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EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 is intended to be used with Olympus ultrasound endoscopes and Olympus ultrasound probes to observe real-time ultrasound images and is indicated for use within the gastrointestinal (GI) tract, biliary and pancreatic ducts and surrounding organs, intraluminal ultrasound for airways, tracheobronchial tree, trans-rectal, trans-urethral, and trans-esophageal (non-cardiac).

The EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 system (including KEYBOARD MAJ-2380), when combined with compatible ultrasound video scopes or ultrasound probes, makes an endoscopic ultrasound imaging system that can acquire and display and record real-time ultrasound images of the target tissue or organs. It supplies the driving voltage to the ultrasound transducers to generate ultrasound waves. Using these transducers, the Subject system can display endoscopic and ultrasound images to provide measurements and calculations of distance, area, circumference, time, blood velocity, strain ratio, strain histogram and shear wave speed of the targeted areas. It also allows the storage and retrieval of images for reviewing and printing. The Subject system enables the user to print and record images to an external recording device. Additionally, the Subject system enables the user to record movies to internal memory. The accessories submitted for clearance with the EU-ME3 that may be purchased separately include three (3) Software Options, which unlock software that is pre-installed on the EU-ME3 (for Contrast Harmonic Echo [MAJ-2381], Elastography [MAJ-2382] and Shear Wave Quantification [MAJ-2383]).

The provided FDA 510(k) summary (K243502 for the OLYMPUS EU-ME3) does not contain the detailed information necessary to answer all the questions regarding acceptance criteria and a study proving the device meets those criteria, particularly concerning AI/software performance in a clinical context.

This document describes a premarket notification for a medical imaging device that primarily focuses on hardware and basic software functionalities of an endoscopic ultrasound system, rather than an AI/ML-driven device that requires performance metrics against a defined ground truth.

Specifically, the document states: "No clinical data were collected to support performance of the Subject device." This explicitly indicates that no clinical study, whether involving human readers, standalone AI, or comparative effectiveness, was performed or presented in this submission to establish performance against acceptance criteria for an AI/ML component.

Therefore, the following points can be directly addressed based on the provided text, while others cannot.

Acceptance Criteria and Device Performance Study Analysis (Based on Provided Document K243502)

The provided document describes the Olympus EU-ME3 (EVIS EUS Endoscopic Ultrasound Center), an ultrasound imaging system. The 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device (OLYMPUS EU-ME2 Premier Plus, K203128) based on technological characteristics and non-clinical performance data, not a study of an AI/ML algorithm's clinical performance.

Therefore, it is crucial to note that the document explicitly states: "No clinical data were collected to support performance of the Subject device." This means there is no clinical study described within this submission that proves the device meets specific performance acceptance criteria for an AI-driven functionality.

The "acceptance criteria" discussed in this document are primarily related to non-clinical bench testing, safety, electrical compatibility, and compliance with regulatory standards for an ultrasound imaging system.

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

Based on the "SUMMARY OF NON-CLINICAL PERFORMANCE DATA" section (Page 8), the following non-clinical tests were completed and demonstrated compliance, implying these are the "acceptance criteria" for the non-AI/ML aspects of the device demonstrated in this submission:

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

• Not applicable / Not provided. The document explicitly states "No clinical data were collected to support performance of the Subject device." The testing described is non-clinical bench testing, not a clinical study involving a test set of patient 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 / Not provided. Since no clinical data or clinical study was conducted for performance evaluation in this submission, there was no need for experts to establish ground truth for a clinical test set.

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

• Not applicable / Not provided. No clinical test set.

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. The document explicitly states, "No clinical data were collected to support performance of the Subject device." Therefore, no MRMC study, especially one involving AI assistance, was conducted.

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

• No. The document describes a full ultrasound imaging system. While it mentions features like "Elastography and Shear Wave Speed Measurement (Shear Wave Quantification)" and "Strain Ratio/Strain Histogram," these are described as modes or measurement functions of the imaging device itself, rather than a separate AI algorithm that performs standalone analysis and requires independent performance validation. The submission focuses on the inherent physical and software capabilities of the ultrasound machine for these measurements.

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

• Not applicable for clinical performance. For the non-clinical bench testing, the "ground truth" would be the known physical properties of the phantoms or test objects used (e.g., known distances, known material properties for elasticity measurements).

8. The sample size for the training set

• Not applicable. This submission does not describe an AI/ML algorithm that requires a training set. The device is an ultrasound imaging system with various modes and measurement capabilities.

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

• Not applicable. No training set was involved as this is not an AI/ML device submission requiring such.

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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.

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.

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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