(21 days)
This ultrasound center is intended to be used with Olympus ultrasound endoscopes, Olympus ultrasound probes or Olympus esophageal ultrasound probes to observe and to store real-time ultrasound images and indicated for use within the gastrointestinal (GI) tract, biliary and pancreatic ducts and surrounding organs, and tracheobronchial tree, and urinary tract.
The subject system (OLYMPUS EU-ME2) combined with Ultrasound videoscopes or Ultrasound probes to make an endoscopic ultrasound imaging system that can acquire and display high-resolution and high-penetration, real-time ultrasound images of the target organs.
The subject system has modes of B, PWD, Color Doppler, Combined (combination of each operating mode) and other (3-D Imaging).The subject system has no Harmonic Imaging function compared to the predicate device.
The subject system provides measurements and calculations of distance, area, circumference, volume, time, and blood velocity. It also allows for 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.
The subject system can identify and recognize the compatible Olympus transducers and display endoscopic and ultrasound images.
The basic design, system configuration, general operation and user interface of this subject system is substantially equivalent to the predicate devices.
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS
The subject system (OLYMPUS EU-ME2 PREMIER PLUS) combined with Ultrasound videoscopes or Ultrasound probes to make an endoscopic ultrasound imaging system that can acquire and display high-resolution and high-penetration, real-time ultrasound images of the target organs.
The subject system has modes of B, PWD, Color Doppler, Combined (combination of each operating mode), other (3-D Imaging and Harmonic Imaging) and Elastography function which visualizes the amount of strain in tissue (hardness of tissue) during compression and retraction.
The subject system provides measurements and calculations of distance, area, circumference, volume, time and blood velocity. It also allows for 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 subject system can identify and recognize compatible Olympus transducers and display endoscopic and ultrasound images.
The basic design, system configuration, general operation, and user interface of this subject system is substantially equivalent to the predicate devices.
The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity for diagnostic purposes. The document details a 510(k) submission for the Olympus EVIS EUS ENDOSCOPIC ULTRASOUND CENTER, focusing on demonstrating substantial equivalence to predicate devices.
The document mentions several types of testing conducted to support the substantial equivalence claim, but these are primarily related to general device safety, software validation, and electrical compatibility rather than performance as a diagnostic tool.
Here's a breakdown of the information that is available, and what is explicitly not available based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
- Not provided in the context of diagnostic performance. The document includes tables comparing the features and specifications of the subject device to its predicate devices (Tables 1 and 2, pp. 6-8), but these do not list acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) or the reported performance against such criteria. The performance data mentioned (Section 7.0, p. 10) refers to general engineering and safety tests.
2. Sample Size for Test Set and Data Provenance
- Not applicable/Not provided. No diagnostic performance study involving a patient test set is described. The "performance testing" referenced is for software, electrical safety, EMC, and risk management.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable/Not provided. Since no diagnostic performance study is described that relies on expert interpretation to establish ground truth, this information is not present.
4. Adjudication Method
- Not applicable/Not provided. As there's no diagnostic performance study with expert interpretations, no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, not performed. The document explicitly states "No clinical study was performed to demonstrate substantial equivalence" (Section 7.4, p. 10). Therefore, no MRMC study or effect size of AI assistance is available.
6. Standalone (Algorithm Only) Performance Study
- No, not performed. The device is an ultrasound center, which is a hardware system for generating and displaying images with various modes. It is not an AI algorithm intended for standalone diagnostic performance evaluation. The document states "No clinical study was performed."
7. Type of Ground Truth Used
- Not applicable/Not provided. Given the absence of a diagnostic performance study, there is no mention of ground truth established by expert consensus, pathology, or outcomes data.
8. Sample Size for Training Set
- Not applicable/Not provided. The device is a hardware system, not an AI model that undergoes a training phase with a specific data set.
9. How Ground Truth for Training Set Was Established
- Not applicable/Not provided. As above, this is not an AI model subject to training.
Summary of available performance testing information:
- Software verification and validation testing: Conducted as per FDA guidance.
- Electrical safety and electromagnetic compatibility (EMC): Tested according to ANSI/AAMI ES 60601-1:2005/(R) 2012, A1:2012, IEC 60601-2-18:2009, IEC 60601-1-2:2014, and IEC 60601-2-37:2015.
- Risk management: Performed in accordance with ISO 14971:2007, and human factors validation based on FDA guidance. This implies that acceptance criteria for design verification tests were identified and met as a result of risk management, but specific diagnostic performance criteria are not detailed.
- Animal and Clinical Studies: Explicitly stated that "No animal study was performed" and "No clinical study was performed" to demonstrate substantial equivalence.
In conclusion, the provided documentation focuses on the substantial equivalence of the device as an imaging system, primarily through comparisons of technological characteristics, safety, and software validation, rather than an evaluation of its diagnostic performance against specific acceptance criteria using a clinical or ex-vivo test set.
§ 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.