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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, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. Model 6400 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, Neonatic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. Model 7400 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 7410 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other. Urologic. Model 7410 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 to move the system. Models 7400 and 7410 are 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, Tissue Enhancement Imaging (TEl), Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D. Models 6400 and 7400 manages Qualitative Elastosonography (ElaXto).

All models 6400, 7400 and 7410 are equipped with a LCD color display where acquired images and advanced image features are shown. All models 6400, 7400 and 7410 can drive Phased array, Convex array, Linear array, Doppler probes and Volumetric probes). Model 6400 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry.

Models 7400 and 7410 the touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry. All models 6400, 7400 and 7410 are equipped with wireless capability. Models 7400 and 7410 have been designed to be powered by battery.

Both models 6400 and 7400 are already cleared via K142008. Model 7410 is already cleared via K142077.

Models 6400, 7400 and 7410 Upgrades, defined herein, combine the cleared features of both 6400, 7400 and 7410 systems with new capabilities, listed below:

• 1. Management of Intraoperative (Abdominal) application on 7410 Upgrade.
• 2. Management of Laparoscopic application on both 7400 and 7410 Upgrades.
• 3. Addition of Transrectal/Urology and Transvaginal applications in 3D/4D on 7410 Upgrade.
• 4. Addition of Urology application in 3D/4D on both 6400 and 7400 Upgrades.
• 5. Implementation of the QAS feature on 6400 and 7400 Upgrades.
• 6. Implementation of the Needle Visibility feature on all 6400, 7400 and 7410 Upgrades.
• 7. Implementation of the on-board tutorial MyLibrary feature on all 6400, 7400 and 7410 Upgrades.

The 6400, 7400 and 7410 Upgrades are manufactured under an ISO 9001 and ISO 13485 certified quality system.

The provided document is a 510(k) premarket notification for Esaote S.p.A.'s 6400, 7400, and 7410 Ultrasound Systems. It details the intended use, technological characteristics, and a summary of non-clinical tests conducted. The document does not describe a study that uses acceptance criteria and reports device performance in terms of specific metrics like sensitivity, specificity, or AUC as one might find for an AI/ML medical device. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and adherence to performance standards.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, training set ground truth) are not applicable or not available from this 510(k) summary, as it is related to an ultrasound system, not an AI/ML device that typically involves such evaluations.

Here's a breakdown of the requested information based on the provided document:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or reported device performance metrics like sensitivity or specificity. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices and adherence to recognized performance standards. The "device performance" is therefore considered equivalent to the predicate devices and compliant with these standards.

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

Not applicable. The document states "No clinical tests were performed," indicating that direct patient data or test sets for performance evaluation in the context of AI/ML or diagnostic accuracy studies were not used for this submission. The evaluation was based on non-clinical performance and substantial equivalence to existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical tests were performed, hence no ground truth was established by experts for a test set in this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) 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. No clinical tests were performed, and this is not a submission for an AI-assisted device requiring an MRMC study.

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

Not applicable. This is not an AI/ML medical device capable of standalone performance.

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

Not applicable. No clinical tests involving ground truth determination were performed.

8. The sample size for the training set

Not applicable. As this is not an AI/ML device, there is no "training set."

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

Not applicable. No "training set" or corresponding ground truth establishment is relevant to this traditional ultrasound system submission.

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Esaote's Model 6200 is a mainframe 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, Transrectal, Pediatric, Intraoperative (Abdominal), Intraoperative (Neurological), Laparoscopic and Other: Urologic. The 6200 system provides imaging for guidance of biopsy and imaging to assist in the placement of needler or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Esaote's Model 6250 is a mainframe 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, Transrectal, Pediatric, Intraoperative (Abdominal), Intraoperative (Neurological), Laparoscopic and Other: Urologic. The 6250 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.

The Virtual Navigator software option for Esaote models 6200 and 6250 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, Musculo-skeletal, 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 should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.

Both 6200 and 6250 models are mainframe ultrasound systems used to perform diagnostic general ultrasound studies. The primary modes of operation are for both systems: B-Mode, Tissue Enhancement Imaging (TEI), M-Mode, Multi View (MView), Doppler (both PW and CW), Color Flow Mapping, Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D, Elastosonography. Both 6200 and 6250 are equipped with an LCD color display where acquired images and advanced image features are shown.

The Virtual Navigator is a software option 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.

6200 and 6250 Upgrades, defined herein, combine the cleared features of both 6200 and 6250 systems with new capabilities, listed below:

• 1. Management of Pulsed Wave (PW) Doppler probe on both 6200 and 6250 Upgrades.
• 2. Management of Quality Arterial Stiffness (QAS) on both 6200 and 6250 Upgrades.
• 3. Addition of Abdominal, Intraoperative abdominal, Transvaginal, Urology applications in Elastosonography analysis on both 6200 and 6250 Upgrades.
• 4. Management of Elastosonography measures on both 6200 and 6250 Upgrades.
• 5. Management of STIC (Spatio-Temporal Imaging Correlation) with volumetric Probes on both 6200 and 6250 Upgrades.
• 6. Management of Intraoperative (Neuro) application on both 6200 and 6250 Upgrades.

The 6200 and 6250 Upgrades are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

This document describes the 510(k) premarket notification for the Esaote S.p.A. 6200 Ultrasound System and 6250 Ultrasound System. It outlines the intended use and technological characteristics of the devices and their upgrades, comparing them to several predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria with numerical targets. Instead, it describes "Substantial Equivalence" as the primary acceptance criterion. The device performance is deemed acceptable if it demonstrates substantial equivalence to legally marketed predicate devices for their intended uses and technological characteristics, and if it conforms to relevant safety and performance standards.

- Virtual Navigator software option: Intended to support radiological clinical ultrasound exams (first modality) and percutaneous procedures/surgical operations by providing additional image information from CT, MR, US, and PET. Can be used in Abdominal, Gynecological, Musculo-skeletal, Obstetrics, Pediatric, Urologic, Small Organs, Peripheral Vascular, and Transcranial applications for radiological examinations only. (The second modality image is not for standalone diagnostic use).

- New functionalities (Upgrades):
- Management of Pulsed Wave (PW) Doppler probe: Equivalent to Esaote 6400 (K142008).
- Management of Quality Arterial Stiffness (QAS): Equivalent to eTracking feature of Hitachi Aloka Arietta 70 (K134016) and Esaote ART.LAB (K061961).
- Addition of Abdominal, Intraoperative abdominal, Transvaginal, Urology applications in Elastosonography analysis: Equivalent to Hitachi Aloka Arietta 70 (K134016) and Hitachi Preirus (K093466).
- Management of Elastosonography measures: Equivalent to Hitachi Aloka Arietta 70 (K134016) and Hitachi Preirus (K093466).
- Management of STIC (Spatio-Temporal Imaging Correlation) with volumetric Probes: Equivalent to STIC feature of Hitachi Aloka Arietta 70 (K134016).
- Management of Intraoperative (Neuro) application: Equivalent to Hitachi Aloka Arietta 70 (K134016). |
| Technological Equivalence to Predicate Devices: The device should employ the same fundamental technological characteristics as its predicate devices. | - Fundamental technological characteristics: The 6200 and 6250 Upgrades employ the same fundamental technological characteristics as their predicate devices (Esaote 6200/6250, Esaote 6400, Esaote ART.LAB, Hitachi Preirus, Hitachi Aloka Arietta 70).

- Modes of operation: Both systems use B-Mode, TEI, M-Mode, MView, Doppler (PW and CW), Color Flow Mapping, Amplitude Doppler (AD), TVM, 3D and 4D, Elastosonography.

- Safety Standards: Esaote 6200 Upgrade, 6250 Upgrade, 6400, Hitachi Aloka Arietta 70 are designed to meet IEC60601-1 and IEC60601-2-37 safety requirements.

- Acoustic Output: Ultrasound models provide an Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values. |
| Conformity to Medical Device Safety Standards: The device should conform to recognized medical device safety standards. | - Non-Clinical Tests: Evaluated for performance, acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electromagnetic, and mechanical safety. 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)
- NEMA UD-2 (Acoustic Output Measurement Standard) |

2. Sample size used for the test set and the data provenance:
The document does not provide any details on a specific "test set" in the context of clinical performance data. The device's substantial equivalence is primarily based on technological comparisons to predicate devices and adherence to recognized standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical test set with corresponding ground truth established by experts is mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set requiring adjudication 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. This is a submission for an ultrasound system and its software options, not an AI-assisted diagnostic device that would typically undergo MRMC studies to evaluate reader performance improvement with AI. The Virtual Navigator software supports radiological clinical ultrasound but is explicitly stated as "not intended to be used as a standalone diagnostic image."

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable for this type of device and software functionality as described. The Virtual Navigator is an aid to a radiological clinical ultrasound examination, implying human-in-the-loop use, but it does not perform standalone diagnostics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable, as no clinical performance study requiring a defined ground truth is mentioned. The submission focuses on demonstrating substantial equivalence based on technological characteristics and adherence to existing standards.

8. The sample size for the training set:
Not applicable, as no AI/machine learning model requiring a training set is explicitly described or evaluated in this regulatory document for establishing substantial equivalence. The document focuses on hardware (ultrasound systems) and software features (Virtual Navigator, QAS, Elastography, STIC) and their equivalence to previously cleared devices.

9. How the ground truth for the training set was established:
Not applicable, as no training set is mentioned.

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