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The TravelSome Standard Portable Oxygen Concentrator is intended to provide supplemental oxygen to patients with respiratory disorders for use in the home, or during travel by car.

The TraveSome® Standard Portable Oxygen Concentrator is a mobile oxygen concentrator intended for use in an automobile, with power from the automobile's battery and, for use off standard house current through the unit's incorporated power supply. The TravelSome uses two molecular sieves to extract oxygen from ambient air, which is similar to most 510(k) cleared oxygen concentrators. The unit provides two switch-selectable operating modes, continuous and demand, with a nonadjustable flow of approximately 1.2 L/min continuous and approximately 3.0 L/min in the demand mode. The unit has a detachable trollev with two wheels and a telescoping handle to provide maneuverability. It has a hinged cover across the top panel to protect against the entry of fluids, and a soft plastic textile cover which further protects the unit aqainst the entry of fluids, and a soft plastic textile cover which further protects the unit aqainst blows and splashes. An alarm warns of low oxygen concentration, lack of current, excessive internal temperature and blocked air inlet filter. The incorporated AC power supply, called the "Switching Power Supply for TravelSome Standard Portable Oxygen Concentrator", is manufactured by an OEM vendor and incorporated into the TravelSome Standard unit by Sim Italia S.r.l., the manufacturer of the TravelSome Standard unit. The power has UL and TUV certification. The code number for the power supply is PM 200. The input power requirements are 110/220 VAC, 50/60 Hz.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the TravelSome Standard Portable Oxygen Concentrator:

Based on the provided 510(k) summary, the device is an oxygen concentrator, and the submission focuses on its substantial equivalence to predicate devices, rather than establishing de novo performance criteria through new clinical trials.

The document explicitly states: "There are no substantial changes to the technical specifications and current function of the unit. Therefore no clinical tests were deemed necessary." This indicates that the safety and effectiveness are established by demonstrating similarity to already cleared predicate devices, not by meeting specific performance thresholds in new studies.

Therefore, for aspects related to clinical performance, direct acceptance criteria in the traditional sense (e.g., specific sensitivity/specificity thresholds) and studies proving those criteria are not presented in this document. Instead, the "acceptance criteria" are effectively that the device's performance is equivalent to its predicates, as shown through non-clinical bench testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document doesn't define specific "acceptance criteria" for clinical performance. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance" described is largely about the device's functional characteristics and how they compare to the predicates.

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

• Sample Size: Not applicable in the context of clinical testing. For non-clinical bench testing, no specific sample sizes are mentioned. The document states: "Test bench testing is the same as that used on the current predicate device."
• Data Provenance: Not applicable for clinical data, as no clinical tests were performed or deemed necessary.

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

• Not applicable. No experts were involved in establishing ground truth for clinical performance, as no clinical tests were performed.

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

• Not applicable. No external adjudication for clinical performance was performed.

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 device is an oxygen concentrator, not an AI-powered diagnostic tool involving human readers.

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

• Not applicable. This device is an oxygen concentrator, not an algorithm.

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

• Not applicable for clinical efficacy. The "ground truth" for substantial equivalence is based on the previously cleared predicate devices' performance, established through their own regulatory processes (which are not detailed here). For the modified components, the "ground truth" for their performance is derived from bench testing, and their similarity to the predicate, as determined by the manufacturer.

8. The sample size for the training set

• Not applicable. No training set for an algorithm was used.

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

• Not applicable. No training set for an algorithm was used.

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The Innosan Travelair® "S" Plus Portable Oxygen Concentrator is a mobile oxygen concentrator for use in an automobile, with power from the automobile's battery or for use with a power supply accessory (off of a mains current - 110 VAC, 60 Hz or 220 VAC, 50 Hz) when the patient is away from their primary home oxygen source, intended to provide a patient with supplemental oxygen. This device delivers oxygen to patients by physical means, using a molecular sieve bed oxygen concentrator and is designed to conserve the use of oxygen during such delivery.

The Innosan Travelair® "S" Plus Portable Oxygen Concentrator is a mobile oxygen concentrator intended for use in an automobile, with power from the automobile's battery and, for use with an AC power supply accessory. The Travelair® uses two molecular sieves to extract oxygen from ambient air; this is similar to most domestic oxygen concentrators. The unit provides two switch-selectable operating modes, continuous and demand, with a nonadjustable flow of approximately 1.2 L/min continuous and approximately 2.6 L/min in the demand mode. The unit has two large wheels, one small caster, and an adjustable handle to provide maneuverability. It has a hinged cover across the top panel to protect against the entry of fluids. An alarm warns of low oxygen concentration, excessive internal temperature and blocked air inlet filter.

The provided text is a 510(k) summary for the Innosan Travelair® "S" Plus Portable Oxygen Concentrator. It describes the device, its intended use, and its comparison to a predicate device. The core of the submission revolves around demonstrating substantial equivalence to a previously cleared device, rather than proving performance against specific acceptance criteria in a study with a defined test set, ground truth, or expert review process, as would be typical for a novel device or AI/ML-based system.

Therefore, many of the requested categories are not applicable or cannot be extracted directly from this document.

Here's an attempt to answer the questions based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission does not present "acceptance criteria" in the traditional sense of measurable performance thresholds for a novel device. Instead, it refers to compliance with existing guidance documents and standards to demonstrate safety and effectiveness. The "reported device performance" is implicitly that the device met all relevant requirements of the cited tests and guidelines, thus demonstrating substantial equivalence.

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

The document refers to "the Travelair® sample tested" for the concentrator and "the AC Power Supply sample tested" for the accessory. This implies a small sample size, likely one unit of each, which is common for testing physical medical devices against engineering specifications.

• Sample Size: Likely 1 unit for the concentrator, 1 unit for the AC power supply accessory.
• Data Provenance: Not explicitly stated, but the testing was conducted by CITECH, an independent testing laboratory. The document is a 510(k) submission from Sim Italia s.r.l. (Italy), but the testing itself seems to be standard regulatory compliance testing, not a clinical data collection from patients or specific regions. It is retrospective in the sense that the testing was completed before the submission.

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

This type of information is not applicable to this submission. The "ground truth" here is compliance with engineering standards and regulatory guidance, which is determined by objective measurements and testing protocols, not by expert interpretation of patient data or images. The "experts" would be the engineers and technicians at CITECH performing the tests, qualified in electrical, mechanical, and environmental testing.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert opinions in clinical studies (e.g., image interpretation). This submission deals with objective engineering compliance testing, where results are typically binary (pass/fail against a specification).

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 device is an oxygen concentrator, not an AI/ML-based diagnostic or therapeutic aid that would involve human readers or AI assistance.

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

Not applicable. This device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used for demonstrating substantial equivalence is compliance with established engineering standards and regulatory guidance documents. This includes:

• FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions" (Electrical, Mechanical & Environmental Performance Requirements).
• IEC-601-1 (1988) for specific tests like mechanical vibration/shock and fluid spill resistance.
• ASTM F1464-93, "Standard Specification for Oxygen Concentrators for Domiciliary Use".
• DCRND Reviewer's Guideline, November 1993 for electromagnetic compatibility.
• UL and TÜV certification requirements for the AC power supply.

8. The Sample Size for the Training Set

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

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

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

Summary of the Study:

The "study" or testing performed for this 510(k) submission was a series of non-clinical bench tests conducted by CITECH. These tests evaluated the electrical, mechanical, and environmental performance of the Innosan Travelair® "S" Plus Portable Oxygen Concentrator (and its AC power supply accessory) against recognized industry standards and FDA guidance documents. The purpose was to demonstrate that the expanded capabilities of the "Plus" model (namely, the AC power supply) did not introduce any new safety or effectiveness concerns compared to the predicate device and that the combined system met all relevant safety and performance requirements for oxygen concentrators. The conclusion of these tests was that the device met all relevant requirements and therefore was substantially equivalent to the predicate device.

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The Innosan Travelair® "S" Portable Oxygen Concentrator is a mobile oxygen concentrator for use in an automobile, with power from the automobile's battery, intended to provide a patient with supplemental oxygen. This device delivers oxygen to patients by physical means, using a molecular sieve bed oxygen concentrator and is designed to conserve the use of oxygen during such delivery.

The Travelair® is a mobile oxygen concentrator intended for use in an automobile, with power from the automobile's battery. The Travelair® uses two molecular sieves to extract oxygen from ambient air; this is similar to most domestic oxygen concentrators. The unit provides two switch-selectable operating modes, continuous and demand, with a nonadjustable flow of approximately 1.2 L/min continuous and approximately 2.6 L/min in the demand mode. The unit has two large wheels, one small caster, and an adjustable handle to provide maneuverability. It has a hinged cover across the top panel to protect against the entry of fluids. An alarm warns of low oxygen concentration, excessive internal temperature, blocked air inlet filter, and loss of power.

This is a 510(k) summary for a medical device called the "Innosan Travelair® 'S' Portable Oxygen Concentrator." This document is focused on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing. It does not describe a study involving AI performance, human readers, or image analysis, as the device is an oxygen concentrator.

Therefore, many of the requested elements of your prompt are not applicable to the information provided in this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a quantitative table format alongside performance metrics for the oxygen concentrator. Instead, it refers to general compliance with established standards and guidance.

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

The document states, "It was CITECH's conclusion that the Travelair® sample tested met all relevant requirements..." This implies that at least one physical unit of the Innosan Travelair® "S" Portable Oxygen Concentrator was used for testing. The exact number of units tested (sample size) is not specified beyond "sample."

• Test Sample Size: Not explicitly stated, implied to be at least one physical "sample" of the device.
• Data Provenance: The testing was conducted by CITECH, presumably in a laboratory setting, to evaluate the physical device's performance against engineering and safety standards. This is prospective testing of a physical device, not retrospective analysis of data. Country of origin not specified for CITECH or the testing location, but the submitter is from Italy.

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

This concept is not applicable here. Ground truth, in the context of this device, refers to the objective performance against engineering and safety standards. This is established through direct measurement and testing methods specified in the standards (e.g., measuring voltage, oxygen concentration, temperature, vibration resistance). The "experts" would be the engineers and technicians at CITECH performing the tests, whose qualifications are in their ability to conduct these specific tests accurately and interpret the results against the cited standards. Their number and specific qualifications are not detailed.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments or when there's disagreement among human readers/interpreters of complex data (e.g., medical images). For physical device testing against objective standards, the outcome is typically a direct measurement or a pass/fail against a specific threshold.

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 device is an oxygen concentrator, not an AI-powered diagnostic tool, and no human readers or AI assistance are involved in its primary function or testing as described.

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

This refers to AI algorithm performance. Not applicable to this oxygen concentrator.

7. The type of ground truth used

The ground truth used is the objective outcome of physical device performance against established engineering, electrical, mechanical, and environmental standards. This includes:

• Measurements of electrical parameters (voltage, current).
• Measurements of mechanical robustness (vibration, shock, fluid spill resistance).
• Measurements of environmental tolerance (temperature, humidity).
• Measurements related to electromagnetic compatibility.
• Measurements of oxygen concentration and flow rates (implied by compliance with ASTM F1464-93 for oxygen concentrators).

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, so there is no "training set."

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

Not applicable, as there is no training set for this device.

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