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The GUAN HONG Model# AC103/DR 103 Ultrasonic Nebulizer is an ultrasonic nebulizer that is intended for use in the treatment of asthma, COPD and other respiratory allments in which an aerosolized medication is required during therapy. The GUAN HONG Model# AC103/DR 103 Ultrasonic Nebulizer is not intended for use with Pentamidine. It is intended for single patient use.

GUAN HONG Ultrasonic Nebulizer (Model MH-AC 103 & MH-DR 103) is designed to spray liquids in aerosol form into gases directly to the patient for use by the adult and pediatric population.

The Ultrasonic Nebulizer units contains a piezoelectric crystal that generate ultrasonic waves which are transmitted through buffer water to medication cap and convert the liquid medication into an aerosol. The Nebulizer medication cap is designed for single-patient use and holds up to 5ml of medication for Model # AC 103 , 8 ml for Model # DR 103.

Inhalation can be made through nose or mouth. Attachments that are used during the nebulization process include MOUTHPIECE, ADULT MASK; PEDIATRIC MASK, NOSE FORK , CONNECTOR, CORRUGATED TUBE.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Guan Hong Model #AC103/DR 103 Ultrasonic Nebulizer:

Based on the provided 510(k) summary, the information regarding specific acceptance criteria and detailed study results is very limited. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a comprehensive clinical performance study as might be seen for novel or high-risk devices.

Therefore, for many of the requested points, the answer will be "Not found in the provided text."

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not found in the provided text.
• Data Provenance: Not found in the provided text. The device is manufactured in Taiwan, R.O.C., but the location of the comparison study is not specified. It is likely a prospective study, but this is not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not found in the provided text. The study mentioned is a "comparison study with a device that uses an auscultatory method" to validate repeatability, implying a technical or clinical measurement of output rather than expert interpretation of images or symptoms which would typically require "ground truth" established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable as no expert adjudication for ground truth is mentioned or implied for this type of device and study.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. This device is an ultrasonic nebulizer, not an AI-powered diagnostic tool. The "comparison study" mentioned is likely focused on the device's physical performance characteristics (e.g., aerosol output, particle size distribution) against a reference or predicate device, not on human reader performance with or without AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Yes, a standalone study was done, though not in the AI sense. The term "standalone" here would apply to the device's own performance characteristics (e.g., nebulization rate, particle size) being evaluated. The document states a "comparison study with a device that use auscultatory method was performed to validate the performance of the GUAN HONG Model# MH-AC103 / MH-DR 103 Ultrasonic Nebulizer." This is a standalone evaluation of the device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not explicitly stated, but inferred to be technical or clinical measurements. For a nebulizer, "ground truth" in a comparison study would likely refer to objective measurements of aerosol output parameters (e.g., Mass Median Aerodynamic Diameter (MMAD), Fine Particle Fraction (FPF), nebulization rate) obtained through standardized characterization methods, and possibly clinical indicators of medication delivery if a clinical study was performed (which is only vaguely alluded to).

8. The sample size for the training set

• Not applicable. This device does not involve AI or machine learning models that require a "training set."

9. How the ground truth for the training set was established

• Not applicable. This device does not involve AI or machine learning models that require a "training set" or ground truth for such a set.

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