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The system is used on the order of a physician for the treatment of asthma, bronchitis and other respiratory diseases. The nebulizer converts the liquid medication into a fine aerosol mist which can be inhaled for home respiratory therapy. This allows the medication to be deposited at the affected areas of the patients airway.

The Sunrise Medical Model 800 Series jet nebulizer is a reusable hand held, small volume jet nebulizer. The nebulizer is designed for use in conjunction with a compressed gas source such as the Sunrise Medical Pulmo-Aide Model 5650 Compressor (FDA 510(k) Registration # K923888), Sunrise Medical Pulmo-Mate Model 4650 Compressor (FDA 510(k) Registration # K931015) or Sunrise Medical Pulmo-Aide LT Model 3650 Compressor (FDA 510(k) Registration # K970289). The nebulizer & compressor system is used on the order of a physician to treat various respiratory problems. The nebulizer converts the liquid medication into a fine aerosol mist, which can be inhaled for home respiratory therapy. This allows the medication to be deposited at the affected areas of the patient's airway. The Sunrise Medical Model 800 Series iet nebulizer is designed to offer high respirable aerosol output for the patient. The nebulizer is intended as a long term usage nebulizer (approximately 1 year) similar to other reusable nebulizers that are currently being marketed by competitors of Sunrise Medical such as the Pari LC Plus and Pari Jet permanent nebulizers manufactured by Pari of Germany and distributed here in the U.S. Accessories include a triggering system to shut off airflow to the nebulizer to conserve medication between breaths.

Here's an analysis of the provided text regarding the acceptance criteria and study for the KG93492 medical device submission:

Based on the provided 510(k) summary for the Sunrise Medical Model 800 Nebulizer (KG93492), the information is very limited regarding specific acceptance criteria and detailed study performance data. This document is a summary provided for FDA clearance of a Class II device, which often focuses on substantial equivalence to predicate devices rather than extensive clinical trials with detailed performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a structured format often seen for software or AI-based devices. Instead, it relies on demonstrating substantial equivalence to existing predicate devices (Sunrise Medical Model 700, Pari LC Plus, Pari Jet).

The key performance claims are related to:

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

The document does not specify a sample size for a "test set" in the context of clinical or performance testing. The statement "Testing performed on the aerosol output and particle size..." indicates that some form of testing was done, but details regarding the number of devices tested, number of measurement cycles, or the specific methodology are not provided in this summary.

Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned.

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

This information is not provided. Given that this is a 510(k) for a medical device (nebulizer) and not an AI/software device, the concept of "ground truth" and expert adjudication in the manner typically discussed for diagnostic algorithms is generally not applicable here. Performance is measured against physical metrics (aerosol output, particle size) rather than expert interpretation of data.

4. Adjudication Method for the Test Set:

An adjudication method (e.g., 2+1, 3+1) is not relevant or described for this type of device submission. Performance is measured objectively rather than through expert consensus on qualitative outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging or AI-assisted diagnostic tools to assess how human readers' performance (e.g., accuracy, speed) is affected by AI assistance. A nebulizer is a therapeutic device, not a diagnostic one.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This device is a physical, mechanical nebulizer, not an algorithm or software. Its performance is inherent to its design and function, not an "algorithm only" performance.

7. The Type of Ground Truth Used:

The "ground truth" for evaluating the nebulizer's performance would be objective, quantitative measurements of physical properties like:

• Aerosol Output Rate: The amount of medication delivered per unit of time.
• Particle Size Distribution: The range and average size of the aerosolized particles (specifically, the respirable fraction).

These are empirical measurements, not expert consensus, pathology, or outcomes data in the usual sense. The document states "Testing performed on the aerosol output and particle size," implying these direct measurements were the basis for comparison.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/machine learning model, so there is no "training set."

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

Not applicable. As there is no training set, there is no ground truth needed for it.

Summary of Limitations from the Provided Text:

The provided 510(k) summary is very high-level and characteristic of device submissions from 1999 for physical medical products. It focuses heavily on establishing substantial equivalence to predicate devices based on functional characteristics, intended use, and general performance claims (high respirable output, similar aerosol treatment, long-term use). It lacks the detailed quantitative performance metrics, study designs, sample sizes, and ground truth methodologies that would be expected for more modern AI/software-as-a-medical-device (SaMD) submissions or even detailed clinical studies for novel physical devices. The FDA clearance is based on the premise that the new device is "substantially equivalent" to already marketed devices, implying that if the predicates were safe and effective, so too would be the new device given similar performance characteristics.

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