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The intended purpose of the I-neb Insight AAD System is that is it is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medication approved for use with the I-neb AAD System for inhalation by the patient in the acute care, nursing home, sub-acute institution, or hospital environment.

The I-neb Insight AAD System is a portable, single patient use, reusable, ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medication (Vibrating Thesh) nebuilder System for inhalation by the patient in the approved for ass mursing home, sub-acute institution, or hospital environment. I-neb insight has a monitoring function and it provides feedback to both patient and clinician regarding different aspects of inhaled aerosol therapy. The I-neb insight is designed to be used by the clinician to display a patients THE I Theo InSight is adaly. And it can be used to aid the teaching of optimized breathing. It may also be used by the clinician to interrogate the I-Neb AAD AND AND AND AND Andress (RLC) which can provide the clinician with de breathing. It Thay also be used by the clinician provide the clinician with device System Patient Logging System (1 ES) Which can provide we was and the make information that they need to

The provided document is a 510(k) Premarket Notification for the I-neb Insight AAD System. It states that "Design verification tests were performed on the I-neb Insight AAD System as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria, confirming the safety and effectiveness of the device." However, the document does not provide a table of acceptance criteria nor the reported device performance for these tests. It also does not detail a specific study that proves the device meets acceptance criteria in the manner requested (e.g., with detailed statistics, sample sizes, ground truth establishment, etc.).

Based on the provided information, I can address the following points:

1. A table of acceptance criteria and the reported device performance: This information is not provided in the document. The document only generally states that "All tests were verified to meet the required acceptance criteria."

2. Sample size used for the test set and the data provenance: This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided in the document.

4. Adjudication method for the test set: This information is not provided in the document.

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: This information is not provided in the document. The device is a nebulizer system, and the document focuses on its mechanical and software aspects, not on AI-driven diagnostic or interpretative capabilities that would typically be evaluated in an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not provided in the document.

7. The type of ground truth used: This information is not provided in the document.

8. The sample size for the training set: This information is not provided in the document.

9. How the ground truth for the training set was established: This information is not provided in the document.

The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices based on:

• Same intended use.
• Same operating principle.
• Same technology.
• Same manufacturing process.

It also notes compliance with "Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices," indicating some level of software verification was conducted, but the specifics of that verification (e.g., acceptance criteria, test results) are not included in this summary.

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The intended purpose of the I-neb AAD System is that is it is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medication approved for use with the I-neb AAD System for inhalation by the patient in the home care, nursing home, sub-acute institution, or hospital environment.

The I-neb AAD system is a portable, single patient use, reusable, ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medication approved for use with the I-neb AAD System for inhalation by the patient in the home care, nursing home, sub-acute institution, or hospital environment.

The I-neb AAD system consists of a hand-piece containing:-

• an ultrasonic horn (to vibrate the mesh) .
• a pressure transducer, (to monitor patient breathing) .
• a microprocessor (to calculate aerosol pulse time based on breathing pattern) ●
• a medication chamber (to hold the medication) .
• a porous mesh (to create aerosol and determine particle size). .
• a mouthpiece, which includes a bi-directional flap valve (to guide aerosol to the patient) .
• a disc, which has a bi-directional, inductively coupled, Rf transponder (to enable fine . tuning operational parameters to be sent to the device).

The I-neb AAD system incorporates the vibrating mesh technology developed and utilized in Omron's ultrasonic nebulizers, and the Adaptive Aerosol Delivery (AAD) technology developed and utilized by Profile's AAD system jet nebulizers.

The vibrating mesh technology creates a low velocity aerosol by squeezing the liquid medication through 5-6,000 separate 3 micron holes during each vibration, creating thousands of droplets. the AAD technology is based on sensitive pressure transducers, microprocessors and firmware which together analyses a patient's breathing pattern and determines the appropriate aerosol wilse time to ensure that medication is only delivered during patient inspiration. The length of each pulse of aerosol is calculated based on the measured inspiration time of the r ne single or breaths and the I-neb continues to monitor the breathing pattern throughout provious into creatis any changes in the breathing pattern. When the appropriate dose of medication has been delivered, the system indicates that the treatment is complete.

The provided document does not contain information about specific acceptance criteria, a study proving the device meets these criteria, or any of the detailed aspects like sample sizes, expert qualifications, or MRMC studies that would be expected for such a description.

The document is a 510(k) Premarket Notification for the I-neb AAD System, primarily focusing on establishing substantial equivalence to predicate devices. It describes the device, its intended use, and compares its attributes and differences with existing legally marketed nebulizers (Prodose AAD System, Halolite AAD System, and NeU04).

Therefore, I cannot provide the requested table and study details as they are not present in the provided text.

The document confirms that:

• Device Name: I-neb AAD System
• Intended Use: An ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medication approved for use with the I-neb AAD System for inhalation by the patient in the home care, nursing home, sub-acute institution, or hospital environment.
• Regulatory Status: The FDA reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices. This allows the device to be marketed.

However, specific performance acceptance criteria (e.g., aerosol particle size distribution, drug delivery efficiency, dosage accuracy) and details of a study demonstrating compliance with such criteria are not included in this summary of safety and effectiveness or the accompanying FDA approval letter. These details would typically be found in test reports, which are not part of this submission summary.

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A jet nebulizer system designed to aerosolize commonly prescribed liquid medication (except pentamidine) for inhalation by the patient in the home care, nursing home, sub-acute institutions or hospital environment.

The Prodose AAD system is a single patient reusable portable pneumatic jet nebulizer, designed to deliver a precise and reproducible dose of aerosolized liquid medication. The device consists of a base unit containing a dedicated air compressor and a hand-piece containing a pressure or a base ann versant control system, a medication chamber, a baffle, and a mouthpiece. The pre-set dose volume is stored on a disc, which has a bi-directional inductively coupled transponder with data storage capacity in a non-volatile memory (EEPROM) embedded in the disc.

The Prodose AAD system analyses the patient's breathing pattern to determine the acrosol pulse time. The system then pulses aerosol during patient inspiration only. The length of each pulse of acrosol is calculated according to the measured inspiratory time. Prodose continues to monitor the breathing pattern throughout treatment in order to adapt to changes in the breathing pattern. When the pre-set dose of medication has been delivered, the system indicates that the treatment is complete.

The provided text describes the Prodose AAD System, a jet nebulizer. However, it does not contain a study section that outlines acceptance criteria, device performance, sample sizes, ground truth establishment, or any comparative effectiveness studies.

The document is a premarket notification (510(k)) that focuses on establishing substantial equivalence to predicate devices. It describes the device, its intended use, and compares its attributes and differences to a legally marketed predicate device (HaloLite AAD System).

Therefore, I cannot provide the requested information from the given text as the detailed study data is absent.

What the document does provide:

• Device Description: The Prodose AAD system is a single-patient reusable portable pneumatic jet nebulizer designed to deliver a precise and reproducible dose of aerosolized liquid medication. It analyzes the patient's breathing pattern to pulse aerosol only during inspiration.
• Intended Use: Aerosolize commonly prescribed liquid medication (except Pentamidine) for inhalation by patients in home care, nursing homes, sub-acute institutions, or hospitals.
• Differences from Predicate Device (HaloLite AAD System):
  • LCD graphic display vs. flashing LED lights for visual feedback.
  • Microprocessor disc stores pre-set dose information vs. colored buttons.
  • Internal DC supply from mains power vs. internal replaceable 9-volt battery.
  • Able to supply longer aerosol pulses into long inhalation cycles, shortening treatment times.
  • Utilizes a larger number of data points to compensate for inhalation airflows.

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