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The VISICLEAR Smoke Evacuation System is designed to remove and filter smoke, aerosols produced during electrosurgical and laser procedures.

Indications for use for the VISICLEAR smoke evacuation system include:

a. To remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures

The VISICLEAR smoke evacuation system is a self-contained system that is used to remove and filter surgical smoke. The device is intended for general electrosurgical and laser applications for removing smoke generated by electrosurgery and laser procedures.

The device is constructed using the same materials and design specifications commonly found in the predicate devices in the smoke evacuation marketplace. The smoke evacuator is comprised of a vacuum motor, aluminum, and plastic components combined with sound reducing insulation. The vacuum motor is used to draw the smoke from the surgical site, through the vacuum tubing and into the VISICLEAR filter where the surgical smoke is processed by a series of filtration stages.

The vacuum flow rate for the VISICLEAR smoke evacuation device ranges from a minimum of 5 liters per minute (LPM) in Laparoscopic Mode to 30 cubic feet per minute in Open Mode. These flow rates are substantially equivalent to the flow range for the predicate devices.

The filter for the VISICLEAR smoke evacuation system, like the filters for the predicate devices, is a replaceable self-contained filter that is completely enclosed to protect health care personnel from potential contamination during filter changes. The VIROSAFE 135 filter ("VS135") is an Ultra Low Penetration Air (ULPA) grade with carbon fitter that has filter efficiency of 99.999% for particle sizes of 0.1 to 0.2 microns or greater. These characteristics are consistent with the predicate devices.

The provided document is a 510(k) summary for the VISICLEAR Smoke Evacuation System. It outlines the device's characteristics and compares it to predicate devices to establish substantial equivalence.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Study Details

The document describes bench testing for verification and validation to demonstrate substantial equivalence to predicate devices, rather than a clinical study involving patients or human readers.

1. Sample size used for the test set and the data provenance:

   • The document primarily refers to "bench testing" and does not specify a "test set" in terms of patient data or clinical images. It implies testing of the device itself and its components.
   • Data provenance is not explicitly stated in terms of country of origin, but the company, Buffalo Filter LLC, is based in Lancaster, NY, USA. The testing appears to be "retrospective" in the sense that it's based on engineering tests rather than prospective patient recruitment.

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

   • This is not applicable as the "ground truth" for this device's performance is established through objective engineering measurements (e.g., flow rate, filter efficiency, safety standards compliance) rather than expert interpretation of data.

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

   • Not applicable, as this was not a study involving human interpretation or adjudication of results.

4. 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 smoke evacuation system and does not involve AI or human readers for diagnostic interpretation.

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

   • Not applicable. The device is a physical system, not an algorithm. Its performance is inherent to its physical design and operation.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" is defined by established engineering and regulatory standards for air handling devices and smoke evacuator performance. This includes:
     • ULPA efficiency standards: 99.999% for particle sizes of 0.1 to 0.2 microns or greater.
     • Flow rate measurements: Minimum 5 LPM (Laparoscopic Mode) to 30 CFM (Open Mode).
     • Filter life: 35 hours (Laparoscopic Mode), 18 hours (Open Mode).
     • Electrical safety standards: IEC/ANSI/AAMI 60601-1 and IEC/ANSI/AAMI 60601-1-2.
     • Mechanical safety standards: IEC/ANSI/AAMI 60601-1.
     • Software functionality: Verification that the filter life decrementing feature works as intended.
     • Smoke removal effectiveness: Quantified ability to remove smoke aerosols.

7. The sample size for the training set:

   • Not applicable. This refers to a physical device, not a machine learning algorithm that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. See point 7.

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The Indications for Use of the ViroSafe EY Filter and Buffalo Filter® EY Prefilter are for the removal and filtration of the smoke and incidental fluid produced during electrosurgery, 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.

Disposable Smoke Evacuation Filter

The provided document is a 510(k) clearance letter from the FDA for a smoke evacuation filter. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. These types of details are typically found in the 510(k) summary or the full submission, not in the clearance letter itself.

Therefore, I cannot extract the requested information from the provided text.

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The Indications for Use of the ViroSafe® 18 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.

Disposable Smoke Evacuation Filter

This document is a 510(k) clearance letter from the FDA for a medical device called the "Buffalo Filter ViroSafe 18 Filter." It is a regulatory approval document and does not contain information about the acceptance criteria or a study proving the device meets those criteria, nor any of the other requested details regarding a study.

Therefore, I cannot provide the requested information based on the input text. The document confirms that the device is "substantially equivalent" to previously marketed devices, which is a regulatory determination, not a performance study outcome as typically described in scientific literature or a clinical trial report.

To answer your request, I would need a document that describes the design and results of a performance study for the Buffalo Filter ViroSafe 18 Filter.

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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.

Not Found

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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