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The E-Brik™ Visualization Assistant is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.

The E-Brik™ Visualization Assistant is designed as an accessory to be used prior to and during procedures that utilize a laparoscope or endoscope. It is designed to warm the scope above body temperature and apply a warmed surfactant. The device is provided sterile and is intended for single use only in a healthcare facility/ hospital.

The E-Brik™ is activated by the user removing the nonconductive slip sheet from the bottom, completing the battery circuit. Once activated, internal circuitry begins the warming function of the device. The user is alerted to this activation by an LED which is illuminated below both ports. The E-Brik™ has two ports that accept endoscopes and/or laparoscopes ranging from 3mm to 10mm in diameter. Both ports can be used prior to the surgical case to warm the scope(s) before the insertion into a body cavity. The E-Brik™ can act as a scope stand as it is designed to support the main axis of the scope, allowing it to rest horizontally on a flat stable surface. A sterile surfactant solution is added to the ports prior to use, which is warmed when the device is active. The ports allow for the user to apply the warmed surfactant prior to and during the case.

The E-Brik™ is powered by alkaline batteries and has a single-use surgical life of a minimum of 4 hours.

Here's a summary of the acceptance criteria and study information for the E-Brik Visualization Assistant, based on the provided FDA 510(k) summary:

Device Name: E-Brik Visualization Assistant
Intended Use: To be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state quantitative acceptance criteria in a table format with corresponding reported performance values for functional aspects. However, it states that "All necessary verification steps met pre-determined acceptance criteria to confirm substantial equivalence."

The following performance characteristics were tested and "passed," implying they met their respective acceptance criteria:

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

The document does not specify a separate "test set" in terms of cases or patients. The studies conducted were primarily bench testing and laboratory evaluations (e.g., sterilization, packaging, electrical safety, biocompatibility).

• Sample Size for Bench/Laboratory Tests: Not explicitly stated as a number of "samples" in a clinical sense. For each functional test (e.g., electrical safety, EMC, sterilization verification), an appropriate number of device units would have been tested according to relevant standards, but these specific numbers are not provided.
• Data Provenance: The studies were conducted as part of the device's design verification and validation. This is retrospective in the sense that it's part of the development process rather than prospective clinical data. The country of origin of the data is not specified, but it's implied to be from the manufacturer's testing facilities or accredited testing laboratories.

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

This information is not applicable as the studies described are bench tests and laboratory evaluations, not clinical studies requiring expert ground truth for interpretation of medical images or patient outcomes. The "ground truth" for these tests are the standards themselves (e.g., ISO 10993, IEC 60601-1).

4. Adjudication Method for the Test Set

This information is not applicable as the studies described are bench tests and laboratory evaluations, not clinical studies requiring human adjudication of results.

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

No MRMC comparative effectiveness study was mentioned. The submission explicitly states:

• "Performance Testing Clinical No clinical testing was conducted for this O submission"

Therefore, there is no information on the effect size of human readers improving with or without AI assistance, as this device itself is not an AI-assisted diagnostic or interpretative tool for medical images. It's a physical accessory.

6. Standalone Performance Study (Algorithm Only)

This is not applicable as the E-Brik Visualization Assistant is a physical device, not an algorithm or AI software, and its primary function is to physically prevent fogging, not to provide an interpretation or analysis.

7. Type of Ground Truth Used

The ground truth used for verifying the device's performance against its intended use and safety standards was:

• Engineering and Performance Standards: Such as ISO 10993-1, ISO 11607, ASTM D4169, ISTA IIIA, IEC 60601-1, and IEC 60601-1-2.
• Manufacturer's Design and Risk-Based Requirements: Internal specifications against which the "performance testing bench" was conducted and "all testing passed."

8. Sample Size for the Training Set

This information is not applicable. The E-Brik Visualization Assistant is a physical medical device, not a machine learning or AI model, thus it does not have a "training set" in the context of algorithm development.

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

This information is not applicable, as there is no training set for this device.

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