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The MABIS NB-02 is an ultrasonic nebulizer intended for use in the treatment of asthma, COPD, and other respiratory ailments in which an aerosolized medication is required during therapy. It may be necessary to perform respiratory therapy at anytime and anywhere the patient needs it. The MABIS NB-02 nebulizer is not intended for use with Pentamidine. It is intended for single patient use.

MABIS NB-02 Ultrasonic Nebulizer

The provided document is a 510(k) premarket notification letter from the FDA for a medical device called the "MABIS NB-02 Ultrasonic Nebulizer." This type of document is a clearance letter, not a study report or technical specification document, and therefore does not contain the detailed information requested regarding acceptance criteria and study particulars for device performance.

The letter states that the device is substantially equivalent to legally marketed predicate devices, meaning it has met the regulatory requirements for clearance based on its similarity to existing devices. However, it does not include:

1. A table of acceptance criteria and reported device performance: This information would typically be found in a performance data section of a 510(k) submission, not in the FDA's clearance letter. The letter only broadly states equivalence, implying that performance is similar to predicate devices.
2. Sample size used for the test set and data provenance: Not mentioned.
3. Number of experts used to establish ground truth and qualifications: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. MRMC comparative effectiveness study results: Not mentioned. This type of study is more common for diagnostic devices where human reader performance is a key metric. A nebulizer is a therapeutic device.
6. Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm.
7. Type of ground truth used: Not mentioned.
8. Sample size for the training set: Not applicable for this type of device and clearance.
9. How ground truth for the training set was established: Not applicable.

In summary, the provided document ("K990506 Re: MABIS NB-02 Ultrasonic Nebulizer") is a regulatory clearance letter and does not contain the detailed technical or clinical study data requested about acceptance criteria and device performance.

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