Search Results

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

The NaviAid™ ICVI 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 intestine. The NaviAid™ ICVI 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 ICVI disposable includes the ICVI Balloon and the ICVI 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 ICVI balloon can be advanced ahead of the endoscope tip or pulled back through pushing/pulling action on the ICVI inflation tube at its proximal side, outside the patient's body. When the ICVI balloon is advanced and then inflated, it functions as a distal anchor, to which the endoscope tip is advanced, and the ICVI inflation tube serves as a rail that leads the endoscope as it is pushed towards the anchoring ICVI balloon. The balloon and tube negligibly compromise the endoscope's flexibility, or its field of view. Additionally, the ICVI disposable negligibly compromise the maneuverability of the endoscope's tip and does not limit the usage of any standard endoscopy tools, such as biopsy forceps, snare, needle etc. though not simultaneously while the device is applied. The NaviAid™ ICVI disposable is intended for single use, while the ASU and SB ASU are re-usable.

The provided document is a 510(k) summary for the NaviAid™ ICVI device, focusing on a modification involving a new "Single Balloon - Air Supply Unit" (SB ASU). The document outlines non-clinical performance data but explicitly states "Clinical Performance Data: Not Applicable." Therefore, information regarding acceptance criteria met by a clinical study is not available in this text.

However, based on the provided text, here's a breakdown of the available information regarding non-clinical testing and ground truth:

1. A table of acceptance criteria and the reported device performance:

The document describes several non-clinical tests performed on the modified NaviAid™ ICVI Device with the new SB ASU component. It states that these tests "demonstrated that the modified NaviAid™ ICVI device with the new SB ASU component meets its design and performance specifications." However, specific numerical acceptance criteria and reported performance values are not detailed in this summary. Instead, it lists the types of tests conducted:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Test set sample size: Not specified. The document only mentions "performance tests were conducted."
• Data provenance: Not specified, but given the applicant's address (Israel), it's likely the non-clinical testing was conducted there. The testing is non-clinical, so the terms "retrospective" or "prospective" are not applicable in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable as no human experts were involved in establishing ground truth for the non-clinical performance and safety tests. The ground truth for these tests would be defined by engineering specifications and recognized international standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable as no human experts or adjudication were involved in these non-clinical tests.

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:

• No MRMC or comparative effectiveness study was done as this is a non-clinical submission for a device modification, and the product is a mechanical accessory, not an AI-driven diagnostic or assistive tool for human readers.
• The document explicitly states: "Clinical Performance Data: Not Applicable".

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

• Not applicable. This device is a mechanical accessory, not an algorithm. The "software validation" refers to the control software for the SB ASU, but its performance is validated against engineering specifications, not as a standalone diagnostic tool.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For the non-clinical performance tests (SB ASU Performance Test), the ground truth would be the design and performance specifications set by the manufacturer (Smart Medical Systems Ltd.).
• For the Electrical & Mechanical Safety Testing, Electromagnetic Compatibility Testing, and Software Validation, the ground truth is defined by recognized international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4) and FDA Guidelines.

8. The sample size for the training set:

• Not applicable. This is a mechanical device, not an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established:

• Not applicable. (See point 8)

Ask a specific question about this device