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The Pocket Chamber Valved Aerosol Holding Chamber is intended to assist with the delivery of aerosolized medications when used in conjunction with commercialized MDI canisters with the associated activator elbow. The spacer device is indicated to assist in the treatment of patients with lung disease such as, but not limited to, asthma, emphysema, chronic bronchitis, and cystic fibrosis.

The Pocket Chamber Valved Aerosol Holding Chamber is a cylindrical tube, approximately 3.1 inches long by 4.5 cm wide, and accepts the MDI manufacturer's mouthpiece. The MDI receptacle has an orifice of size and shape similar to the MDI mouthpiece. The device is designed to prevent offcenter actuations. A one-way valve is located at the juncture between the mouthpiece and the body.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Ferraris Medical, Inc. Pocket Chamber Valved Aerosol Holding Chamber:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the sample size used for the Cascade Impactor Test.
The data provenance is retrospective, as it describes a study that has already been performed.
The country of origin for the data is not explicitly stated, but given the submitter and FDA contact information, it is likely the United States.

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

This information is not applicable as the study described is a performance test on a device, not a diagnostic or image-based assessment requiring expert interpretation for ground truth. The "ground truth" here is the objective measurement obtained through the Cascade Impactor Test, measuring physical characteristics of the aerosol.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. There is no human interpretation or consensus required for the physical measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improve with AI vs without AI assistance:

This is not applicable. The device is an aerosol holding chamber, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI or human reader improvement is not relevant.

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

This is not applicable. The device is a physical medical device, not an algorithm. The "performance" described is the device's ability to facilitate aerosol delivery, which is an inherent mechanical function, not an algorithmic output.

7. The type of ground truth used:

The ground truth for the performance study was objective physical measurements obtained through the Cascade Impactor Test. These measurements directly quantify the characteristics of the aerosol produced by the device, such as total dose, respirable dose, mass median aerodynamic diameter, and geometric standard deviation. For resistance to flow and cleaning instructions, it's based on device specifications and validation testing.

8. The Sample Size for the Training Set:

This information is not applicable as there is no "training set" in the context of this device's performance study. Physical devices do not typically undergo "training" in the way an AI algorithm would.

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

This information is not applicable for the same reasons as point 8.

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The PocketSpacer is intended to assist with the delivery of aerosolized medications when used in conjunction with commercialized MDI canisters with the associated activator elbow. The spacer device is indicated to assist in the treatment of patients with lung disease such as, but not limited to, asthma, emphysema, chronic bronchitis, and cystic fibrosis.

The PocketSpacer is a cylindrical tube, approximately 10 cm long by 4.5 cm wide, and accepts the MDI manufacturer's mouthpiece. The MDI receptacle has an orifice of size and shape similar to the MDI mouthpiece. The device is designed to prevent off-center actuations. An open mesh with varying size circular orifices, but no valve, is in the round mouthpiece. The mesh with concentrically placed circular orifices removes the throat dose by permitting only respirable particles to be inhaled by the user.

Here's an analysis of the provided text regarding the PocketSpacer device, focusing on acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria for the PocketSpacer. Instead, it relies on a comparison to a predicate device (MicroChamber) and general performance improvements over MDI alone. The acceptance is implicitly based on the device performing "comparably" to the predicate for key metrics and "finer, more highly respirable aerosols" than MDI alone.

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

• Sample Size (Test Set): The document states "four categories of drugs" were tested. It does not specify the number of individual tests, devices, or MDI actuations performed for each drug category.
• Data Provenance: Not explicitly stated. However, given that Ferraris Medical Inc. is a US company and the submission is to the US FDA, it's highly probable the testing was conducted within the United States. The study appears to be prospective as it's a performance test for a new device.

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

This information is not applicable to this type of device and study. The "ground truth" here is objective physical measurements (total dose, respirable dose, MMAD) obtained through a standardized laboratory test (Cascade Impactor Test), not expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable for this type of performance study. Adjudication methods like 2+1 or 3+1 are used for expert consensus in cases where subjective interpretation is involved (e.g., grading medical images). Here, the results are derived from objective measurements.

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

No, an MRMC comparative effectiveness study was not conducted. This type of study involves multiple human readers interpreting cases, often with and without AI assistance, to assess the impact of AI on reader performance. The PocketSpacer is a physical medical device, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence, a "standalone" performance test was done, although it's crucial to understand the context. The "Performance Data" section describes a laboratory test (Cascade Impactor Test) that directly measured the device's physical performance (total dose, respirable dose, MMAD) when used with MDIs. This is a standalone assessment of the device's physical capabilities, independent of human interaction beyond operating the test equipment.

7. The Type of Ground Truth Used

The "ground truth" was established by objective, quantitative laboratory measurements using the Cascade Impactor Test. These measurements directly assess the physical properties of the aerosol produced (total dose, respirable dose, mass median aerodynamic diameter).

8. The Sample Size for the Training Set

This information is not applicable as the PocketSpacer is a physical medical device, not an AI algorithm that requires a training set. The "training" for such devices involves engineering design, prototyping, and manufacturing process development.

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

This is not applicable as there is no "training set" in the context of an AI algorithm. For a physical device, the equivalent would be the R&D and engineering processes, where design specifications and performance targets are set, and verified through various tests and simulations to ensure the device performs as intended.

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