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The revised DeVilbiss 5 Liter Oxygen Concentrator is designed to provide supplemental low flow oxygen therapy for patients suffering from COPD, cardiovascular disease, and lung disorders. The oxygen concentrator is used in home type environments: homes, patient care facilities, etc.

The DeVilbiss 5 Liter Oxygen Concentrator is intended for use as an oxygen concentrator to provide supplemental low flow oxygen therapy in the home, nursing homes, patient care facilities, etc.

The revised DeVilbiss 5 Liter Oxygen Concentrator is a 1-5 lpm, pressure swing adsorption, oxygen concentrator based on molecular sieve technology. Room air is drawn into the concentrator via a piston style compressor. The air then passes through a series of filters that remove dust, bacteria, and other particulates. A pneumatic valve directs air into one of the two sieve beds. Nitrogen is adsorbed in the bed as the pressure increases while oxygen flows through, thereby producing an enriched oxygen product for the patient. Simultaneously in the other bed, nitrogen is desorbed as the pressure decreases and is exhausted into the atmosphere. A momentary intermediate pneumatic sequence ties the beds together with the exhaust blocked for an enhanced nitrogen purge. The cycle continues, providing a continuous flow of oxygen at a purity of 93% +/-3% to the patient. The concentrator is available with or without an oxygen monitoring device.

The provided text describes a 510(k) submission for a medical device, the DeVilbiss 5 Liter Oxygen Concentrator. However, it does not contain information about a study with acceptance criteria in the typical sense of a clinical or performance study with a test set, ground truth established by experts, or sample sizes for training and testing.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices in the United States. This pathway primarily relies on comparing the technological characteristics and performance of the new device to a device that is already legally on the market.

Here's an analysis based on your requested categories, highlighting where the information is available and where it's not applicable in this context:

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria: The "acceptance criteria" here are largely implicit, derived from industry standards and the comparison to the predicate device. The primary performance metric mentioned is oxygen purity.

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

• Sample Size for Test Set: Not applicable. This document does not describe a clinical or performance study with a test set of human/animal subjects or a dataset in the way an AI/ML study would. The performance data is stated as "Based on tests performed," implying internal engineering or bench testing, not a formal clinical trial with a defined test set.
• Data Provenance: Not applicable in the context of clinical data. The "tests performed" would likely be internal V&V (Verification and Validation) carried out by the manufacturer.

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

• Not applicable. Ground truth, in the sense of expert consensus on clinical cases, is not part of this 510(k) submission for an oxygen concentrator. The "ground truth" for this device's performance is objective measurement of oxygen purity.

4. Adjudication method for the test set

• Not applicable. There is no test set in the clinical/AI sense that would require 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

• Not applicable. This is not an AI-powered device, nor is it a diagnostic imaging device that would involve human readers.

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

• Not applicable. This is a standalone medical device (oxygen concentrator), but not in the context of an "algorithm only" performance study. Its performance (oxygen purity) is inherent to the device's function, not an algorithm's output.

7. The type of ground truth used

• Ground Truth: Objective measurements of oxygen purity (e.g., using an oxygen analyzer) and verification of other mechanical/electrical specifications (e.g., pressure relief valve function, alarm functionality). This is not an expert consensus, pathology, or outcomes data in a clinical sense.

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. No training set is involved.

Summary:

The provided document describes a 510(k) submission for an oxygen concentrator, which demonstrates substantial equivalence to "legally marketed predicate devices." The "study" referenced is not a typical clinical trial or AI performance study. Instead, it involves bench testing and engineering verification to confirm that the revised device meets established performance specifications (primarily oxygen purity) and that any changes (e.g., to the valve, cycling mechanism, or alarms) do not negatively impact safety and effectiveness compared to the predicate device. The "acceptance criteria" are therefore derived from the established performance of similar devices and general regulatory requirements for medical device safety and efficacy.

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