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The Systems Integration ENDOALPHA 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 Systems Integration ENDOALPHA has been designed to be used with an Olymous endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment.

The ENDOALPHA integrated electrosurgical system has the following system functions.

1. Centralized control from a non-sterilized area
   2} Centralized control from a sterilized area
2. Centralized display
3. Message display
4. Voice reply .
5. Automatic settings
6. Scene settings
7. Display customization
8. Still image viewing
9. Automatic smoke evacuation

The modifications made to the subject device are as follows:
A) Addition or deletion of recommended ancillary equipment
B) A change involving the communication interface
C) A change in the design of the Graphical User interface (GUI)
D) Addition of a voice reply function
E) Deletion of Surgeon's controller for EndoALPHA (MAJ-1140)
F) Transfer of Input/Output function for video signals to the Advanced system
G) Addition of additional connectable touch panel
H) Addition of Scene settings function
l) Addition of system components
Changes to the specifications of system components S

This document is a 510(k) summary for the Olympus Systems Integration ENDOALPHA, a system designed to integrate and control various ancillary equipment used with Olympus endoscopes. The summary focuses on establishing substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics (like sample size, ground truth, expert qualifications, MRMC study, standalone performance, and training set details) are not available in the provided text because the 510(k) premarket notification process for this type of device (an integration system, not a diagnostic or AI-driven tool) does not typically require such detailed performance studies in the same way as, for example, an AI diagnostic algorithm. The primary goal here is to demonstrate that the new device is as safe and effective as a legally marketed predicate device.

However, I can extract the available information and explain why other details are absent.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation for Missing "Acceptance Criteria" Details:
For a device like the ENDOALPHA, which is an integration and control system, "acceptance criteria" for demonstrating substantial equivalence are typically evaluated against the predicate device's functionality and safety profile, rather than quantitative performance metrics like accuracy or sensitivity. The FDA's review for a 510(k) largely focuses on whether the new device is as safe and effective as the predicate. The "performance" in this context refers to its functional capabilities and how they compare to the predicate, and whether any changes introduce new risks or questions of effectiveness.

2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not provided in the document.
This document does not describe a clinical performance study using a test set of data (e.g., images, patient records). The evaluation for this device appears to be based on engineering verification and validation, functional testing, and comparison to the predicate device's specifications and intended use.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable/Not provided in the document.
Since there's no clinical performance study involving a "test set" with "ground truth" (e.g., diagnosing conditions), expert review for establishing ground truth is not part of this 510(k) summary for the ENDOALPHA system.

4. Adjudication Method for the Test Set
Not applicable/Not provided in the document.
No clinical test set requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No.
This document does not mention or report the results of an MRMC study. The device is a system integration tool, not a diagnostic aid that would typically involve human readers interpreting output to improve diagnostic performance.

6. Standalone Performance Study
Not applicable/Not provided in the document in the context of diagnostic performance.
While the system itself has standalone functional performance (e.g., its ability to control equipment, display messages), the concept of "standalone performance" as it relates to AI algorithms or diagnostic tools (i.e., algorithm only without human-in-the-loop performance) is not relevant or evaluated for this type of system in this document. The document describes its functional capabilities in isolation and in integration.

7. Type of Ground Truth Used
Not applicable/Not provided in the document.
There is no mention of "ground truth" (e.g., pathology, outcomes data) as this pertains to diagnostic accuracy studies. For this system, the "truth" would refer to whether the system correctly performs its programmed functions (e.g., does it centralize control as intended, do automatic settings work). This is validated through engineering and functional testing rather than clinical "ground truth" data.

8. Sample Size for the Training Set
Not applicable/Not provided in the document.
This device is an integration and control system, not an AI/machine learning algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided in the document.
As there is no training set mentioned, this information is not relevant.

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