(147 days)
The Canogen Portable Oxygen Generator, Model 615 is intended to produce oxygen for emergency use.
The Canogen Portable Oxygen Generator, Model 615 provides an average of 6.5 liters a minute for a minimum of 15 minutes, through a chemical reaction. The Canogen Portable Oxygen Generator, Model 615 consists of three parts. The first part is a reaction vessel in which the chemical reaction takes place. The reaction vessel may be reused. The second part is the cartridge containing the chemicals required to generate the oxygen produced by this device. The third part of the generator consists of the plastic tubing and gas mask which are attached to the outlet of the generator.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Canogen Portable Oxygen Generator, Model 615:
The provided text is a 510(k) summary for a medical device and is primarily focused on demonstrating substantial equivalence to a predicate device. It details product specifications and some basic bench testing. It does not describe a complex study involving human readers, AI, or extensive ground truth establishment as might be found in a clinical trial or AI/ML device submission.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Produce humidified oxygen at >99% purity | Determined to produce humidified oxygen at a purity of greater than 99% |
| Produce oxygen for a minimum of 15 minutes | Determined to produce oxygen for a minimum of fifteen (15) minutes |
| Produce oxygen at an average flow rate of 6.5 L/minute | Determined to produce oxygen at an average flow rate of six and a half (6.5) liters per minute (The Device Description also states "provides an average of 6.5 liters a minute for a minimum of 15 minutes"). |
Study Details
The provided document describes a bench test rather than a full clinical study or comparative effectiveness study.
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of devices or test runs. The text states "Bench test runs were conducted," implying multiple runs, but no specific count is given.
- Data Provenance: The tests were conducted internally by Canogen International, Ltd. and are "bench tests." There is no indication of country of origin for data or whether it's retrospective or prospective beyond the internal testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" here is based on physical measurements from calibrated instruments (flow gauges, temperature sensors, pressure gauges). There are no human experts establishing a subjective ground truth for the performance of this type of device in the context of this summary.
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Adjudication method for the test set:
- Not applicable. This was a bench test involving objective measurements, not a test set requiring expert adjudication for subjective interpretation.
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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. An MRMC comparative effectiveness study was not performed. This device is an oxygen generator, not an imaging or diagnostic AI device that would involve human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable directly as an AI algorithm. However, the performance assessment described is a standalone performance evaluation of the physical device itself (without human intervention in its oxygen generation function). The device operates independently once activated.
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The type of ground truth used:
- Instrumental Measurements/Physical Standards. The "ground truth" for purity, flow rate, and duration was established by measurements from "flow gauges, temperature sensors, data logger and pressure gauges." These instruments provide objective, quantitative data against which the device's performance was compared to established physical parameters and its own design specifications.
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The sample size for the training set:
- Not applicable. This device does not use machine learning or AI algorithms, and therefore, there is no "training set."
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How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI algorithm, this requirement does not apply.
Summary of Device and Study Type:
This K982143 submission describes a portable oxygen generator. The "study" referenced is a series of internal bench tests designed to verify the physical operating specifications of the device (oxygen purity, flow rate, and duration) against its pre-defined performance goals. This is a common and appropriate type of testing for a device of this nature to demonstrate its fundamental functionality. The submission is not for a computational or AI-driven device, hence many of the requested categories related to AI/ML studies are not applicable.
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).