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The antistatic Compact Space 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 device is intended for use in neonates, infants, children, adolescents and adults. The intended environments for use include home, hospitals and clinics.

Antistatic Compact Space Chamber

The provided document is a 510(k) premarket notification letter from the FDA regarding an "Antistatic Compact Space Chamber" (K143615), which is a nebulizer. It indicates the device has been found substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria for device performance, outcomes from a study proving it meets acceptance criteria, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment.

The letter is a regulatory approval document and focuses on the administrative aspects of FDA clearance, such as:

• Trade/Device Name: Antistatic Compact Space Chamber
• Regulation Number/Name: 21 CFR 868.5630, Nebulizer
• Regulatory Class: Class II
• Product Code: NVP
• Indications for Use: Administer aerosolized medication from most pressurized Metered Dose Inhalers to neonates, infants, children, adolescents, and adults in home, hospitals, and clinics.

To answer your request, information regarding the device's technical performance and the studies demonstrating it would need to be found in the original 510(k) submission itself or in relevant performance data documents, which are not included in this provided text.

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The Space Chamber Plus and Compact Space Chamber Plus are intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The devices are 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 home, hospitals and clinics.

The Space Chamber Plus and Compact Space Chamber Plus are devices designed to assist patients with inhaling aerosolized medication dispensed through a Metered Dose Inhaler. The devices consist of a cylindrical chamber with an opening at each end. One opening is for the aerosol medication to be inserted, the other is tapered into a mouthpiece for inhalation. The mouthpiece can be used with or without a mask. The Compact Space Chamber Plus is a smaller version of the Space Chamber Plus that allows for easier storage and handling.

Here's a breakdown of the acceptance criteria and the study details for the Space Chamber Plus and Compact Space Chamber Plus devices, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria for the Space Chamber Plus and Compact Space Chamber Plus devices are based on demonstrating substantial equivalence to the predicate device, AeroChamber Plus aVHC with Flow-Vu IFI (K070674), particularly with respect to particle size distribution and respirable dose. The study performed involved non-clinical testing of particle size distribution.

Table of Acceptance Criteria and Reported Device Performance (Summary of Equivalence)

^(NA: Not applicable when results for each individual run are the same)

Study Details Proving Acceptance Criteria

The study performed was a non-clinical performance study focused on the particle size distribution of aerosolized medication delivered by the Space Chamber Plus and Compact Space Chamber Plus, in comparison to the predicate device and the pMDI alone.

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

   • The document does not explicitly state the specific numerical sample size for each test run (e.g., number of inhalations tested, number of devices tested). However, the presence of 95% Confidence Intervals (CI) suggests multiple replicates were performed for each measurement.
   • Data Provenance: The study was conducted by Medical Developments International Limited, an Australian company. The testing was performed in accordance with relevant sections of the CDRH Guidance Document "Reviewers Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH/ODF/DCRD/ADDB -1993), implying a controlled laboratory environment. The data is retrospective to the submission date.

2. 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 performance study involving physical measurements of particle size distribution, not an evaluation requiring expert interpretation of clinical images or patient data. The "ground truth" was established by the physical testing methodology itself, following established guidance.

3. Adjudication method for the test set:

   • Not Applicable. As this was a non-clinical, objective measurement study, there was no need for expert adjudication.

4. 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. This was a non-clinical performance study of a medical device (spacer/valved holding chamber) focused on drug delivery characteristics, not an AI-based diagnostic or imaging device. Therefore, no MRMC study, human reader improvement, or AI assistance was involved.

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

   • Not Applicable. This study assessed the physical performance of a mechanical medical device, not an algorithm.

6. The type of ground truth used:

   • The "ground truth" was established through objective physical measurements using scientific instruments (e.g., cascade impactors for particle size distribution) following the methodology outlined in the "Reviewers Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators" and generating quantitative data for MMAD, respirable dose, and respirable fraction.

7. The sample size for the training set:

   • Not Applicable. This was a non-clinical performance validation against a predicate device, not a machine learning model requiring a training set.

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

   • Not Applicable. No training set was used.

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