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The PureFill Oxygen Compressor is indicated to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. The device is not intended to be life supporting or life sustaining.

Environment of use: - Sub-acute care facilities and home settings

The PureFill Oxygen Compressor is designed to accept low pressure (14-30 PSIG) oxygen from existing oxygen concentrators and pressurize the oxygen to 2,000 PSIG to fill patient's portable oxygen cylinders.

This document describes the PureFill Oxygen Compressor, a device designed to pressurize low-pressure oxygen from concentrators to fill portable oxygen cylinders. The submission is a 510(k) premarket notification, aiming to demonstrate substantial equivalence to previously cleared predicate devices.

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

Since this is a 510(k) submission for a physical medical device (an oxygen compressor), the "acceptance criteria" are based on demonstrating substantial equivalence to predicate devices across various aspects, including indications for use, technology, environment of use, patient population, and performance specifications. There are no explicit "acceptance criteria" in terms of clinical accuracy metrics like sensitivity or specificity as would be found for an AI/ML device. Instead, the performance is compared to the predicate devices.

Here's a table summarizing the comparison of the PureFill Oxygen Compressor to its predicate devices, which serves as the "reported device performance" against the implicitly accepted standards of the predicate devices:

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

This document details a 510(k) submission for a physical medical device (an oxygen compressor), not a software or AI/ML device. Therefore, the concept of a "test set" with "data provenance" as applied to clinical data (e.g., patient images, electronic health records) is not applicable here.

The "testing" mentioned is primarily non-clinical bench testing to confirm the device meets engineering and safety standards, and performance specifications comparable to predicates. The document does not specify sample sizes in terms of, for example, number of patients or clinical cases.

The non-clinical tests performed included:

• Materials testing (VOC, PM25, Ozone, CO, CO2)
• Performance Bench Testing (ES60601-1, IEC 60601-1-2, IEC 61000-6-3, EN55011 CISPR 22, Altitude, Fill rate, Oxygen Pressure Surge Testing, Material Selection and Cleaning of Components, Autogenous Ignition Temperature Test, Acoustic Noise, Audible Acoustic Energy).

These tests are typically conducted in a controlled laboratory environment by the manufacturer or a contracted testing facility, rather than derived from real-world patient data in a specific country. They are prospective tests conducted on prototypes or production units of the device.

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. As explained above, this is a physical device with non-clinical testing. "Ground truth" in the context of expert medical opinion for diagnostic accuracy is not relevant here. The "truth" for this device's performance is objective measurements from engineering tests (e.g., pressure output, filling time, oxygen concentration verified by laboratory equipment).

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

Not applicable. There is no clinical test set requiring expert adjudication for this type of device. Performance is determined by objective measurements against engineering specifications and comparison to predicate device specifications.

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. MRMC studies are specific to evaluating the impact of diagnostic aids (often AI) on human reader performance in interpreting medical images or other diagnostic data. This device is an oxygen compressor, not a diagnostic aid.

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 or AI.

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

The "ground truth" for this device's performance is established through:

• Engineering Specifications: The device is tested against its own design specifications for parameters like pressure output, fill rates, power consumption, and alarm thresholds.
• International Standards: Compliance with recognized electrical safety, electromagnetic compatibility, and medical device standards (e.g., ES60601-1, IEC 60601-1-2) serves as a "ground truth" for safe operation.
• Predicate Device Performance: The functional and performance characteristics of the legally marketed predicate devices serve as an established benchmark for "acceptable" performance in the market.

8. The sample size for the training set

Not applicable. This is a physical device; there is no "training set" like there would be for an AI/ML algorithm. The device design and manufacturing processes are developed based on engineering principles and regulatory requirements.

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

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

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