(18 days)
The SeQual Model 6323A-OM-10, Integra Oxygen Concentrator, is intended for the administration of supplemental oxygen up to 10 LPM. The device is not intended for life support nor does it provide any patient monitoring capabilities.
The SeQual Model 6323A-OM-10, Integra Oxygen Concentrator, is a 0.5 to 10.0 Liter per minute (LPM) continuous flow pressure swing adsorption (PSA) type system that produces oxygen.
The SeQual Model 6323A-OM-10, Integra Oxygen Concentrator, consists of pneumatic and electrical components. The system has inlet filtration, air compressors, heat exchanger, and Synthetic Zeolite molecular sieve beds with a rotary valve, outlet filtration, electronic flow control and audible / visual alarms.
The provided document is a 510(k) summary for the SeQual Model 6323A-OM-10, Integra Oxygen Concentrator. This document describes a medical device for oxygen delivery and its equivalence to predicate devices, not an AI/ML powered device. Therefore, many of the requested criteria (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set size) are not applicable to this type of submission.
However, I can extract information related to the device's acceptance criteria and the study proving it meets them.
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Standard | Reported Device Performance |
|---|---|---|
| Oxygen Concentration | Meets specifications to ISO 8359 and ASTM 1464 standards | Confirmed to meet specifications |
Note: The document states "meets specifications" without detailing the specific percentage of oxygen concentration required by ISO 8359 and ASTM 1464. These standards define requirements for oxygen concentrators, including oxygen purity.
2. Sample size used for the test set and the data provenance
Not applicable for this type of device and submission. The performance data focuses on device specifications rather than clinical data from a "test set" in the context of an AI/ML evaluation. The “test set” here refers to the device itself being tested for its functional specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the sense of expert consensus on diagnostic interpretations, is not relevant for an oxygen concentrator's performance evaluation. The "ground truth" here is the physical measurement of oxygen concentration against established engineering standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically for subjective assessments (e.g., image interpretation). The performance of an oxygen concentrator is measured objectively.
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. This is not an AI/ML-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for evaluating the device's performance is based on objective measurements against established international and national standards for oxygen concentrators (ISO 8359 and ASTM 1464). These standards define the acceptable range of oxygen concentration for such devices.
8. The sample size for the training set
Not applicable. This is not an AI/ML-powered device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML-powered device.
Summary of the Study Proving Device Meets Acceptance Criteria:
The study referenced is "oxygen concentration testing to ISO 8359 and ASTM 1464 standards." These are internationally recognized standards for oxygen concentrators. The document states that these tests "confirm the device meets specifications and is substantially equivalent to the predicate devices." This implies that the device underwent testing to verify its ability to produce oxygen within the purity and flow specifications outlined by these standards at various operational parameters (e.g., flow rates, as the device is specified for 0.5 to 10.0 LPM). The details of the specific tests performed (e.g., number of units tested, environmental conditions, duration of tests) are not provided in this 510(k) summary, but the reference to these standards indicates the methodology.
§ 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).