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The Sidestream Plus is a handheld nebulizer designed to aerosolize medication approved for nebulization and prescribed by a physician. The Sidestream Plus is intended for adult and pediatric patients consistent with the indications for the aerosol medication.

Sidestream Plus is a Class II device. It is a breath-enhanced reusable nebulizer to be used with a compressor that is capable of providing appropriate air pressure and flow to operate the device according to specification. The Sidestream Plus is a breath-enhanced nebulizer and works utilizing the same operating principles as the Ventstream (K933535), the Pari LC Star (K963924) and the Pari LC + (K935540).

The provided text does not contain detailed information about acceptance criteria and the study that proves the device meets those criteria, as typically found in comprehensive medical device studies. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical or performance study with specific acceptance criteria and outcome metrics.

The document states that the "Sidestream Plus is a Class II device. It is a breath-enhanced reusable nebulizer to be used with a compressor that is capable of providing appropriate air pressure and flow to operate the device according to specification." It also mentions that it "works utilizing the same operating principles as the Ventstream (K933535), the Pari LC Star (K963924) and the Pari LC + (K935540)."

Without a dedicated section detailing performance criteria and a study to meet them, I cannot populate the requested tables and information. The 510(k) process primarily relies on demonstrating equivalence through design, operating principles, and intended use as compared to legally marketed predicate devices, along with some basic performance testing, which is generally not detailed in the summary itself.

Therefore, many of the requested fields cannot be filled based on the provided text.

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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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