(231 days)
Smoklean is a passive smoke evacuation system which removes particles from surgical smoke generated in laparoscopic procedures while maintaining a clear field of vision.
During the laparoscopic surgery, the smoke generated by the electrocautery dims the surgeon's vision, affecting the operation and causing the smoke to have a negative effect on the surgeon. It is used in connection with a laparoscopic trocar body or a single port used to expand the surgical site during laparoscopic surgery. This product filters smoke generated when the tissue is cauterized through the laparoscopic trocar body and a single port. The connecting part of the Trocar body or single port is 4.25 * 5.04mm in diameter. The device is consisted of 35cm tubing, a body with filters and an adaptor.
The provided text describes a 510(k) premarket notification for a medical device called "Smoklean," a passive smoke evacuation system for laparoscopic procedures. The document details the device's intended use, comparison to a predicate device, and performance data from various tests. However, it does not contain the specific acceptance criteria for these tests or a detailed study report that proves the device meets those criteria with specific performance metrics (e.g., specific filtration efficiency percentages, or quantitative measures of visual clarity).
Therefore, based on the provided text, I cannot complete all sections of your request. I will extract the information that is present and indicate where information is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document for specific performance metrics. The document identifies various tests performed. | The performed tests "support that the subject device is substantially equivalent to the predicate devices." (Quantitative results are not provided). |
| Example Criteria (hypothetical, as not provided in text): |
- Particle filtration efficiency > 99.9% for 0.3 micron particles
- Ammonia removal efficiency > 90%
- Formaldehyde removal efficiency > 90%
- Maintain clear field of vision (qualitative assessment) | Example Performance (hypothetical, as not provided in text):
- Achieved 99.99% filtration efficiency for 0.3 micron particles
- Achieved 95% ammonia removal
- Achieved 92% formaldehyde removal
- Surgeons consistently reported a clear field of vision during simulated procedures. |
Missing Information: The document lists types of performance tests (e.g., "Smoke particulate filtration verification test," "Deodorization: Ammonia," "Deodorization: Formaldehyde") but does not provide the specific quantitative acceptance criteria or the numerical results achieved by the device against those criteria.
2. Sample Size Used for the Test Set and Data Provenance
Missing Information: The document lists "Performance Tests" but does not specify the sample size used for these tests. Data provenance (e.g., country of origin, retrospective/prospective) is also not detailed for the performance tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable for this type of device and performance testing. The "ground truth" for a smoke evacuation system generally refers to measurable physical properties (like filtration efficiency, odor reduction) rather than expert interpretation of medical images or conditions.
4. Adjudication Method for the Test Set
Not Applicable for this type of device and performance testing, as it doesn't involve subjective interpretation that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done, as this is a smoke evacuation device, not an AI-assisted diagnostic tool.
6. Standalone Performance Study
Yes, a standalone (algorithm only without human-in-the-loop) performance was done. The "Performance Data" section lists various tests performed directly on the device, such as "Smoke particulate filtration verification test," "Deodorization: Ammonia," and "Deodorization: Formaldehyde." These are objective, standalone tests of the device's physical capabilities.
7. Type of Ground Truth Used
The ground truth for the performance tests would be based on objective, measurable physical and chemical standards, such as:
- Pre-defined concentrations of particles or gases (e.g., ammonia, formaldehyde) for filtration/deodorization tests.
- Standardized methods for measuring particle counts, gas concentrations, tensile strength, sterility, etc.
- Industry standards (e.g., ISO) for sterilization and biocompatibility.
8. Sample Size for the Training Set
Not Applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The "training set" concept is relevant for machine learning models.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As above, this device does not use an AI/ML algorithm that requires a training set.
§ 878.5070 Air-handling apparatus for a surgical operating room.
(a)
Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.(b)
Classification. Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.