicable medical device safety and performance standards.

Therefore, most of the requested information regarding acceptance criteria and performance studies, if they were based on clinical data, cannot be extracted from this document as such studies were explicitly stated as not performed.

However, I can extract information related to the device's technological characteristics and the non-clinical tests performed.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Since no clinical studies were performed, there are no specific performance metrics (e.g., sensitivity, specificity, accuracy) or quantitative acceptance criteria for diagnostic capability that can be reported from this document.
The acceptance criteria are implicitly based on:

• Substantial Equivalence: The new features and devices (6400 and 7400 Upgrades) are deemed substantially equivalent to previously cleared predicate devices (Esaote 6200, 7340, 6400, 7400 models). This means their performance is expected to be no worse than the predicate devices, which were already deemed safe and effective.
• Conformity to Safety Standards: The devices meet various international and national safety standards.

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

• Not Applicable. No clinical test set data was used as "No clinical tests were performed." The submission relies on comparative data with predicate devices and non-clinical engineering tests.

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

• Not Applicable. No clinical tests were performed, so no expert ground truth for a clinical test set was established as part of this submission.

4. Adjudication Method for the Test Set:

• Not Applicable. 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 device is an ultrasound imaging system, not an AI-assisted diagnostic tool in the sense of software interpreting images for human readers. No MRMC comparative effectiveness study was done for AI assistance. The submission focuses on hardware and software feature upgrades to existing ultrasound systems.

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 algorithm.

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

• Not Applicable. For the purpose of establishing clinical performance, no ground truth data from clinical trials was used, as no clinical trials were performed. The "ground truth" for substantial equivalence is based on the cleared status and established safety and effectiveness of the predicate devices and conformity to engineering standards.

8. The sample size for the training set:

• Not Applicable. No clinical data was used for training purposes, as no clinical tests or AI/machine learning components requiring such training are described.

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

• Not Applicable. No clinical training set was used.

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