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The PVOCS HF system is intended to provide respiratory gases to include pre and post operative respiratory oxygen, pneumatic drive gas for ventilators and anesthesia machines, and oxygen enrichment for ventilators and anesthesia machines. It may be used in military field hospitals and other applications where oxygen stored in high pressure cylinders or liquid oxygen is not available, practical or safe to use. It is appropriate for use by military personnel only.

The PVOCS HF is a dual-mode medical gas system which supplies both oxygen-enriched gas at 93 ± 3% oxygen (hereafter referred to as OXY 93% or USP Oxygen 93%) and medical-grade air (MED AIR). In the High Flow OXY 93% mode, the PVOCS HF can supply up to 30 lpm of oxygen and 30 lpm of medical-grade air, and in the Low Flow OXY 93% mode oxygen mode, up to 20 lpm of oxygen and 75 lpm of medical-grade air. The system requires a separate compressed air supply from which oxygen is concentrated using pressure swing adsorption (PSA) techniques with synthetic zeolite. The oxygen is supplied at two low-pressure (6-psig) ports for patient respiration via nasal cannula and four moderate-pressure (50-psig) ports for patient ventilators. A storage plenum (purge tank) is included in the product line to ensure that short-term, high-demand flows do not cause a drop in oxygen concentration or pressure drops below rated output pressure in the product gas. The medical-grade air is provided to four ports at 50 psig by filtering the compressed air supply and drying it using PSA techniques.

This document describes the Patient Ventilation Oxygen Concentrating System, High Flow (PVOCS HF). However, it does not contain a study section with acceptance criteria and device performance in the format requested. The provided text is a 510(k) premarket notification for a medical device and typically focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing rather than detailed clinical trial results with specific acceptance criteria as might be found in a later-stage study.

Based on the provided text, here's what can be extracted and what cannot:

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

The document mentions performance benchmarks but these are stated as capabilities rather than formal acceptance criteria. No explicit "acceptance criteria" are defined.

• Up to 30 lpm of USP 93% oxygen
• Up to 30 lpm of medical grade air |
  | Not explicitly stated in the document | Low Flow OXY 93% mode:
• Up to 20 lpm of USP 93% oxygen
• Up to 75 lpm of medical grade air |
  | Not explicitly stated in the document | Oxygen concentration: 93 ± 3% oxygen |
  | Not explicitly stated in the document | Oxygen port pressure: 6-psig (low-pressure) or 50-psig (moderate-pressure) |
  | Not explicitly stated in the document | Medical-grade air port pressure: 50 psig |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size: Not applicable. The "study" mentioned is "Non-clinical bench testing," which typically involves evaluating the physical device's output and specifications, not a patient-related test set.
• Data provenance: "Non-clinical bench testing by Carleton Life Support Systems, Inc." Implies internal company testing, likely in their facilities (Davenport, IA, USA would be the most likely location).
• Retrospective or prospective: Not applicable for bench 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)

Not applicable. This was non-clinical bench testing assessing physical and chemical properties (oxygen concentration, flow rates, pressure), not a study requiring expert interpretation of medical data or images.

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

Not applicable. This was non-clinical bench 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

No. This is a medical device (oxygen concentrator), not an AI-powered diagnostic tool. Therefore, an MRMC study is not relevant or mentioned.

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

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

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

The "ground truth" for non-clinical bench testing would be established engineering specifications, chemical analysis standards, and measurement protocols for parameters like oxygen concentration, flow rate, and pressure. These are not derived from expert consensus, pathology, or outcomes data in the medical sense.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm.

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

Not applicable. This is a physical medical device, not an AI/machine learning algorithm.

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