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The HOMED Mesh Nebulizer is an ultrasonic vibrating mesh nebulizer system designed to aerosolize physician-prescribed liquid medications for inhalation to a patient except for Pentamidine. The device may be used with patients 5 years and older in the home, hospital, and sub-acute care settings.

The HOMED Mesh Nebulizer is a small, handheld, internally powered general purpose nebulizer which utilizes vibrating mesh technology to generate aerosol.

The document provided outlines the K170886 510(k) premarket notification for the HOMED Mesh Nebulizer, comparing it to a predicate device, the Omron NE-U22 (K062263). The study described focuses on demonstrating substantial equivalence, primarily through non-clinical performance testing related to aerosol particle characterization, rather than human-in-the-loop clinical studies.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the HOMED Mesh Nebulizer are primarily established through comparative testing against a predicate device (Omron NE-U22). The goal is to demonstrate "substantial equivalence" in terms of performance and safety.

1. Table of Acceptance Criteria and Reported Device Performance

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The Breeze Nebulizer (NBR-101) is a vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (ages 2 years old and above) and adult patients in the home. It is not intended for use with Pentamidine.

Breeze Nebulizer (NBR-101) is a vibrating mesh nebulizer that delivers aerosolized medication to the lower respiratory tract by using a vibrating mesh to create aerosol and provide fine particles to the patient's lungs. It is similar to the predicate device, the FDA-cleared Model NE-U22 Micro Air Vibrating Mesh Nebulizer, cleared under 510(k) K062263. They are identical in purpose, function, core technology and method of operation.

Breeze nebulizer (NBR-101) is a portable size, curvaceous body design that is convenient to hold, and ability to detect the amount of medications available and to turn off automatically. The open button is made of soft materials and gives off an ice blue light, coupled with an overall elegant white exterior.

Breeze Nebulizer (NBR-101) is battery powered, 4 "AAA" and the dimensions is 58(W) X 145(H) X 70(D). The medication container capacity is 8ml maximum and the residual volume is approximately 0.1ml.

This document describes the 510(k) premarket notification for the Breeze Nebulizer (NBR-101), specifically focusing on its substantial equivalence to a predicate device rather than a study demonstrating it meets specific clinical performance acceptance criteria. As such, information regarding AI, ground truth, sample sizes for training/test sets, or expert involvement in establishing ground truth is not applicable.

The core of the submission relies on non-clinical testing to demonstrate safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various standards and regulations applied for different testing items. The reported performance is generally stated as meeting the requirements of these standards. Specific numerical acceptance criteria or detailed performance metrics are not provided in this summary.

The document also provides a comparative table of characteristics between the proposed device and the predicate device, highlighting their similarities and differences. While this is not "acceptance criteria" in the traditional sense, it demonstrates how the device's characteristics are compared against a legally marketed device.

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

The document does not specify a "test set" in the context of a clinical performance study. The studies mentioned are non-clinical (bench tests, safety tests), and the sample size for these engineering and regulatory compliance tests is not provided in this summary. The data provenance is from digiO2 International Co., Ltd. in New Taipei City, Taiwan, performing internal non-clinical testing. These are assumed to be prospective tests conducted for the purpose of the 510(k) submission.

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

Not applicable. This is a submission for a medical device that relies on non-clinical engineering and regulatory compliance testing rather than clinical data or expert-derived ground truth.

4. Adjudication method for the test set

Not applicable.

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 device is not an AI-powered diagnostic tool, and no MRMC study was performed.

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

Not applicable. This device is not an algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" implicitly refers to the specified performance parameters and safety limits defined by the referenced international standards (e.g., IEC 60601-1, ISO 10993, EN 13544-1). Compliance with these standards serves as the benchmark.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

Not applicable.

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The ultrasonic mesh nebulizer model NE105 is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient. The device may be used by adult and pediatric patients at the discretion of their physician at home, hospital &sub-acute care setting.

The Ultrasonic Mebulizer NE105 is similar to the predicate device, the FDA-cleared Model NE-U22 Micro Air Vibrating Mesh Nebulizer, cleared under 510(k) K062263. Similarities are that both, the NE105 and the predicate NE-U22, are identical in purpose, function, core technology and method of operation. They are single-patient use, reusable electronic nebulizers, using micro-perforated vibrating mesh technology to aerosolize liquid medications. They have the same 'Indication for Use' stating that they are for inhalation therapy by adults and pediatric patients in a home, hospital & sub-acute care setting. Both devices are hand-held and portable. Power input for both devices is provided by either AA batteries or an AC/DC adapter. The model NE105 incorporates several design differences in comparison with the predicate NE-U22, mainly body shape, dimension/weight, a larger capacity reservoir, power source and software controlled electronics.

The provided 510(k) summary for the Ultrasonic Mesh Nebulizer NE105 focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance data in a typical clinical trial format.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a nebulizer, the "acceptance criteria" are primarily based on demonstrating performance similar to the predicate device and compliance with relevant safety and performance standards. There isn't a direct table of clinical performance metrics like sensitivity/specificity. Instead, the performance is assessed through non-clinical tests.

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

• Sample Size for Test Set: The document does not specify a "sample size" in the context of human subjects or clinical data, as it explicitly states, "The NE105 did not conduct, nor rely upon, clinical tests to determine substantial equivalence." The testing described is primarily laboratory-based and engineering/design validation. For simulated lifetime testing, "an in-house 1000-cycle life test was performed," which could be considered a sample size for that specific test.
• Data Provenance: Not applicable as clinical data was not used for this submission. The tests were performed by various "testing laboratories" and "Piper Medical Lab," implying engineering/testing facilities. The submitter is from China.

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

Not applicable. This submission relies on objective engineering and laboratory test results against established standards and comparison to a predicate device, not subjective expert assessment of clinical data to establish a "ground truth."

4. Adjudication Method for the Test Set

Not applicable. There's no clinical test set requiring adjudication in this submission.

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 is a medical device for drug delivery (nebulizer), not an AI-powered diagnostic or interpretive device. Therefore, no MRMC or AI-assisted studies were performed or are relevant.

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

Not applicable. This device does not involve an algorithm for interpretation or diagnosis; it is a physical device for drug delivery.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Compliance with recognized standards: IEC 60601-1, IEC 60601-1-2, ISO 10993-1.
• Benchmarking against a predicate device: Specifically for aerosol characterization (particle size distribution and total medication dose delivered).
• Design validation tests: Ensuring the device meets its own specified design requirements (e.g., software functionality, cleaning effectiveness, simulated lifetime).

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a "training set."

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

Not applicable, as no training set was used.

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The Clever TD-7001 Nebulizer is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize physician-prescribed solution for inhalation by the patient, except for Pentamidine. The Clever TD-7001 Nebulizer is for use with children and adult patients in the homecare environment.

Clever TD-7001 Nebulizer is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize physician-prescribed solution for inhalation by the patient. It is for use with children and adult patients in the homecare environment. Clever TD-7001 Nebulizer consists of a Nebulizer unit, a medication cap and a Jand Medication cup are single medication cup. The Nebulizer unit, me patient re-usable. The Nebulizer unit trol circuitry and is powered by using 2 AA alkaline batteries organ A onnects to electrical outlets. The patient interface comprises a mouthpiê medication cap contains the metal alloy mesh. When the device is turne ultrasonic piezoelectric element vibrate to cause the mesh vibrate. ation solution tin the reservoir of medication cup is aerosolized by the vibrating the aerosols can be inhaled through the mouthpiece or mask.

Here's a breakdown of the acceptance criteria and study information for the Clever TD-7001 Nebulizer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for the test sets in the performance characteristic studies. It mentions "three drugs (Ipratropium bromide, Ventolin, and Cromolyn sodium)" were used for the aerosol characterization testing, implying at least three distinct test cases.

The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. It is, however, implied to be generated specifically for the submission of this device, suggesting prospective testing conducted by the manufacturer, TaiDoc Technology Corporation (Taiwan).

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 given text. For device performance testing of a nebulizer, "ground truth" would typically refer to objective measurements obtained from controlled laboratory conditions, rather than expert interpretation of data.

4. Adjudication Method for the Test Set

This information is not applicable/provided in the context of the described performance testing. The studies are objective measurements (e.g., particle size distribution, gas analysis) rather than subjective assessments requiring adjudication.

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

An MRMC comparative effectiveness study was not conducted. This type of study is typically relevant for AI-powered diagnostic imaging devices, not for a medical device like a nebulizer.

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

This concept is not applicable as the device is a nebulizer and does not involve an algorithm or AI. The performance tests described (aerosol characterization, airpath, materials, safety/EMC) are inherently "standalone" in the sense that they measure the device's physical and functional properties directly.

7. The Type of Ground Truth Used

The ground truth used for these studies is based on:

• Objective Measurement Standards:
  • For Aerosol Characterization: Comparison to the performance of a legally marketed predicate device (K062263) using established methods like Cascade Impactor, with statistical significance testing (p > 0.035).
  • For Airpath Testing: Compliance with EPA requirements (PM2.5 standard) and general toxic gas emission limits.
  • For Materials: Adherence to international biocompatibility standards (ISO 10993 series).
  • For Safety and EMC: Compliance with international electrical safety and electromagnetic compatibility standards (EN 60601 series, CISPR 11).

8. The Sample Size for the Training Set

This information is not applicable as the device is not an AI/ML algorithm requiring a training set.

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

This information is not applicable as the device is not an AI/ML algorithm requiring a training set.

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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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