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The PENTAX Medical EG-J10U Endoscopic Ultrasound System is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

The EG34-J10U, EG36-J10UR and EG38-J10UT Ultrasound Upper GI Video Scopes, are endoscopes used to provide visualization of, and therapeutic access to, the upper gastrointestinal tract. They are used with cleared Pentax Video Processors (a softwarecontrolled device) and cleared Hitachi Ultrasound Scanners (a software-controlled device). The endoscopes have a flexible insertion tube, a control body, PVE umbilical connector, and ultrasound scanner umbilical connector. The PVE umbilical connector will be attached to the Video Processor and has connections for illumination, video signals, air/ water/ and suction. The ultrasound scanner umbilical connector will be attached to the ultrasound scanner unit. A sterile, single use disposable natural rubber latex balloon is fitted over the convex array ultrasound transducer prior to the procedure. During an ultrasound endoscopy procedure, the latex balloon is inflated with water. The water that is contained within the balloon creates a water field that covers the transducer. The water field enables more effectively transport of ultrasonic pulses from the ultrasound transducer to the target anatomical site and back to the ultrasound transducer. The control body includes controls for up/ down/ left/ right angulation, air/ water delivery, and an accessory inlet port. The endoscope contains light carrying bundles to illuminate the body cavity, a charge couple device (CCD) to collect endoscopic image data, and a linear or radial array ultrasound transducer to collect ultrasonic image data. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced.

The provided text is a 510(k) premarket notification for the PENTAX Medical EG-J10U Endoscopic Ultrasound System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.

Therefore, many of the requested details, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set information (which are typical for AI/ML device submissions), are not present in this document.

The document primarily addresses hardware, software, and reprocessing aspects of the endoscopic ultrasound system. The "performance data" mentioned refers to non-clinical testing for functionality, safety, human factors, reprocessing validation, sterilization, shelf life, software verification/validation, EMC, electrical safety, and optical testing, rather than clinical performance metrics for a diagnostic or AI/ML algorithm.

Here's an attempt to answer the questions based on the available information, noting significant gaps:

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

The document describes performance testing in general terms rather than specific quantifiable acceptance criteria with corresponding results in a table format. It states that the system "has been successfully tested for its functions, performance and safety as per FDA recognized consensus standards." For optical testing, it notes "All results show that there are no differences between the subject device, and the predicate device."

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

• Sample Size: Not specified in the document for any of the non-clinical tests.
• Data Provenance: Not specified. The tests are described as being conducted "as a part of Design Verification and Validation" and for "support of the substantial equivalence determination," implying internal company testing rather than clinical trials.

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

• Not applicable / Not specified. This document describes a medical device, not an AI/ML algorithm that requires expert ground truth for diagnostic accuracy. The "human factors" study involved reprocessing staff, not clinical experts establishing ground truth for diagnostic images.

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

• Not applicable / Not specified. No adjudication method is mentioned as it's not a diagnostic AI/ML study.

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. This is not an AI-assisted device. The document does not describe any MRMC studies or human reader improvement with AI assistance.

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

• Not applicable. This is not an AI/ML algorithm. The device is a physical endoscope with associated control software.

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

• Not applicable. The "ground truth" for this device's performance testing would be engineering specifications, industry standards (e.g., IEC standards for electrical safety), and validated reprocessing protocols, rather than clinical ground truth for disease states.

8. The sample size for the training set:

• Not applicable. This document describes a medical device, not an AI/ML algorithm requiring a training set.

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

• Not applicable. As above, no training set for an AI/ML algorithm is described.

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The PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows.
Clinical Application: Endoscopy
Mode of Operation: B, M, PWD, Color Doppler, Amplitude Doppler

The PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U connects with a video processor and an ultrasound scanner, both of which are software controlled devices.

The endoscope has a flexible insertion tube, a control body, PVE connector, and scanning unit connector. The PVE connector attaches to the video processor and has connections for illumination and video signals. The ultrasound umbilical connector attaches to the ultrasound scanner unit.

The control body includes remote buttons for functions assigned from the video processor. It also includes controls for up/down angulation or neutral position, suction control, and ports for manual balloon insufflation/evacuation and accessory inlet.

The endoscope contains light carrying bundles to illuminate the body cavity, a change couple device to collect endoscopic image data, and a convex array ultrasound transducer to collect ultrasonic image data. The instrument contains a working channel through which biopsy devices, or other devices may be introduced. The video processor contains a lamp that provides white light focused at the endoscope PVE connector light guide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects endoscopic image data. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display.

The ultrasound transducer delivers ultrasonic pulses, reflections of the pulses are received and the signals are passed to the ultrasound scanner for processing and display. The instrument is immersible (with the use of supplied cleaning accessories). EB19-J10U is connected to the ultrasound scanners Arietta 70 and Noblus via the scanning unit connector of the endoscope directly to the probe connector of the scanning unit. In order to connect to the Preirus scanning unit, junction box PUN-JBP1 is required to connect the scanning unit connector to the probe connector.

The instrument is immersible (with the use of supplied cleaning accessories).

The provided text is a 510(k) Summary for the PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U. It details the device's technical specifications, intended use, and a summary of testing conducted to demonstrate substantial equivalence to predicate devices. However, it does not contain any information about a study proving that the device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, accuracy, or reader performance with or without AI assistance.

The document focuses on non-clinical testing to demonstrate that the device is equivalent to a legally marketed predicate device, especially regarding safety and effectiveness from a design and manufacturing perspective. It mentions "Performance Testing - Bench" for "System compatibility" and "Optical characteristics," but does not provide specific acceptance criteria or quantitative results for these tests.

Therefore, I cannot fully answer your request for acceptance criteria and a study that proves the device meets them, as the provided text does not include the necessary information regarding a clinical performance study involving AI, human readers, or specific diagnostic performance metrics.

Here's an breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. The document lists various types of non-clinical testing (Sterilization, Reprocessing, Biocompatibility, Software, EMC + Electrical Safety, System Compatibility, Optical Characteristics), and states that "Testing results confirm the subject device is safe and effective as the predicate device, and performs as intended." However, it does not provide specific quantitative acceptance criteria or detailed numerical results for these tests. For example, it says "The subject device demonstrates equivalent or better optical characteristics than the predicate device," but gives no numerical value for either.

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

• Cannot be provided definitively for a performance study. The document outlines non-clinical bench testing. These tests typically don't involve "samples" in the same way clinical studies do (e.g., patient data). The data provenance (country of origin, retrospective/prospective) is not applicable or mentioned for the types of tests described.

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

• Not applicable. This information is relevant for studies establishing diagnostic ground truth, often used for AI/clinical performance evaluations. The document describes engineering and safety testing, not clinical diagnostic performance.

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

• Not applicable. Adjudication methods are used in clinical studies to resolve discrepancies in expert interpretations for ground truth establishment. This document doesn't describe such a study.

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, such a study was not done according to this document. This device is a bronchoscope, which is a physical instrument for visualization and access, not an AI software intended to assist human readers in image interpretation. The document does not mention any AI component or any MRMC studies.

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

• No, this is not an AI algorithm. This is a hardware device (bronchoscope) with associated software for its operation. Therefore, a standalone algorithm performance study is not applicable.

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

• Not applicable in the context of diagnostic performance. The "ground truth" for the tests described relates to engineering specifications and safety standards (e.g., whether the device sterilizes correctly, whether electrical current is within safe limits, whether optical clarity meets design specs).

8. The sample size for the training set:

• Not applicable. There is no mention of a "training set" as this is not an AI device being trained.

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

• Not applicable. (See point 8).

In summary, the provided FDA 510(k) summary focuses on demonstrating the substantial equivalence of a medical device (a bronchoscope) through non-clinical testing of its physical, electrical, and reprocessing characteristics. It does not involve AI or diagnostic performance studies that would require the types of acceptance criteria and study details you requested for AI-driven devices.

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The ARIETTA 750 is intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel clinical applications.

The ARIETTA 750 is a multi-functional ultrasound diagnostic scanner in which Doppler. Color Flow Mapping, etc. are provided and all circuits related to image quality are fully digitalized. This device can be utilized with linear, convex, radial and phased array scan type probes for usage with a variety of clinical applications.

The ARIETTA 750 can be used for individual or combined display in the image display model listed below.

• B mode is a display mode in which the tomographic imaqe is formed with plural ultrasound beams by the methods mentioned above. During the process of creating the tomographic image, adaptive filters (HI REZ) that modify the characteristics of each echo filter are used to produce a clear image.
• M mode is a display mode of ultrasound beams received sequentially and repeatedly on the screen from the same direction. It indicates these reflected echoes in one direction from the interior of the patient's body's on time-series scale.
• There are two types of D (Doppler) mode: PW Doppler mode and CW Doppler mode. PW Doppler mode displays bloodstream information consecutively at a sample point that is detected by pulsed Doppler sonography. CW Doppler mode displays bloodstream information continuously in the single-direction ultrasound beam that is detected by the CW Doppler method.
• Color Doppler mode receives ultrasound from the same direction and detects any . changes that occur over time to identify three types of bloodstream information: its direction, its speed, and its inconsistency. The mode then colors that information and displays it as an overlay on B mode or M mode. Color Flow Mode, Power Doppler Mode, High-Resolution Power Doppler (eFlow) Mode can be used with this instrument according to need.

The 5 methods of electronic scanning are as follows.

• Linear Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted in a straight line (linearly) and draws a tomographic image of the test subject.
• Convex Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted radially and draws a tomographic image of the test subject.
• Sector Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted in a fan shape (sector) and draws a tomographic image of the test subject.
• Radial Scanning Method: By this method, the ultrasound probe emits a 360 degree (radial) ultrasound beam and draws a tomographic image of the test subject.
• Trapezoidal Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted radially without regard to the form of the probe head and draws a tomographic image of the patient.

This document is a 510(k) Premarket Notification for the Hitachi ARIETTA 750 ultrasound system. It claims substantial equivalence to several predicate devices. While it discusses performance characteristics and standards met, it does not include acceptance criteria or a study that proves the device meets specific performance metrics in the way you've outlined for AI/CADe systems.

The document states "Clinical testing was not required" and "Analysis confirms the performance characteristics of the ARIETTA 750 are comparable to the predicate device and support our conclusion that the subject system is substantially equivalent." This indicates that the primary method of demonstrating acceptable performance for this traditional diagnostic ultrasound device is through comparison to already cleared devices and adherence to established safety and performance standards for ultrasound equipment, rather than a clinical trial with specific performance metrics for diagnostic accuracy.

Therefore, I cannot extract the detailed information requested in points 1 through 9 for an AI/CADe system's performance study because this document pertains to a traditional diagnostic ultrasound device that establishes substantial equivalence through different criteria.

Key takeaway for this specific document: The performance proof is based on demonstrating the new device is comparable to existing, legally marketed predicate devices and adheres to relevant safety standards. It's not a study proving improved diagnostic accuracy via an algorithm against a ground truth dataset.

If you are looking for information regarding the acceptance criteria and study proving performance for a software algorithm (like AI/CADe), you would typically look for a different type of FDA submission document (e.g., a De Novo request or a 510(k) for a novel AI-enabled device) that would specifically include clinical performance data to demonstrate acceptable diagnostic accuracy.

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ARIETTA Prologue is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of following clinical applications: FETAL; ABDOMINAL - (Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis)); INTRA-OPERATIVE (SPEC.)-(Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures)); INTRA-OPERATIVE (NEURO); LAPAROSCOPIC; PEDIATRIC; SMALL ORGAN (SPEC.)-(Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy): NEONATAL CEPHALIC: ADULT CEPHALIC; TRANS-RECTAL - (Includes imaging for guidance of trans-rectal biopsy); TRANS-VAGIAL -(Includes imaging for guidance of trans-vaginal biopsy); TRANS-ESOPHAGEAL (NON-CARDIAC & CARDIAC) -ADULT/PEDIATRIC; MUSCULOSKELETAL (CONVENT./SUPERFIC.); Other (spec.) -WOUND (Includes imaging for Cavernous/Non-Cavernous wounds); Other (spec) - GYNECOLOGICAL; CARDIAC: ADULT/ PEDIATRIC and PERIPHERAL VESSEL.

An ultrasound diagnostic system with the following features:

• Ultrasound transducer(s) to generate the transmitted ultrasound energy and detect the reflected echoes
• Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) in various modes of operation
• A computer system to control the transducer and analyze the signals resulting from the reflected echoes
• A video monitor with optional image recorder to display the computed image or derived Doppler data

The provided text is a 510(k) Premarket Notification for the ARIETTA Prologue Diagnostic Ultrasound System and Transducers. It focuses on demonstrating substantial equivalence to a predicate device (Noblus K142368, and K134016 for some indications) and does not contain detailed information about specific performance acceptance criteria or a dedicated study proving performance against such criteria in the way a clinical trial for an AI/CADe device would.

Instead, the document asserts substantial equivalence based on similarities in intended use, clinical applications, modes of operation, technology, and adherence to safety standards. The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical testing performed to ensure the device is safe and effective as per FDA regulations for ultrasound devices, rather than a clinical performance study with specific quantifiable metrics.

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

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

The document does not specify quantitative performance acceptance criteria (e.g., sensitivity, specificity, accuracy) for an AI/CADe component, as it is a diagnostic ultrasound system, not an AI/CADe device with specific diagnostic algorithms being validated. The acceptance criteria described are broadly related to safety and effectiveness compared to a predicate device.

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

The document does not describe a test set or data provenance in the context of a performance study for an AI/CADe device. The evaluations conducted were non-clinical tests (acoustic output, biocompatibility, EMC, electrical/mechanical safety) which typically involve testing the physical device and its components according to engineering standards, rather than analyzing clinical data.

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 this is not a study for an AI/CADe device requiring expert-established ground truth from clinical data. The "ground truth" for the non-clinical tests would be the established engineering standards and specifications.

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

Not applicable. No clinical data 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. The document describes a diagnostic ultrasound system, not an AI-assisted diagnostic tool subject to MRMC studies comparing human readers with and without AI assistance.

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

Not applicable. This is a diagnostic ultrasound system, not a standalone algorithm.

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

For the non-clinical testing, the "ground truth" would be engineering specifications, applicable safety standards (e.g., IEC 60601-1, IEC 62304, ISO 10993-1), and FDA guidance documents. There is no mention of clinical ground truth (like pathology or outcomes data) being used for performance evaluation in this 510(k) submission.

8. The sample size for the training set

Not applicable. This is not an AI/CADe device, and no training set for an algorithm is mentioned.

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

Not applicable, as there is no training set mentioned for an AI/CADe 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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