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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 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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