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The NaviAid™ BGC device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope during endoscopy of the small and large intestine (standard endoscope-i.e., an endoscope that has an instrument channel that is at least 3.7mm diameter and is used for standard endoscopic visualization).

The modified NaviAid™ BGC is an on-demand disposable that is inserted through the instrument channel of the endoscope in order to enable advancement and positioning of a standard endoscope in the small and large intestine.

The modified NaviAid™ BGC system comprises a disposable balloon system and an Air Supply Unit ("ASU") or a Single Balloon - Air Supply Unit ("SB ASU") for inflating and deflating the balloon system.

The role of the BGC disposable is to facilitate advancement of a standard endoscope into the small and large intestine. The NaviAid™ BGC disposable includes the BGC Balloon and the BGC inflation tube. The balloon is inflated by ambient air. The ASU or SB ASU operate and control the inflation and deflation of the balloon through a foot-pedal. The balloon is connected to a dedicated inflation tube that runs inside the instrument channel of the endoscope, and is connected at its proximal (user) end to the ASU or SB ASU.

The BGC balloon can be advanced ahead of the endoscope tip or pulled back through pushing/pulling action on the BGC inflation tube at its proximal side, outside the patient's body. When the BGC balloon is advanced and then inflated, it functions as a distal anchor, to which the endoscope tip is advanced, and the BGC inflation tube serves as a rail that leads the endoscope as it is pushed towards the anchoring BGC balloon.

The balloon and tube negligibly compromise the endoscope's flexibility, or its field of view. Additionally, the BGC disposable negligibly compromise the maneuverability of the endoscope's tip and does not limit the usage of any standard endoscopy tools. During the procedure the disposable can be removed from the instrument channel of the endoscope and a therapy tool may be inserted instead.

The NaviAid™ BGC disposable is intended for single use, while the ASU and SB ASU are re-usable.

The provided text is a 510(k) summary for the NaviAid™ BGC device. It describes a modification to an existing device, specifically the addition of an alternative component (SB ASU). The application relies heavily on previously cleared devices (predicates) to demonstrate substantial equivalence, rather than conducting new standalone studies for the modified device.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is Not Applicable or Not provided in the given text for the modified NaviAid™ BGC device. The application relies on non-clinical performance data from previously cleared predicate devices (K102616 and K110291). The text explicitly states:

• "Performance tests relating to the BGC Disposable component are located in the submission of the first predicate device, the NaviAid™ BGC device (document number K102616)."
• "Performance tests relating to the SB ASU component are located in the submission of the second predicate device, the NaviAid™ ICVI device (document number K110291)."
• "Clinical Performance Data: Not Applicable"

Therefore, no new test set was used for this specific 510(k) submission (K111760).

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

Not Applicable or Not provided. As per point 2, no new test set was used for this submission. The application relies on predicate device data.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not Applicable or Not provided. No new test set and clinical study were conducted for this submission.

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 accessory to an endoscope, not an AI-powered diagnostic system involving human readers. No MRMC study was conducted or mentioned.

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

Not Applicable. This device is a mechanical accessory (balloon system and air supply unit), not an algorithm or software requiring standalone performance testing in that sense.

7. The Type of Ground Truth Used

Not Applicable for this specific 510(k) submission (K111760). The application relies on engineering specifications, performance tests (electrical, mechanical, EMC, software validation) for the components as demonstrated in prior 510(k) submissions, and a comparison of technological characteristics to establish substantial equivalence.

8. The Sample Size for the Training Set

Not Applicable or Not provided. This device is a mechanical accessory and does not involve machine learning or a "training set" in the typical sense.

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

Not Applicable. As per point 8, there is no "training set" for this device.

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