(85 days)
The MEDICATOR®/RediNeb® Aerosol Drug Delivery System is indicated to aerosolize medication approved for nebulization and prescribed by a physician. This Healthline MEDICATOR®/RediNeb® Aerosol Drug Delivery System is intended for adult and pediatric patients consistent with the indications for delivery of aerosolized medication to/or through the patient's pulmonary system.
The MEDICATOR®/RediNeb® Aerosol Drug Delivery System is for patient use in all areas where the administration of medication by aerosol means is warranted. This includes hospital/institutional settings, home care use, schools, and long term care facilities.
The MEDICATOR®/RediNeb® Aerosol Drug Delivery System is a miniaturized nebulizer attached to a valved manifold. During patient inhalation, aerosol mist being generated from the nebulizer is substantially increased through Breath-Enhancement technology, and configuration is such that a filter can be added to the air exit port if so desired.
The provided text does not contain a study with detailed acceptance criteria and performance results in the format typically used for AI/ML device evaluations. The document is a 510(k) summary for a medical device (nebulizer) that demonstrates substantial equivalence to a predicate device.
However, I can extract the "acceptance criteria" by interpreting the comparison table provided, where the new device's performance is compared against a predicate device. The "acceptance criteria" here implicitly refer to the performance of the predicate device, as the new device aims to be substantially equivalent.
Here's the information extracted and formatted to best fit your request, acknowledging the limitations of the provided document for AI/ML study details:
Acceptance Criteria and Device Performance (Interpreted from Substantial Equivalence Comparison)
Acceptance Criteria (Implied by Predicate Device Performance)
| Feature or Specification | Acceptance Criteria (Predicate PARI LC-Star) | Reported Device Performance (Healthline MEDICATOR®/RediNeb®) |
|---|---|---|
| Particle Size (MMAD) | 2.0 um | 1.5 um |
| Aerosol Generation Rate (static) | 0.26 ml/min. | 0.23 ml/min. |
| Aerosol Generation Rate (enhanced) | 0.38 ml/min. | 0.42 ml/min. |
| Dead Volume | 1.0 ml | 0.72 ml |
| Drive Gas/Flow Rate | 6-8 LPM (Air/Oxygen) | 6-8 LPM (Air/Oxygen) |
| Intended Use | Same | Same |
Study Details (Based on available information)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This document does not describe a "test set" or clinical study in the context of AI/ML performance evaluation. The data presented is likely derived from laboratory testing of the nebulizer's physical and performance characteristics.
- No information on data provenance (country, retrospective/prospective) is provided.
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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. This is not an AI/ML device that relies on expert interpretation for ground truth. The "ground truth" here would be objective measurements of physical properties (particle size, flow rate, etc.).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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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:
- Not applicable. This device is a physical aerosol drug delivery system, not an AI/ML diagnostic or assistive tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the performance characteristics listed (e.g., particle size, aerosol generation rate) would be established through objective laboratory measurements using established test methods for nebulizers.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable.
Summary of Testing Statement from the Document:
"All materials used in the fabrication of the Healthline MEDICATOR®/RediNeb® Aerosol Drug Delivery System is currently in use in the manufacture of similar nebulizer devices and have FDA approval for this type application."
Interpretation: The "study" proving the device meets the acceptance criteria is a comparison of its performance specifications (Particle Size, Aerosol Generation Rate, Dead Volume, Drive Gas/Flow Rate, Intended Use) against a legally marketed predicate device (PARI LC Star Nebulizer). The implication is that if these key performance metrics are sufficiently similar or improved, the device is considered substantially equivalent and meets the necessary criteria for market entry. This is a common approach for 510(k) clearances of non-AI/ML medical devices.
§ 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).