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This ARETTA 65 is intended for use in a Healthcare facility (hospital, private medical office, etc.) by Healthcare 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, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculoskel. (Superfic.), Other (spec.) -Gynecological, Other (spec.) - Wound, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel, clinical applications.

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

Device Description

The ARIETTA 65 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 65 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 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.

AI/ML Overview

The provided document describes the ARIETTA 65 ultrasound diagnostic system. It does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of diagnostic performance metrics like sensitivity or specificity.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (ARIETTA 65 (K181376) and ALOKA ARIETTA 850 (K173739)) based on technological characteristics, safety standards, and intended use. The rationale is that since the new device has equivalent safety and effectiveness to a previously cleared device, it does not require new comprehensive clinical performance studies in the same way a novel device might.

Therefore, many of the requested details about acceptance criteria and clinical study specifics are not available in this regulatory submission.

Here's a breakdown based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria for diagnostic performance (e.g., specific sensitivity, specificity, or accuracy thresholds) or provide reported device performance metrics against such criteria. The "performance comparison" mentioned refers to demonstrating conformance with special controls or recognized standards and comparing technological characteristics to a predicate device, not clinical performance metrics.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. The document states "Clinical testing was not required." The "Validation Testing - Bench" was conducted, but it's not described as a clinical performance test with a "test set" in the context of diagnostic accuracy.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable, as no clinical test set with ground truth establishment is described.

4. Adjudication Method for the Test Set:

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. The document explicitly states "Clinical testing was not required."

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

Not applicable. This is an ultrasound system, not an AI algorithm intended for standalone diagnostic interpretation.

7. The Type of Ground Truth Used:

Not applicable, as no clinical study requiring ground truth is described.

8. The Sample Size for the Training Set:

Not applicable. This document describes a medical device (ultrasound system), not an AI algorithm that typically has a "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable.

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K Number

K181376

Device Name

ARIETTA 65

Manufacturer

Hitachi Healthcare Americas Corporation

Date Cleared

2018-07-18

(55 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

The ARIETTA 65 is intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous/Non-Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), 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.