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The ARIETTA x10 is intended for use by trained personnel (doctor, Sonographer, etc.) while in a healthcare facility for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intraoperative (Specify1), Intra-operative (Neurosurgery), Laparoscopic, Pediatric, Small Organ (Specify2), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Transesophageal (non-Cardiac), Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Other (Specify - Gynecological), Other (Specify - Wound), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac), Peripheral vessel, clinical applications.

The Modes of Operation are B mode, M mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Power Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging.

*1. Includes imaging for organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).

*2. Includes thyroid, parathyroid, breast, scrotum, penis.

ARIETTA x10 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 and phased array scan type probes for usage with a variety of clinical applications.

The ARIETTA x10 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 image 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 4 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.
• . 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.

The provided text describes a 510(k) premarket notification for the ARIETTA x10 ultrasonic pulsed Doppler imaging system. It states that an analysis confirms the performance characteristics of the ARIETTA x10 are comparable to the predicate device and support the conclusion of substantial equivalence. However, it explicitly states that "Clinical testing was not required" and provides no information about any specific study, acceptance criteria, or device performance metrics for the ARIETTA x10. Therefore, the requested information cannot be extracted from this document.

The document focuses on demonstrating substantial equivalence to a predicate device (ALOKA ARIETTA 850, K183456) based on technological characteristics, safety standards conformance, and the lack of new hazards.

The document does not contain the information required to populate the table or answer the specific questions regarding acceptance criteria and a study that proves the device meets those criteria.

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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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