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The GOLFF Sterile Anti-Fog Solution is a single-use, medical device, anti-fog solution used by hospital staff to apply on lenses of endoscopic and laparoscopic cameras. The solution is provided in an easy-to-squeeze bottle and comes with an adhesive-backed sponge for secure placement.

GOLFF Sterile Anti-Fog Solution is used to prevent fogging on endoscopic lenses. It ensures clearer vision and avoids unnecessary interruptions during surgery. It also comes with an adhesive-backed sponge, for secure placement, which is also radio-opaque and not made with natural rubber latex. The product is available under reference code GOLFF-R1.

The provided document describes the GOLFF Sterile Anti-Fog Solution, a medical device intended to prevent fogging on endoscopic and laparoscopic camera lenses during surgery. The device's substantial equivalence to predicate devices is established through a series of tests and comparisons.

Here's a breakdown of the requested information:

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

2. Sample size used for the test set and the data provenance

The document does not specify exact sample sizes for each individual test. It states "A series of the tests were performed to evaluate the safety and effectiveness of GOLFF Anti-Fog Solution." The data provenance is internal testing performed by Batrik Medical Manufacturing Inc. The document does not specify the country of origin of the data, nor whether the studies were retrospective or prospective, but given they are for a premarket notification, they are by nature prospective for the device under consideration.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The tests performed are primarily benchtop, biocompatibility, and sterilization validation tests, which rely on standardized protocols and empirical measurements rather than expert human interpretation to establish a "ground truth."

4. Adjudication method for the test set

This information is not applicable and not provided. The types of tests conducted (e.g., functional, biocompatibility, sterility) typically involve objective measurements against predefined acceptance criteria, rather than subjective interpretation requiring adjudication among experts.

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

This is not applicable to the GOLFF Sterile Anti-Fog Solution. This device is an anti-fog solution for endoscopes, not an AI-powered diagnostic or imaging device that would involve "human readers" or AI assistance.

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

This is not applicable to the GOLFF Sterile Anti-Fog Solution. This device is a physical product (anti-fog solution), not an algorithm or software.

7. The type of ground truth used

The "ground truth" for the tests performed can be characterized as follows:

• Product Functional Testing: Defined physical and performance characteristics of the device (e.g., non-deformation, effective anti-fogging as per internal protocols).
• Biocompatibility Testing: Compliance with established international standards (ISO 10993 series) for biological responses (cytotoxicity, sensitization, irritation).
• Sterilization Validation: Achievement of sterility assurance levels as defined by international standards (ISO 11137, ISO 11737).
• Product Aging Validation: Maintenance of package integrity, seal strength, sterility, and fog resistance over a simulated shelf-life, as per relevant ASTM and ISO standards and internal protocols.

8. The sample size for the training set

This is not applicable as the GOLFF Sterile Anti-Fog Solution is a physical medical device, not an AI or software product that requires a training set.

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

This is not applicable as the GOLFF Sterile Anti-Fog Solution is a physical medical device, not an AI or software product.

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