Search Results

The intended use of the MPCF is to provide mobility to adults, limited to a sitting position that have the capability to operate a few simple controls and the ability to control a power wheelchair.

Not Found

This document is a 510(k) clearance letter from the FDA for a powered wheelchair, the MP3CF. It declares substantial equivalence to a predicate device.

There is no information in the provided text regarding acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria. The document is strictly an FDA clearance letter.

Therefore, I cannot provide the requested information. The letter only confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed, subject to general controls and potentially additional special controls.

Ask a specific question about this device

The Oxygen Concentrator is indicated for the delivery of supplemental oxygen in the home or medical institutions. The device is not intended for life support nor does it provide any patient monitoring capabilities.

The Merits Health Products Oxygen Concentrators are prescription devices designed to provide an inexpensive supply of supplemental oxygen in a home or institution without a continuous source of purified oxygen. They are not lifesupporting nor life-sustaining devices. The devices operate through the use of molecular sieve material that binds with the water and nitrogen in filtered room air to leave a gas that is approximately 93% oxygen when delivered to the patient. The compressor creates a vacuum to draw room air into a holding tank. At the same time, downstream of the compressor, the air from the previous cycle is pressurized into one of the two aluminum welded molecular sieve tanks. As the oxygen is forced out of the end of the tank, it enters a 'T' fitting that directs most of the gas to flush the nitrogen out of the second molecular sieve tank into the ambient air. The remaining oxygen is delivered to the patient. On the next cycle, the air is directed into the second molecular sieve tank with the oxygen generated flushing the first tank and continuing the supply to the patient. This repetitive cycle generates the oxygen necessary to flush and prepare the saturated sieve tank while supplying the patient with a continuous flow of high concentration oxygen. Other options will include an Oxygen alarm and a pediatric flowmeter.

The provided text is a 510(k) summary for an oxygen concentrator, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices and does not describe acceptance criteria, a detailed study proving performance, or specific AI/algorithm performance metrics. The information requested falls outside the scope of this particular submission for a Class II medical device like an oxygen concentrator, which typically relies on established performance standards for its product category rather than complex efficacy studies with AI components.

Therefore, most of the requested information cannot be extracted from the given text.

Here's a breakdown of what can be inferred or directly stated:

1. Table of acceptance criteria and the reported device performance

The document states: "The Device meets the requirements of the FDA recognized standard of the first The Device meets the requirements of the PDF roosgnitations of the predicate devices."

This implies that the acceptance criteria are based on the FDA-recognized standards applicable to oxygen concentrators and that the device's performance met these standards. However, the specific quantitative criteria (e.g., oxygen purity levels, flow rates) and the exact reported performance values are not detailed in this summary. It only indicates compliance.

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. This submission is for a physical medical device (oxygen concentrator), not a data-driven AI algorithm. There is no "test set" in the context of diagnostic performance. Performance tests would relate to the physical operation of the concentrator itself (e.g., oxygen output, reliability).

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

Not applicable/Not provided. This information is relevant for studies validating diagnostic algorithms, not for the regulatory submission of an oxygen concentrator.

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

Not applicable/Not provided. Similar to point 3, this is for diagnostic studies.

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/Not provided. The device is an oxygen concentrator, not an AI diagnostic tool.

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

Not applicable/Not provided. The device is an oxygen concentrator, not an AI algorithm.

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

Not applicable/Not provided. For an oxygen concentrator, performance "ground truth" would be objective measurements like oxygen concentration, flow rate, noise levels, and durability, measured against established engineering and medical device standards. These specific measurements are not presented in this summary.

8. The sample size for the training set

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

In summary, the provided document is a 510(k) Pre-Market Notification for an oxygen concentrator. Its purpose is to demonstrate "substantial equivalence" to other legally marketed devices, primarily by showing that it has the same intended use, technological characteristics, and performs according to established FDA-recognized standards for its device class. It does not contain the detailed study results, acceptance criteria, or AI-specific information requested, as these are not typically part of a 510(k) submission for this type of device.

Ask a specific question about this device

Ask a specific question about this device

The intended use of the MERITS Pioneer 3 Powered Scooter is to provide mobility to adults, limited to a siting position and have the capability to operate a simple hand control.

MERITS Pioneer 3 Electric powered four wheel drive scooter

Due to the nature of the provided document, which is an FDA 510(k) clearance letter for a powered scooter, the requested information about acceptance criteria and a study proving a device meets acceptance criteria using AI/ML methodologies is not present.

This document pertains to a physical medical device (MERITS Pioneer 3 Electric Powered Four Wheel Drive Scooter) and its clearance through the 510(k) pathway, which focuses on demonstrating substantial equivalence to a predicate device. It does not involve AI/ML performance studies, ground truth establishment, or multi-reader multi-case studies typically associated with AI/ML-driven medical devices.

Therefore, I cannot extract the requested information as it is not contained within the provided text.

Ask a specific question about this device

The intended use of the MP3C is to provide mobility to adults, who have the capability to operate a few simple controls and the ability to control a power wheelchair.

MP3C Power Base Chair, Model MP3C

This document is a 510(k) clearance letter from the FDA for a power-operated chair, the "MP3C Power Base Chair, Model MP3C". It states that the device is substantially equivalent to legally marketed predicate devices.

This document does NOT contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, expert qualifications, ground truth, or an MRMC comparative effectiveness study.

The letter is a regulatory approval, not a technical report or study summary. Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device

The intended use of Travel Ease Electric Scooter, Pioneer 4 is to provide mobility to adult persons limited to a sitting position and capable to operate a few simple controls.

Travel Ease Electric Scooter, Pioneer 4

I am sorry, but the provided text from the FDA 510(k) summary for the "Travel Ease Electric Scooter, Pioneer 4" does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific details regarding a medical device's performance evaluation as requested in your prompt.

The document is a clearance letter from the FDA, confirming that the device is substantially equivalent to a legally marketed predicate device and can be marketed. It discusses regulatory matters such as the device's classification, general controls, and compliance with regulations, but it does not include performance data or studies.

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

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Merits Health Products MP3 is a handicap piece of equipment and it is used to assist disabled people to negotiate their daily living. People with muscular disease use this chair to improve their daily living.

MP-3 Power Base Chair

This document is a 510(k) clearance letter from the FDA for a medical device (MP-3 Power Base Chair) and does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter confirms substantial equivalence to a predicate device and provides regulatory guidance for marketing.

Therefore, I cannot provide the requested information.

Ask a specific question about this device

The Merits MP-3 power base wheelchair will be used by handicapped people who are unable to ambulate. People who cannot ambulate and have weak upper body strength and cannot propel a manual wheelchair will be the ones who will benefit from the use of the MP-3 power base wheelchair.

MP-3 Power Base Chair

This document is a 510(k) clearance letter from the FDA for a power base chair (MP-3 Power Base Chair). It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any other details related to the efficacy or safety testing of the device.

The letter only states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

Therefore, I cannot provide the requested information based on the input document.

Ask a specific question about this device