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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 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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