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• The Medisize Red devices are breathing circuit bacterial filters, which are intended to remove microbiological and particulate matter from the gases in the breathing circuit.
• These devices are intended to remove microbiological and particulate matter from the gases in the breathing circuit and at the same time the device in intended to be positioned over a trached to trached to the pollows during the-same into the using by passive means gases breathed in by patient dynng anaesthesia and ventilator care

Bacterial/Viral filter and HME combination device

The provided document is a 510(k) premarket notification letter for "Bacterial/Viral Medisize Blue and Medisize Red Filters." It establishes substantial equivalence to legally marketed predicate devices. However, this document does not contain a study that proves the device meets specific acceptance criteria in the way a clinical or performance study would for an AI/ML device.

This document is a regulatory approval notice based on demonstrating equivalence to existing devices, not a detailed performance study with acceptance criteria and results. Therefore, I cannot extract the requested information regarding AI/ML device performance.

The information I can provide from the document is related to the approved devices and their intended use:

Device Name: Bacterial/Viral Medisize Blue and Medisize Red Filters
Regulation Number: 21 CFR 868.5260
Regulation Name: Breathing Circuit Bacterial Filter
Regulatory Class: II
Product Code: CAH

Indications for Use:

• Medisize Red devices: Breathing circuit bacterial filters, intended to remove microbiological and particulate matter from the gases in the breathing circuit.
• Medisize Blue devices: Intended to remove microbiological and particulate matter from the gases in the breathing circuit AND provide heat and moisture exchange (HME) by passive means to the gases breathed in by the patient during anesthesia and ventilator care.

The document does not contain any of the following information:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study or effect size.
6. Standalone performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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