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The InnoSpire Go is a vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (2 years and older), defined by the prescribed medication, and adults patients in the home environment or in a hospital/clinic setting.

The InnoSpire Go nebulizer is a small, handheld, internally powered nebulizer which utilizes vibrating mesh technology to generate aerosol.

The provided document describes the InnoSpire Go nebulizer's acceptance criteria and the study that proves it meets those criteria, primarily through comparison to a predicate device, the Aerogen AeroNeb Go.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct pass/fail thresholds but are implied through the comparison to the predicate device's performance, aiming for "substantially equivalent" results. The study demonstrates that where differences exist, the InnoSpire Go either performs comparably or better, particularly in delivering a higher total respirable dose or having smaller particle sizes.

The general acceptance criterion is "substantially equivalent" to the predicate device (Aerogen AeroNeb Go), meaning that any differences do not raise new questions of safety or effectiveness. The discussion sections confirm that where statistically significant differences were found, the InnoSpire Go either provided a higher Total Dose, smaller particle size (MMAD and GSD), or larger Total Respirable Dose, all of which are considered beneficial or at least not detrimental, thus supporting substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the number of samples (e.g., number of nebulizers tested for performance) for each test. However, the performance tables provide "mean and 95% confidence interval," which implies that multiple measurements were taken for each drug and parameter. The nature of these tests (aerosol performance) suggests they are conducted in a controlled lab environment.

• Sample Size: Not explicitly stated as a single number of devices. The "mean and 95% confidence interval" for each parameter suggests statistical analysis from multiple runs/samples.
• Data Provenance: The tests are "Bench Testing" (Non-clinical performance testing). The document does not specify country of origin for the performance test data itself, but the company is "Respironics Respiratory Drug Delivery (UK) Ltd." The tests are prospective in the sense that they are specifically conducted to compare the new device to the predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable. The study is a bench performance test comparing aerosol characteristics of device-generated output to a predicate device, not an evaluation requiring human expert interpretation or a "ground truth" derived from clinical experts (like radiologists for image analysis). The "ground truth" here is the physical measurement of aerosol particles and drug delivery.

4. Adjudication Method for the Test Set

This section is not applicable. There is no human adjudication process described, as the test involves objective physical measurements of aerosol properties by instruments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This document describes the 510(k) premarket notification for a nebulizer, which involves laboratory performance testing and comparison to a predicate device, not a clinical trial involving human readers or cases. Therefore, no effect size of human readers improving with or without AI assistance is reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This is also not applicable. The device is not an AI/algorithm-driven system. It is a physical medical device (nebulizer). The "standalone" performance here refers to the device's technical specifications and aerosol output in a laboratory setting, which is precisely what the performance tables (Tables 3 & 4) describe.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance tests (Tables 3 & 4) is objective physical and chemical measurements of aerosol characteristics and drug concentration. This includes:

• Delivered dose of drug (µg)
• Mass median aerodynamic diameter (MMAD in µm)
• Geometric standard deviation (GSD)
• Particle size fractions (e.g., fine particle fraction <5 µm, coarse particle fraction >5 µm, respirable fraction 1-5 µm, ultra-fine particle fraction <1 µm)
• Corresponding doses for these particle fractions.

These are quantitative measurements, not subjective evaluations or clinical outcomes.

8. The Sample Size for the Training Set

This is not applicable. This is a medical device submission based on predicate device comparison and bench testing, not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set was Established

This is not applicable, as there is no training set mentioned or required for this type of device submission.

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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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