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VitreOx® is a temporary anti-fog coating and therein defogs devices such as a laparoscopic accessory intended to facilitate intraoperative defogging of the laparoscope lens thereby maintaining visualization of the surgical site.

The device, VitreOx®, is a biocompatible, aqueous solution, when used as indicated. In addition, the solution is alcohol-free. It functions in the same manner as the predicate device. The device is intended to be used prior and during minimal invasive surgeries, to prevent fogging of the lens of devices (laparoscope) that provide visualization during the procedure. The device accessory VitreOx®, can be removed from the lens with typical surgical cleaning methods such as scrubbing with soap and water, autoclaving, etc.

It is a sterile, single-use, disposable, long-lasting (beyond average surgery time of 90 minutes) anti-fog solution that can be applied on endoscope and laparoscope lenses, as well as endoscope sheaths. It is effective instantaneously, wet; but is even more lasting if allowed to dry, or applied prior to surgery to lenses.

The provided text describes the performance testing of the VitreOx Anti-fogging Device. However, it does not explicitly state specific acceptance criteria in a quantifiable manner, nor does it present the study results in a formal table directly comparing the device's performance against predefined acceptance metrics. Instead, it describes comparative performance against a control and a predicate device.

Here's an attempt to structure the information based on the provided text, while acknowledging the lack of explicit acceptance criteria and formal reporting:

1. Table of Acceptance Criteria and Reported Device Performance

As explicit acceptance criteria are not provided in the document, I will infer them from the reported observations and comparisons to the predicate device and control. The primary goal of an anti-fogging device is to prevent fogging and maintain visualization.

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

• Sample Size (Animal Study): 2 male Yucatan swine (from the same litter).

• Data Provenance: Prospective animal study conducted in Peoria, Arizona, USA (All Pets Animal Hospital).

• Sample Size (Bench Studies):

  • One handheld endoscope (Clarus 30000-10).
  • One electronic endoscope (generic electronic endoscope 14.55 mm, wide angle).
  • Various diameters of endoscope lenses (1, 1.2, 1.9, 2.7, 3.5, 4, 10 mm) were tested with the solution application methods.

• Data Provenance (Bench Studies): In vitro, simulated closed-body cavity surgical conditions. Location of bench study not explicitly stated but implied to be part of the manufacturer's testing.

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

• The text describes "veterinarians" monitoring and maintaining surgical conditions during the animal study. It does not explicitly state these veterinarians were establishing ground truth for fogging observation or if "experts" formally adjudicated video footage for fogging.
• Qualifications of Experts: "Veterinarians" who administered anesthesia and monitored vitals. Their specific qualifications (e.g., years of experience, board certification) are not detailed.
• Ground Truth Establishment for Fogging Observation: The text states, "Fogging is noted in the experiment: When there is a change of the light reflection on tissue, the light reflection will not be as crisp. In addition, veins on the tissue as also observed, because it will look less defined when fogging is present." This suggests direct visual observation by the study personnel (likely including the veterinarians) during the procedure. It doesn't mention a separate panel of experts for ground truth.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated as a formal adjudication process using multiple reviewers. The description implies direct observation and documentation by the study team during the animal procedure. There is no mention of 2+1, 3+1, or similar consensus methods.

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

• No, an MRMC study was NOT done. The study involved comparing the device's performance against a control and a predicate device in an animal model and bench tests. It did not involve multiple human readers assessing cases with and without AI assistance.

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

• This question is not applicable as the VitreOx® is a physical anti-fogging device (an solution/coating), not an AI algorithm. Its performance is entirely "standalone" in the sense that its anti-fogging effect is inherent to the solution itself, without requiring human real-time intervention beyond initial application.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Ground Truth for Fogging: Direct visual observation of fogging characteristics (change in light reflection, clarity of tissue/veins) during live animal procedures.
• Ground Truth for Safety: Clinical observation of the animals post-procedure (for 2 weeks and then 1 year), including physical health, discharge status ("healthy"), and absence of adverse reactions or complications.

8. The Sample Size for the Training Set

• This question is not applicable. The VitreOx® is a physical device/solution, not a machine learning algorithm, so there is no "training set" in the context of AI.

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

• This question is not applicable for the same reason as above (not an AI algorithm).

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