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The indications for use of the RapidVac™ Smoke Evacuator System are to remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures.

The RapidVac™ Smoke Evacuator System consists of a painted aluminum housing, a painted solid polyurethane front panel, a high suction/high flow rate variable speed centrifugal action pump, and a multi stage filter. The system can also use accessories such as sterile tubing sets in various sizes/diameters which are single-use and are used in conjunction with ultrasonic, laser or electrosurgery generators to remove and filter the smoke from the surgical field,. The RapidVac™ Smoke Evacuator System captures particulates and adsorbs gases from surgical smoke. The smoke evacuator is specifically designed to improve visibility and reduce potential health hazards associated with surgical smoke. It can be used in both open and laparoscopic procedures with available accessories. The RapidVac Smoke Evacuator System is designed with a high suction, high flow rate variable speed centrifygal action pump. The ultra-quiet motor is used to draw the smoke from the surgical site through the vacuum tubing and into the system where it is passed through four stages of filtration.

The provided text describes the RapidVac™ Smoke Evacuator System and its substantial equivalence to predicate devices, but it does not contain information about a study to prove acceptance criteria in the typical sense of AI/CADe systems.

Instead, the document focuses on performance verification testing to demonstrate that the device meets its technical and performance design requirements, and that it is substantially equivalent to existing devices based on technological characteristics and safety standards.

Therefore, many of the requested fields for AI/CADe studies cannot be directly answered from the provided text. I will answer based on the information that is present and indicate where information is not available or not applicable.

Here's the breakdown of the acceptance criteria and performance as presented in the document:

Acceptance Criteria and Device Performance (RapidVac™ Smoke Evacuator System)

• Filter life verification of ULPA efficiency.
• Flow verification testing to meet specified flow requirements for each mode of operation.
• Product verification and validation testing to meet all product requirements.
• Smoke removal verification via flow testing.
• Reliability testing to demonstrate longevity and no degradation.
• Laparoscopic Smoke Evacuation Verification to confirm ability to maintain pneumoperitoneum while clearing smoke.
• Smoke Removal Effectiveness via particulate count. |
  | Substantial Equivalence (to predicate devices: Visiclear™ Smoke Evacuation System (K131402) and Optimumm™ Smoke Evacuation System (K980915) regarding smoke evacuation technologies, mechanical, electrical, software, and safety.) | Found to be substantially equivalent to the predicate devices based on shared technological characteristics and compliance with safety standards. |

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

The document describes performance verification testing rather than a clinical trial or AI model testing with a distinct "test set" of patient data. The testing appears to be primarily laboratory/bench testing of the device's physical and functional attributes.

• Sample Size: Not explicitly stated in terms of a "test set" size. The document refers to various tests performed on the device(s).
• Data Provenance: Not applicable in the context of patient data. The testing was conducted on the RapidVac™ Smoke Evacuator System itself.

3. 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 study involved engineering and performance testing of a medical device, not interpretation of clinical data requiring expert consensus or ground truth in the AI context. Device compliance with standards and functional performance were assessed.

4. Adjudication method for the test set:

Not applicable. The testing described focuses on objective measurements and compliance with established engineering and safety standards (e.g., IEC standards), rather than subjective interpretation requiring adjudication among experts.

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:

No. This study is for a physical medical device (smoke evacuator) and not an AI or CADe system. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not performed.

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

No. This is not an AI/algorithm-based device. The "standalone" performance refers to the device's functional capabilities (e.g., filtration, flow rate) as a piece of equipment.

7. The type of ground truth used:

The "ground truth" for this device's performance is based on:

• Engineering specifications and design requirements: The device was tested against its own design specifications.
• Industry standards: Compliance with standards such as IEC 60601-1 and IEC 60601-1-2.
• Performance metrics: Objective measurements of filtration efficiency (ULPA), flow rates, particulate counts, and duration (filter life).
• Bench testing: Laboratory verification of various operational aspects, including smoke removal effectiveness and laparoscopic pneumoperitoneum maintenance.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. There is no training set for this device.

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