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The Indications for Use of the ViroSafe® ODR Filter is for the removal and filtration of the smoke and incidental fluid produced during electrosurgery, laser surgery, or other smoke plume producing devices. This device is not intended for contact with the patient. It is intended to be used during either open or endoscopic surgical procedures.

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This is a 510(k) premarket notification for the Buffalo Filter Virosafe ODR Filter, a smoke evacuation filter. The document indicates that the device has been found substantially equivalent to a predicate device marketed prior to May 28, 1976. This type of regulatory submission primarily focuses on demonstrating equivalence rather than conducting a de novo study to establish acceptance criteria and prove performance through a new clinical trial.

Therefore, the provided text does not contain the detailed information necessary to answer the questions about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment. These aspects are typically found in a de novo submission or a more extensive clinical study report, which are not part of this 510(k) clearance letter.

Based on the provided document, the following information is not available:

1. A table of acceptance criteria and the reported device performance: This document does not specify performance acceptance criteria or report specific device performance data. It focuses on regulatory clearance based on substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance information is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No information on expert review or ground truth establishment for a test set is present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no test set evaluation details are provided.
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: Not applicable. This device is a filter, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a filter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth information is provided as it's not a diagnostic device requiring such validation in this context.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.

The "Indications for Use" section (Page 3) briefly describes the intended function of the device: "for the removal and filtration of the smoke and incidental fluid produced during electrosurgery, laser surgery, or other smoke plume producing devices." However, it does not state specific performance metrics or acceptance criteria related to filtration efficiency, flow rate, or other technical specifications that would typically be associated with such a filter and evaluated in a performance study.

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