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This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

The EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V is a flexible video endoscope used for endoscopic diagnosis and treatment within the duodenum. The device has a sealed elevator wire channel and a dual guidewire locking mechanism.

This document, K143153 for the Olympus EVIS EXERA II Duodenovideoscope Olympus TJF Type Q180V, describes a 510(k) premarket notification. This type of submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study to prove the device meets specific performance acceptance criteria like an AI device would.

Therefore, the provided document does not contain the information requested in your prompt regarding acceptance criteria, a study proving device performance against those criteria, or details related to AI/algorithm performance. The non-clinical testing described is primarily focused on demonstrating the safety and effectiveness of the device's technological characteristics (e.g., sealed elevator wire channel, dual guidewire locking mechanism, reprocessing, biocompatibility, software validation, electromagnetic compatibility, electrical safety, thermal safety) through engineering tests and adherence to established standards and guidance documents.

Here's how the provided document aligns (or doesn't align) with your request:

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

• Not Applicable. The document describes non-clinical engineering tests and adherence to standards (e.g., IEC, ISO, FDA guidance documents) to establish safety and effectiveness, and substantial equivalence to a predicate device. It does not provide a table of performance acceptance criteria and reported device performance in the manner typically seen for clinical or AI-based performance studies. For example, it states "Performance testing and design analysis was carried out to demonstrate the safety and effectiveness of the sealed elevator wire channel and the dual guidewire locking mechanism," implying that tests were done and passed, but specific quantitative acceptance criteria and results are not detailed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This information is generally for clinical or AI-based performance studies. The document describes engineering tests, not a study involving a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. This pertains to clinical studies often involving AI. The document describes engineering and safety testing.

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

• Not Applicable. This pertains to clinical studies often involving AI.

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

• Not Applicable. This device is a duodenovideoscope, not an AI or imaging interpretation system requiring an MRMC study.

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

• Not Applicable. This device is hardware; it does not have a standalone algorithm as described.

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

• Not Applicable. For the engineering and safety tests performed, the "ground truth" would be established by engineering specifications, validated test methods, and adherence to regulatory standards, not by clinical or pathological diagnoses.

8. The sample size for the training set

• Not Applicable. This pertains to AI/machine learning models.

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

• Not Applicable. This pertains to AI/machine learning models.

In summary, the provided document is a 510(k) clearance letter and summary for a medical device (a duodenovideoscope). It focuses on demonstrating substantial equivalence to a predicate device through engineering tests, adherence to standards, and verification of new features' safety and effectiveness. It does not involve AI, clinical performance studies with patient data, or the type of acceptance criteria and study designs you've asked about, which are common for AI/software as a medical device (SaMD) submissions.

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