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This product is intended to be used by patients (5+ years) who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers. It is a single patient, multiple use device intended for home use.

The AeroChamber2go* Anti-Static Valved Holding Chamber (VHC) is a portable holding chamber intended to be used by patients (5+ years) who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers. It is a single patient, multiple use device intended for home use. This device is not used with a specific druq nor is it distributed with such drugs.

The provided text is a 510(k) summary for a medical device (AeroChamber2go Anti-Static Valved Holding Chamber). It describes the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

It does NOT describe a study that proves the device meets the acceptance criteria of an AI/ML model for an image analysis task.

Therefore, I cannot fulfill your request for information related to AI/ML model performance, ground truth, expert adjudication, or MRMC studies based on this document. The document pertains to the physical and chemical properties of a medical device, not a software-driven diagnostic or image analysis tool.

The "acceptance criteria" discussed in this document refer to the device's mechanical, material, and aerosol delivery performance characteristics, not the performance of an AI system.

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The corrugated tube is an accessory to the MC 300 ® Nebulizer. It is designed to work in conjunction with the MC 300 ® Nebulizer to extend the patient interface away from the nebulizer. The accessory is a single patient is intended to be used with either mouthpiece or mask for pediatric (ages 2 years and above) and adult patients, who are under the care of a licensed healthcare provider or physician.

The corrugated tube with mouthpiece accessory is designed to work in conjunction with the cleared predicate device, MC300 * Nebulizer (K173367) to extend the patient interface away from the nebulizer. In line with FDA's definition of a "medical device accessory", the corrugated tube with mouthpiece accessory is intended to supplement the performance of the parent device, MC300* Nebulizer (K173367). The principle of operation of MC300* Nebulizer remains the same as cleared under K173367.

Here's a breakdown of the acceptance criteria and study information based on the provided text, assuming the "device" refers to the "Corrugated tube with mouthpiece accessory":

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance data in terms of aerosol characterization and biocompatibility testing. The acceptance criteria generally revolve around demonstrating substantial equivalence to the predicate device (MC300* Nebulizer) for these metrics. The reported performance refers to the actual test results of the subject device in comparison to the predicate device.

• Albuterol: Total Mass (1248.8±57.8 µg vs 1409.0±84.5 µg), FPF (70.5±1.1% vs 69.1±1.9%), FPM (905.7±51.9 µg vs 974.4±76.7 µg), MMAD (2.9 µm vs 2.9 µm), GSD (2.2 vs 2.2)
• Budesonide: Total Mass (403.6±54.6 µg vs 381.2±21.4 µg), FPF (53.6±8.2% vs 58.9±4.5%), FPM (212.9±9.9 µg vs 223.9±14.5 µg), MMAD (5.0 µm vs 4.6 µm), GSD (1.7 vs 1.8)
• Ipratropium: Total Mass (535.3±28.2 µg vs 583.2±17.1 µg), FPF (70.3±0.9% vs 70.7±1.8%), FPM (376.6±22.1 µg vs 412.7±17.2 µg), MMAD (3.4 µm vs 3.1 µm), GSD (2.2 vs 2.1)

For 13 psi (4 L/min) (Mouthpiece):

• Albuterol: Total Mass (1394.4±121.8 µg vs 1348.8±158.9 µg), FPF (71.6±3.5% vs 72.0±2.5%), FPM (995.9±67.0 µg vs 971.3±124.8 µg), MMAD (2.8 µm vs 2.4 µm), GSD (2.2 vs 2.2)
• Budesonide: Total Mass (358.1±16.5 µg vs 383.3±21.8 µg), FPF (59.5±3.9% vs 59.4±7.0%), FPM (213.0±16.5 µg vs 227.8±22.8 µg), MMAD (4.7 µm vs 4.6 µm), GSD (1.7 vs 1.9)
• Ipratropium: Total Mass (513.3±40.3 µg vs 555.4±35.8 µg), FPF (74.4±1.1% vs 72.1±2.4%), FPM (381.8±28.2 µg vs 400.8±32.2 µg), MMAD (2.4 µm vs 2.9 µm), GSD (2.2 vs 1.9)

With Mask at 8 L/min:

• Albuterol: Total Mass (1396.7±124.7 µg vs 1435.4±92.2 µg), FPF (71.5±1.3% vs 69.5±2.1%), FPM (999.7±103.9 µg vs 997.5±72.5 µg), MMAD (2.6 µm vs 2.8 µm), GSD (2.2 vs 2.2)
• Budesonide: Total Mass (356.3±13.0 µg vs 333.5±22.8 µg), FPF (64.2±1.7% vs 61.3±7.1%), FPM (228.8±9.6 µg vs 203.6±16.6 µg), MMAD (4.3 µm vs 4.5 µm), GSD (1.8 vs 1.8)
• Ipratropium: Total Mass (607.9±33.5 µg vs 570.5±29.8 µg), FPF (73.4±1.4% vs 70.3±1.9%), FPM (446.1±26.0 µg vs 401.3±21.2 µg), MMAD (2.6 µm vs 3.1 µm), GSD (2.1 vs 2.0) |
  | Biocompatibility Testing | All biological endpoints applicable to the corrugated tube with mouthpiece accessory must satisfy the requirements of ISO 10993-1 (2018). | All in vitro and in vivo studies were performed and included the following battery of tests: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Genotoxicity, Extractables, and Chemical Characterization with a Biological Risk Assessment. The results satisfied the requirements of ISO 10993-1 (2018). |
  | Dry Gas Pathway Testing | Exposure to volatile organic compounds (VOCs) and fine particles (PM2.5) during use of the corrugated tube with mouthpiece accessory must be unlikely to result in toxicological effects under worst-case dry gas conditions. | Testing results and risk assessment demonstrated that exposure during use is unlikely to result in toxicological effects. |

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

• Aerosol Characterization: The tables indicate results as "mean ± standard deviation," implying multiple measurements were taken for each metric under different conditions and for different medications. However, the exact sample size (number of nebulizer units tested for each condition) is not explicitly stated in the provided text. The data provenance is not specified (e.g., country of origin). The study appears to be prospective laboratory testing conducted to evaluate the device's performance.
• Biocompatibility Testing: Similar to aerosol characterization, the exact sample sizes for each specific biological test (e.g., number of cells for cytotoxicity, number of animals for systemic toxicity) are not explicitly stated. The data provenance is not specified. This is also prospective laboratory testing.
• Dry Gas Pathway Testing: The sample size for this testing is not explicitly stated. The data provenance is not specified. This is prospective laboratory testing.

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

• Not applicable. The studies described are performance and safety (non-clinical) studies for a medical accessory, not diagnostic accuracy studies that involve human experts establishing a "ground truth" for interpretations. The "ground truth" in this context is based on established scientific methods and regulatory standards for aerosol characteristics and biocompatibility.

4. Adjudication Method for the Test Set:

• Not applicable. As these are performance and safety studies rather than diagnostic studies with human interpretation, there is no need for an adjudication method like 2+1 or 3+1. The results are objective measurements from laboratory tests.

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:

• No. An MRMC study is not mentioned as this relates to a medical accessory, not an AI-powered diagnostic device that would involve human readers.

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

• No. This device is a physical medical accessory (corrugated tube with mouthpiece), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant or applicable.

7. The Type of Ground Truth Used:

• Performance Standards and Scientific Methods:
  • For Aerosol Characterization: The "ground truth" is defined by the objective physical and chemical properties of the aerosolized medication (e.g., mass, particle size distribution) as measured by established methods and referenced to relevant sections of the CDRH Guidance Document "Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH - 1993). The comparison is against the predicate device's performance.
  • For Biocompatibility Testing: The "ground truth" is compliance with international standards, specifically ISO 10993-1 (2018) and related sub-standards.
  • For Dry Gas Pathway Testing: The "ground truth" is the assessment that exposure levels are unlikely to result in toxicological effects, based on scientific risk assessment principles.

8. The Sample Size for the Training Set:

• Not applicable. This device is a physical medical accessory, not a machine learning or AI model that requires a training set.

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

• Not applicable. As there is no training set for a physical accessory, this question is not relevant.

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The AeroEclipse* ONE BAN is intended to be used with adults and pediatric patients over 5 years old, who are under the care or treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.

The subject device. AeroEclipse* ONE BAN (Breath Actuated Nebulizer) is a jet nebulizer intended to administer medication (prescribed by a physician or health care provider) in the form of an aerosol for patient inhalation. It operates in conjunction with a compressed air source and a liquid medication. The subject device is designed to produce and deliver aerosolized medication only during the patient inspiratory cycle, thus significantly reducing fugitive emissions to the environment. It can be used in hospitals, clinics and in the home. Liquid medication is placed in the medication cup of the nebulizer bottom, into which the nebulizer top sub-assembly is attached. The air supply tubing provides the interface for the pressurized air. Aerosol is inhaled by the patient via the oral interface of the mouthpiece. As the patient inhales, ambient air travels down through the nebulizer, creating a pressure drop which causes the actuator, connected to the diaphragm to move down into the nebulizing position. As inhalation continues, aerosol is created and inhaled through the mouthpiece. When inhalation ceases, the actuator returns to the up position thereby eliminating the pressure drop which leads to the device discontinuing the creation of an aerosol. As the patient inhales through the mouthpiece, the actuator drops, and the creation of aerosol begins again. The overall device is comprised of a nebulizer bottom with nozzle feature, a nebulizer top sub-assembly, a mouthpiece and air supply tubing.

The provided document is a 510(k) premarket notification for a medical device, specifically a nebulizer (AeroEclipse* ONE BAN). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a study involving AI or human readers.

Therefore, the document does not contain the information requested regarding:

• Acceptance Criteria for an AI-powered device: This document is for a mechanical nebulizer, not an AI device.
• Study proving device meets acceptance criteria: There is no AI performance study described.
• Sample sizes for test sets, data provenance, expert ground truth establishment, or adjudication methods: These details are specific to AI model validation, not mechanical device testing.
• MRMC comparative effectiveness study or standalone AI performance: Not applicable to this type of device submission.
• Training set information for an AI model: No AI model is being submitted.

Instead, the document details physical performance testing (aerosol characterization, design verification), biocompatibility, and dry gas pathway testing to ensure the safety and effectiveness of the nebulizer. The primary objective is to show that the new device is "substantially equivalent" to an already cleared predicate device.

Key relevant points from the document regarding its performance evaluation:

1. Device Type: AeroEclipse* ONE BAN (Breath Actuated Nebulizer) - a mechanical device for administering aerosolized medication.
2. Performance Data:
   • Aerosol Characterization: Performed in accordance with CDRH Guidance Document "Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH - 1993). Results "demonstrated substantially equivalent in-vitro performance" to the predicate device.
   • Design Verification Testing: Included Flow Performance, Drop Testing, Environmental Testing, and Life Cycle Testing. Results "demonstrate the subject device... meets the requirements outlined in the design verification plan."
   • Biocompatibility Testing: Not performed, as materials are identical to the cleared predicate device.
   • Dry Gas Pathway Testing: Included assessments for volatile organic compounds (VOCs), fine particles (PM2.5), and inorganic gases (ozone, CO2, CO) per ISO 18562. "Testing results and risk assessment demonstrated that exposure during use is unlikely to result in toxicological effects."
3. Clinical Performance Summary: "Not applicable. The determination of substantial equivalence is not based on Clinical Performance data."

In summary, this document is for a traditional medical device and does not involve AI or the associated acceptance criteria and study designs you've inquired about.

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The Combined VersaPAP™ and Aerobika® OPEP device is intended for use as a Positive Airway Pressure (PAP) device and a Positive Expiratory Pressure (PEP) device. The combined device has the ability to provide supplemental oxygen when used with compressed oxygen. The combined device is for patients (ages 5 years and above) who are capable of following directions for Positive Airway Pressure Therapy and capable of generating exhalation flow of 10 lpm for 3 - 4 seconds. The combined device is a single patient, multiple use device intended to be used in a hospital environment under the supervision of a healthcare professional.

The Aerobika® OPEP device and VersaPAP™ device can be used independently or combined. When combined for ease of use. The combined device creates oscillations during the exhalation phase (OPEP) to aid in secretion clearance and during the inhalation phase (PAP) helps to maintain positive airway pressure for the treatment and prevention of atelectasis.

The provided text is a 510(k) summary for the "Combined VersaPAP™ device and Aerobika® OPEP" and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria in the format requested.

Therefore, I cannot directly extract "acceptance criteria and the study that proves the device meets the acceptance criteria" in the detailed format you requested (table, sample size, expert information, MRMC study, standalone performance, ground truth). The document is a regulatory submission for a medical device that performs a physical function (providing positive airway pressure and positive expiratory pressure), not an AI/software as a medical device (SaMD) that typically undergoes rigorous performance studies with the criteria you outlined.

However, I can extract the information relevant to what I can infer as "acceptance criteria" and "study" within the context of this device application:

The "acceptance criteria" for this type of device are primarily demonstrating substantial equivalence to existing legally marketed predicate devices, meaning it is as safe and effective as the predicates. The "study" that proves this involves bench testing and comparison of features and performance characteristics to the predicates.

Here's how I can reframe the information based on the provided text:

Inferred Acceptance Criteria and Study to Prove Device Meets Them:

For this device, "acceptance criteria" are not reported as specific numerical thresholds for diagnostic performance (like sensitivity/specificity for AI), but rather as proof of substantial equivalence to legally marketed predicate devices. The "study" involves bench testing and a detailed comparison of technical and performance characteristics to demonstrate this equivalence.

1. Table of Acceptance Criteria (as inferred) and Reported Device Performance:

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

• Sample Size: Not applicable in the context of an FDA 510(k) for this type of physical device; there isn't a "test set" of patient data for diagnostic performance. The "testing" refers to bench testing of the device's physical performance. The document states, "We performed comparative testing at adult and child breathing setting to the predicates and reference." However, no specific number of test runs or 'samples' is given.
• Data Provenance: Not applicable in the way it would be for an AI model (e.g., retrospective/prospective patient data, country of origin). The data provenance is from bench testing conducted by the manufacturer, Trudell Medical International (located in London, ON, Canada).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable. This is not a study requiring expert consensus for ground truth as it's a physical device, not an AI diagnostic tool.

4. Adjudication Method for the Test Set:

• Not applicable. There's no "test set" that requires adjudication by human readers/experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This type of study is typically done for AI-assisted diagnostic tools to assess human reader improvement. This is a physical medical device.

6. Standalone (Algorithm Only) Performance:

• Not applicable. This is a physical device, not an algorithm. Its "standalone" performance would refer to its physical output which is measured via bench testing as described in bullet 1.

7. Type of Ground Truth Used:

• The "ground truth" for this device's performance is established by engineering and physiological measurement standards (e.g., measuring pressure, flow rate, and frequency) during bench testing, and comparing these measurements to the established performance of predicate devices and expected physiological ranges.

8. Sample Size for the Training Set:

• Not applicable. This is a manufactured physical device, not a machine learning model.

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

• Not applicable. There is no concept of a "training set" or "ground truth establishment" in the AI sense for this device. Its design and manufacturing (analogous to "training") are based on engineering principles and regulatory requirements for medical devices.

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The AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber is intended to be used by adult and pediatric patients who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers and Soft Mist Inhalers. The intended environments for use include the home. It is a single patient, multiple use device.

The AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) is a holding chamber used for the administration of aerosolized medications. The AeroChamber Plus* Flow-Vu* Anti-Static VHC line of products is designed to be used with a broad range of FDA approved pressurized metered dose inhaler (pMDI) or soft mist inhaler (SMI) pharmaceutical formulations prescribed by a healthcare provider. It is a single patient, multi-use device intended to be used by patients who are under the care or treatment of a licensed health care professional. This device is not used with a specific drug nor is it distributed with such drugs.

The provided text describes two main evaluations for the AeroChamber Plus Flow-Vu Anti-Static Valved Holding Chamber (VHC):

1. Change in Intended Use: Evaluating the device's performance with "Soft Mist Inhaler" (SMI) formulations, in addition to its existing use with Metered Dose Inhalers (MDIs).
2. Addition of a New Configuration: Evaluating the "Adult Small Mask" configuration.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the comparison to existing methods (SMI alone for the new intended use) or predicate devices (Adult Large Mask for the new VHC configuration). The goal is to demonstrate comparable performance and no new safety/effectiveness concerns.

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 sample size (number of devices or measurements per condition) for the aerosol characterization tests. It provides mean and standard deviation values for the aerosol characteristics, which suggests multiple measurements were taken for each condition.

• Data Provenance: The studies are non-clinical, involving in vitro aerosol characterization testing and biocompatibility/mechanical testing. The data provenance is internal to the manufacturer (or contracted labs) conducting the tests in a controlled laboratory environment. There is no mention of country of origin for the data or whether it's retrospective or prospective, as it pertains to controlled lab testing, not clinical patient data.

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

This question is not applicable as the studies are non-clinical. The "ground truth" for aerosol characteristics is established by direct physical measurement using standardized laboratory techniques (e.g., cascade impaction, chemical analysis) based on recognized guidance documents ("Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators" FDA/CDRH - 1993). Similarly, biocompatibility and mechanical testing follow ISO standards and engineering principles. There are no human "experts" establishing ground truth in the sense of clinical interpretation.

4. Adjudication Method for the Test Set

This question is not applicable as the studies are non-clinical. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation (e.g., radiology reads) where discrepancies between experts need to be resolved. For laboratory-based performance testing, the "ground truth" is determined by reference methods or validated instrumentation.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data. The submitted information focuses on the physical and performance characteristics of a valved holding chamber, not a diagnostic imaging AI.

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

This question is not applicable. The device is a physical medical device (a valved holding chamber), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm does not apply. The performance data presented (aerosol characteristics) is "standalone" in the sense that it measures the device's physical output without human intervention during the measurement process, but not in the context of an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used for these non-clinical studies is based on:

• Physical Measurement: For aerosol characteristics, the ground truth is the direct measurement of particle size distribution, mass recovery, and fine particle dose using validated laboratory equipment and methods (e.g., cascade impactors, chemical analysis) as per FDA/CDRH guidance.
• Standardized Protocols: For biocompatibility, adherence to and successful completion of tests defined by ISO 10993 standards (e.g., in vitro cytotoxicity, in vivo sensitization).
• Engineering Specifications/Industry Standards: For mechanical testing (e.g., environmental, flow performance, life cycle, drop, resistivity), performance against pre-defined engineering specifications or relevant industry standards.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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

This question is not applicable for the same reason as #8.

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VersaPAP* is indicated for the treatment and prevention of atelectasis. VersaPAP* also has the ability to provide supplemental oxygen when used with compressed oxygen. The VersaPAP* device is for patients (ages 5 years and above) who are capable of following directions for Positive Airway in a hospital environment. The VersaPAP* device is a single patient, multiple use device intended to be used under the supervision of a healthcare professional.

The VersaPAP* device is a hand held respiratory therapy device that creates a positive airway pressure. The VersaPAP* device is intended to be used by pediatric (ages 5 years and above) and adult patients in the hospital environment, under the supervision of a healthcare professional. The VersaPAP* device is a single patient use device and may be used for two treatments per day for 7 days. A manometer gauge is included to monitor airway pressure while operating the VersaPAP* device. The VersaPAP* device consists of seven components: a mouthpiece, the VersaPAP* backpiece (includes 3 components: the baffle, body and end cap), a manometer adapter, a manometer gauge, and oxygen tubing.

The provided text is a 510(k) summary for the VersaPAP Positive Airway Pressure (PAP) Device. It describes the device, its intended use, and its comparison to a predicate device (EzPAP). However, it does not contain any information about acceptance criteria or specific study data to prove the device meets performance metrics.

The document explicitly states:

• "*Performance testing included comparative testing against the predicate device using representative patient generated breathing patterns. Testing confirmed that the VersaPAP device is substantially equivalent to the predicate.**" (Page 6, Section 9.1)
• "Not applicable, the determination of substantial equivalence is not based on Clinical Performance data." (Page 8, Section 10)

This type of 510(k) submission generally relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical performance studies with predefined acceptance criteria and human expert adjudication, especially for devices like PAP devices where safety and effectiveness are often established through engineering and comparative testing.

Therefore, I cannot populate the requested table or answer most of the questions because the information is not present in the provided text. The document clearly indicates that performance demonstration was done through comparative engineering testing against a predicate device, not through a study involving human readers, ground truth consensus, or clinical performance metrics in the way your questions imply for AI/diagnostic devices.

Here's what can be inferred or explicitly stated from the document:

1. A table of acceptance criteria and the reported device performance:

• No explicit acceptance criteria or reported device performance metrics are provided in the text. The submission states that "Performance testing included comparative testing against the predicate device using representative patient generated breathing patterns. Testing confirmed that the VersaPAP* device is substantially equivalent to the predicate." This implies that the device performed similarly to the predicate, but no quantitative acceptance criteria (e.g., specific pressure ranges, flow rates) or detailed results from this comparative testing are included in this summary.

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

• This information is not provided. The "test set" in this context would likely refer to the parameters or conditions under which the comparative engineering tests were performed (e.g., range of simulated breathing patterns), not a clinical data set.

3. 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 / not provided. This device is a mechanical Positive Airway Pressure device, not an image-based diagnostic or AI system requiring expert ground truth for a test set. The performance testing was comparative engineering testing.

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

• Not applicable / not provided. This is not a study requiring adjudication of expert interpretations.

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:

• No, an MRMC study was not done. This device is not an AI-assisted diagnostic tool.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Not applicable. The "ground truth" for this device's performance would be engineering specifications and the established performance characteristics of the predicate device, against which it was compared using simulated breathing patterns.

8. The sample size for the training set:

• Not applicable. This document describes a traditional 510(k) for a physical device, not an AI or machine learning model that requires a training set.

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

• Not applicable.

In summary, the provided document focuses on demonstrating substantial equivalence through general performance testing (likely bench testing) and material biocompatibility against a predicate device, rather than providing detailed clinical study data with predefined acceptance criteria as would be expected for a novel diagnostic or AI-driven system.

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The nebulizer is intended to be used with pediatic (ages 2 years and above) and adult patients, who are under the care of a licensed healthcare provider or physician. The device is designed to aerosolize prescribed medication by a patient in the hospital, clinic or home care environment. The nebulizer is a single patient use device.

The MC 300R Nebulizer is a small volume jet nebulizer designed to deliver aerosolized medications for inhalation to the respiratory system. The device is intended to be used by pediatric (ages 2 years and above) and adult patients in hospital, clinic or home settings. The MC 300R Nebulizer is a single patient use device and may be used for multiple treatments. This device is not used with a specific drug nor is it distributed with such drugs. The MC 300R Nebulizer consists of four components: mouthpiece, nebulizer top, nozzle cover, and nebulizer bottom. It is marketed with oxygen tubing. The MC 300R Nebulizer is not packaged with a mask, however the Disposable Aerosol Mask Assembly can be ordered per the reorder information on the IFU.

The provided text describes the MC 300R Nebulizer and its comparison to a predicate device, the AeroEclipse Durable (XL) Nebulizer. The device's substantial equivalence is established through non-clinical performance data, primarily aerosol characterization, biocompatibility testing, and dry gas pathway testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a typical pass/fail format for all tests. Instead, it presents performance data for the subject device (MC 300R Nebulizer) across various aerosol characteristics, and implicitly compares these to the performance of a predicate device (AeroEclipse Durable (XL) Nebulizer), as well as against relevant guidance documents. For biocompatibility and dry gas pathway testing, the "acceptance criteria" would be compliance with the specified ISO standards and successful completion of the toxicity assessments.

Given the information, the table below will summarize the reported performance data for the MC 300*R Nebulizer. The "acceptance criteria" in this context are primarily implied to be "comparable to the predicate device" and "in accordance with relevant guidance/standards."

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

• Sample Size: The document does not specify a distinct "sample size" for a test set in terms of patients or images. For the aerosol characterization, the data presented includes mean ± standard deviation, suggesting multiple measurements were taken for each characteristic and drug combination. However, the exact number of replicates is not provided.
• Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. It mentions that testing was "conducted in accordance with the relevant sections of the CDRH Guidance Document" and that biocompatibility and dry gas pathway tests were "performed by an independent source" or "conducted by an independent source." This suggests laboratory-based testing, not human subject data.

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

This information is not applicable (N/A) because the study described is a non-clinical performance evaluation of a nebulizer device. There is no "ground truth" to be established by human experts in the context of diagnostic interpretation or clinical outcomes. The performance is measured objectively through aerosol characterization, chemical analysis, and biological safety testing.

4. Adjudication Method for the Test Set

This information is not applicable (N/A) for the same reason as point 3. There is no human interpretation or diagnostic decision-making involved that would require an adjudication method.

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 applicable (N/A). The device is a nebulizer, not an AI-powered diagnostic tool. No MRMC study or AI assistance evaluation was conducted.

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

This information is not applicable (N/A). This is a non-clinical performance study of a medical device (nebulizer), not an algorithm.

7. The type of ground truth used

As mentioned in point 3, the concept of "ground truth" as typically used in AI/diagnostic studies does not apply here. The evaluation relies on:

• Physical measurements: For aerosol characteristics (e.g., particle size, mass output).
• Standardized laboratory tests: For biocompatibility (e.g., cytotoxicity assays) and dry gas pathway analysis (e.g., chemical emissions testing).
• Predicate device comparison: The performance of the subject device is implicitly compared to the predicate device to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable (N/A). There is no training set mentioned or implied, as this is a non-clinical device performance study, not an AI model development or evaluation.

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

This information is not applicable (N/A) for the same reason as point 8.

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The nebulizer is intended to be used with pediatic (ages 2 years and above) and adult patients, who are under the care of a licensed healthcare provider or physician. The device is designed to aerosolize prescribed medication by a patient in the hospital, clinic or home care environment. The nebulizer is a single patient use device.

The MC 300* Nebulizer is a small volume jet nebulizer designed to deliver aerosolized medications for inhalation to the respiratory system. The device is intended to be used by pediatric (ages 2 years and above) and adult patients in hospital, clinic or home settings. The MC 300* Nebulizer is a single patient use device and may be used for multiple treatments. This device is not used with a specific drug nor is it distributed with such drugs. The MC 300* Nebulizer consists of four components: mouthpiece, nebulizer top, nozzle cover, and nebulizer bottom. It is marketed with oxygen tubing. The MC 300* Nebulizer is not packaged with a mask, however the Disposable Aerosol Mask Assembly can be ordered per the information on the IFU.

The provided text describes the acceptance criteria and the results of the studies conducted for the MC 300* Nebulizer.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MC 300* Nebulizer appear to be based on demonstrating "similar performance" or performance that does not affect safety or effectiveness, relative to the predicate device (VixOne™ Nebulizer, K926055), and compliance with relevant guidance documents and standards. The "performance" section primarily focuses on aerosol characteristics and biocompatibility.

Acceptance Criteria (Implied from comparison to predicate and guidance documents):

• Aerosol Characteristics: Performance comparable to, or better than, the predicate device (VixOne™ Nebulizer) as assessed by the CDRH Guidance Document "Reviewer Guidance for Nebulizer, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH – 1993). This includes metrics like Total Mass, Total Output Rate, Fine Particle Fraction, Fine Particle Mass, Fine Particle Output Rate, Particle Size (MMAD), and GSD for various medications. The subject device should demonstrate comparable or improved delivery of medication compared to the predicate.
• Biocompatibility: Compliance with ISO 10993 series standards for biological endpoints applicable to an externally communicating device with tissue contact via gas pathway for permanent duration (>30 days). This includes tests for cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, and chemical characterization.
• Dry Gas Pathway: Acceptable levels of emissions (VOCs, fine particles PM2.5, inorganic gases like ozone, CO2, and CO).

*Reported Device Performance (MC 300 Nebulizer vs. Predicate Device)**:

Note: The table above clearly shows that the MC 300 Nebulizer (both with mouthpiece and mask) generally performs as well as, and in many critical aspects (e.g., Fine Particle Fraction, and often MMAD), better than the predicate device for aerosol characteristics.*

Biocompatibility Testing Summary:

• ISO Standard compliance: 10993-5 (Cytotoxicity), 10993-10 (Irritation and Sensitization), 10993-11 (Acute Systemic Toxicity), 10993-3 (Genotoxicity), 10993-12 (Sample preparation), 10993-17 (Allowable limits for leachable substances), 10993-18 (Chemical characterization).
• Result: All in vitro and in vivo studies were performed, and the results are presumed to be acceptable for substantial equivalence, though specific numerical results are not provided for each test, only that they were conducted by an independent source.

Dry Gas Pathway Testing:

• Emissions of volatile organic compounds (VOCs)
• Fine particles (particulate matter PM2.5)
• Inorganic gases (ozone, CO2, and CO)
• Result: Testing was conducted by an independent source, and associated risk assessments/conclusions were made, presumed to be acceptable for substantial equivalence.

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

• Aerosol Characterization: The document implies that "testing was performed at both low and high supplied air flow rates," but the table presents data at "8 l/min supplied air flow rate to the nebulizer and 15 l/min flow rate through the cascade impactor." The phrasing "the table below reflects data" suggests that the displayed values are representative results from a set of tests rather than a single measurement. Standard deviations are provided, indicating multiple trials were conducted for each medication and configuration, typically 3-5 replicates for such tests, but the exact number of runs or samples for each data point (e.g., how many nebulizers were tested, how many times each nebulizer was run) is not explicitly stated.
• Biocompatibility and Dry Gas Pathway Testing: The sample sizes for these tests are not specified in the document.
• Data Provenance: Not explicitly stated. The submitter is Trudell Medical International from London, Ontario, Canada. Testing was conducted "by an independent source," but the country of origin of the testing laboratory is not mentioned. The data is presented as "performance testing" and "summary" of tests, implying prospective testing for the 510(k) submission.

3. 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)

• This information is not applicable to the type of device and testing described. The "ground truth" here is objective physical and chemical measurements (aerosol particle sizes, drug output, chemical emissions, biological reactions) rather than subjective expert interpretation of medical images or patient conditions. These measurements are performed by laboratory instruments and protocols, not by expert consensus.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 refer to independent review and dispute resolution by multiple experts, typically for diagnostic studies. The tests described are laboratory-based, objective measurements. The results are based on instrumental readings and established analytical methods.

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

• A MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that AI would assist human readers in interpreting. The MC 300* Nebulizer is a drug delivery device, not a diagnostic one incorporating AI.

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

• A standalone algorithm performance study was not done. This device does not incorporate AI or algorithms that would operate independently.

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

• The "ground truth" for the performance claims of the MC 300* Nebulizer is based on objective laboratory measurements in accordance with recognized standards and guidance documents:
  • Aerosol Characterization: Physical measurements from cascade impactors and other analytical instruments to determine particle size distribution, drug mass output, etc. This is a direct physical measurement.
  • Biocompatibility: Results from standardized in vitro and in vivo biological tests (e.g., ISO 10993 series protocols) and chemical analysis.
  • Dry Gas Pathway: Analytical results from emission testing equipment.

8. The sample size for the training set

• Not applicable. This device is a medical device for drug delivery, not a Machine Learning/AI algorithm. Therefore, there is no "training set." The device itself undergoes physical and biological testing.

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

• Not applicable, as there is no training set for this type of device.

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The Aerobika* Oscillating Positive Expiratory Pressure device intended for use as a Positive Expiratory Pressure (PEP) device. The Aerobika* Oscillating PEP device may also be used simultaneously with nebulized aerosol drug delivery. The device is intended to be used by patients capable of generating an exhalation flow of 10 lpm for 3 – 4 seconds.

The Aerobika* OPEP with Manometer device combines Positive Expiratory Pressure (PEP) with oscillations upon exhalation with visual feedback relative to the patient's expiratory pressure. The device is mechanically driven using only the energy from the patient's exhaled breath. Upon exhalation, a portion of the patient's exhaled breath is routed through the manometer device and exits through it. While the manometer is pressurized by the patient's exhaled breath, an indicator contained within the manometer housing indicates the patient's exhaled pressure. The manometer adapter consists of plastic components constructed of polypropylene material, and the manometer is a purchased component to TMI, and is previously cleared under K040991.

This document, a 510(k) Premarket Notification for the Aerobika* OPEP with Manometer, describes non-clinical testing performed to establish substantial equivalence to a predicate device. It does not contain information about clinical studies with human participants. Therefore, many of the requested details about acceptance criteria for clinical performance, ground truth, expert adjudication, or MRMC studies are not applicable or available in this document.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document details several non-clinical tests performed. While explicit "acceptance criteria" are not numerically stated in a table format, the narrative indicates that the device "meets specifications and performs comparably to the predicate Aerobika* OPEP device." The performance reported is that the device did meet these specifications.

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

This document describes non-clinical laboratory testing. Specific sample sizes for each mechanical or environmental test are not provided in this summary. The data provenance is Trudell Medical International, located in London, ON, Canada, conducting design verification and validation activities. The studies are prospective in nature as they are 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 (e.g. radiologist with 10 years of experience)

Not applicable. This document describes non-clinical mechanical and material testing, not diagnostic or clinical performance requiring expert ground truth establishment.

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

Not applicable. This document describes non-clinical mechanical and material testing, not diagnostic or clinical performance 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

Not applicable. This device is not an AI-assisted diagnostic tool, and no MRMC study was conducted.

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

Not applicable. This device is a mechanical OPEP device, not an algorithm. The "standalone" performance refers to the device's inherent mechanical function. The non-clinical testing evaluates this.

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

For the non-clinical tests, the "ground truth" is established by engineering specifications, recognized standards (like ISO 10993-1:2009 for materials), and the performance characteristics of the legally marketed predicate device (Aerobika* OPEP device, K123400).

8. The sample size for the training set

Not applicable. This document describes a medical device, not a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for a mechanical device.

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