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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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The Olympus GF-UM30P Ultrasonic Endoscope is intended to be used in combination with the Ultrasound System, EU-M20, for endoccopic ultrasound inaging of the gastrointestinal tract wall, billiary and pancreatic duct, and surrounding organs. This instrument also provide for Endoscopic Ultrasound (EUS) guided fine needle aspiration (FNA) to acquire submucosal tissue.

In examining the GI tract, endoscopic ultrasound may be indicated. The conventional type ultrasound endoscope does not provide the capability for ultrasonic guidance of endoscopic accessories (i.e. biopsy forceps, aspiration biopsy needles, etc.) The mechanically radially scanning GF-UM30P ultrasound endoscope provides this capability since the direction of the sonographic scan coincides with the geometric plane in which the accessory enters.

The subject devices operates in B mode using the de-aerated water immersion or balloon contact method and offers a 250° scan. The outer diameter of the insertion tube is 11.7 mm and it's working length is 1265 mm.

Both subject and predicate devices have similar design, construction, intended use, and method of operation. The only difference between the two is that the subject device's scanning plane is parallel, rather than perpendicular, to the axis of the insertion tube. The Olynpus Endoscopic Ultrasound System. EU-M20, received marketing clearance in the 510(k) # K926514.

The MAJ-213 Balloon will be provided clean and should be EtO sterilized before use. The balloon is intended for single use only and should be discarded after use. All other components and related ancillary equipment of the subject device will be marketed non sterile and can be reprocessed as described in the Instruction Manuals.

This document, K963023, is a 510(k) summary for a medical device (Olympus GF-UM30P Ultrasonic Endoscope). It does NOT contain information about acceptance criteria, device performance studies, or AI/algorithm-related details.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on:

• Device Name and Classification: Identifies the device as an ultrasonic endoscope.
• Intended Use: Describes how the device is meant to be used, including endoscopic ultrasound imaging and fine needle aspiration.
• Device Description: Details its features, such as scanning type, outer diameter, working length, and comparison to a predicate device.
• Sterilization and Reprocessing: Instructions for use of accessories.

There is no mention of acceptance criteria, study results, sample sizes (for training or test sets), expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to AI or algorithmic performance evaluation.

To answer your questions, I would need a different type of document, such as a clinical study report, a performance evaluation section from a regulatory submission, or a scientific publication describing a study on an AI-powered device.

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