(157 days)
A bacterial filter is indicated for use when the care provider desires to protect the patient, care provider, equipment, or all three from the transference of bacteria or virus through the breathing circuit. This filter is provided only in combination with a King Systems Universal F2™ breathing circuit. Within this combination the overall intended use is to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.
Breathing Circuit Bacterial Filter
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a "Breathing Circuit Bacterial Filter" and discusses regulatory aspects, not performance studies or acceptance criteria for a device.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
- If a standalone performance study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).