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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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