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The SIMEOX 200 airway clearance device is intended to promote airway clearance and to improve bronchial drainage by enhancing mobilization of bronchial secretions via high frequency oscillatory vibrations and intermittent negative pressure to the airway during exhalation. The device is intended to be prescribed for use in patients capable of independently generating cough.

SIMEOX 200 is intended for use in the home, hospital, and other healthcare institutions by individuals weighing at least 23 Kg.

The SIMEOX 200 Airway Clearance Device consists of a portable generator and a single patient use expiratory kit. The patient inhales from the ambient environment, naturally and independent of the device, and then exhales into the device mouthpiece. During the patient's exhalation, the SIMEOX 200 generates a pneumatic vibration throughout the airway. This vibration, applied at 6 Hz or 12 Hz via negative pressure pulses, disseminates throughout the bronchial tree in order to decrease mucus viscosity and increase secretion mobility. During or after therapy, the patient can clear the secretions by coughing independently.

This document describes the FDA's 510(k) clearance for the SIMEOX 200 Airway Clearance Device. It primarily focuses on demonstrating substantial equivalence to predicate devices through technical specifications and non-clinical performance testing.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of human-in-the-loop performance, AI assistance, or expert-based ground truth establishment for diagnostic purposes.

The document states:

• "Performance verification testing was conducted on the bench with the SIMEOX 200 Airway Clearance Device to demonstrate the subject device performs to its pre-specified requirement specifications, which align with those of the predicate devices."
• "The SIMEOX 200 device also went through comprehensive software verification and validation testing to confirm the device operates within specification."
• "Testing demonstrated the SIMEOX 200 performed as intended and was safe and effective."
• "A human factors validation study was conducted with simulated first-time use of the product in adult users and dyads of children with caregivers. The study concluded that the device is safe for its intended users."

This indicates that the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and safety performance specifications, rather than clinical performance metrics typically associated with AI/diagnostic devices (like sensitivity, specificity, or reader improvement).

Therefore, I cannot populate the requested table and study details as they are not present in the provided text. The document describes a medical device (Airway Clearance Device), not an AI or diagnostic device that would typically involve the type of acceptance criteria and studies you've outlined.

The acceptance criteria implied are the device's ability to meet its pre-specified parameters (e.g., pressure range, oscillation frequencies) and demonstration of safety and effectiveness through bench testing, software validation, and human factors validation.

Here's a summary of the information that is available, reframing it in the context of device performance rather than AI/diagnostic performance:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other requested information, it is largely not applicable or not provided for this type of device and submission:

2. Sample size used for the test set and the data provenance:
* Test Set: Not explicitly stated in terms of a "test set" for performance metrics like sensitivity/specificity. Performance testing was "on the bench" and included software V&V and human factors simulation.
* Data Provenance: Not applicable for this type of technical/safety validation. The human factors study involved "simulated first-time use," but details about participant numbers or demographic provenance are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* This is not relevant for this device's 510(k) submission, as it's not a diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) 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, as this is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable, as this is not an AI/algorithm-driven device in the sense of image analysis or diagnostic prediction. Its "performance" is based on its physical and software operation parameters.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* "Ground truth" in this context refers to the pre-defined engineering specifications and safety standards (e.g., pressure measurements, frequency measurements against a calibrated standard, successful execution of software functions, successful completion of simulated tasks in human factors). It's not a clinical or diagnostic ground truth.

8. The sample size for the training set:
* Not applicable. This device does not use machine learning that requires a "training set."

9. How the ground truth for the training set was established:
* Not applicable.

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The Inogen Rove 6 Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis. It may be used in the home, institution, and transport modalities. This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.

The Inogen Rove 6 Portable Oxygen Concentrator (Inogen Rove 6) is a Class 2, low risk, portable oxygen generator that provides a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis. It may be used in home, institution, vehicle, and other transport modalities. It is used with a nasal cannula to channel oxygen from the device to the patient. The concentrator and the nasal cannula are non-sterile. The Inogen Rove 6 Portable Oxygen Concentrator is capable of continuous use in a home, institution, vehicle, and various mobile environments. Power options include 100 - 240 V-AC (50-60Hz) power supply, rechargeable battery packs, or a 13.5 -15.0 V-DC power cable. The Inogen Rove 6 Portable Oxygen Concentrator uses molecular sieve/pressure swing adsorption technology. Ambient air is drawn through particle filters by a compressor and forced through molecular sieve beds, which adsorb nitrogen and allow oxygen to pass. The airflow is then changed, and nitrogen is desorbed from the molecular sieve, allowing it to adsorb again during the next cycle. Oxygen is collected in an accumulator reservoir. Waste nitrogen is exhausted back into the room. A series of sieve beds, manifolds and precision valves, sensors and embedded software are used to control the cycle to make the system function. Oxygen is delivered to the patient on a pulse dose basis in precise amounts during the inhalation part of the breathing cycle. This conserver technology eliminates waste of unused oxygen at other times in the breathing cycle when it is not needed. The Inogen Rove 6 Portable Oxygen Concentrator senses the beginning of the inhalation cvcle and releases a specified dose of oxygen enriched gas from the accumulator reservoir, through a final filter, into the connected nasal cannula and on to the patient. The Inogen Rove 6 Portable Oxygen Concentrator utilizes Bluetooth technology that pairs the portable oxygen concentrator to a mobile device or tablet using the Inogen Connect App.

This is information extracted from a medical device 510(k) submission.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Inogen Rove 6 Portable Oxygen Concentrator are based on comparison to its predicate device (Inogen Rove 4) and a reference device (GCE Zen-O), as well as compliance with relevant international standards.

• Setting 1 (10-40 BPM): 7.0-21.0 ml/breath
• Setting 4 (10-40 BPM): 21.0-84.0 ml/breath
• Max total volume per minute: 840 ml/min.
  Reference (GCE Zen-O):
• Pulse mode settings 1-6 (15-40 BPM): ml/breath varies from 5.25 ml/breath at setting 1, 40 BPM to 66ml/breath at setting 6, 15-35 BPM. Max total volume per minute: e.g., setting 6 at 35 breath/min = 2310 ml/min. | Inogen Rove 6:
• Setting 1 (10-40 BPM): 5.25-21.0 ml/breath
• Setting 6 (10-40 BPM): 31.5-126.0 ml/breath
• Max total volume per minute: 1260 ml/min. Similar, with 2 additional flow settings delivering a higher maximum output. The maximum output is similar to Zen-O setting 6 at 20 breaths/min (1320 ml/min). |
  | Maximum Outlet Pressure | 30 days) per ISO 18562-2: 2017 (Particulate matter) and ISO 18562-3:2017 (Volatile organic compounds) (Predicate).
  Externally Communicating, Tissue, Limited duration (30 days) per ISO 18562-2: 2017 (Particulate matter) and ISO 18562-3:2017 (Volatile organic compounds). Similar to predicate. |

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

The document does not explicitly state the sample size used for the test sets in non-clinical testing. It only mentions "Inogen performed testing to demonstrate and support safety and effectiveness when compared to the predicate and the applicable standards."

The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It refers to "Bench Testing" and "testing at a nationally registered test laboratory," implying laboratory-based testing rather than clinical data from human subjects.

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

This information is not provided in the given document. The testing described is non-clinical bench testing and compliance with performance standards, which does not typically involve expert ground truth establishment in the same way clinical studies or image-based AI studies do.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The document describes non-clinical bench testing against technical specifications and performance standards, not a study requiring adjudication of human-read results.

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 applicable/provided. The Inogen Rove 6 Portable Oxygen Concentrator is a hardware medical device (portable oxygen generator), not an AI-assisted diagnostic or interpretative tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not have been performed for this device.

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

This information is not applicable/provided. As explained above, this device is not an AI algorithm. Its performance is evaluated through bench testing of its mechanical and electrical functions and oxygen delivery specifications. The device does contain "embedded software" (page 4), and "Software verification and validation" (page 19) was performed, indicating standalone testing of the software components. However, this is not an "algorithm only" study in the context of AI performance, but rather software testing for the device's operational control.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" is defined by:

• Established Technical Specifications: Such as oxygen concentration levels (90% -3%/+6%), pulse volumes (± 15% of rated volume), pressure values, sound levels, etc.
• International Standards: Specifically, ISO 80601-2-69, ISO 80601-2-67, various parts of IEC 60601, and IEC 62366-1.
• Comparison to Predicate and Reference Devices: Demonstrating "substantial equivalence" to the performance and characteristics of previously cleared devices, particularly for aspects like oxygen delivery mode, purity, and flow.

This is primarily performance data and compliance with objective technical and regulatory standards, not expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

This information is not applicable/provided. No AI model requiring a "training set" in the context of machine learning is described for this device. The software validation mentioned refers to verification of the device's embedded control software.

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

This information is not applicable/provided, as no AI model with a training set is described.

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The Inogen Rove™ 4 Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis. It may be used in home, institution and transport modalities.

This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.

The Inogen Rove™ 4 Portable Oxygen Concentrator is a portable oxygen generator that provides a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis. It may be used in home, institution and transport modalities. It is used with a nasal cannula to deliver oxygen from the device to the patient. This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.

The Inogen Rove 4 Portable Oxygen Concentrator is capable of continuous use in a home, institution, and various mobile environments. Power options include 100 - 240 V-AC (50-60Hz) power supply, rechargeable battery packs, or a 13.5 -15.0 V-DC power cord.

The Inogen Rove 4 Portable Oxygen Concentrator uses molecular sieve/pressure swing adsorption technology. Ambient air is drawn through particle filters by a compressor and forced through molecular sieve beds, which adsorb nitrogen and allow oxygen to pass. The airflow is then changed and nitrogen is desorbed from the molecular sieve, allowing it to adsorb again during the next cycle. Oxygen is collected in an accumulator reservoir. Waste nitrogen is exhausted back into the room. A series of sieve beds, manifolds, valves, sensors, and software are used to control the cycle to make the system function.

Oxygen is delivered to the patient on a pulse dose basis in pre-set amounts during the inhalation part of the breathing cycle. This conserver technology eliminates waste of unused oxygen at other times in the breathing cycle when it is not needed. Inogen Rove 4 Portable Oxygen Concentrator senses the beginning of the inhalation cycle and releases a specified dose of oxygen enriched gas.

The Inogen Rove 4 Portable Oxygen Concentrator utilizes Bluetooth technology that pairs the portable oxygen concentrator to a mobile device or tablet using the Inogen Connect App.

The Inogen Rove™ 4 Portable Oxygen Concentrator's acceptance criteria and the study that proves its performance are described below.

1. Acceptance Criteria and Reported Device Performance

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

The submission does not explicitly detail a "test set" in the context of clinical data for performance evaluation that would typically measure diagnostic accuracy. Instead, the testing described is primarily non-clinical bench testing to demonstrate safety and effectiveness against standards and comparison to a predicate device's specifications.

Therefore, for aspects like pulse volume, oxygen purity, trigger sensitivity, alarms, software verification/validation, electrical/EMC/RFID, and biocompatibility, there isn't a "test set" sample size in the traditional sense of patient data. The "test set" would consist of the performance parameters measured on the device itself under various conditions.

The provenance of this data is from bench testing conducted by the manufacturer and a nationally registered test laboratory. No specific country of origin for this testing is mentioned, nor is it categorized as retrospective or prospective clinical data, as it is technical performance testing.

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 as the evaluation relies on objective performance measurements against established engineering standards and technical specifications (e.g., oxygen concentration, pressure), rather than expert interpretation of medical images or patient conditions to establish a "ground truth."

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

This information is not applicable as the performance evaluation is based on objective measurements against engineering standards and specifications, not expert consensus on qualitative data.

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 applicable as the device is a portable oxygen concentrator, not an AI-assisted diagnostic or interpretative medical device. The submission describes a comparison between the subject device and a predicate device based on technical specifications and non-clinical testing, not a study involving human readers or AI assistance.

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

This information is not applicable for the core function of the oxygen concentrator. The device does have "Software verification and validation" and a mobile app, but this does not imply a "standalone algorithm-only" performance evaluation in the context of diagnostic accuracy or a similar clinical endpoint. The mobile app's function is for displaying device settings and alerts to the user, not for standalone diagnostic interpretation.

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

The "ground truth" for the device's performance evaluation is based on:

• Established engineering standards: e.g., IEC 60601 series, ISO 80601 series, IEC 62366-1.
• Objective physical measurements: such as oxygen purity, flow rates, output pressure, trigger sensitivity, battery life, sound levels, dimensions, and weight.
• Predicate device specifications: used as a benchmark for comparison during the "Substantial Equivalence Discussion."

There is no mention of expert consensus, pathology, or outcomes data as "ground truth" for this device.

8. The sample size for the training set

This information is not applicable. The submission describes the premarket notification for a medical device (portable oxygen concentrator) based on physical and technical performance testing, not a machine learning model that would require a "training set."

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

This information is not applicable as there is no "training set" for a machine learning model in this submission.

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The Inogen At Home Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Inogen At Home Oxygen Concentrator may be used in a home or institution.

The Inogen At Home is a stationary concentrator providing approximately 90% oxygen to patients on a continuous flow basis at a rate of 1.0 liter per minute (LPM) to 5.0 liters per minute (LPM), in 1.0 liter per minute (LPM) increments. Nasal cannula channels oxygen from device to patient; both concentrator and nasal cannula are non-sterile. The device is capable of continuous use in the home or in an institutional setting. The Inogen At Home can be powered by mains AC power found in the home or in an institutional setting. The Inogen At Home includes a detachable AC power cord to make the electrical connection to the AC mains. The Inogen At Home utilizes Pressure Swing Adsorption (PSA) technology to produce oxygen. Oxygen is separated from ambient air under pressure by molecular characteristics and affinity for adsorbent material. The molecular sieve preferentially adsorbs nitrogen, allowing enriched oxygen to collect in an accumulator; the process then swings to low pressure to desorb the nitrogen, exhausting it back into the environment. A series of sieve beds, manifold with precision valves, sensors, and embedded software are used collectively to govern system functionality.

The provided document describes the Inogen At Home Oxygen Concentrator, a medical device for supplemental oxygen delivery. It includes details about its purpose, technological characteristics, and conformance to relevant standards. However, the document does not contain a study that validates the device against specific acceptance criteria in the format requested.

Here's an analysis based on the information provided in the document, highlighting what is missing for a complete answer to your request:

The document clearly states the device's conformance to several international and national standards (EN ISO 8359:2012, ASTM F 1464:2005, IEC 60601-1). It also lists "performance testing" that was done, but does not provide specific acceptance criteria for these tests or the reported performance data in a quantitative table.

Here's a breakdown of what can and cannot be answered based solely on the provided text:

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

• Acceptance Criteria Mentioned (Implicitly by conformance to standards or general tests):

  • Oxygen Concentration: Approximately 90% (This is a design spec, not explicitly an "acceptance criterion" from a study).
  • Flow Rate: 1.0 to 5.0 LPM in 1.0 LPM increments (Design spec).
  • Electrical Safety/Compatibility: Conformance to IEC 60601-1.
  • Software Functionality: Tested.
  • Fire Mitigation: Tested.
  • Noise, Temperature, and Altitude Ranges: Tested.
  • Outlet Pressure: Tested.
  • Flow Indicator Accuracy: Tested.
  • Particulate Matter, Ozone, Volatile Organic Compounds, Carbon Dioxide, Carbon Monoxide: Biocompatibility testing included evaluation of these.
  • Overall safety requirements per EN ISO 8359:2012 and ASTM F 1464:2005.

• Reported Device Performance: The document states that "Performance testing included the assessment of electrical safety/ compatibility, software functionality, fire mitigation and noise, temperature and altitude ranges, outlet pressure, flow indicator accuracy, and oxygen concentration." It also mentions "Biocompatibility testing included the evaluation of particulate matter, Ozone, Volatile Organic Compounds, Carbon Dioxide, and Carbon Monoxide." However, no specific quantitative results or performance data against numerical acceptance criteria are provided in the text. For example, it doesn't say "oxygen concentration met specific criteria of X% +/- Y%" or "noise levels were Z dB below threshold."

Therefore, a table cannot be fully constructed with specific quantitative acceptance criteria or reported performance from this document.

Regarding the study that proves the device meets the acceptance criteria:

The document describes "Non-clinical Performance Data" and "Performance testing" as well as "Biocompatibility testing." These are the studies mentioned. However, the details required for points 2-9 are not present in the provided text.

Missing Information:

• 2. Sample sized used for the test set and the data provenance: Not mentioned.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of device testing. "Ground truth" in this context would be objective measurements from calibrated equipment, not expert consensus interpretation.
• 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-assisted diagnostic device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical oxygen concentrator, not an algorithm.
• 7. The type of ground truth used: For performance tests, the ground truth would be objective measurements from calibrated sensors and analytical equipment (e.g., oxygen analyzers, flow meters, pressure gauges, sound level meters, gas chromatographs for impurities). For biocompatibility, it would be analytical results against established safe limits. This is implied by the testing, but not explicitly detailed.
• 8. The sample size for the training set: Not applicable. This is a hardware device, not an AI algorithm requiring a training set.
• 9. How the ground truth for the training set was established: Not applicable.

Summary:

The provided text serves as a 510(k) summary for a medical device (oxygen concentrator). It broadly discusses performance and biocompatibility testing and conformance to standards to demonstrate "substantial equivalence" to predicate devices. However, it does not detail a specific quantitative study with acceptance criteria and results in the manner typically expected for AI/diagnostic devices as implied by your questions, which are more tailored to software-based systems or image analysis. The "acceptance criteria" here are largely defined by compliance with the cited medical device standards (EN ISO 8359, ASTM F 1464, IEC 60601-1) and internal design specifications.

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The Inogen One Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Inogen One Oxygen Concentrator may be used in a home, institution, vehicles and various mobile environments.

The Inogen One Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. Patients may include but are not restricted to those with chronic obstructive pulmonary disease (COPD). The device is not intended to be life sustaining or to be life supporting. It is used with a nasal cannula to channel oxygen from the device to the patient. The concentrator and the nasal cannula are non-sterile.

The Inogen One Oxygen Concentrator provides approximately 90% oxygen to the patient on a demand flow basis at an "equivalent" rate of 1.0 liters per minute to 5.0 liters to minute in increments of 0.5 liters per minute.

The Inogen One Oxygen Concentrator is capable of continuous use in a home, institution, vehicles and various mobile environments. Power options include 110 -- 220 VAC, 12 -- 14 VDC or rechargeable batteries.

The Inogen One Oxygen Concentrator uses molecular sieve / pressure swing adsorption technology. Ambient air is drawn thru particle filters by a compressor and forced thru molecular sicve beds, which adsorb nitrogen and allow oxygen to pass. The airflow is then changed and nitrogen is desorbed from the molecular sieve, allowing it to adsorb again during the next cycle. Oxygen is collected in an accumulator reservoir. Waste nitrogen is exhausted back into the room. A series of sieve beds, a manifold with precision valves, sensors and embedded software to control the cycle are used to make the system function.

Oxygen is delivered to the patient on a demand flow basis in precise amounts during the inhalation part of the breathing cycle. This conserver technology eliminates waste of unused oxygen at other times in the breathing cycle when it is not needed. Inogen One Oxygen Concentrator senses the beginning of the inhalation cycle and releases a specified dose of oxygen enriched gas from the accumulator reservoir, thru a final filter, into the connected nasal cannula and onto the patient.

The design of the Inogen One Oxygen Concentrator has focused on maximizing subsystem efficiencies and miniaturizing components to enable continuous duty use and to provide minimal weight and battery operation for mobile use.

The basic technology of the Inogen One Oxygen Concentrator is equivalent to other approved oxygen concentrators. The principles of operation are equivalent to the predicate device noted in the submission.

The provided text is a 510(k) summary for the Inogen One Oxygen Concentrator. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain any information about a study proving the device meets acceptance criteria, nor does it explicitly list acceptance criteria in a table format with reported device performance.

Therefore, I cannot fulfill the request to build a table of acceptance criteria and reported device performance or provide details about a study that proves the device meets those criteria, as that information is not present in the given text.

The document only states that:

• "Benchtop performance testing has demonstrated that the Inogen One Oxygen Concentrator is equivalent to the AirSep LifeStyle Oxygen Concentrator."

This is a statement of equivalence based on testing, but the specifics of that testing, the acceptance criteria used, or the results are not detailed in this summary.

In summary, the requested information is absent from the provided text.

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