(274 days)
The OLYMPUS UM-S30-25R ULTRASONIC PROBE have been designed to be used with an OLYMPUS Endoscopic Ultrasound System for intraluminal ultrasonic imaging of the gastrointestinal tract and surrounding organs.
The Olympus UM-S30-25R Ultrasonic Probe has been designed to be used with an Olympus Endoscopic Ultrasound center, Probe Driving Unit and an endoscope for intraluminal ultrasonic imaging of the gastrointestinal tract and surrounding organs. The probe is connected to the endoscopic ultrasound center through the probe driving unit. The probe is attached to the endoscope which allows the user to use probe. The probe is inserted into the patient through a channel of the endoscope. A probe driving unit controls the rotation of the transducer.
UM-S30-25R Ultrasound Probe produces a B-mode scans using the de-aerated water immersion method and balloon method. The probe offers 360 degree mechanical /radial scanning of the tissue under observation. The outer diameter of the insertion tube is 2.4mm and the length is 2050mm.
The provide information does not describe specific acceptance criteria a study proving the device meets them. Instead, it is a 510(k) summary for a medical device (Olympus UM-S30-25R Ultrasonic Probe) seeking substantial equivalence to predicate devices. The document focuses on demonstrating that the new device does not introduce significant changes that would affect its safety or effectiveness compared to already cleared devices.
Therefore, many of the requested sections about acceptance criteria, study design, expert involvement, and separate performance metrics cannot be directly extracted from this document.
However, I can extract information related to the non-clinical tests conducted to support substantial equivalence.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the document. The submission is a 510(k) for substantial equivalence, which assesses whether a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria in a clinical study.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not applicable as no clinical test set is described in the provided document. The non-clinical tests mentioned are related to design and material comparisons and compliance with standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable as no clinical test set or ground truth establishment by experts is described for performance evaluation.
4. Adjudication Method for the Test Set:
This information is not applicable as no clinical test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not applicable. The document does not describe a MRMC study or any study involving human readers with or without AI assistance. The device in question is an ultrasonic probe, not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only) Performance Study:
This information is not applicable. The device is an ultrasonic probe, not an algorithm, and the document describes non-clinical tests for the device itself, not for an algorithm's standalone performance.
7. Type of Ground Truth Used:
This information is not applicable. The document focuses on comparing the new device to predicate devices and compliance with safety standards, not on establishing ground truth for diagnostic accuracy.
8. Sample Size for the Training Set:
This information is not applicable as the device is not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable as the device is not an AI algorithm that requires a training set.
Summary of what is provided regarding testing for substantial equivalence:
The document describes non-clinical tests conducted to support a determination of substantial equivalence for the Olympus UM-S30-25R Ultrasonic Probe and its associated ancillary equipment.
- Type of Study: Non-clinical tests focusing on design, materials, and compliance with recognized standards. This is to demonstrate that the new device is as safe and effective as the predicate devices.
- Acceptance Criteria (Implied):
- Design: Compliance with IEC 60601-1 (medical electrical equipment safety) and Revised 510(k) Diagnostic Ultrasound Guidance for 1993, 1995.
- EMC: Compliance with IEC 60601-1-2 (electromagnetic compatibility) for the Ultrasonic Probe UM-S30-25R.
- Materials: Patient-contacting materials are identical to the predicate device.
- Reported Device Performance / Results of Non-clinical Tests:
- Endoscopic Ultrasound Center EU-M30 and Probe Driving Unit MH-240: "have been designed, manufactured and tested in compliance with IEC 60601-1 and Revised 510(k) Diagnostics ultrasound Guidance for 1993,1995. It meets the requirements of IEC 60601-1 and Revised 510(k) Diagnostics ultrasound Guidance for 1993,1995."
- Ultrasonic Probe UM-S30-25R: "has been tested to verify electromagnetic compatibility (EMC) with IEC 60601-1-2. It meets the requirements of IEC 6060-1-1-2."
- Conclusion: "When compared to the predicate device, the Olympus UM-S30-25R Ultrasonic probe and associated ancillary equipment do not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness."
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.