(100 days)
The OxySure™ System is intended to produce oxygen for emergency use.
The OxySure™ System creates medically pure [USP] oxygen at an average flow rate of 6.5 liters per minute for 15 minutes from a catalytic reaction of dry compounds. The OxySure 1 System is comprised of an outer housing, self-contained disposable cartridges that house the dry compounds and water, and a single-use mask and tubing system to deliver the oxygen to the user.
The provided text describes the OxySure™ Portable Oxygen Generator, Model 615, and its substantial equivalence to a predicate device. However, it does not explicitly state formal acceptance criteria in a table format with numerical targets or a detailed study proving the device meets acceptance criteria as one would expect for a diagnostic or AI-driven device.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Canogen Portable Oxygen Generator Model 615, K982243) based on intended use and performance characteristics relevant to an oxygen generator. The "Testing" section describes the methodology used to assess the device's performance.
Here's an interpretation of the information provided, framed to address your questions as much as possible given the nature of this submission for an oxygen generator rather than a diagnostic or AI device:
1. Table of Acceptance Criteria and Reported Device Performance
Formal acceptance criteria with specific thresholds are not explicitly laid out, but the "Testing" section implies that the device had to generate medical-grade oxygen at a certain flow rate for a specified duration. We can infer the performance targets from the description.
| Acceptance Criteria (Inferred from Device Description & Testing) | Reported Device Performance |
|---|---|
| Production of medically pure [USP] oxygen | Creates medically pure [USP] oxygen |
| Average flow rate | 6.5 liters per minute |
| Duration of oxygen production | For 15 minutes |
| Chemical reaction commencement | Commenced instantaneously |
| No stirring/agitation required | No stirring, swirling, or agitation administered or required |
| Maintenance of properties over time (implicitly) | Measurements of flow rate, oxygen purity, humidity, and temperature recorded at 15-second intervals. (Implies these characteristics met appropriate thresholds, though explicit thresholds are not given). |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of an algorithm or diagnostic device. For this oxygen generator, the "Testing" section describes a process of combining predetermined amounts of base powder, water, and catalyst. It doesn't mention a sample size for multiple units of the device being tested, nor does it specify the provenance of data (e.g., country of origin, retrospective/prospective), as this type of information is typically for clinical data. The testing appears to be a laboratory-based performance assessment of the device's chemical reaction and output.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is an oxygen generator, not a diagnostic tool requiring expert interpretation of results to establish ground truth. Its performance is assessed through direct physical measurements (flow rate, purity, humidity, temperature).
4. Adjudication method for the test set
Not applicable. There's no "test set" in the sense of clinical cases requiring expert adjudication.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
Not applicable. An MRMC study is relevant for diagnostic imaging or interpretation tasks involving human readers and AI assistance. This device is an oxygen generator.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm or AI. It is a physical device that produces oxygen through a chemical reaction. The "Testing" described is a standalone performance assessment of the device itself.
7. The type of ground truth used
The "ground truth" for this device's performance would be the direct physical measurements taken during the "Testing" phase, such as:
- Oxygen Purity (USP standard)
- Oxygen Flow Rate (6.5 LPM)
- Duration of Oxygen Production (15 minutes)
- Humidity levels
- Temperature of the oxygen
These are objective, measurable outcomes, not expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
Not applicable. This device does not employ machine learning or AI, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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).