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The RespiChamber Valved Holding Chamber is intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.

The RespiChamber* Valved Holding Chamber (VHC) is a device used for the administration of metered dose inhaler medication to a spontaneously breathing patient. By means of a one-way valve, medication particles are held in the chamber for several seconds after actuation has occurred enabling inhalation by the patient. The device is designed to minimize delivery of the larger particles of aerosolized medication, which may otherwise lodge in the mouth, throat and upper airway, while allowing the smaller therapeutic particles to be inspired.

This document describes a 510(k) premarket notification for the RespiChamber* Valved Holding Chamber (VHC). The submission aims to demonstrate substantial equivalence to a predicate device, the OptiChamber Advantage Valved Holding Chamber (K962822).

Here's an analysis of the acceptance criteria and study information provided:

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

The provided document doesn't explicitly state acceptance criteria in a quantitative format with corresponding reported performance values. Instead, it refers to a qualitative assessment of "no new issues of safety or effectiveness."

The core performance evaluation is based on "Particle size distribution testing" with the metric "Fine Particle Mass (μg < 4.7 um)." The document states:

2. Sample size used for the test set and the data provenance

The document does not specify a distinct "test set" sample size for the particle size distribution testing. It mentions "three drug classification types" were used for testing, implying multiple tests were run for each drug type. The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). However, it's clear this was a non-clinical, in-vitro study performed in support of regulatory submission, suggesting a controlled laboratory environment.

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

Not applicable. This was a non-clinical, in-vitro engineering performance study, not a clinical study requiring expert assessment of ground truth. The "ground truth" here is the physical measurement of particle size distribution.

4. Adjudication method for the test set

Not applicable. There was no clinical data or subjective assessments requiring adjudication. The performance was measured objectively through laboratory testing.

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

Not applicable. This device is a medical device (a valved holding chamber for medication delivery), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI are irrelevant to this submission.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" essentially refers to the objective, quantitative measurements obtained from the particle size distribution testing. This is a form of in-vitro performance data or engineering performance data, directly assessing the device's functional characteristics (emitted drug mass in a specific particle size range).

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is a physical medical device, not a machine learning algorithm.

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

Not applicable, as there is no training set for this device.

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