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The "OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2)" has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, interlocking of the ancillary equipment.

The "OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2)" has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, interlocking operation of the ancillary equipment.

The additional voice control function enables the subject device to control the ancillary equipment by voice, while the conventional products control them manually. You could find the details for voice commands and voice controllable equipment in "Standard set and ancillary equipment" and "Operation by voice control" of this section.

Addition of Image switching, recording and playback functions enables the followings;

• Images input into the UCES-2 and MAJ-1139 are displayed on two monitors by switching from one to another.
• · Images input into the UCES-2 and MAJ-1139 are displayed on the MAJ-1176 as reference images.
• · Still images input into UCES-2 and MAJ-1139 are recorded in a PC card (SmartMedia) The images recorded in the PC card (SmartMedia) are displayed on the MAJ-1176.

The intended use of the EndoALPHA is to enable a central system to control various pieces of ancillary equipment. However, the approved indications for use for each separate ancillary device dictate the type of procedures that may be performed. This information is included in the instruction manual for each ancillary piece of equipment.

The provided text describes the Olympus Integrated Endosurgery System EndoALPHA (Control Unit for Endosurgery UCES-2) and the non-clinical tests performed for its voice operation function. Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample size for voice recognition test: "some sample voice data" - The exact number of samples is not specified.
• Data provenance: Recorded by "members of Olympus America Inc." This suggests retrospective data from internal company personnel, likely collected in the USA for the purpose of testing.

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

This section of the document describes non-clinical tests for software functionality (voice control). While "members of Olympus America Inc." provided the voice samples for testing, these are not described as "experts" establishing a medical ground truth for a diagnostic or clinical outcome. The ground truth for voice recognition would be the intended interpretation of the spoken commands, which is inherent in the device's design specifications. No medical experts are mentioned as being involved in establishing this ground truth.

4. Adjudication method for the test set

The document does not describe an adjudication method for these non-clinical tests. The tests appear to be direct verification against predefined functional specifications.

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 MRMC study is mentioned. The device described, the Olympus Integrated Endosurgery System EndoALPHA, is a control unit for ancillary surgical equipment with added voice control and image management functions. It is not an AI diagnostic or interpretive tool that would typically be evaluated in an MRMC study for human reader improvement.

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

This is essentially what the voice recognition and wrong recognition tests describe. They assess the algorithm's performance (voice recognition system) independently of a human "in-the-loop" making clinical decisions. The tests evaluate the system's ability to correctly interpret voice commands and avoid misinterpretations from noise.

7. The type of ground truth used

For the voice recognition test, the ground truth is the correct interpretation of the spoken command as defined in the device's specifications. For the wrong recognition test, the ground truth is the absence of an action when noise is present, implying the noise should not be recognized as a command. This is a functional truth, not a clinical or pathological one.

8. The sample size for the training set

The document does not mention a training set for the voice recognition function. It only describes the test phase.

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

Since no training set is mentioned, information on how its ground truth was established is not available in the provided text.

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