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The FG-36UX, Ultrasound Fiber Gastroscope, is intended to provide optical and sonographic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper GI Gastrointestinal Tract includes, but is not limited to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when the indications consistent with the requirement for procedure(s) are observed in Adult and Pediatric patient populations.

The FG-36UX Ultrasound Fiber Gastroscope, can be used with any Endoscopic Light Source (with the appropriate lightguide receptacle) and Hitachi Ultrasound Scanners (models EUB-405, -515, -555). The instrument has a flexible insertion tube (for entry into the body cavity), a control body, and umbilicus. The Umbilicus is bifurcated where one connected to the light source and the other is connected a the Ultrasound Scanner. The control body includes controls for up/ down and left right angulation, accessory elevator, air/ water delivery, suction control, a biopsy inlet port, ultrasound balloon inflation port, and the viewing ocular. The device contains light carrying bundles, one to illuminate the body cavity, another to optically visualize anatomy. The instrument also contains a working channel through which biopsy devices, or other accessories, may be introduced (the instrument is supplied with two biopsy forceps). A convex linear array all electronic transducer is mounted in the insertion tube. The instrument is completely immersable (with the use of supplied cleaning accessories).

The provided document is a 510(k) summary for the FG-36UX Fiber Ultrasound Upper GI Gastroscope. It describes the device, its intended use, and compares it to predicate devices. However, it explicitly states: "the submission for substantial equivalence was not based on in assessment of clinical performance data."

Therefore, based solely on the provided document, the following information cannot be determined or is explicitly stated as not applicable:

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

• Cannot be determined from the provided document. The document does not include any performance data or acceptance criteria for clinical efficacy or accuracy.

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. No clinical performance data was provided for substantial equivalence, so there is no test set or related provenance information.

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. No clinical performance data was provided, so there is no ground truth established by experts for a test set.

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

• Not applicable. No clinical performance data was provided, so there is no test set or 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

• Not applicable. This device is an instrumentation device (ultrasound gastroscope), not an AI algorithm. The document explicitly states no clinical performance data was used.

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

• Not applicable. This device is an instrumentation device, not an AI algorithm. The document explicitly states no clinical performance data was used.

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

• Not applicable. No clinical performance data was provided, so there is no ground truth of any type.

8. The sample size for the training set

• Not applicable. This device is an instrumentation device, not an AI algorithm. No clinical performance data was used, therefore no training set.

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

• Not applicable. This device is an instrumentation device, not an AI algorithm. No clinical performance data was used, therefore no training set ground truth.

Summary based on the document:

The 510(k) summary for the FG-36UX Fiber Ultrasound Upper GI Gastroscope explicitly states that "the submission for substantial equivalence was not based on in assessment of clinical performance data." This means that the information requested regarding acceptance criteria, device performance, study details (sample sizes, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training sets) is not available within this document. The substantial equivalence was likely based on comparison of technological characteristics and intended use to the predicate devices.

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