(287 days)
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
| Parameter | Acceptance Criteria (Implicit) | Reported Device Performance (Flaem Nuova RF6 Basic & Plus) |
|---|---|---|
| MMAD (Mass Median Aerodynamic Diameter) | Equivalent to predicate devices | Equivalent to predicate devices |
| FPF (Fine Particle Fraction) | Equivalent to predicate devices | Equivalent to predicate devices |
| DD (Deposited Dose) | Equivalent to predicate devices | Equivalent to predicate devices |
| DDR (Deposited Dose Rate) | Equivalent to predicate devices | Equivalent to predicate devices |
Study Details
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).