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The Flaem Nuova RF6 Basic and RF6 Plus Nebulizers are reusable single patient use nebulizers which are used where a fine aerosol mist of medication must be delivered to a patient for the treatment of respiratory disorders. The Flaem Nuova RF6 Basic and RF6 Plus Nebulizers are intended to be used for both adult and pediatric patients who have been prescribed inhalation therapy or medication in both home health care and hospital use. The Flaem Nuova RF6 Basic and RF6 Plus Nebulizers may be used with compressed air or an air gas source providing air flow between 4 to 10 lmin.

The Flaem Nuova RF6 Basic and RF6 Plus Nebulizers are hand-held, reusable, single patient use and pneumatically powered nebulizers. Both devices are made using similar materials and are used by patients with the same accessories set (mouthpiece, masks etc ... ). The primary difference between the two devices is that the RF6 Plus is equipped with inspiration and expiration valves while the RF6 Basic is not.

Here's a breakdown of the acceptance criteria and study information for the Flaem Nuova RF6 Basic and RF6 Plus Nebulizers, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Test Set Sample Size: Not specified. The document states "bench tests presented" but does not give specific numbers of nebulizer units or test runs.
   • Data Provenance: Not explicitly stated, but given that Flaem Nuova is based in Italy, the testing was likely conducted in Europe, possibly Italy, and the data was submitted to the FDA in the US. The term "bench tests" implies laboratory conditions.

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

   • Number of Experts: Not applicable. This study primarily involved "performance tests" and "bench tests" to evaluate physical device parameters (MMAD, FPF, DD, DDR). These are objective measurements, not subjective evaluations requiring expert consensus for ground truth.
   • Qualifications of Experts: Not applicable.

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

   • Adjudication Method: Not applicable. The performance evaluation was based on objective physical measurements, not human interpretation that would require an adjudication process.

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:

   • MRMC Study: No. This document describes the testing of a medical device (nebulizer), not an AI algorithm for diagnostic imaging or similar applications. Therefore, an MRMC study is not relevant to this submission.
   • Effect Size: Not applicable.

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

   • Standalone Study: Not applicable. This is not an AI algorithm. The performance tests ("bench tests") are a form of standalone testing for the device's technical specifications.

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

   • Type of Ground Truth: The ground truth for this study was established through objective physical measurements and standardized testing procedures for nebulizer performance parameters (MMAD, FPF, DD, DDR). The comparison was made against the published or known performance of the predicate devices.

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

   • Ground Truth Establishment for Training Set: Not applicable. This device is not an AI/ML algorithm.

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The nebulizer compressors Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, FJ03, and Q03 are intended to provide a source of compressed air for medical purposes, to be used in home health care and hospital use. The Walkie-Neb model is intended to be used only in home health care.

These devices are indicated for use with all commercially available small volume pneumatic nebulizers, to produce a fine aerosol mist of medication for respiratory therapy, for both adult and pediatric patients who have been prescribed inhalation therapy or medication.

The nebulizer compressors Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb. FJ03, Q03 and Walkie-Neb are a family of nebulizer compressors intended to be used as compressed air generators for pneumatic nebulizers used by patients for aerosol therapy. There are 7 model families with an AC powered motor (Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, FJ03, and Q03) and one model with a DC low voltage motor (Walkie-Neb), with a rechargeable battery pack and an external charger/power supplier.

The 7 AC model families have different plastic housings, which define the model name of the product. Inside they have the same compressor but with different electrical motors, to provide different pneumatic performances.

Here's an analysis of the provided 510(k) summary regarding the nebulizer compressors, focusing on acceptance criteria and the study proving device performance:

1. Acceptance Criteria and Reported Device Performance

For this device, the acceptance criteria are not explicitly stated as numerical thresholds (e.g., "sensitivity must be >90%"). Instead, the core acceptance criterion for these nebulizer compressors is substantial equivalence to their predicate devices based on equivalent operating flow rate and pressure. The study demonstrates this equivalence through performance tests.

• Flaem Nuova compressors (Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, FJ03, Q03 and Walkie-Neb): Have the same performance, safety, and EMC requirements as the predicate devices.
• AC Flaem Nuova compressors (series F700): Have the identical operating pressure and flow ranges as the Respironics Mister Neb compressor (K013027).
• AC Flaem Nuova compressors (series F1000 and F1500): Have the identical operating pressure and flow ranges as the Healthdyne Inc. NEBULIZER SYSTEM compressor (K922623).
• Walkie Neb Model: Has equivalent operating pressure and flow ranges to the Respironics Mister Neb compressor (K013027). |
  | Intended Use: The new devices must have the same or equivalent intended use as the predicate devices. | Achieved Equivalence:
• The Flaem Nuova compressors and the predicate devices (explicitly mentioning Salter Labs, Salter Aire Compressor, K992285) are indicated for the same intended use.
• The new devices are intended to provide a source of compressed air for medical purposes, for use with pneumatic nebulizers to produce aerosol mist for respiratory therapy in adult and pediatric patients. This aligns with typical nebulizer compressor intended uses. |
  | Technology/Design: The new devices' technological characteristics should be substantially equivalent to the predicate devices. | Achieved Equivalence:
• AC and DC power supply: Same as predicate devices.
• Internal Compressor (for AC models F700, F1000, F1500) and electrical motors: Identical or very similar to specific predicate devices, leading to identical performance.
• Walkie Neb: Mechanical configuration, batteries, charging system, and accessories are substantially equivalent to Invacare Portable Desktop (K042483). |

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

The document does not specify a "test set" in the context of clinical trials involving human subjects or a defined set of performance measurements on a specific number of units in a population study. The performance tests are described as in-house laboratory engineering tests performed by Flaem Nuova on their own devices.

• Sample Size: Not specified quantitatively. It likely refers to testing individual units of each model family (Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, FJ03, Q03, and Walkie-Neb) rather than a statistically significant sample size of manufactured devices.
• Data Provenance: The tests were conducted by Flaem Nuova, the manufacturer, in Italy. The data is thus retrospective in the sense that it's based on tests already completed on their devices. It is not clinical data from patients.

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 the measured physical performance (flow rate and pressure) of the devices, compared against the known specifications or performance of the predicate devices. This does not involve expert interpretation or subjective assessment of clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable. Since there is no expert interpretation or human assessment of results where discrepancies might occur, no adjudication method (like 2+1, 3+1) is needed. The performance is measured objectively.

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

No, an MRMC comparative effectiveness study was not performed. This type of study would involve human readers (e.g., clinicians) assessing cases both with and without AI assistance, which is not relevant for a nebulizer compressor. The submission explicitly states: "Clinical data were not required."

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

This question is not applicable as the device is a physical medical device (nebulizer compressor), not an AI algorithm. Its performance is inherent to its mechanical and electrical design, not dependent on an algorithm's output.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on engineering performance specifications and comparative measurements. Specifically:

• The "Reviewer guidance for nebulizers, metered dose inhalers, spacers and actuators" issued in October 1993, which outlines the expected performance parameters for such devices.
• The known operating flow rate and pressure of the identified predicate devices. The new devices' measurements were compared directly against these established values to demonstrate equivalence.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of machine learning for this physical device. The device's design and manufacturing are based on engineering principles, not an iterative learning process from a dataset.

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

This information is not applicable as there is no training set for a physical nebulizer compressor.

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