Search Results

This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract and surrounding organs under the management of physicians at medical facilities. This product is intended for adults.

Modes of Operation: B-mode

Never use this product for any other purposes.

FUJIFILM Endoscopic Ultrasonic Probe converts the electrical signal from the ultrasonic observation device connected via the probe scanner into ultrasonic waves by the ultrasonic transducer placed and emits it and receives reflected waves from the human body. The received wave is converted into an electric signal by transducer and sent to an ultrasonic device to create an ultrasonic image. The scanning method is a mechanical radial method by using a probe scanner.

Based on the guidance, Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (Feb. 2023), this device follows the track 3 designation, as it does conform to IEC 60601-2- 37. The transducer model designation and type are a mechanical radial scan, with a size and spacing of elements of 1.9×2.0×0.6mm(M×L×T). There is one element in the array, with array dimensions of one and the maximum number of active elements for a single pulse is one. The nominal ultrasonic frequency of the P2612S-L is 10MHz and for P2620S-L is 17MHz, both in combination with SP-900.

This document describes the Fujifilm Endoscopic Ultrasonic Probe (P2612S-L/P2620S-L), which is a medical ultrasonic probe intended for the observation and diagnosis of the gastrointestinal tract and surrounding organs in adults.

Here's the information regarding acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria for performance metrics (like accuracy or sensitivity) for the ultrasound imaging itself. The performance data presented are related to safety and compatibility with regulatory standards.

2. Sample Size Used for the Test Set and the Data Provenance:

The document does not describe a test set in the context of clinical performance or image analysis. The "testing" mentioned refers to engineering and safety performance evaluations. Therefore, information on sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided here for clinical performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

As no clinical performance test set involving image interpretation or diagnosis is described, this information is not applicable and not provided in the document.

4. Adjudication Method for the Test Set:

Since a clinical test set requiring expert adjudication is not present, this information is not applicable and not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document states, "Clinical testing is not applicable to this submission." Therefore, an MRMC comparative effectiveness study was not done, and there is no reported effect size of human readers improving with AI vs. without AI assistance. This device is an ultrasonic probe, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

This device is an ultrasonic probe, a hardware component for ultrasound imaging. It does not contain an algorithm for standalone performance evaluation in the context of AI or diagnostic software. Therefore, a standalone performance study was not done.

7. Type of Ground Truth Used:

For the technical and safety evaluations, the "ground truth" was established by adherence to recognized international standards and guidance documents (e.g., ISO 10993, ANSI/AAMI ES60601-1, IEC 60601-2-37, IEC 60601-1-2) confirmed through specific tests. For example, biocompatibility tests themselves generate the "ground truth" (e.g., cytotoxicity results, sensitization/irritation responses).

8. Sample Size for the Training Set:

This device is a hardware component and is not an AI/ML-driven device that requires a training set in the typical sense. Therefore, information regarding a training set sample size is not applicable and not provided.

9. How the Ground Truth for the Training Set Was Established:

As there is no training set for an AI/ML algorithm described, this information is not applicable and not provided.

Ask a specific question about this device