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The Ombra® Table Top Compressor is designed to deliver compressed air to a jet or pneumatic nebulizer. This compressor may be used with adult, child or pediatric patients. The Ombra* Table Top Compressor is a medical device, and should only be used as directed by your healthcare professional. The intended environments for use include the home, hospitals and clinics.

The Ombra* Table Top Compressor provides a source of compressed air for use with jet nebulizers. The device is a motor-driven compressor, housed in a plastic case with rubber skids. It operates from 120V/60Hz. It is supplied with several replaceable air filters. The Ombra* Table Top Compressor is intended for adult, child and pediatric patients. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments.

The Ombra* Table Top Compressor is a medical device designed to provide compressed air for use with jet nebulizers. The provided text details the device's characteristics and its comparison to predicate devices, but it does not describe a study involving acceptance criteria in the traditional sense of clinical performance or algorithm evaluation.

Instead, the submission focuses on demonstrating substantial equivalence to existing legally marketed devices (predicates) through non-clinical testing and comparison of technological characteristics. This is a common pathway for medical devices seeking 510(k) clearance, where direct clinical trials or extensive performance studies with acceptance criteria based on patient outcomes are often not required if the new device is sufficiently similar to a predicate.

Therefore, many of the requested elements for describing an acceptance criteria study (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training sets) are not applicable in this context.

Here's the information that can be extracted from the provided text, framed within the substantial equivalence approach:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission seeking substantial equivalence, the "acceptance criteria" are typically defined by demonstrating that the new device's parameters are comparable to or within acceptable limits relative to the predicate devices, and that it complies with relevant safety and performance standards.

The "study" that proves the device meets these criteria is the "Non-Clinical Test Summary."

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

• Sample size: Not specified as a "sample size" in the context of patient data. The testing involved one unit of the Ombra* Table Top Compressor to characterize its operating parameters.
• Data provenance: Not applicable in the context of clinical data. The tests were conducted internally to characterize the device's physical and electrical properties.

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

• Not applicable. Ground truth in this context refers to objective measurements of the device's physical and electrical performance, not expert clinical interpretation.

4. Adjudication method for the test set:

• Not applicable. There was no human interpretation or adjudication involved in the objective measurements.

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 a compressor, not an AI-powered diagnostic or assistive tool.

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

• Not applicable. This device is a standalone hardware component. Its performance is measured directly, not via an algorithm.

7. The type of ground truth used:

• Objective physical and electrical measurements of the device's operating parameters (e.g., pressure, flow rate, current, sound level, temperature ranges) and compliance with recognized safety and EMC standards. Comparisons were made against the specifications of predicate devices.

8. The sample size for the training set:

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

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

• Not applicable. As there is no training set, this question is irrelevant.

In summary, the Ombra Table Top Compressor gained clearance through a 510(k) submission based on demonstrating substantial equivalence to predicate devices, primarily through non-clinical bench testing and adherence to recognized electrical and electromagnetic compatibility standards.* The "acceptance criteria" were met by showing that its technical specifications were comparable to predicates and that it complied with relevant safety standards, raising no new safety or effectiveness concerns. No clinical performance studies or AI-related evaluations were conducted or required for this type of device.

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The Aerobika* Oscillating Positive Expiratory Pressure device is 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* Oscillating Positive Expiratory Pressure (PEP) device is indicated as a single patient use, hand held secretion clearance and lung expansion device that creates vibrating positive expiratory pressure when a patient exhales through the device. The Aerobika* device may be used simultaneously with aerosol drug delivery from a nebulizer.

The Aerobika* Oscillating Positive Expiratory Pressure (PEP) Device was found substantially equivalent to a predicate device (Acapella, K002768) based on mechanical testing and biocompatibility.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for mechanical testing. The submission mentions "ranges of data" and "mean Frequency and Amplitude values," implying multiple measurements were taken and statistically compared. For cascade impactor testing, three different drugs were used with the nebulizer.
• Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted by Trudell Medical International. This is a pre-market submission, so the data would be prospective in the context of the device's clearance, but retrospective for the performed tests themselves (i.e., tests were concluded before submission). Country of origin is Canada (manufacturer).

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

• Not applicable. This submission focuses on demonstrating substantial equivalence through mechanical and biocompatibility testing, not on diagnostic accuracy requiring expert interpretation of results. The "ground truth" here is the measured physical properties and biological reactions against established standards and the predicate device's performance.

4. Adjudication Method for the Test Set

• Not applicable. As the tests are objective mechanical and biological evaluations, there is no human adjudication of results in the traditional sense. The comparison is made against quantitative measurements from the predicate device and established ISO standards.

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

• No. This was not a clinical performance study involving human readers.

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

• Yes, in essence. The mechanical and biocompatibility testing can be considered standalone performance evaluations of the device's characteristics against a predicate device and predetermined standards, without human interaction influencing the measurement results themselves. The "algorithm" here is the device's inherent mechanical function.

7. The Type of Ground Truth Used

• Objective measurements against established standards and predicate device performance.
  • For mechanical parameters (frequency, amplitude): The ground truth was the measured performance of the predicate device (Acapella) and the statistical comparison of the Aerobika* device's performance to it. Clinical insignificance was supported by literature (Volsko et al, 2003; Okeson and McGowen, 2007) indicating acceptable oscillation ranges for similar devices.
  • For biocompatibility: The ground truth was compliance with ISO 10993-1, 10993-5, and 10993-10 standards.
  • For aerosol drug delivery: The ground truth was the comparative performance against the predicate device in cascade impactor testing.

8. The Sample Size for the Training Set

• Not applicable. This device is a mechanical medical device, not an AI/machine learning model that typically requires a training set. The "training" for such a device would be its engineering design and manufacturing process.

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

• Not applicable. As stated above, this is not an AI/ML device.

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Solarys* Ventilator Aerosol Delivery System (AS) is a nebulizer intended to deliver prescribed aerosolized medication to mechanically ventilated pediatric and adults patients able to use an Endotracheal Tube equal to or greater than 4.5 mm in diameter. The device is designed to operate in-line with ventilator circuits and mechanical ventilators in acute and sub-acute care environments.

The Solarys* Ventilator Aerosol Delivery System (AS) is a single-use (disposable) continuous nebulizer system designed for use with mechanically ventilated patients to aerosolize physician-prescribed medications for inhalation.

The Solarys* Ventilator Aerosol Delivery System (AS) is a nebulizer intended to deliver prescribed aerosolized medication to mechanically ventilated pediatric and adult patients. The device was evaluated non-clinically to demonstrate substantial equivalence to its predicate device, the Aeroneb Professional Nebulizer System (K070642).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating that the performance of the Solarys* AS "raises no new issues of safety or effectiveness from the legally marketed predicate device." This was primarily evaluated through aerosol characterization testing, comparing the Solarys* AS against the predicate using common prescribed drugs.

Below is a table summarizing the aerosol characterization data for the Solarys* AS, with the understanding that these values, when compared to the predicate device (which are not explicitly provided in the text in a comparative table), were deemed substantially equivalent.

Note: The "Equivalent to Predicate?" column is based on the statement "demonstrates that the performance of the Solarys AS raises no new issues of safety or effectiveness from the legally marketed predicate device." Specific numerical comparisons for the predicate device were not provided in the summary.*

2. Sample Size and Data Provenance for the Test Set

• Sample Size Used for the Test Set: Not explicitly stated as a numerical sample size (e.g., N=X devices). The evaluation involved testing with "3 commonly prescribed drugs" using the cascade impactor method and simulating normal device usage in a ventilator circuit with a "simulated adult mechanically ventilated patient." The results were based on "statistical analysis (95% confidence interval) of the observed data collected." This implies multiple measurements were taken for each drug and test condition to achieve statistical confidence.
• Data Provenance: The study was a non-clinical, laboratory-based evaluation conducted by Trudell Medical International. The country of origin for the data is not specified beyond the manufacturer being in London, Ontario, CANADA. The data is prospective, generated specifically for this 510(k) submission.

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

Not applicable. This was a non-clinical performance study (aerosol characterization and engineering tests), not a study involving medical image interpretation or human expert judgment for ground truth.

4. Adjudication Method for the Test Set

Not applicable. This was a non-clinical performance study without human-based adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "Not applicable, the determination of substantial equivalence is not based on Clinical Performance Data."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was performed. The non-clinical tests (aerosol characterization, biocompatibility, and mechanical safety testing) evaluated the device's performance independently without human-in-the-loop interaction in a clinical setting. The "device's performance" was directly measured and compared to the predicate.

7. Type of Ground Truth Used

The ground truth for the non-clinical tests was established through objective, laboratory-based measurements and experimental protocols.

• For aerosol characterization: Measurements of Total Delivered Dose, Particle Fraction at various sizes, MMAD (Mass Median Aerodynamic Diameter), and GSD (Geometric Standard Deviation) obtained through cascade impactor methodology and collection at the exit of an ETT in a simulated patient model.
• For biocompatibility: Adherence to ISO 10993-1 standards.
• For mechanical safety: Specific engineering tests (simulated use, pressure, environmental limits, drop, leakage, strain relief fatigue/tensile testing).

8. Sample Size for the Training Set

Not applicable. This is a medical device 510(k) submission for a nebulizer, not an AI/ML-based device that requires a training set.

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

Not applicable. As noted above, this is not an AI/ML-based device and does not involve a training set for an algorithm.

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The RespiChamber Valved Holding Chamber is intended to be used by patients 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 from most pressurized Metered Dose Inhalers, prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.

The RespiChamber* Valved Holding Chamber (VHC) is a device used for the administration of metered dose inhaler medication to a spontaneously breathing patient. By means of a one-way valve, medication particles are held in the chamber for several seconds after actuation has occurred enabling inhalation by the patient. The device is designed to minimize delivery of the larger particles of aerosolized medication, which may otherwise lodge in the mouth, throat and upper airway, while allowing the smaller therapeutic particles to be inspired.

This document describes a 510(k) premarket notification for the RespiChamber* Valved Holding Chamber (VHC). The submission aims to demonstrate substantial equivalence to a predicate device, the OptiChamber Advantage Valved Holding Chamber (K962822).

Here's an analysis of the acceptance criteria and study information provided:

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

The provided document doesn't explicitly state acceptance criteria in a quantitative format with corresponding reported performance values. Instead, it refers to a qualitative assessment of "no new issues of safety or effectiveness."

The core performance evaluation is based on "Particle size distribution testing" with the metric "Fine Particle Mass (μg

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The AeroChamber mini Ventilation Chamber is a single patient, disposable device, intended to be used for the administration of metered dose inhaler medication prescribed by a physician or health care professional. The device is intended for use with patients on mechanical ventilation via resuscitation bag or ventilator circuit. The intended environments for use include the home, hospitals and clinics.

The AeroChamber mini Ventilation Chamber is a single patient, disposable device, intended to be used for the administration of metered dose inhaler medication prescribed by a physician or health care professional.

Here's the analysis of the provided text regarding the acceptance criteria and study for the AeroChamber Mini Ventilation Chamber:

Analysis of Acceptance Criteria and Study for AeroChamber Mini Ventilation Chamber

The provided FDA 510(k) summary (K090065) for the AeroChamber Mini Ventilation Chamber primarily focuses on establishing substantial equivalence to a predicate device. It certifies that the device can be legally marketed based on its comparison to existing devices.

However, this document does not contain information about specific acceptance criteria or an analytical study proving the device meets those criteria, as one would typically find for a new, novel AI/ML-driven medical device requiring performance validation.

The document states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This heavily implies that the device's acceptable performance is based on its similarity to already approved devices, rather than a de novo clinical or analytical study with defined performance metrics and acceptance thresholds.

Therefore, most of the requested information regarding acceptance criteria and performance studies for an AI/ML device cannot be extracted from this document.

Summary Table (Based on available information):

Detailed Breakdown (Responding to your specific questions):

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

   • As noted above, explicit quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy, or other measurable outcomes) are not present in this 510(k) letter. The "acceptance" is based on the FDA's determination of substantial equivalence to a predicate device. The reported performance is implicitly that it functions similarly to the predicate for its intended use.

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

   • Not applicable / Not provided. The document does not describe a test set or a study conducted to evaluate the device's performance against defined metrics. The decision is based on a comparison to a predicate device, which would involve reviewing documentation and design specifications, not experimental data collection with a "test set" in the context of an AI/ML device.

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. No ground truth establishment is described for this type of submission.

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

   • Not applicable / Not provided. No test set or adjudication method is described.

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 a mechanical ventilation chamber, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant.

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

   • Not applicable. This is a hardware device (ventilation chamber), not an algorithm.

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

   • Not applicable / Not provided. No ground truth is described.

8. The sample size for the training set:

   • Not applicable / Not provided. This is a physical medical device, not an AI algorithm requiring a training set.

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

   • Not applicable / Not provided. No training set or ground truth establishment is described.

In conclusion, the provided FDA letter confirms the substantial equivalence of the AeroChamber Mini Ventilation Chamber to a predicate device, enabling its market authorization. It is not a document detailing the performance validation of a novel device, particularly an AI/ML-driven one, against specific acceptance criteria through a dedicated study.

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The AeroEclipse® Durable Breath Actuated Nebulizer is a single patient, reusable device, intended to be used by patients 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 device may be used with a compressor capable of delivering a flow of 2.75 to 8 lpm under an operating pressure of 15 to 50 psi.

AeroEclipse® Durable Breath Actuated Nebulizer is a single patient, reusable device.

The provided text is a 510(k) summary for the AeroEclipse® Durable Breath Actuated Nebulizer. This document is a regulatory submission for a medical device and does not contain information about acceptance criteria, performance studies, or clinical validations in the way a scientific paper or a more detailed regulatory submission (like a PMA) would.

Therefore, based solely on the provided text, I cannot extract the information required to populate a table of acceptance criteria and reported device performance, or answer questions about sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

The document primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device, which is a regulatory pathway for lower-risk devices. This means the manufacturer demonstrated that their device is as safe and effective as another device already on the market, rather than conducting extensive clinical trials to establish its efficacy against predefined acceptance criteria for a novel technology.

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The AeroChamber Plus® aVHC with Flow-Vu® IFI is intended to be used by patients 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 from most pressurized Metered Dose Inhalers, prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for the "AeroChamber Plus® aVHC with Flow-Vu® IFI" device, indicating that it has been found substantially equivalent to a legally marketed predicate device.

The letter mentions:

• The device name and its intended use (to administer aerosolized medication from Metered Dose Inhalers).
• The regulatory classification and product code.
• The date of clearance.
• General FDA regulations and requirements for marketing a medical device.

However, it does not include details on:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone performance studies.
7. Type of ground truth used.
8. Sample size for training sets.
9. How ground truth for training sets was established.

Therefore, I cannot fulfill your request based on the provided text.

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The AeroEclipse® II Breath Actuated Nebulizer is intended to be used by patients 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.

AeroEclipse® II Breath Actuated Nebulizer

The provided text is a 510(k) clearance letter from the FDA for the AeroEclipse® II Breath Actuated Nebulizer. It indicates that the device has been found substantially equivalent to a legally marketed predicate device. However, this document does not contain specific details about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications as typically found in a study report.

The 510(k) clearance process primarily evaluates substantial equivalence based on the device's technological characteristics and intended use compared to a predicate device. It doesn't typically require a separate clinical study with detailed performance metrics and statistical analyses as would be needed for a PMA or de novo submission.

Therefore,Based on the provided text, I cannot complete the table or answer most of the questions as the information is not present within this FDA clearance letter. The letter confirms clearance but does not detail the specific studies, acceptance criteria, or performance data used to demonstrate substantial equivalence internally.

Here's an explanation of what can be inferred or what is missing:

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

• Cannot be provided. The document does not specify any acceptance criteria or reported device performance metrics (e.g., nebulization rate, particle size distribution, drug delivery efficiency) from a performance study. The 510(k) is a regulatory clearance, not a performance report.

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

• Cannot be provided. The document does not mention any specific test set sample sizes or data provenance.

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)

• Cannot be provided. This information is not relevant to a 510(k) clearance letter for a nebulizer. Ground truth establishment with experts is typically for diagnostic devices, not for a device like a nebulizer.

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

• Cannot be provided. This is not applicable or mentioned 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

• Cannot be provided. MRMC studies are typically for AI-enabled diagnostic devices. This is a nebulizer and does not involve human readers or AI assistance in a diagnostic capacity.

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

• Cannot be provided. This device is not an AI algorithm.

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

• Cannot be provided. Ground truth, in the context of diagnostic performance, is not applicable to this device and is not mentioned. For a nebulizer, performance is evaluated against engineering specifications and standards (e.g., aerosol output, particle size), not against a "ground truth" derived from patient data in the same way a diagnostic device would.

8. The sample size for the training set

• Cannot be provided. This device does not involve a "training set" in the context of machine learning.

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

• Cannot be provided. Not applicable to this device.

What the document does tell us:

• Trade/Device Name: AeroEclipse® II Breath Actuated Nebulizer
• Regulation Number: 868.5630
• Regulation Name: Nebulizer
• Regulatory Class: II
• Product Code: CAF
• Intended Use: To be used by patients under the care or treatment of a licensed healthcare provider or physician to administer aerosolized medication prescribed by a physician or healthcare professional. Intended environments include home, hospitals, and clinics.
• Regulatory Mechanism: 510(k) premarket notification, cleared based on substantial equivalence to a legally marketed predicate device.

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The AeroChamber Z-STAT Plus™ Valved Holding Chamber is intended to be used by patients 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 from most pressurized Metered Dose Inhalers, prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA to Traudell, Medical International for their Aerochamber Z-Stat Plus Valved Holding Chamber. This document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies in the same way a PMA (Premarket Approval) would.

Therefore, I cannot provide the requested information from the given text.

To address your request, I would need a different type of document, such as a study report, clinical trial results, or a detailed product submission that outlines performance testing and acceptance criteria.

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