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The Ventlab Pressure-Chek Disposable Column Manometer provides visual indication of a patient's airway pressure during ventilation. It may be connected to the manometer or proximal ports on ventilator devices such as resuscitation bags, hyperinflation systems, CPAP masks and CPAP circuits. This device is a single patient use, non-sterile device that is indicated in both hospital and homecare applications.

Ventlab Pressure-Chek Disposable Column Manometer

Analysis of Ventlab Pressure-Check Disposable Column Manometer (K120118)

This document is a 510(k) clearance letter from the FDA. It declares the Ventlab Pressure-Check Disposable Column Manometer substantially equivalent to a predicate device. However, it does not contain details about the specific acceptance criteria or a study proving the device meets those criteria.

FDA 510(k) clearance is primarily based on demonstrating substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. The detailed study data outlining performance metrics against specific acceptance criteria is usually submitted by the manufacturer as part of their 510(k) submission, but this information is not typically included in the public-facing clearance letter.

Therefore, based solely on the provided text, I cannot answer most of your questions as the requested information is not present. The document focuses on the regulatory clearance process rather than specific performance study details.

Here's what I can extract from the provided text and what I cannot:

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

• Cannot provide. The document does not specify acceptance criteria or report specific device performance metrics from a study.

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

• Cannot provide. The document does not mention any specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective).

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

• Cannot provide. The document does not describe any expert ground truth establishment process or qualifications.

4. Adjudication method for the test set:

• Cannot provide. The document does not describe any adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Cannot provide. This device is a manometer (a physical device for measuring pressure), not an AI algorithm. Therefore, an MRMC study related to AI assistance would not be applicable or expected for this type of product.

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

• Cannot provide. As noted above, this is a physical manometer, not an algorithm.

7. The type of ground truth used:

• Cannot provide. The document does not describe the specific ground truth used for any testing. For a manometer, ground truth would typically involve reference pressure measurements from calibrated equipment.

8. The sample size for the training set:

• Not applicable. This is a hardware device, not a machine learning model, so there is no "training set."

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

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

In summary, the provided FDA clearance letter confirms the regulatory status of the Ventlab Pressure-Check Disposable Column Manometer but does not contain the detailed technical study information you are requesting. That information would typically be found in the manufacturer's 510(k) submission, which is not publicly available in its entirety.

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The Ventlab Cuff Sentry Cuff Inflation Device is designed to measure and regulate intracuff pressures of endotracheal and tracheostomy tubes. This device is a single patient use, non-sterile prescription device that is indicated for patients in all age groups who are managed with inflatable air-filled cuffs. It is intended for use in hospitals, pre-hospitals (EMS), extended care facilities and outpatient clinics.

Ventlab Cuff Sentry Cuff Inflation Device

The provided document is a 510(k) premarket notification letter from the FDA regarding the Ventlab Cuff Sentry Cuff Inflation Device. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, detailed study designs, sample sizes, expert qualifications, adjudication methods, or specific performance metrics of the device. It is a regulatory approval letter, not a technical report or study summary.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text.

To answer your questions, I would need access to the actual 510(k) submission (e.g., summary of safety and effectiveness, or the full submission) which would detail the performance data and the methods used to demonstrate substantial equivalence.

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The Ventlab 6000 Series Humidifier is a device intended to add moisture to breathing gases for administration to a patient. Its use is indicated whenever a physician or other healthcare provider prescribes humidification to patients receiving supplemental oxygen via oxygen tubing and nasal cannulae. This device is single patient use, non-sterile prescription device that is indicated in both hospital and homecare applications.

The Ventlab 6000 Series Humidifier is a device intended to add moisture to breathing gases for administration to a patient.

The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Ventlab 6000 Series Humidifier." This document does not contain information about acceptance criteria, device performance studies, or the methodologies for establishing ground truth as requested in the prompt.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (fir the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the FDA granted clearance based on the device's substantial equivalence to existing predicate devices, not on a new study demonstrating its performance against specific acceptance criteria. The document defines the "Indications for Use" but does not provide performance metrics.

Therefore, I cannot fulfill the request using the provided text. The requested information (acceptance criteria, study details, sample sizes, expert qualifications, ground truth methods, MRMC study, standalone performance) is not present in this 510(k) clearance document.

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The ACE/StatCheck II is intended for use as an adjunct assessment tool for verification of successful ventilation/intubation in patients >2.2 kilograms(51bs.).

Not Found

This document is a 510(k) clearance letter from the FDA for the ACE/StatCheck II CO2 Indicator. It does not contain the specific information requested about acceptance criteria or a study proving the device meets those criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory obligations.

Therefore, I cannot extract the requested information from the provided text.

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The Ventlab Disposable Electrosurgical Pad is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to Ventlab Corporation regarding their Disposable Electrosurgical Pad. This document is a regulatory approval letter and does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as would be found in a study report summarized for such a request.

Therefore, I cannot fulfill your request for the specific details outlined in the prompt from this document. The document primarily focuses on:

• The FDA's determination of substantial equivalence for the device.
• Regulatory requirements and general controls provisions.
• Instructions for marketing the device.
• Contact information for various FDA offices.
• The intended use of the device.

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The Ventlab End-Tidal CO2 Nasal Cannula is an accessory to a carbon dioxide analyzer used when there is a need to measure the percentage of exhaled carbon dioxide of a nonintubated patient while administering oxygen during inhalation.

Not Found

The provided document is an FDA 510(k) clearance letter for the Ventlab End-Tidal CO2 Nasal Cannula. This type of document primarily confirms that a new medical device is "substantially equivalent" to a legally marketed predicate device, rather than providing a detailed technical study report with performance metrics, acceptance criteria, or ground truth establishment.

Therefore, the information requested in your prompt regarding acceptance criteria, specific performance data, sample sizes for test/training sets, expert qualifications, and adjudication methods is not available in the provided text.

This document focuses on regulatory approval based on equivalence to a predicate, not on a detailed clinical or technical performance study as would be found in a research paper or a more extensive submission report.

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The Ventlab Nasal CPAP Cannula is an accessory to positive pressure ventilation devices for patients suffering from Obstructive Sleep Apnea requiring positive airway pressure therapy (i.e., CPAP, BiLevel).

Ventlab Nasal CPAP Cannula

This document is a 510(k) clearance letter from the FDA for a medical device called the "Ventlab Nasal CPAP Cannula." It indicates that the device has been found substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria, device performance results, sample sizes for testing or training, ground truth establishment, or details about any studies conducted (like MRMC or standalone studies).

Therefore, I cannot fulfill your request for this information from the provided document. The document primarily focuses on the regulatory clearance process and includes an "Indications for Use" statement, but no technical study details.

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The BF100 Disposable Bacterial/Viral Filter is intended for use within respiratory breathing circuits where filtration of particulate matter is desired. Each filter is broading of single patient use for up to 24 hours, and is not intended for reuse.

Ventlab Bacterial Filter BF100

This document is a 510(k) clearance letter from the FDA for a medical device called the "Ventlab Bacterial Filter BF 100". It states that the device is substantially equivalent to a predicate device, allowing it to be marketed. However, this document does not contain any information about acceptance criteria, device performance, studies, ground truth establishment, or sample sizes.

Therefore, I cannot provide the requested information. The provided text is purely a regulatory approval letter and does not include the technical details of a study or performance evaluation.

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Ventlab Corporation's Hyperinflation Bag System is a pulmonary-assist device intended to provide assisted ventilation to patients. It is designed for patients suffering from respiratory insufficiency. The system's mode of operation is to ventilate a patient by forcing a volume of fresh gas into the patient via compression of the reservoir bag. The operating clinician controls peak pressure and monitors several respiratory parameters by use of a built-in manometer. Additional high pressures within the system may be controlled by use of the optional Pop-Off Valve.

Ventlab Hyperinflation Bag System with Built-In Pressure Monitor and Optional Pop-Off Valve

The provided text describes a 510(k) premarket notification for a medical device called the "Ventlab Hyperinflation Bag System with Built-In Pressure Monitor and Optional Pop-Off Valve." This document is a clearance letter from the FDA, and as such, it does not contain the detailed information required to answer your specific questions about acceptance criteria and study design.

FDA 510(k) clearance letters primarily state that a device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing. They generally do not include the underlying performance study results, acceptance criteria, sample sizes, ground truth methodologies, or details about expert involvement.

To answer your questions, one would typically need access to the original 510(k) submission document itself, which contains the summary of safety and effectiveness, including performance data and the study design.

Therefore, based solely on the provided text, I can state the following:

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

• Cannot be provided. The text does not contain any specific acceptance criteria or detailed performance metrics. It only states that the device is "substantially equivalent" to predicate devices.

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

• Cannot be provided. The text does not describe any specific test set, its sample size, or its provenance.

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

• Cannot be provided. The text does not mention any experts or ground truth establishment relevant to a performance study.

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

• Cannot be provided. The text does not describe any 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:

• Cannot be provided. This device is a mechanical hyperinflation bag system, not an AI-powered diagnostic device. Therefore, an MRMC study related to AI assistance would not be applicable or expected.

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

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

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

• Cannot be provided. The text does not detail any ground truth methodologies. For a mechanical device like this, performance testing would typically involve engineering and bench testing against established standards for flow, pressure, etc., rather than clinical "ground truth" as you might see for diagnostic AI.

8. The sample size for the training set:

• Not applicable / Cannot be provided. There's no indication of a "training set" as this is not an algorithm requiring machine learning. Performance testing for a mechanical device would not involve a training set in this context.

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

• Not applicable / Cannot be provided. As above, no training set is mentioned or implied for this type of device.

In summary, the provided FDA clearance letter is a regulatory document affirming substantial equivalence, not a scientific publication detailing performance studies. The information requested typically resides in the 510(k) Summary or other accompanying technical reports submitted to the FDA, which are not part of this document.

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