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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Trans-esophageal(non-cardiac) Other 1) Gastrointestinal tract and the surrounding organs

These subject devices have been designed to be used with the HDI5000 Ultrasound system (Philips Ultrasound), Olympus video system center, light Source, documentation equipment, video monitor, endo-therapy accessories such as an aspiration biopsy needle and electrosurgical unit except for endoscopic ultrasound (EUS) guided electrosurgery. These subject devices are designed for endoscopic real-time ultrasonic imaging, for performing endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper gastrointestinal tract and surrounding orgains.

The provided text is a 510(k) summary for the Olympus Ultrasonic Gastrovideoscope. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than detailing comprehensive clinical studies with acceptance criteria and specific performance metrics in the way a PMA or a de novo submission would.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment is not available in this document.

Here's a breakdown of what can be extracted or inferred:

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

• Acceptance Criteria: Not explicitly stated as numerical performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria implicitly are that the device performs similarly to the predicate device and meets safety standards.
• Reported Device Performance: Not reported in terms of quantitative clinical performance. The document focuses on demonstrating that the technological characteristics and intended use are equivalent to the predicate.

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

• Not Available. The document does not describe a clinical test set or patient data. The evaluation primarily relies on technical specifications and comparisons to existing devices.

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 / Not Available. There is no mention of a test set requiring expert ground truth establishment for clinical performance evaluation. The review is focused on engineering and regulatory equivalence.

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

• Not Applicable / Not Available. No test set or adjudication method is described.

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 an ultrasonic gastrovideoscope, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device and was not performed.

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

• Not Applicable. This is a hardware medical device (endoscope), not a standalone algorithm.

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

• Not Applicable / Not Available. As no clinical performance study involving a test set is detailed, no ground truth type is specified. The "ground truth" for this submission is regulatory compliance and substantial equivalence to predicate devices, which is demonstrated through technical standards compliance and comparative analysis of design and intended use.

8. The sample size for the training set

• Not Applicable / Not Available. There is no mention of a "training set" as this is not an AI/machine learning device.

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

• Not Applicable / Not Available. See point 8.

Summary of the Study:

The "study" presented is a 510(k) premarket notification which aims to demonstrate that the Ultrasonic Gastrovideoscope OLYMPUS GF Type UC160P-AT8 and UCT160-AT8 are substantially equivalent to legally marketed predicate devices. This involves comparing the new device's intended use, technological characteristics, and safety to existing devices.

The evidence provided includes:

• Comparison of Intended Use: The intended use (Trans-esophageal (non-cardiac) and for the gastrointestinal tract and surrounding organs) is stated to be consistent with predicate devices. The "Diagnostic Ultrasound Indications for Use Form" lists specific modes of operation (B, M, PWD, Color Doppler, Amplitude Doppler, Combined) for various clinical applications, noting which are "new" (N) for this specific device but are established modes generally.
• Comparison of Technological Characteristics: The document states the device "operate identically to the predicate device in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body."
• Compliance with Standards: The device is designed to comply with several IEC and CISPR standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-18, CISPR11).
• Biocompatibility Testing: For a new patient-contacting material in the distal tip, biocompatibility tests were conducted, concluding the material is safe.

The "study" is not a clinical trial in the traditional sense designed to quantify diagnostic performance metrics. Instead, it's a regulatory submission affirming that the device design, materials, and function align with pre-existing, legally marketed devices.

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