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The DDI Ultrasonic Nebulizer System is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient. The device may be used with pediatric and adult patients in the home, hospital, and sub-acute care settings.

The DDI Ultrasonic Nebulizer System is a mesh screen ultrasonic nebulizer that operates in an identical fashion as other mesh screen nebulizers. The device creates aerosols of liquid medication by ejection of droplets from a mesh vibrated at ultrasonic frequencies and provide fine particles to the patient's lungs. The DDI Ultrasonic Nebulizer System is powered by a cable connecting to a 115 VAC power source with the AC adapter or two AA alkaline batteries.

Here's an analysis based on the provided text, outlining the acceptance criteria and the study details for the DDI Ultrasonic Nebulizer System:

The provided document (K090307) is a 510(k) summary for a Medical Device. For 510(k) submissions, the primary "study" is often a comparison of technical characteristics and performance to a legally marketed predicate device, rather than a traditional clinical trial with acceptance criteria for new device performance metrics. The goal of a 510(k) is to demonstrate substantial equivalence, not necessarily to prove absolute efficacy or safety with new, independent studies.

Therefore, the "acceptance criteria" for this device are implicitly the performance specifications and safety standards met by its predicate devices, and the "study" is the comparison against those predicates to establish substantial equivalence.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as quantitative targets in the document. Instead, the DDI Ultrasonic Nebulizer System is deemed acceptable because its performance parameters are "statistically identical" to the predicate devices. The table below presents the key performance characteristics reported for the new device and its predicates, implying that matching or being substantially similar to these predicate values constitutes acceptance.

Study Details Proving Acceptance

The "study" for this 510(k) submission is primarily a nonclinical comparison of technical characteristics and performance against two legally marketed predicate devices:

1. Omron Micro-Air Vibrating Mesh Nebulizer (K062263)
2. Health & Life Co. Ultrasonic Nebulizer System Model HL 100 (K081738)

The conclusion states that "All of the performance parameters of the devices are statistically identical, and do not raise any new safety or efficacy." This forms the basis of the substantial equivalence determination.

1. Sample size used for the test set and data provenance:

   • The document does not describe a clinical "test set" in the traditional sense of patient data. The evaluation appears to be based on bench testing of the device's technical specifications and electrical safety.
   • Data provenance is not explicitly stated as country of origin, but it is implied to be from the manufacturer's internal testing as part of their regulatory submission. The data is retrospective in the sense that it's comparing a new device against established predicate device specifications, and the testing of the new device likely occurred prior to the submission date.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This is not applicable as there was no "test set" requiring expert ground truth in the context of diagnostic interpretation. Ground truth for device performance parameters (e.g., nebulization rate, particle size) would have been established through standardized engineering and laboratory testing protocols.

3. Adjudication method for the test set:

   • Not applicable, as there was no "test set" requiring human adjudication in the context of interpretation.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, a MRMC comparative effectiveness study was not done. This submission is for a medical device (nebulizer) that delivers medication, not a diagnostic imaging or screening tool that would involve human readers interpreting cases.

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

   • This is not applicable, as the device is a physical medical device (nebulizer), not an algorithm or AI system. Its performance is inherent to its design and mechanical/electrical operation.

6. The type of ground truth used:

   • The "ground truth" for the device's performance characteristics (e.g., nebulization rate, particle size, battery life, dimensions) would have been established through laboratory measurements and engineering specifications. For electrical safety, the ground truth is defined by compliance with the referenced international standards (IEC 60601, EN 60601-1, EN 60 601-1-2).

7. The sample size for the training set:

   • Not applicable. This device is not an AI or machine learning system, so there is no concept of a "training set" in this context.

8. How the ground truth for the training set was established:

   • Not applicable as there is no training set.

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