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Olympus GF-UM130 Ultrasound Gastroscope has been designed to be used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy accessories and other ancillary equipment for endoscopic ultrasound imaging of the gastrointestinal wall, biliary and pancreatic duct, and surrounding organs.

Olympus GF-UM130 Ultrasound Gastrovideoscope, its associated accessories and ancillary equipment.

The provided documentation is a K971660 FDA 510(k) clearance letter and summary for the Olympus GF-UM130 Ultrasound Gastrovideoscope. This type of document focuses on establishing substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study as would be detailed for a novel device or software.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of AI/software performance. It primarily details the regulatory classification, intended use, and substantial equivalence to existing devices.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set, data provenance, or details about a test set.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for a test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
6. Results of a standalone algorithm performance study.
7. The type of ground truth used for performance evaluation.
8. Sample size for a training set.
9. How ground truth for a training set was established.

This document precedes widespread AI in medical devices and focuses on the hardware and its established uses.

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