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This instrument has been designed to be used with a video system center, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.

The ENDOEYE HD II - High Definition Digital Video Laparoscope is a rigid video telescope used for endoscopic diagnosis, treatment, video observation and surgery within the thoracic and abdominal cavities including female reproductive organs. For laparoscopic applications, the video telescope is inserted via a trocar into the patient. The ENDOEYE HD II is used with a video system center, light source and monitor to achieve its intended function. In addition, the ENDOEYE HD II can be inserted in compatible instrument trays for reprocessing. The ENDOEYE HD II can provide an image with either white light or narrow band imaging and WA50040A and WA50042A include a heater function at the distal tip to reduce fogging of the lens.

This document describes the premarket notification (510(k)) for the Olympus ENDOEYE HD II, a rigid video telescope used for endoscopic diagnosis, treatment, video observation, and surgery. This is primarily a regulatory submission for a medical device and not a study proving an AI/ML device meets acceptance criteria.

Therefore, many of the requested details, such as acceptance criteria for AI/ML performance metrics, sample sizes for AI/ML test/training sets, expert adjudication methods for AI/ML ground truth, and MRMC studies, are not applicable to this document. This document focuses on demonstrating substantial equivalence to a predicate device through engineering performance data rather than sophisticated clinical or AI/ML performance studies.

However, based on the provided text, I can infer and state the following regarding "acceptance criteria" and "study" in the context of this device:

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide a table of specific numerical acceptance criteria for each performance test, nor does it present detailed quantitative performance results in a table. Instead, it states that "All samples tested met their predefined acceptance criteria." The acceptance criteria would be linked to the standards mentioned for each test.

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

• Sample size: The document does not specify the exact sample sizes (number of units) used for each individual test. It generally refers to "All samples tested."
• Data provenance: Not explicitly stated regarding country of origin or specific patient data. The tests are lab-based design verification and validation tests rather than clinical data tests. It's a regulatory submission from a German manufacturer (Olympus Winter & Ibe GmbH) to the US FDA. The tests are "Performance Data" and are likely performed in a controlled, prospective manner as part of the design and manufacturing process.

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

• Not applicable. This device is a hardware endoscopic camera. The "ground truth" for its performance is established by meeting engineering specifications and recognized international standards (e.g., IEC, ISO, ASTM) through objective physical and software testing, not by expert human interpretation of medical images or conditions.

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

• Not applicable. As the "ground truth" is established by adherence to engineering standards and objective measurements, there is no need for expert adjudication of medical findings.

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. This is not an AI-enabled device. Therefore, no MRMC study looking at human reader improvement with or without AI assistance was conducted or is relevant for this regulatory submission.

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

• Not applicable. This device is a camera system, not an algorithm that performs a standalone diagnostic or analytical function.

7. The type of ground truth used:

• The ground truth is based on engineering specifications, recognized international standards (e.g., IEC, ISO, ASTM), and internal company acceptance criteria for hardware and software performance. This includes electrical safety, EMC, thermal safety, mechanical performance, transport resistance, service life, illumination, and software functionality.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a "training set."

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

• Not applicable. See point 8.

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This instrument has been designed to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.

The ENDOEYE HD II - High Definition Digital Video Laparoscope is a video endoscope used for endoscopy and endoscopic surgery within the abdominal cavities, which is basically identical to the predicate devices for the same application areas.

Here's a breakdown of the acceptance criteria and study information for the Olympus EndoEYE HD II, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not present a formal table of acceptance criteria with corresponding performance metrics for the Olympus EndoEYE HD II as one might expect from a detailed clinical or performance study report. Instead, it describes various non-clinical tests and validations performed to demonstrate substantial equivalence to predicate devices.

However, based on the information provided, we can infer the types of acceptance criteria and the confirmation that the device met these criteria through testing.

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

The document describes non-clinical testing for performance, safety, and reprocessing. It does not mention a "test set" in the context of clinical data or human evaluation (e.g., patient images). Therefore:

• Sample Size for Test Set: Not applicable as no clinical test set/data is described. The testing involved physical devices and their components.
• Data Provenance: Not applicable as no clinical data is described. The tests were likely conducted internally by the manufacturer (Olympus Winter & Ibe GmbH) in Germany.

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

This information is not provided in the document. Since the testing described is non-clinical/technical (e.g., resolution, sterilization, durability), the "ground truth" would be established by engineering and quality assurance standards and measurements, not by medical experts interpreting data like radiologists.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable given the non-clinical nature of the described testing. Adjudication methods are typically used in studies involving human interpretation of data where consensus among experts is required.

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

No, an MRMC comparative effectiveness study is not mentioned in the provided text. The submission focuses on demonstrating substantial equivalence through technical characteristics and non-clinical performance, not through a comparative clinical study with human readers assessing diagnostic performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

No, a standalone algorithm study is not mentioned. The device is a video laparoscope, a physical instrument for visualization during surgery, not an AI algorithm.

7. Type of Ground Truth Used

The ground truth used for the described non-clinical testing would be based on objective technical specifications, engineering standards, and validated measurement techniques. For example:

• Resolution: Measured against established optical resolution charts/targets.
• Color Correctness: Measured against color calibration standards.
• Sterilization Effectiveness: Demonstrated through biological indicator kill rates and physical/chemical indicators conforming to sterilization standards (e.g., DIN EN ISO 17665-1).
• Durability: Assessed by subjecting devices to a specified number of sterilization cycles and then re-evaluating performance against initial specifications.
• Software Functionality: Verified against software requirements specifications.

8. Sample Size for the Training Set

This information is not applicable as the device is a physical instrument, not an AI/machine learning algorithm that requires a "training set" of data.

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

This information is not applicable as there is no training set for an AI/machine learning algorithm described.

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