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The DigiFLO Concentrator ANALYZER is a tool used by service personnel to measure Oxygen purity, Flow at the outlet of an oxygen concentrator. Also, it measures gas pressure inside and at the outlet of an oxygen concentrator. It is not intended to be used by patients who are prescribed oxygen, nor is it intended to continuously monitor or confirm oxygen delivery to a patient. The DigiFLO Concentrator ANALYZER is intended to be used in an environment where oxygen concentrators are being serviced or repaired. This includes Hospitals, Nursing Homes, Extended Care Facilities, Patient Homes, and Respiratory Device Service and Repair Centers.

The DigiFLO Concentrator ANALYZER is a lightweight, battery operated device, which measures oxygen concentrator outlet oxygen gas concentration and flow rate by means of ultrasonic wave, which travels from one piezoelectric transducer to another, and Oxygen pressure by means of a piezoresistive pressure transducer. The device is a standalone product and does not have any accessories, power supply adapters and fittings. The device is intended as a tool for use by oxygen concentrator service personnel, to evaluate the output and internal pressures in an oxygen concentrator. It is not intended to be used by patients who are prescribed oxygen, nor is it intended to continuously monitor or confirm oxygen delivery to a patient.

The device connects to an oxygen concentrator through existing therapy tubing presently in use throughout the industry. The device is designed and calibrated for use only on the species gas mixture inherent with the output flow of a concentrator. Information provided by DigiFLO Concentrator ANALYZER is the concentrator's oxygen concentration, flow rate, and pressure. Continuous monitoring of output gas flow between an operating oxygen concentrator and the patient is not possible. Use with any downstream devices or patient accessories is also not possible.

It is further intended that this device be used on clean, dry and unhumidified concentrator output gas. In conjunction with the operating temperature of oxygen concentrators, the ambient temperature range of DigiFLO Concentrator ANALYZER is within +10 to +40 degrees Celsius and should remain in dry indoor environment.

The provided text focuses on the 510(k) summary for the DigiFLO Concentrator ANALYZER, including its description, intended use, and substantial equivalence determination by the FDA. However, it does not contain information about acceptance criteria, the study design (including sample sizes, data provenance, expert ground truth, adjudication methods, or MRMC studies), or how ground truth was established for training data.

The document primarily states the device's technical specifications and how they align with its intended use for servicing oxygen concentrators.

Here's a breakdown of what can be extracted and what cannot based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists the expected operational ranges for the device and its accuracy, which can be interpreted as its performance specifications. However, it doesn't explicitly state "acceptance criteria" vs. "reported performance" from a specific validation study that demonstrated it met those criteria. It's more of a declaration of its capabilities.

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

This information is not provided in the document. The 510(k) summary focuses on regulatory approval based on substantial equivalence, not detailed study results.

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)

This information is not provided in the document. The device is a measurement tool, and its "ground truth" would likely be established against calibrated reference instruments, not expert human interpretation.

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

This information is not provided in the document. As a measurement device, adjudication by experts is not applicable in the typical sense for medical imaging or diagnostic devices.

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 is not applicable and not mentioned in the document. The DigiFLO Concentrator ANALYZER is a standalone measurement tool, not an AI-assisted diagnostic device used by human readers.

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

The document describes the DigiFLO Concentrator ANALYZER as a "standalone product" that measures oxygen concentrator output. While it's a "standalone device" in terms of its physical form and function, the document does not describe a "standalone (algorithm only)" performance study in the context of typical AI/software-as-a-medical-device (SaMD) evaluations. It is a hardware measurement device, and its performance would be evaluated against calibrated standards.

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

The document does not explicitly state the type of ground truth used for validation. However, for a measurement device like an oxygen gas analyzer, the ground truth would typically be established using calibrated reference instruments (e.g., a highly accurate benchtop oxygen analyzer, flow meter, and pressure gauge) that are traceable to national or international standards.

8. The sample size for the training set

This information is not provided in the document. Measurement devices like this are typically calibrated during manufacturing rather than "trained" on a dataset in the way an AI algorithm would be.

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

This information is not provided in the document. As mentioned for point 8, the concept of a "training set" and establishing "ground truth" for it in the context of an AI/machine learning device is not directly applicable to a physical measurement device like the DigiFLO Concentrator ANALYZER. Its accuracy is established through calibration against known standards.

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