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The intended use of the Happyneb II. Happyneb III. Speedy, Nebby Plus and the Myneb is to spray liquids in aerosol form into gases that are delivered directly to adult or pediatric patients who have been prescribed inhalation therapy or medication. Each of these devices must be used exclusively with their own nebulizer and mouthpiece.

The devices Happyneb II, Happyneb III, Speedy, and the Nebby Plus are intended to be used primarily by patients in the home care market, although they may also be used by trained hospital staff personnel as well. The Myneb model is intended to be used only in home health care.

The Happyneb II, Happyneb III. Speedy, Nebby Plus and the Myneb are intended for multiple use, are non-sterile and for use with pharmaceutical products which are under physician prescription.

The family of 3A Health Care nebulizers include 5 different devices: 4 are AC powered devices (Happyneb II, Happyneb III, Speedy, Nebby Plus) and one model (Myneb) with a DC motor, a rechargeable battery pack and an external charger/power supplier.

The 4 AC compressors (Happyneb II, Happyneb III, Speedy, and Nebby Plus) have different plastic housings. There are three different types of electrical motors for AC models and one type for the DC model (Myneb). The 5 models of compressors are designed to use two nebulizers, the Fasterjet and Nebjet.

The provided text is for a 510(k) Summary for nebulizers. Nebulizers are medical devices used to deliver medication to the respiratory system. The submission focuses on demonstrating substantial equivalence to predicate devices based on performance bench tests, not on diagnostic accuracy or clinical outcomes as would be typical for many AI-powered medical devices. Therefore, many of the requested categories related to AI performance, expert review, and clinical studies are not applicable or not detailed in this document.

Here's an analysis based on the provided text:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The acceptance criteria for these nebulizers are based on demonstrating equivalent performance parameters to legally marketed predicate devices through non-clinical bench tests. The study performed aimed to show this equivalency.

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 a "sample size" in the context of patients or data points, as the testing was non-clinical performance bench tests. The data provenance is from 3A Health Care Srl, the submitter, and the tests were executed as requested in the "Reviewer guidance for nebulizers, metered dose inhalers, spacers and actuators" issued in October 1993. These were prospective bench tests conducted on the newly designed nebulizer models.

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

Not applicable. This was a non-clinical bench test study evaluating physical performance parameters of a medical device, not a diagnostic or AI-powered system that requires expert interpretation to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable. As stated above, this was a bench test, not a study requiring adjudication of expert opinions or interpretations.

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

No. This was not an MRMC study. The comparison was device-to-device (new nebulizer models to predicate nebulizer models) based on physical performance parameters, not an evaluation of human reader performance with or without AI assistance.

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

Not applicable. This device is a nebulizer, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the established performance benchmarks and specifications for nebulizer characteristics (MMAD, GSD, FPF, PFD) as defined by regulatory guidance and demonstrated by legally marketed predicate devices. The new devices' performance was measured and compared against these established physical and functional parameters.

8. The Sample Size for the Training Set

Not applicable. This document describes a medical device, not an AI model, and therefore there is no concept of a "training set" for an algorithm.

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

Not applicable. As there is no training set, this question is not relevant to the provided document.

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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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The eFlow is a handheld nebulizer that will be used with patients for whom doctors have prescribed medication for nebulization. The eFlow is intended for adult and pediatric patients.

The PARI eFlow™ is a small, single patient use, reusable electronic nebulizer for the inhalation treatment of aerosol medications. It is a hand-held device containing a capped medication cup that can be filled by the user. Power input is provided by cither 4 AA batteries, a DC adapter or an AC adapter. Alternate power cords/plugs/adapters allow use in any country.

This 510(k) submission for the eFlow™ Electronic Nebulizer does not contain a study proving the device meets specific acceptance criteria in the way described in your request.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical testing. It explicitly states that clinical testing was not completed/is not required to show substantial equivalence.

Therefore, I cannot fill out the requested table for acceptance criteria and reported device performance, nor can I provide information on sample sizes for test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance. These types of studies are not part of this 510(k) submission for this particular device.

Here's a breakdown of what is provided, addressing your points where possible, and clearly indicating when information is absent based on the provided text:

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

• Not applicable. The submission does not define specific acceptance criteria (e.g., a "target accuracy of 90%") or report performance against such criteria. It makes comparative statements against predicate devices.

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

• Not applicable. No clinical test set details are provided as no clinical testing was performed for substantial equivalence demonstration. The "test set" described relates to non-clinical engineering performance.

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)

• Not applicable. No expert ground truth establishment method is described for this submission's non-clinical testing.

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

• Not applicable. No adjudication method is described for this submission's non-clinical 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 is a medical device (nebulizer), not an AI-powered diagnostic or decision support system. Therefore, an MRMC study related to human reader improvement with AI assistance is irrelevant and not mentioned.

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

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

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

• Not applicable. For the non-clinical tests (MMAD, RF, TOR), the "ground truth" would be the measured physical properties of the aerosol generated by the device, as determined by standard laboratory methods. There is no mention of expert consensus, pathology, or outcomes data.

8. The sample size for the training set

• Not applicable. No training set for an algorithm is relevant or provided.

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

• Not applicable. No training set for an algorithm is relevant or provided.

Summary of Non-Clinical Test Findings (as provided):

The submission states: "EFlow was tested to compare performance to the predicate devices, including:"

• MMAD (Mass Median Aerodynamic Diameter): "eFlow MMAD is comparable to or lower than prodicate devices."
• RF (Respirable Fraction): "eFlow RF is comparable to or greater than predicate devices."
• TOR (Total Output Rate): "eFlow TOR is comparable to or greater than predicate devices."
• Safety/EMC (Electromagnetic Compatibility): "eFlow meets the requirements of EN/IEC 60601-1, DIN EN 60601-2 and UL 1431."

The conclusion from these tests is: "eFlow meets performance requirements and raises no new issues of safety or effectiveness." This demonstrates "substantial equivalence" as required for a 510(k) submission, rather than meeting acceptance criteria for a specific clinical performance claim.

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