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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, and interlocking operation of the ancillary equipment.

The Olympus Integrated Endosurgery System EndoALPHA (Control Unit for Endosurgery UCES-2) is the remote control unit of legally marketed ancillary equipment. The new clinical functions are not added to the ancillary equipment by the subject device. The subject device enables the remote control of the ancillary equipment, the display of their active states and the memory of the previous set-up values. The remote control is achieved by a touch-panel monitor, remote controller, and voice control. The voice control function enables the subject device to control the ancillary equipment by voice. The subject device does not come in contact with patients and is not subject to sterilization.

The Olympus Integrated Endosurgery System EndoALPHA (Control Unit for Endosurgery UCES-2) Software Version 3 did not conduct a study with specific performance metrics such as sensitivity, specificity, or AUC against a ground truth. Instead, the device's modifications were verified against established in-house acceptance criteria based on ISO 14971:2000 through design verification tests.

Here is the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Surgeon's controller operation test: Confirmed whether the Surgeon's controller operation is performed correctly.
3. Voice operation test: Confirmed whether the voice operation is performed correctly. | 1. All the operations that are in specification operate.
4. All the operations that are in specification operate.
5. All the operations that are in specification operate. | The document implies that these tests were performed and passed, meeting the acceptance criteria, as the device was deemed substantially equivalent. |

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a "test set" in the traditional sense of a dataset for evaluating AI performance. The tests described are functional verification tests of the device's operational capabilities. Therefore, there is no information on sample size or data provenance as it pertains to clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not applicable. The tests performed are functional verification tests related to the device's operation, not clinical performance requiring expert ground truth in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The device is a control unit for endosurgery, and the modifications involved adding operating functions for new ancillary equipment and different input methods (wireless microphone, larger touch panel). The studies were functional verification tests.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The device itself is a control unit that facilitates human interaction with other ancillary equipment. Its "performance" is inherently linked to its ability to control these devices. The tests performed are functional verification tests of these control capabilities, not an algorithm performing a task independently. Therefore, the concept of a "standalone" algorithm-only performance study as typically understood for AI/ML devices is not applicable here.

7. The Type of Ground Truth Used:

The "ground truth" for the functional verification tests was the device specification itself. The tests confirmed whether the operations performed by the device (nurse's control panel, surgeon's controller, voice operation) operated as specified.

8. The Sample Size for the Training Set:

Not applicable. The device is not described as an AI/ML device in the context of learning from a training set of data. The modifications are related to integrating new hardware and input methods.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no mention of a training set or an AI/ML component that requires establishing ground truth for training.

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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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