(66 days)
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:
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Acoustic Output | Tested and compliant. (Specific values not provided but implied to be |
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.