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The I-neb AAD system with TIM is a nebulizer system designed to aerosolize liquid medication for inhalation by the patient in the home care, nursing home, sub-acute institution, or hospital environment.

The I-neb Insight AAD System is monitoring software that provides feedback to the patient recording treatment events, including treatment times and compliance data which is also available to the clinician. It is an accessory to an accessory for use with the I-neb AAD system.

The I-neb AAD system with TIM is intended for patients 3 years and older who can coordinate breathing.

The I-neb AAD System is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medication (except pentamidine) for inhalation by the patient in the home care, nursing home, sub-acute institution, or hospital environment.

The I-neb Insight AAD System is an accessory for use with the I-neb AAD system and controls monitoring software that provides feedback to the patient recording treatment events, including treatment times and compliance data which is also available to the clinician.

The I-neb AAD system with TIM incorporates a modification of the predicate I-neb AAD system with (tidal breathing mode (TBM)), K042991. While the I-neb Insight incorporates updated software to accommodate the added TIM feature, it is a modification of the predicate I-neb Insight AAD System, K052941.

The provided text describes a 510(k) summary for the I-neb AAD Systems with TIM and I-neb Insight AAD System. The primary method for demonstrating substantial equivalence is through comparative bench testing against predicate devices. The document does not describe a study in the context of AI/ML device performance, as it is a medical device from 2011, long before the widespread use of AI in medical imaging. Therefore, many of the questions related to AI device performance are not applicable.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to existing predicate devices (K062263 – Omron U-22, K870027 - Salter 8900 nebulzier, K072019 - Activaero - AKITA2 APIXNEB, K042991 - I-neb AAD, K052491 - I-neb Insight). The "acceptance criteria" are not explicitly stated as numerical thresholds but rather as the proposed device exhibiting comparable performance characteristics to the predicates in specific areas.

Study Details:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • The document mentions "3 drugs" were used for particle characterization.
   • The testing was "performed at flow rates of 15 lpm and 30 lpm."
   • The sample sizes for "comparative dosing" are not explicitly stated, but it was done between the I-neb AAD system in TBM vs. TIM mode and compared to Omron U22 and Salter 8900.
   • This was bench testing, not human clinical data. Therefore, the concept of "country of origin for data" or "retrospective/prospective" human data does not apply here.

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 submission relies on bench testing, not expert-adjudicated ground truth from human data for AI/ML performance.

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

   • Not applicable. This was bench testing, not a human consensus or adjudication study.

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

   • No. This is a 2011 submission for a nebulizer, not an AI/ML diagnostic tool. An MRMC study was not conducted, nor would it be relevant for this device.

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

   • Not applicable. This device is a nebulizer system, not an AI algorithm.

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

   • The "ground truth" for this submission are the performance specifications and characteristics of the predicate devices, against which the proposed device's bench test results (e.g., MMAD, GSD, gravimetric dose) were compared to demonstrate substantial equivalence.

7. The sample size for the training set

   • Not applicable. This device does not involve an AI/ML algorithm requiring a training set.

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

   • Not applicable. This device does not involve an AI/ML algorithm.

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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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