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The Olympus UM-2R and UM-3R Ultrasonic Probes have been cleared for use within the gastrointestinal tract in 510(k) #K944610.

The Olympus UM-2R and UM-3R Ultrasonic Probes have been designed for use in combination with Olympus Endoscopic Ultrasound System for intraluminal sonographic imaging of the urinary tract.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intraluminal ultrasound for urinary tract. Previously cleared indications=Intraluminal ultrasound for gastrointestinal tract.

In routine examination of the urinary tract, there are situations where the physician prefers to perform an intensive examination, observation, and diagnosis of the urinary tract. The ponventional type therapeutic urethro-cystoscope limits the physician's ability to access certain areas of interest. The UM-2R / UM-3R Ultrasonic Probes, when used with an endoscope offer transendoscopic access to the urinary tract. The 2.4 mm insertion tube of these probes can be advanced through strictures and anatomical ducts. The Olympus Ultrasonic Probes to be used in conjunction with therapeutic urethro-cystoscope with a minimum capacity size of 9Fr.. A probe-driving unit controls the rotation of the transducer.

The UM-2R and UM-3R probes produce a B-mode scans using the de-aerated water immersion method and offer 360 degree mechanical/radial scanning of the tissue under observation. The outer diameter of the insertion tube is 2.4 mm and the length is 2050 mm. Both probes incorporate similar design, construction, intended use, and method of operation. The only difference between these two probes is that the UM-2R probe operates at 12 MHz and is compatible with both Olympus EU-M30, EU-M20 and EU-M3 Endoscopic Ultrasound Systems, while the UM-3R probe operates at 20 MHz and is compatible with the EU-M30 and the EU-M20 Endoscopic Ultrasound System.

The provided text describes a 510(k) submission for the Olympus UM-2R and UM-3R Ultrasonic Probes, seeking clearance for use within the urinary tract. The document primarily focuses on establishing "substantial equivalence" to predicate devices, rather than detailing a specific study with acceptance criteria and performance data for the new intended use.

Therefore, much of the requested information regarding detailed study design, sample sizes, expert qualifications, and specific performance metrics for acceptance criteria is not present in the provided text. The document states that the devices meet existing safety and performance requirements for ultrasound products and are substantially equivalent to previous models for their general operating principles.

However, I can extract information related to the devices and their intended use.

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" and "reported device performance" in the context of this 510(k) summary primarily relates to demonstrating substantial equivalence to predicate devices and adherence to established regulatory standards for diagnostic ultrasound transducers. Specific quantitative performance metrics for the new intended use (urinary tract imaging) are not detailed as they would be in a clinical trial report.

Study Information (Based on provided text)

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified in the provided text. The submission is focused on demonstrating substantial equivalence to predicate devices and compliance with existing standards, rather than reporting on a specific test set from a clinical study for the urinary tract indication.
   • Data Provenance: Not specified. There is no mention of specific clinical data (country of origin, retrospective/prospective) for the urinary tract indication. The clearance is based on the devices' existing design and safety profile.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified. The document does not describe a process for establishing ground truth via expert consensus for a test set.

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

   • Adjudication Method: Not specified. There is no mention of a formal adjudication process for a test set in relation to the new urinary tract indication.

4. 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:

   • MRMC Study: No. This document is from 1998, well before the common use of AI in medical imaging interpretation, and it describes a hardware device (ultrasonic probe), not an AI algorithm.
   • Effect Size: Not applicable.

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

   • Standalone Performance: Not applicable. This document describes a physical medical device (ultrasound probe), not a standalone algorithm.

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

   • Type of Ground Truth: Not specified in the context of a study for the urinary tract indication. The basis for clearance relies on established safety and performance of the device type and its substantial equivalence to previously cleared devices. For the new indication, it is likely that the FDA evaluated the technical specifications and existing safety profile to determine that it could be safely and effectively used in the urinary tract, without requiring a specific "ground truth" study for this 510(k) process.

7. The sample size for the training set:

   • Sample Size: Not applicable. This document describes a physical device, not a machine learning model that requires a training set.

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

   • Ground Truth Establishment: Not applicable. This document describes a physical device, not a machine learning model that requires a training set.

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