(41 days)
The OxyTec 900 is intended for prescription use by patients requiring high concentrations of oxygen on a supplemental basis. It is small, portable and is capable of continuous use in the home, institutional, and travel / mobile environments.
The OxyTec 900 is a small, portable oxygen concentrator which operates by pressure swing adsorption, molecular sieve. It has various flow rate settings, utilizes a conserver trigger method, and delivers 89% ± 3% pure oxygen. It is capable of continuous use in the home, institutional settings and mobile environments. It may be powered by 100-250 VAC, 12-14 VDC or batteries.
This document describes the OxyTec 900, a portable oxygen generator. However, the provided text does not contain a study proving the device meets specific acceptance criteria in the format requested. The document is primarily a 510(k) summary for regulatory submission, focusing on device description, indications for use, and a comparison to predicate devices to establish substantial equivalence.
Therefore, many of the requested sections (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set information) cannot be extracted from the given text as they are not present.
The only "acceptance criteria" discussed are implicit in the comparison to the predicate device, particularly regarding oxygen purity.
Here's the information that can be extracted or inferred based on the provided text, with notes indicating what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Predicate) | Reported Device Performance (OxyTec 900) |
|---|---|
| Oxygen purity: 90% ± 3% (from AirSep) | 89% ± 3% |
| Portable, battery operated: Yes | Yes |
| Alarms: Yes | Various user alarms |
| Variable flow settings with pulsed doses: Yes | Yes |
| Conserver integrated in system: Yes | Yes |
Note: The document states, "There are no significant differences between the proposed device, OxyTec 900 and the identified predicates." This implies that meeting the predicate's performance characteristics serves as the "acceptance criteria" for substantial equivalence.
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The document does not describe a performance study with a test set.
- Data Provenance: Not applicable, as no specific performance data from a test set is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable, as no performance study or ground truth establishment process is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no performance study or adjudication process is described.
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
- No MRMC study was done. This device is an oxygen concentrator, not an AI or imaging device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is mechanical/electronic, not an algorithm. Its performance (e.g., oxygen purity, flow rate accuracy) would be evaluated standalone, but the document does not detail these specific tests or their results beyond the summary table.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the context of an AI device. For this medical device, the "ground truth" for its performance would be established through engineering specifications, scientific measurements, and established medical standards for oxygen delivery (e.g., precise oxygen concentration validated by analytical instruments). The document only states the claimed purity.
8. The sample size for the training set
- Not applicable. This is not an AI device that uses training sets.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI device that uses training sets.
§ 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).