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AMD Anti-Fog Solution is a sterile and single-use laparoscopic accessory device for use prior to and during endoscopic and laparoscopic procedures. The product is intended to prevent condensation of the distal lenses of the endoscopic/ laparoscopic instruments during the surgery. The product is intended for prescription use only.

The AMD Anti-Fog Solution is a single-use, sterile, and biocompatible laparoscopic accessory device. The product is packaged by the Tyvek" Pouch which includes one clear plastic screw top dispenser bottle with the volume of 6 mL and one polyurethane (PU) foam pad with x-ray detectable radiopaque ribbon. The solution is a clear/colorless, odorless, and aqueous solution which comprises of surfactant (≤2%), isopropyl alcohol (≤2%), and water (≥96%). The polyurethane (PU) foam pad is an adhesivebacked sponge with radiopaque ribbon that can be used to introduce the solution into the surface of the lenses.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than defining explicit performance acceptance criteria with numerical targets for the AMD Anti-Fog Solution itself (beyond biocompatibility, sterility, and shelf life). However, the "Performance" row in Table 5.1 and the "Product Performance Test" section provide the core performance claim.

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

• Biocompatibility Testing: The specific number of samples (e.g., number of animals for in vivo tests, number of cell cultures for in vitro tests) is not explicitly stated in the provided document for each test. The tests were performed according to ISO standards, which would typically specify sample sizes.
• Sterilization Validation: The VDmax 25 method was used, implying a standard number of samples derived from product bioburden testing to establish the sterilization dose. The document states bioburden was < 1000 CFU/sample, but the number of samples tested for bioburden is not specified.
• Product Aging Validation (Shelf Life Study): The number of samples for each test (Package Integrity, Seal Peel Strength, Product Sterility, Product Stability/Fog Resistance) is not explicitly stated. These tests were performed for a 5-year shelf life validation.
• Product Performance Test (Fog Resistance Test): The sample size for this test is not explicitly stated.
• Data Provenance: The studies were conducted by the manufacturer, Advanced Medical Design Co., Ltd., based in Taiwan. The location where the tests were performed (e.g., specific labs) is not detailed. The data is retrospective in the sense that it was completed prior to the 510(k) submission.

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

• This information is not applicable in the context of this submission. The device is a physical product (anti-fog solution), and its performance (biocompatibility, sterility, fog resistance, shelf life) is evaluated through objective laboratory tests against established standards, not through human interpretation or expert-driven ground truth. Therefore, no "experts" were required to establish ground truth in the sense of clinical assessment or image interpretation.

4. Adjudication Method for the Test Set:

• Not applicable. As the performance is based on objective laboratory tests against specified standards, there is no need for an adjudication method as would be used for subjective assessments or disputes among human readers/interpreters.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• No. This type of study is typically used for diagnostic or screening devices where human interpretation plays a role. The AMD Anti-Fog Solution is a laparoscopic accessory intended to prevent fogging, not a diagnostic tool requiring human reader interpretation. Therefore, an MRMC study and analysis of AI vs. human reader improvement is not relevant.

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

• Not applicable. The device is a physical solution, not an algorithm or AI system.

7. The Type of Ground Truth Used:

• Objective Laboratory Measurements and Standard Criteria:
  • Biocompatibility: Ground truth was established by recognized international standards (ISO 10993 series) which define acceptable biological responses.
  • Sterility: Ground truth was established by microbiological testing methods (ISO 11137-2, ISO 11737-1, ISO 11737-2) to achieve a specified sterility assurance level (SAL).
  • Shelf Life (Packaging Integrity, Seal Strength): Ground truth was established by recognized ASTM and ISO standards for packaging materials.
  • Shelf Life (Product Stability/Fog Resistance): Ground truth was established by an "internal testing protocol." The specifics of this protocol are not detailed, but it would involve a measurable criterion for fog resistance.
  • Overall Performance (Fog Resistance): The claim is based on equivalence to the predicate device, implying that its fog resistance is at least as good as the predicate's, which itself would have been demonstrated through specific test methods.

8. The Sample Size for the Training Set:

• Not applicable. This device is not an AI/ML algorithm or software that requires a training set.

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

• Not applicable. See point 8.

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