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When properly installed: (i) the ScopeSeal® Duodenoscope Protective barrier at the scope's distal end to significantly reduce the level of contamination of the distal end during use and prior to reprocessing, and (ii) the ScopeSeal®'s working channel also provides a protective barrier sealing the duodenoscope's elevator area during use, and (iii) the ScopeSeal® device provides an additional protective benefit after use when kept in place during the ScopeSeal Pre-Cleaning Procedure™ performed after use.

The ScopeSeal® is compatible for use with the Olympus Duodenoscope Model TJF-Q180V.

The GI Scientific ScopeSeal® Duodenoscope Protective Device is provided as a sterile, single-use device that attaches to the distal end of a duodenoscope. When properly installed the device creates a protective barrier or shield that seals the distal end of the duodenoscope to protect it from contamination during the procedure. The device is designed to preserve the mechanical and optical functionality of the duodenoscope. The ScopeSeal® Duodenoscope Protective Device includes a flexible Working Channel Extension™ that seals against the end of the duodenoscope's working channel, providing a sealed, passageway from the end of the duodenoscope's working channel through the ScopeSeal® device's working channel extension and out to the patient's gastrointestinal tract. This element of ScopeSeal®'s design allows instruments to be passed down the duodenoscope's working channel, through the ScopeSeal® device's Working Channel Extension™, and out to the patient's gastrointestinal tract, without instruments coming into contact with the duodenoscope's elevator, effectively sealing over the elevator area of the duodenoscope. The ScopeSeal® allows passage of device up to 10.7Fr (3.5mm) in diameter.

The provided text describes the regulatory clearance of a medical device, the ScopeSeal® Duodenoscope Protective Device, via a 510(k) premarket notification. This process determines substantial equivalence to a legally marketed predicate device, rather than requiring the extensive clinical studies typically associated with proving a device meets specific acceptance criteria in the comprehensive manner of a de novo or PMA submission.

Therefore, the information focuses on non-clinical performance testing and a comparison to a predicate device to demonstrate substantial equivalence rather than defining a detailed set of acceptance criteria for clinical efficacy and a direct study proving the device meets those criteria.

However, based on the provided "Performance Data" section, we can infer the implied acceptance criteria and the nature of the study that was conducted (non-clinical performance testing).

Here's an attempt to answer your request based on the available information, acknowledging that a full clinical trial with precise acceptance criteria for human outcomes is not detailed as part of this 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "No animal or clinical studies were required to demonstrate substantial equivalence."
The performance data described are stated as "Nonclinical performance testing."

• Test Set Sample Size: Not specified for the non-clinical tests. The tests would likely involve a specific number of devices or simulated use cycles, but the exact number is not provided.
• Data Provenance: The data is from "Nonclinical performance testing" conducted by G.I. Scientific LLC. There is no mention of country of origin for this testing or whether it was retrospective or prospective in the sense of a clinical study. It would inherently be prospective in the context of laboratory testing.

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

Given that "No animal or clinical studies were required," there was no "test set" in the sense of patient data requiring expert ground truth for diagnosis/outcomes. The performance data seems to be based on engineering and laboratory testing. Therefore, this information is not applicable from the provided text.

4. Adjudication Method for the Test Set

Not applicable, as there was no test set of patient data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No animal or clinical studies were required to demonstrate substantial equivalence."

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

This pertains to an AI/Software as a Medical Device (SaMD). The ScopeSeal® Duodenoscope Protective Device is a physical medical device. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable to this device.

7. The Type of Ground Truth Used

For the non-clinical performance testing and biocompatibility, the "ground truth" would be established by:

• Engineering specifications and test methodologies: For seal integrity, scope compatibility, function maintenance, and delivery/retention.
• Established ISO standards (ISO 10993) and laboratory protocols: For biocompatibility testing (Cytotoxicity, Intracutaneous Irritation, Sensitization, Systemic Toxicity).

8. The Sample Size for the Training Set

This refers to a training set for an AI/machine learning model. Since the ScopeSeal® is a physical device and not an AI/ML product, the concept of a "training set" in this context is not applicable.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for an AI/ML model for this device.

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