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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)

Study Details (Based on available information)

1. 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.

2. 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.).

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

   • Not applicable.

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:

   • Not applicable. This device is a physical aerosol drug delivery system, not an AI/ML diagnostic or assistive tool.

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

   • Not applicable.

6. 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.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set.

8. 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.

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The Healthline RediNeb® Small Volume Medication Nebulizer (SVN) is indicated to aerosolize medication approved for nebulization by a physician. The Healthline RediNeb® Medication Nebulizer is intended for adult and pediatric patients consistent with the indications for aerosolized medication to or through the patient's pulmonary system.

The RediNeb® Nebulizer device 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 RediNeb® is basically a miniaturized jet nebulizer, functioning very similarly to both of the predicate devices. Physical differences are that the maximum fill volume is 3 ml versus 6ml and design is such that the RediNeb® can be incorporated with breath enhanced features of a manifold delivery body. The RediNeb® nebulizer, though very small in size (creating minimal waste if used once and discarded), is fabricated of polymers such that it may be properly cleaned for reuse multiple times.

The provided text is a 510(k) Premarket Notification for a medical device called the RediNeb® Small Volume Medication Nebulizer. This document describes the device, its intended use, and its substantial equivalence to predicate devices based on technological characteristics and performance specifications.

However, the information provided does not contain details about acceptance criteria, the study design, sample sizes for test or training sets, ground truth establishment, or any data related to AI or human reader performance. The document is a regulatory submission demonstrating substantial equivalence to already approved devices, primarily through comparison of key performance characteristics.

Therefore, I cannot fulfill all parts of your request as the information is not present in the provided text. I can, however, extract the acceptance criteria (which are implied by the predicate device's performance) and the reported device performance.

Here's what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the performance of the predicate devices, which the RediNeb® is claiming substantial equivalence to. The study involved comparing the characteristics of the RediNeb® to two predicate devices: the Salter NebuTech and the Medi/Nuclear Neb-3A SVN.

2. Sample size used for the test set and the data provenance:

• Sample Size for the Test Set: Not specified. The document doesn't detail a "test set" in the context of clinical trials or data analysis. The comparison is based on device specifications and performance characteristics, likely measured in a laboratory setting.
• Data Provenance: Not specified. The data provided is a summary of technical specifications and performance measurements, not clinical data from patients or a retrospective/prospective study.

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

• Not applicable. This device is a nebulizer, a mechanical device. The "ground truth" here relates to its physical and functional performance, not interpretations that require expert consensus (like medical imaging).

4. Adjudication method for the test set:

• Not applicable. (See #3 explanation).

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 document pertains to a mechanical medical device (nebulizer), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies or AI involvement are not relevant.

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

• Not applicable. (See #5 explanation).

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

• The "ground truth" for this device's performance are the physical and functional specifications (e.g., particle size, aerosol generation rate, gas flow rate) measured and verified, likely through standard engineering and laboratory testing methods for nebulizers.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

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

• Not applicable. (See #8 explanation).

In summary, the provided document describes a regulatory submission for a medical device, focusing on its substantial equivalence to existing devices based on technical specifications rather than clinical trials or AI-related performance metrics.

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The Neb-90™ Large Volume Medication Nebulizer is indicated for the continuous aerosol administration of respiratory medication (inhalable solution) including, but not necessarily limited to, beta adrenergic bronchodilator (albuterol sulfate) and/or a wetting agent such as sodium chloride solution (saline) that is used for the treatment of respiratory and related diseases and conditions including, but not necessarily limited to asthma, COPD, bronchiolitis and cystic fibrosis. The Neb-90™ Large Volume Medication Nebulizer is for use in hospital Emergency Department, ICU or other similar settings for delivery of aerosolized medication to patients undergoing severe respiratory distress.

The Nebulizer is a single patient/single use device which is filled with a fluid, typically respiratory medication and connected to a gas source via flexible tubing. The nebulizer works by Pavipng a cluid come into contact with the stream of gas. The gas shatters the liquid into small particles. These particles then impact a baffle that further reduces the size of the particles. The majority of the larger particles settle inside the nebulizer as a result of gravity and inertia, returning the mist to liquid to repeat the nebulization process. The smaller particles are then administered as the patient inhales. The treatment is completed when the majority of liquid has been nebulized.

The provided text describes a 510(k) summary for the Neb-90™ Large Volume Medication Nebulizer but does not include any acceptance criteria or details of a study demonstrating the device meets such criteria.

The document states that the Neb-90™ is a single-patient/single-use device for the continuous aerosol administration of respiratory medication. It also mentions that "Specific issues, as mentioned in 'CDRH Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators; October 1, 1993' are addressed herewith," but the document does not elaborate on what these issues are or how they were addressed with data.

Therefore, based on the provided input, I cannot generate the requested table or answer the questions regarding acceptance criteria and study details. The 510(k) summary focuses on device description, predicate devices, general device characteristics, and the FDA's clearance letter, but it omits the specific performance data and acceptance criteria that would typically be found in a study report.

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