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This ARIETTA 50 is intended for use by trained personnel (doctor, sonographer, etc.) while in a healthcare facility for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Pediatric, Small Organ (Spec.), A Small Organ (Spec.), Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Other (Wound), Cardiac Adult, Cardiac Pediatric, Transesophageal (card.), Peripheral vessel, Other (Gynecological), 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).

The ARIETTA 50 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 50 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.

This document describes the Fujifilm ARIETTA 50 ultrasound system and its substantial equivalence to a predicate device. Below is a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain a table of specific acceptance criteria (e.g., specific quantitative metrics for performance) or a direct comparison of the reported device performance against such criteria. Instead, the document focuses on demonstrating substantial equivalence to a predicate device (ARIETTA 50, K190248) through a comparison of physical, performance, and technological characteristics.

The "Performance Comparison" section states: "No new hazards were identified with the ARIETTA 50. The subject device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform to applicable medical device safety standards."

The implicit acceptance criteria are the safety and effectiveness standards met by the predicate device and the applicable medical device safety standards mentioned. The reported device performance is that the ARIETTA 50 "conforms to applicable medical device safety standards" and its "performance characteristics... are comparable to the predicate device."

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

The document explicitly states: "Performance Testing - Clinical: None required." This indicates that no clinical test set of patient data (retrospective or prospective) was used for evaluating the device's performance in a clinical setting against specific acceptance criteria for diagnostic accuracy or efficacy. The evaluation appears to be based on an engineering and regulatory comparison to a predicate device.

Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable as no such clinical study was conducted.

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

Since no clinical test set was used for performance testing (as clinical testing was not required), there is no information about experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

As no clinical test set was used, there is no adjudication method to report.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

No MRMC comparative effectiveness study was mentioned or implied. The device is an ultrasound diagnostic scanner, and the evaluation focused on physical and technical equivalence to a predicate, not on human-in-the-loop performance or AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

The document does not describe any standalone algorithm performance study. The ARIETTA 50 is an ultrasound system with various imaging modes, not an AI-driven algorithm designed to perform diagnostic tasks without human interaction. Its evaluation focuses on the overall system's safety and performance characteristics compared to a predicate ultrasound system.

7. The Type of Ground Truth Used

Given that clinical testing was not required and the submission relies on substantial equivalence to a predicate device, there is no mention of ground truth established through expert consensus, pathology, or outcomes data for the ARIETTA 50 itself. The basis for safety and effectiveness is compliance with standards and comparability to the predicate.

8. The Sample Size for the Training Set

No training set is mentioned as neither an AI/ML component requiring a training set nor a clinical study with a training phase was conducted.

9. How the Ground Truth for the Training Set Was Established

Since no training set was used, this information is not applicable.

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This ARIETTA 50 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.), A Small Organ (Spec.), Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Other (Wound), Cardiac Adult, Cardiatric, Transesophageal (card.), Peripheral vessel, Other (Gynecological), clinical applications.

The ARIETTA 50 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 50 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.

The ARIETTA 50 is an ultrasound diagnostic scanner.

1. Acceptance criteria and reported device performance:

The device did not set explicit performance acceptance criteria in the provided document. Instead, the manufacturer, Hitachi, Ltd., argues for substantial equivalence to a predicate device (ARIETTA 65, K181376) by demonstrating comparable performance characteristics. The lack of an acceptance criteria table stems from this approach.

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

No test set was used for clinical performance evaluation. The submission explicitly states "Clinical testing was not required."

3. Number of experts and qualifications for ground truth:

Not applicable, as no clinical testing was performed and therefore no ground truth was established from clinical data for performance evaluation.

4. Adjudication method for the test set:

Not applicable, as no clinical testing was performed.

5. Multi-reader multi-case (MRMC) comparative effectiveness study:

No MRMC study was conducted. The document states that clinical testing was not required.

6. Standalone performance (algorithm only without human-in-the-loop performance):

Not applicable. The device is an ultrasound system and there is no mention of an algorithm or AI component performing standalone interpretations. Performance evaluation was based on demonstrating substantial equivalence to a predicate device.

7. Type of ground truth used:

Not applicable for performance evaluation. The substantial equivalence argument relies on the established safety and effectiveness of the predicate device (ARIETTA 65) and demonstrating that the ARIETTA 50 has comparable physical and performance characteristics, along with adherence to applicable safety standards.

8. Sample size for the training set:

Not applicable. The document does not describe any machine learning or AI components that would require a training set.

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

Not applicable, as there is no mention of a training set or AI component in the document.

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