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A HaloLite Adaptive Aerosol Delivery, (AAD) system, a handheld nebulizer system including a dedicated compressor is designed to aerosolize commonly prescribed liquid medication (except Pentamidine) for inhalation by the patient in the home care, nursing home or hospital environment. The new dedicated compressor provides a compressed air source similar to the original predicate device compressed air sources, Invacare Mobilaire and regulated wall air.

The Medic-Aid HaloLite AAD system with dedicated compressor is a single patient use, prescribed portable nebulizer designed to deliver a precise and reproducible dose of aerosolized liquid medication. The device consists of a hand-piece containing a pressure transducer, a microprocessor control system, a medication chamber, and dedicated compressor to provide a compressed air source. Other compressed air sources can be -Invacare Mobilaire (50 psi compressor) and regulate wall compressed air. The HaloLite system analyses the patient's breathing pattern to determine the aerosol pulse time. The system then pulses aerosol during inspiration only. Each pulse of aerosol is matched according to the inspiratory time. HaloLite continues to monitor the breathing pattern in order to adapt to changes in breathing throughout the treatment. When the preset dose has been delivered, the system indicates that the treatment is complete.

This document is a 510(k) premarket notification for a nebulizer system, specifically the Medic-Aid HaloLite AAD with a dedicated compressor. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a standalone clinical study with acceptance criteria and performance data for a new AI/software device.

Therefore, many of the requested sections (acceptance criteria, specific study details like sample size, ground truth, expert qualifications, adjudication, MRMC studies, or standalone performance for an AI/software device) are not applicable and cannot be extracted from the provided text.

The document describes a medical device (nebulizer) and its functional characteristics, comparing them to existing predicate devices to show equivalence. It is not a study assessing the performance of software against clinical acceptance criteria.

Here's what can be extracted based on the provided text, with clarifications where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the context of specific acceptance criteria and performance metrics for the HaloLite AAD system as a new measurement or diagnostic device. The document focuses on demonstrating equivalence to predicate devices rather than meeting new, explicit performance targets.

Instead, the document implicitly demonstrates "acceptance" by showing that the new device operates similarly to existing, legally marketed devices.

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

• This document does not describe a "test set" in the context of evaluating a new device's performance against ground truth data. It is a 510(k) submission focused on substantial equivalence.
• Therefore, no sample size for a test set is provided.
• Data provenance is not applicable as there isn't a dataset being analyzed for performance. The comparison is based on device specifications and intended functionality.

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

• Not applicable. There is no "test set" requiring expert ground truth establishment for an AI/software device. The document is about a nebulizer's functional equivalence.

4. Adjudication Method for the Test Set

• Not applicable. No test set or expert ground truth requiring adjudication.

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

• Not applicable. This document is for a nebulizer, not an AI-assisted diagnostic tool.

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

• Not applicable. This document is for a nebulizer, not an algorithm. The "software-driven" aspect refers to a microprocessor controlling the nebulizer's physical operation (pulsing aerosol during inspiration), not an interpretive algorithm.

7. The Type of Ground Truth Used

• Not applicable. The "ground truth" in this context is the functional behavior and specifications of the predicate devices. The new device is considered "equivalent" if its design and function match or perform similarly to the predicates.

8. The Sample Size for the Training Set

• Not applicable. This document is for a nebulizer and does not involve machine learning or a training set.

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

• Not applicable. As there is no training set mentioned, this question is not relevant.

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A Nebulizer system designed to aerosolize commonly prescribed liquid medication ( except Pentamidine) for inhalation by the patient in the home care, nursing home or hospital environment.

The Medic-Aid HaloLite AAD system is a single patient use, prescribed portable nebulizer designed to deliver a precise and reproducible dose of aerosolized liquid medication. The device consists of a hand-piece containing a pressure transducer, a microprocessor control system, and a medication chamber, based on the Medic-Aid -Ventstream Nebulizer, K933535, and mouthpiece.

The HaloLite system analyses the patient's breathing pattern to determine the aerosol pulse time. The system then pulses aerosol during inspiration only. Each pulse of aerosol is matched according to the inspiratory time. HaloLite continues to monitor the breathing pattern in order to adapt to changes in breathing throughout the treatment. When the preset dose has been delivered, the system indicates that the treatment is complete.

The provided text is a 510(k) summary for the Medic-Aid HaloLite AAD system, a nebulizer. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with acceptance criteria and performance data in the format requested. Therefore, much of the requested information is not available in the provided document.

Here's an attempt to answer based on the available information, with clear indications where the information is "Not Provided":

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not Provided.
• Data Provenance: Not Provided. The document describes the device and compares it to predicate devices, but does not detail a specific test study with a described sample set. It's likely that performance data was generated internally for technical verification, but the specifics are not included in this summary.

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

• Number of Experts: Not Provided.
• Qualifications of Experts: Not Provided.

4. Adjudication method for the test set

• Adjudication Method: Not Provided.

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

• This device is a nebulizer, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is Not Applicable and was not performed.

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

• This device is a hardware nebulizer with a microprocessor, not a standalone algorithm. Therefore, a standalone algorithm-only performance study is Not Applicable and was not performed. The device's "standalone" performance would relate to its ability to accurately deliver aerosolized medication. While the document mentions "accurate method of dose measurement," specific study details are not provided here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: Not Provided in terms of a formal study assessing device performance. The "ground truth" for substantial equivalence is based on the features and performance of legally marketed predicate devices. The device's own performance would be verified against engineering specifications, likely through bench testing, but the methodology and "ground truth" for those tests are not detailed here.

8. The sample size for the training set

• Sample Size: Not Applicable. This is a hardware medical device (nebulizer), not an AI/machine learning model that would require a training set.

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

• Ground Truth Establishment: Not Applicable. As this is not an AI/machine learning model, no training set or ground truth for a training set was established.

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To provide a portable compressed air source for the nebulization of drugs to be delivered to a patient via a hand-held nebulizer in the home, nursing home or hospital environments.

The Medic-Aid Porta-Neb is an electrically powered compressor which provides 6-8 Lpm of air flow under a back pressure of 12 psi. It is designed to be connected to a hand-held nebulizer to provide the air source to nebulize drugs to be inhaled by a patient.

The provided document is a 510(k) Non-Confidential Summary of Safety and Effectiveness for the Medic-Aid Porta-Neb Nebulizer Compressor. This type of submission is a premarket notification to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device).

Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical or performance study with defined thresholds for sensitivity, specificity, accuracy, etc. Instead, it demonstrates substantial equivalence to a predicate device by comparing various attributes. The 'acceptance criteria' in this context are implicitly that the Porta-Neb device's attributes are equivalent to or better than the predicate device, or meet recognized standards, without introducing new questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes a submission for substantial equivalence to a predicate device, not a clinical study involving a test set of patient data or specific samples for performance evaluation in the usual sense. Therefore, there is no traditional "test set" sample size as would be used for evaluating diagnostic accuracy or clinical outcomes. The evaluation is based on comparing the device's technical specifications and intended use against a known predicate device and recognized standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since there is no traditional "test set" or clinical study described in the document, no experts were used to establish ground truth in the context of a clinical validation study. The ground truth for this submission is based on established engineering and safety standards, and the known characteristics of the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

As there is no clinical "test set" and no human interpretation of data being evaluated, no adjudication method was used. The comparison is based on objective device specifications and regulatory standards.

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

No MRMC comparative effectiveness study was done. This document pertains to a medical device (nebulizer compressor) that is not an AI/software device requiring such studies to evaluate a human reader's performance with or without AI assistance.

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

Not applicable. The Medic-Aid Porta-Neb is a hardware device (nebulizer compressor), not an algorithm or software requiring standalone performance testing in the context of AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is the established performance and safety characteristics of the predicate device (DeVilbiss Pulmo-Aide K854520) and compliance with recognized electrical/medical device safety standards (e.g., EN 60601, UL 2601, IEC 601-1, CAN / CSA C22.2 No.60 1.1).

8. The sample size for the training set

Not applicable. This is a hardware device submission, not an AI/ML model needing a 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 established for one.

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