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Esaote's MyLabSix ultrasound system 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, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal, Laparoscopic and Other: Urologic. The 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 MyLabSix is a mainframe ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, Amplitude Doppler (AD), Tissue Enhancement Imaging (TEI), Multi View (MView), Tissue Velocity Mapping (TVM), Color Flow Mapping (CFM), Pulse Wave Doppler, 3D and 4D. The MyLabSix is equipped with a free orientable LCD Color Display were acquired images and advanced images are shown. The MyLabSix is also equipped with a height adjustable/rotating keyboard. A second LCD Display for additional controls and mode-depending keys, includes touch screen technology and is integrated in the control panel. The MyLabSix can drive phased (PA), convex (CA), linear array (LA) probes, Doppler probes and Volumetric probes. The MyLabSix is equipped with an internal Hard Disk and with a DVD-RW disk drive that can be used for image storage. Data can also be stored directly to external archiving media (Hard-Disk, PC, server) via a LAN/USB port. The MyLabSix is already cleared via K141486. The MyLabSix Upgrade, defined herein, combine the cleared features of MyLabSix system with new software capabilities, listed below: 1. Management of motorized probes (Bi-Scan probes) that allow volumetric acquisition in 3D/4D mode for Transrectal/Urologic and Transvaginal applications 2. Management of Laparoscopic application 3. Implementation of the Needle Visibility feature 4. Implementation of the on-board tutorial MyLibrary feature. The MyLabSix Upgrade is manufactured under an ISO 9001 and ISO 13485 certified quality system.

The acceptance criteria and study proving it are described below.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The provided document describes a 510(k) premarket notification for the MyLabSix Ultrasound System Upgrade (K161168). The study proving the device meets acceptance criteria is primarily a non-clinical bench testing and comparison to predicate devices, rather than a human clinical trial.

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

• Sample Size for Test Set: Not applicable in the traditional sense of patient data. The "test set" here refers to the extensive series of non-clinical tests and comparisons performed on the device and its components. No patient data or images were used to "test" the algorithm's performance in a diagnostic capacity.
• Data Provenance: Not applicable for patient data. The "data" evaluated were the results from engineering, electrical, acoustic, and biological safety tests performed on the MyLabSix Ultrasound System Upgrade. This would originate from the manufacturer's (Esaote Europe B.V.) internal testing and quality control processes.

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

• Not applicable. As this was a non-clinical evaluation focusing on technical specifications and substantial equivalence, the concept of "ground truth" established by clinical experts for diagnostic accuracy does not apply. The "ground truth" was adherence to established industry safety and performance standards (e.g., IEC, ISO, NEMA).

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

• Not applicable. Adjudication methods are typically used in clinical studies when multiple human readers interpret data, and their findings need to be reconciled to establish a consensus ground truth. This submission relies on objective engineering measurements and direct comparison to predicate devices' specifications and established standards.

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. An MRMC study was not conducted. The submission explicitly states: "No clinical tests were performed." The MyLabSix is an ultrasound system and an upgrade to existing systems for expanded functionalities and modes, not an AI-assisted diagnostic tool.

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

• Not applicable. The MyLabSix is an ultrasound system that provides imaging, not a standalone AI algorithm. Its performance is evaluated based on its ability to generate images and provide functional modes, assumed to be interpreted by human operators.

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

• For the non-clinical tests, the "ground truth" was compliance with established national and international safety, acoustic, and performance standards (e.g., IEC 60601 series, ISO 10993-1, NEMA UD 2, NEMA UD 3).
• For the expanded clinical applications, the "ground truth" for demonstrating substantial equivalence was the existence of legally marketed predicate devices (MyLabSeven, SonoSite Edge, MyLabOne) that already possess the new functionalities being added to the MyLabSix Upgrade. The claim is that the technology used to implement these features is equivalent to those already cleared.

8. The sample size for the training set:

• Not applicable. This is a medical device for imaging, not a machine learning or AI algorithm in the context of diagnostic interpretation that would require a "training set" of patient data.

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

• Not applicable, as there was no training set in the context of an AI algorithm.

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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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