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U-RIGHT Compressor Nebulizer, model TD-7013/ TD-7012, is designed to provide a compressed air source to aerosolize physician-prescribed liquid medication when used in combination with the packaged Nebulizer kit, except for Pentamidine. The packaged Nebulizer kit is intended for single use by single patient. U-RIGHT Compressor Nebulizer, model TD-7013/ TD-7012, is intended for use with children, adolescents ( 2 years to 18 years old), and adult patients in the homecare settings.

U-RIGHT Compressor Nebulizer is a light weight portable aerosol nebulizer, which uses a pneumatic piston that compresses air, forcing it to flow into the nebulizer container. And the force of the air flowing into the nebulizer container disperses the liquid medicine into aerosol particles for inhalation treatment of a physician's prescription medicine.

The only difference between model TD-7012 and TD-7013 is the outer casing design. The operating principle, the compressor type, working mechanism, and the accessories Nebulizer kit are all the same in these two models.

The submission describes the acceptance criteria and study for the U-RIGHT Compressor Nebulizer (model TD-7013/TD-7012).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

The provided text describes performance testing comparing the U-RIGHT Compressor Nebulizer to a predicate device. For the Aerosol Characterization Testing, the test involved comparing aerosol particle distributions with three specific drugs (Ipratropium bromide, Ventolin, and Cromolyn sodium) to the predicate device. The sample size for this comparative testing is not explicitly stated as a number of devices or number of tests per device, but the comparison was made across these three drugs.

Data provenance: The testing was conducted by TaiDoc Technology Corporation as part of their 510(k) submission. The location of the testing facility is not specified, but the applicant is based in Taiwan. The study appears to be prospective as it involves performance testing of the newly developed device against an existing predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information is not applicable to this submission. The "ground truth" in this context is referring to measurable physical properties and compliance with engineering standards, not expert interpretations of medical images or conditions. The "ground truth" for the aerosol characterization would be the measured particle size distribution from the predicate device and the specified statistical equivalence, while for other tests it's compliance with safety and environmental standards.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are focused on objective performance measurements and compliance with technical standards, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The study described is a technical performance comparison between a new device and a predicate device (device-to-device comparison), not a reader study involving human interpretation of data/images.

6. Standalone Performance Study

Yes, a standalone performance study was done for the device. The "Aerosol Characterization Testing" assessed the particle size distribution of the U-RIGHT Compressor Nebulizer with different drugs and demonstrated its performance characteristics and repeatability. The "Airpath Testing" and "Materials" testing (biocompatibility) also assessed the device's standalone performance regarding air quality output and material safety. The "Safety and EMC" testing specifically evaluated the device's adherence to relevant electrical safety and electromagnetic compatibility standards. While these tests had a comparative element to a predicate where applicable, they fundamentally assessed the device's inherent performance and compliance.

7. Type of Ground Truth Used

The ground truth used in these studies is primarily based on:

• Predicate Device Performance: For aerosol characterization, the performance of the legally marketed predicate device (Bestneb Portable Aerosol Therapy Unit, Model AP-10010, K990435) served as the reference point for equivalence (statistical significance p>0.05).
• Regulatory and Engineering Standards: For airpath testing, biocompatibility, electrical safety, and EMC, the ground truth is defined by compliance with established international standards (e.g., ISO 10993 series, EN 60601 series, CISPR 11) and EPA requirements (PM2.5 standard).
• Product Specifications: The device's own product specifications were also used as a benchmark for performance.

8. Sample Size for the Training Set

This information is not applicable. This device is a medical nebulizer, not an AI/machine learning algorithm, and therefore does not have a "training set" in the computational sense. The product development likely involved design iterations and internal testing, but not a formal 'training set' as used in AI validation.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reason stated in point 8.

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