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The Intended Use of the GENTLEFEED DUO BREAST PUMP is to express milk from the breast of lactating women.

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This document is a 510(k) clearance letter from the FDA for a breast pump, "MEBBY GENTLEFEED DUO." It does not contain information about the acceptance criteria for a study, the study itself, device performance results, sample sizes, ground truth establishment, or any of the other specific details requested in your prompt.

The letter's purpose is to inform Medel S.p.A. that their device has been found substantially equivalent to a legally marketed predicate device, allowing them to market it. It discusses regulatory requirements but no performance study data.

Therefore, I cannot fulfill your request using the provided input. The information you're looking for (acceptance criteria, study details, performance data) would typically be found in the 510(k) submission document itself, or in a separate clinical or non-clinical study report, not in the FDA's clearance letter.

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The Medel AG-CLASSIC Nebulization System, which includes the Medel AG-CLASSIC Compressor and the Medel Jet Nebulizer, is intended for the production of medical aerosol for respiratory disorders such as asthma, chronic obstructive pulmonary disease (COPD), bronchitis and emphysema for children or adults in the home. The Medel Jet nebulizer is a "single patient reuse" nebulizer and is to be used by one person multiple times. The use of the Medel AG-CLASSIC is for the production of medical aerosols with approved medications and requires the order of a physician for medical use. The AG-CLASSIC is not intended as a life sustaining or life-supporting device.

The Medel AG-CLASSIC Nebulization System, which includes the Medel AG-CLASSIC Compressor and the Medel Jet Nebulizer, is intended for the production of medical aerosol for respiratory disorders such as asthma, chronic obstructive pulmonary disease (COPD), bronchitis and emphysema for children or adults in the home. The Medel Jet nebulizer is a "single patient reuse" nebulizer and is to be used by one person multiple times.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The document is a 510(k) premarket notification letter from the FDA to Medel S.P.A. regarding their AG-CLASSIC Nebulizer. It states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance requirements. The "Indication for Use" section describes the intended use of the device but does not include any performance metrics or study details.

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The intended use of the AG EDGE is to convert liquid medication into a fine mist that can be drawn into the lungs to treat respiratory conditions for adult and pediatric patients who have been prescribed inhalation therapy or medication.

The AG EDGE is indicated only for use with nebulizer provided and viceversa.

The AG EDGE is transportable equipment intended for home health care use. The AG EDGE is not intended as a life sustaining or life support device.

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I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) premarket notification letter from the FDA regarding the "AG EDGE" nebulizer, determining its substantial equivalence to legally marketed predicate devices.

The text focuses on regulatory aspects such as:

• The FDA's review and determination of substantial equivalence.
• The device's classification (Class II).
• General controls provisions of the Act (annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration).
• Contact information for further guidance.
• Indications for Use.

It does not contain details about:

• Specific acceptance criteria for performance.
• Any study design, methodology, or results related to device performance against such criteria.
• Sample sizes for test or training sets.
• Ground truth establishment, number or qualifications of experts, or adjudication methods.
• MRMC comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot provide the requested table or details about a study from the given input.

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The intended use of the AG PLUS is to convert liquid medication into a fine mist that can be drawn into the lungs to treat respiratory conditions for adult and pediatric patients who have been prescribed inhalation therapy or medication.

The AG PLUS compressor is to be used only with specific 510(k) cleared nebulizer whose input specifications may be met by the pressure and flow characteristics of the AG PLUS compressor. The initial nebulizer distributed with the AG PLUS compressor will be the Medel Jet Pro, the performance of which is contained in this 510(k) notification.

The AG PLUS is transportable equipment intended for home health care use. The AG PLUS is not intended as a life sustaining or life support device.

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This document is a 510(k) clearance letter for a medical device called "AG PLUS", a nebulizer. It indicates that the device has been found substantially equivalent to a legally marketed predicate device. However, this letter does not contain the acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, not necessarily on presenting a detailed study proving performance against defined acceptance criteria in the manner typically seen for AI/ML device clearances.

Therefore, based only on the provided text, I cannot extract the requested information.

Here's why and what kind of document would typically contain this information:

• Acceptance Criteria & Device Performance: This information is usually found in the performance testing sections of the 510(k) submission, specifically detailing studies conducted to characterize the device's technical specifications (e.g., aerosol particle size, drug delivery rate, compressor flow/pressure). These studies would compare the new device's performance to the predicate or to established standards.
• Study Details (Sample Size, Data Provenance, Ground Truth, Experts, MRMC, Standalone): These are details specific to the design and execution of clinical or performance studies. If this were an AI/ML device, these points would be critical. However, for a nebulizer, the "studies" typically focus on engineering performance (e.g., aerosol characterization, compressor output) rather than diagnostic accuracy studies with human readers or pathology.
• Training Set Information: This is entirely relevant to AI/ML devices. A nebulizer is a mechanical device, so it doesn't have a "training set" in the context of machine learning.

What to look for if this were an AI/ML device (which it isn't):

If this document were for an AI/ML device, I would expect to find the requested information in sections detailing:

• Clinical Performance Study: This is where the results of the device's diagnostic accuracy, sensitivity, specificity, etc., would be presented, often against a ground truth.
• Reader Study / Multi-Reader Multi-Case (MRMC) Study: If human-in-the-loop performance or comparison to human readers was evaluated.
• Validation Study: Detailing the test set characteristics, ground truth establishment, and standalone performance metrics.
• Algorithm Development / Training Details: Describing the training data and how its ground truth was established.

In summary, the provided document is a regulatory clearance letter, not a technical report or clinical study summary. It confirms market authorization based on substantial equivalence but does not contain the detailed performance study information requested.

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