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The Oxygen Concentrators are indicated for provide supplemental oxygen when the patient is away from their primary home oxygen source. The devices are not intended for life support nor do they provide any patient monitoring capabilities.

The Merits Health Products Portable Oxygen Concentrator is the prescription device designed to use in an automobile, with power from the automobile's battery and for use with an AC power supply. It is not for life-supporting 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 90% 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. This submission covers a model that has 1-liters per minute continuous flow output and 2-6 liters per minute for demand flow which is actuated by breathing and detecting oxygen concentration whenever greater than 85%. An oxygen alarm is built in the oxygen concentrator.

The provided text is a 510(k) summary for Merits Health Products Oxygen Concentrators. This document describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria or a detailed study proving the device meets said criteria in a quantifiable manner typical for studies involving AI/ML devices.

The document generally states: "The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device." without elaborating on what those specifications are or what specific tests were performed beyond general performance and design.

Therefore, many of the requested categories cannot be filled from the provided text.

Here's an attempt to extract what information is present and indicate where information is missing:

Acceptance Criteria and Device Performance Study for Merits Health Products Oxygen Concentrator

Based on the provided K053230 510(k) summary, specific acceptance criteria and detailed study results demonstrating the device meets those criteria are not explicitly provided in a quantifiable table format. The document generally states that the device "meets specifications" and is "substantially equivalent to the predicate device."

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Comprehensive, quantifiable acceptance criteria (e.g., minimum oxygen purity at specific flow rates, alarm activation thresholds, pressure specifications, battery life, etc.) are not detailed in this summary.

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

• Sample size for test set: Not specified. The document refers to "testing" but does not detail the size or nature of the test subjects or samples.
• Data provenance: Not specified. It can be inferred that testing was conducted by Merits Health Products Co., LTD. (Taiwan) but details on the type of data (e.g., patient data, engineering test data) or its origin are not provided.

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

• This information is not applicable to this type of device and submission. The device is a hardware oxygen concentrator, not an AI/ML-driven diagnostic or prognostic tool that would typically require expert-established ground truth for a test set. The performance would be measured against engineering specifications and industry standards.

4. Adjudication method for the test set

• Not applicable. This is typically relevant for studies involving human interpretation or AI output review against a gold standard. Device performance for an oxygen concentrator is assessed through engineering and functional testing.

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 is an oxygen concentrator, 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 hardware device; there is no "algorithm only" performance to evaluate in this context. The device's function is standalone in its operation to produce oxygen.

7. The type of ground truth used

• Type of ground truth: Implied to be engineering specifications and established performance standards for oxygen concentrators (e.g., oxygen purity measured by analytical equipment, flow rates verified by flow meters). The document indicates "comparison to currently marketed devices" (predicate device: Innosan Travelair "S" Plus Portable Oxygen Concentrator K971947), suggesting the predicate's performance or relevant standards serve as a benchmark.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. This is not an AI/ML device that requires ground truth for a training set.

Summary of Study:

The provided document describes a 510(k) submission for an oxygen concentrator. The "study" mentioned is general "testing" to confirm the device meets specifications and is "substantially equivalent" to a predicate device (Innosan Travelair "S" Plus Portable Oxygen Concentrator - K971947). The submission relies on established technologies (molecular sieve material, demand flow delivery systems) and claims that "There are no major technologies differences." The document does not provide a detailed, quantitative study with specific acceptance criteria, sample sizes, or detailed performance metrics. Instead, it makes a high-level assertion of compliance and equivalence.

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The Oxygen Concentrators are indicated for the delivery of supplemental oxygen in the home or medical institutions. The devices are not intended for life support nor do they 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 for life-supporting 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 first chamber of the dual-chambers aluminum extruded molecular sieve tank. As the oxygen is forced out of the end of the first chamber and then enters the Oxygen tank for patient use. As the remaining Oxygen flush the nitrogen out of the first molecular sieve chamber into the ambient air, the air is directed into the second molecular sieve chamber 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. Optional oxygen-driven-nebulizer is provided for patients who are prscribed for oxygen aerosol therapy by physician, using higher purity oxygen to drive a nebulizer while oxygen therapy is being undertaken. Optional oxygen-driven-nebulizer allows a single wnit to meet the different needs of oxygen or oxygen-aerosol therapy patients. This submission covers a model that will have a maximum output of 10-liters per minute as compared to the currently marketed model. Options will include an Oxygen alarm, pediatric flowmeter and nebulizer.

The provided text describes a 510(k) submission for the Merits Health Products Oxygen Concentrators. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness through extensive studies with acceptance criteria and statistical analysis typical of new drug or high-risk device approvals. Therefore, the information requested in the prompt, particularly regarding acceptance criteria, sample sizes, expert ground truth, adjudication, and MRMC studies, is largely not applicable or not present in this document.

Here's an analysis based on the available information:

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

The document states: "The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device." However, specific acceptance criteria (e.g., oxygen purity within a certain range at specific flow rates) and a detailed table of measured performance against these criteria are not provided in this summary. The assessment of equivalence is based on "design, performance specifications, testing and 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)

The document does not mention a "test set" in the context of clinical data or human subjects. The testing performed would likely have been engineering and performance testing on the device itself (e.g., oxygen purity, flow rate, pressure, noise levels, internal component specifications). Details about the sample size of devices tested or the provenance of any data beyond the general manufacturing location (Taichung, Taiwan R.O.C.) are not provided. This was likely internal validation testing.

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 concept is not applicable to this type of device and submission. "Ground truth" established by experts is typically for diagnostic imaging devices or other medical technologies where human interpretation or a gold standard diagnosis is involved. For an oxygen concentrator, the "ground truth" would be objective measurements of its physical performance parameters.

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

This is not applicable as there is no mention of a human-interpreted "test set" or diagnostic assessment 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

An MRMC study is not applicable here. This type of study is relevant for AI-powered diagnostic tools or imaging interpretation software where multiple human readers assess cases with and without AI assistance. This device is an oxygen concentrator, not a diagnostic AI tool.

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

This is not applicable as the device is a physical medical device (an oxygen concentrator), not an algorithm or AI system.

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

For an oxygen concentrator, the "ground truth" for performance would be objective engineering measurements of parameters such as:

• Oxygen purity (%)
• Flow rate (LPM)
• Output pressure
• Noise levels
• Power consumption
• Alarm functionality (e.g., low oxygen purity alarm)

These would be measured using calibrated equipment according to industry standards. The document states "The results of the testing confirm that the device meets specifications," implying these types of objective measurements were performed.

8. The sample size for the training set

This is not applicable. "Training set" refers to data used to train machine learning models. This device is not an AI/ML product.

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

This is not applicable as there is no training set for an AI/ML model.

Summary of Device Performance (Based on Substantial Equivalence Claim):

The document does not provide specific numerical performance data against acceptance criteria. Instead, it makes a general statement of compliance and substantial equivalence:

• Claim: "The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device."
• Basis for Substantial Equivalence:
  • Comparison to 5-liter Merits Health Products Oxygen Concentrators (K011844) in "main structure."
  • Comparison to 10-liter INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10 (K042262) in "functions."
  • Comparison of optional oxygen-driven nebulizer to 5-liter AIRSEP NEWLIFE AIR OUTLET OPTION (K944020).
• Key Performance Area (Implicit): The device is intended to provide "supplemental oxygen up to 10 LPM" with an oxygen purity of "approximately 93%." The testing would have verified these parameters against the predicate devices or established specifications.

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The Oxygen Concentrators with the Oxygen Filling accessory are indicated to provide supplemental oxygen to patients in the home and to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. The device is not intended for life support nor does it provide any patient monitoring capabilities.

The Profill Q601 series home oxygen filling machines are prescription devices designed for use in home by patients that require supplemental oxygen. It is intended to pressurize oxygen from an oxygen concentrator to fill gas cylinders for the patient's personal ambulatory use. It is not intended for life support nor does it provide any patient monitoring capabilities.

The device consists of a compressor module and a portable oxygen cylinder with a specially adapted cylinder fitting. It is compatible with available standard oxygen concentrators as the source of oxygen. The oxygen generated by the oxygen concentrator is inducted into a buffer tank. Then it is split into two streams. The first stream flows to the outlet on the control panel. The patients can use this as their source of supplemental oxygen while they are filling their cylinders. The second stream flows to the compressor where the oxygen is pressurized and filled into the cylinder. The devices are not sold or labeled as sterile

This is a 510(k) premarket notification for an oxygen concentrator accessory, not a study evaluating the performance of an AI/ML device. Therefore, many of the requested categories, such as acceptance criteria, sample size, ground truth, and MRMC studies, are not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not provide specific acceptance criteria or quantitative device performance data in a format applicable to evaluating an AI/ML device or a medical imaging system. The performance is summarized qualitatively.

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

Not applicable. This is a premarket notification for a physical medical device, not a study involving a test set of data.

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

Not applicable. Ground truth establishment with experts is not relevant for this type of device submission.

4. Adjudication method for the test set:

Not applicable.

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 is not an AI/ML device or an imaging device that would typically undergo such a study.

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

Not applicable.

7. The type of ground truth used:

Not applicable. The "ground truth" for this device would be its ability to perform its intended function (pressurize oxygen and fill cylinders) according to its engineering specifications, not expert consensus or pathology on medical data.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device.

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

Not applicable.

Additional Information from the Document:

• Device Name: Merits Health Products Oxygen Tank Filling Accessory (for Merits Health Products Oxygen Concentrators)
• Manufacturer: Merits Health Products Co., LTD.
• Intended Use: To provide supplemental oxygen to patients in the home and to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. Not intended for life support nor does it provide any patient monitoring capabilities.
• Comparison to Predicate Device: Substantially equivalent to the Invacare Corporation Model HomeFill II Complete Home Oxygen System (K003939).
• K Number: K050430
• Date: Submitted April 26, 2005 (FDA approval letter dated August 4, 2005)
• Regulatory Classification: Class II, Portable Oxygen Generator (21 CFR 868.5440), Product Code CAW.
• Performance Data: "Verification testing has confirmed the product meets its specifications." This generally refers to engineering and functional tests to ensure the device operates as designed.

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The Oxygen Concentrators are 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 life-supporting 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. Options will include an Oxygen alarm and a pediatric flowmeter

The provided text is a 510(k) summary for the Merits Health Products Oxygen Concentrator. It describes the device and claims substantial equivalence to a predicate device. However, it does not contain details about specific acceptance criteria, a study proving the device meets those criteria, or information related to AI/algorithm performance analysis.

Based on the provided text, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance
   The document states: "The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device." However, it does not provide a table of the specific specifications (acceptance criteria) or the detailed performance results. It generally claims equivalence to the predicate device (K011884).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
   This information is not present in the provided text.

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 present in the provided text. The device is an oxygen concentrator, not an imaging or diagnostic AI device that would typically involve expert ground truth for a test set in the same way.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   This information is not present in the provided text. It is not relevant for this type of device submission.

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 present in the provided text. This is a medical device (oxygen concentrator), not an AI-assisted diagnostic tool, so an MRMC study with human readers and AI assistance would not be applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
   This information is not present in the provided text. This is an oxygen concentrator, not an algorithm, so "standalone algorithm performance" is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   This information is not present in the provided text. For an oxygen concentrator, "ground truth" would likely relate to objective measurements of oxygen concentration, flow rates, and safety parameters, rather than expert consensus on diagnostic images or pathology.

8. The sample size for the training set
   This information is not present in the provided text. This device is not an AI/ML algorithm that requires a training set in the conventional sense.

9. How the ground truth for the training set was established
   This information is not present in the provided text, as it's not applicable to this type of device.

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.

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