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The Unimax Anti-Fog Solution is intended to be used to prevent "fogging" (caused by condensation) on the lenses of endoscopic/laparoscopic instruments which are likely to fog during use.

The Unimax Anti-Fog Solution is a clear / colorless, water soluble solution. The model with alcohol is comprised of DPGMME (=2%), Isopropyl alcohol (=6%), and Deionized water (=92%), while the model without alcohol is comprised of DPGMME (=2%) and Deionized water (=98%). Unimax Anti-Fog Solution functions by reducing the surface tension of water, thus preventing water droplets (fog) from forming on the lenses of endoscopic / laparoscopic instruments during use. This solution is bottled in a volume of 6cc's in a 10cc clear plastic dropper bottle. Included in the tyvek pouch packaging of this product is a 4.54.50.5 (LWH) adhesive backed, non-abrasive, x-ray detectable radiopaque/nonradiopaque, polyurethane foam pad for applying the product to endoscopic / laparoscopic lenses. This product is sold sterile to healthcare professionals only.

The provided text describes a 510(k) premarket notification for the "Unimax Anti-Fog Solution." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving new acceptance criteria for an AI device. Therefore, the requested information about AI device acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance is not available in the given text.

The document states that a series of safety and effectiveness tests were performed to assess the Unimax Anti-Fog Solution. The results of these tests demonstrate that the device meets its predefined acceptance criteria and intended uses.

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

The document mentions that all test results demonstrate Unimax Anti-Fog Solution meets the requirements of its pre-defined acceptance criteria and intended uses. However, it does not explicitly list the acceptance criteria or specific performance values for the fog resistance test, cleaning ability test, extractable test, or prolonged fog resistance test. It only states that the results indicate the new device is "as safe and effective as the predicate device."

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

This information is not provided in the document.

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)

This information is not provided in the document as it refers to a medical device's physical properties, not an AI model requiring ground truth from experts.

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

This information is not provided in the document.

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 information is not provided in the document. This is not an AI device.

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

This information is not provided in the document. This is not an AI device.

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

This information is not provided in the document. This is not an AI device. The tests performed are laboratory standard tests.

8. The sample size for the training set

This information is not provided in the document. This is not an AI device and does not involve training sets.

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

This information is not provided in the document. This is not an AI device and does not involve training sets.

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