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The Olympus GF-UE160-AL5 Ultrasonic Endoscope is intended to be used for endoscopic ultrasonic inaging of the gastrointestinal wall, bile and pancreatic ducts and surrounding organs. It is to be used with the Aloka SSD-5000 (K033311) Diagnostic Ultrasound system and various other video and light source accessories.

The Olympus GF-UE160-AL5 is an ultrasonic gastro video endoscope to be used with an Aloka diagnostic ultrasound system, video system center, light source, video monitor, endo-therapy accessories for endoscopic ultrasound imaging of the gastrointestinal wall, bile and pancreatic ducts and surrounding organs.

The Olympus GF-UC140P-A15 is an electronic radial scan ultrasound endoscope providing a 360° view angle.

The provided document is a 510(k) summary for the Olympus GF-UE160-AL5 Endoscope used with the Aloka SSD-5000 Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a clinical study. As such, it does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a study proving their fulfillment.

Here's a breakdown of what can be extracted and what is missing:

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

The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics. Instead, it compares the technological characteristics of the subject device to its predicate devices to demonstrate substantial equivalence. The implication is that if the new device has similar characteristics, it will perform equivalently.

The "acceptance criteria" here are implicitly that the new device's specifications are comparable to, or within acceptable variations of, the predicate devices, thereby ensuring equivalent safety and effectiveness.

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

The document describes a submission for substantial equivalence based on technological characteristics and intended use comparison. It does not refer to a clinical "test set" in the context of performance evaluation with patient data. Therefore, there is no information on:

• Sample size used for a test set.
• Data provenance (e.g., country of origin, retrospective or prospective).

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

Since no clinical test set for performance evaluation is described, there is no information on:

• Number of experts used to establish ground truth.
• Qualifications of those experts.

4. Adjudication method for the test set

Similarly, as there is no clinical test set for performance evaluation, there is no information on an adjudication method.

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

The device is an endoscope and ultrasound system, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned in the document.

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

This point is not applicable as the device is not an algorithm for standalone performance. It is a medical imaging device used by a human operator.

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

The document does not describe a study involving "ground truth" as typically understood in performance validation of diagnostic accuracy (e.g., against pathology). The "ground truth" for this 510(k) submission is effectively the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

The document describes a comparison to predicate devices, not a machine learning model. Therefore, there is no information on a "training set" sample size.

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

As there is no training set for a machine learning model, this question is not applicable.

Summary of the Study (as described in the 510(k) submission):

The "study" presented here is a comparison to predicate devices to demonstrate substantial equivalence, as required for a 510(k) submission to the FDA. It is not a clinical study designed to test novel performance claims against specific acceptance criteria.

• Purpose: To demonstrate that the Olympus GF-UE160-AL5 Endoscope used with the Aloka SSD-5000 Diagnostic Ultrasound System is substantially equivalent to legally marketed predicate devices, specifically the Olympus GF-UC140P-AL5 Endoscope (K011314) and the GF-UM130 Endoscope (K971660).
• Methodology: Direct comparison of technological characteristics (physical specifications, optical characteristics, angulations, etc.) and intended use between the subject device and the predicate devices.
• Conclusion: The submission concludes that "When the GF-UE 160-AL5 is compared to its predicates, the device does not incorporate any significant changes in intended use, method of operation, material or design that could affect the safety and effectiveness." The FDA concurred with this finding of substantial equivalence.
• Key Finding for Equivalence: The key "performance" demonstrated is that the device's technical specifications and intended use are similar enough to existing, cleared devices that it can be considered equally safe and effective without requiring new clinical performance data.

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