(77 days)
The Model 535D Oxygen Cyling System is intended for use in supplying pressurized oxygen to fill oxygen cylinders for patients' ambulatory use. The device is intended to provide 93% (± 3%) oxygen. This device can be used in homes, nursing homes, patient care facilities, etc.
Oxygen Cylinder Filling System
This document is a 510(k) summary for the DeVilbiss Oxygen Cylinder Filling System (K053240). It focuses on administrative information and the FDA's clearance letter, rather than detailed performance studies or acceptance criteria.
Therefore, the requested information for acceptance criteria and study details cannot be fully extracted from the provided text. The document is primarily focused on the regulatory clearance process.
Here's an analysis of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
Cannot be fully extracted.
The document states the device's indication to "provide 93% (± 3%) oxygen." This implies an acceptance criterion for oxygen purity but does not provide a table of performance results or other acceptance criteria (e.g., filling speed, pressure limits, safety features).
2. Sample size used for the test set and the data provenance
Cannot be extracted. The document does not describe any specific test sets, sample sizes, or data provenance (country of origin, retrospective/prospective).
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 Cylinder Filling System, not an AI or diagnostic device that would require expert-established ground truth for a test set in the traditional sense of medical imaging or clinical diagnosis. The performance would be assessed against technical specifications (e.g., oxygen purity, pressure, filling time).
4. Adjudication method for the test set
Not applicable. See point 3.
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-assisted diagnostic or interpretive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical device for filling oxygen cylinders, not an algorithm. Its performance would inherently be "standalone" in terms of its function as a machine.
7. The type of ground truth used
Cannot be extracted as described in the prompt's examples. For this type of device, "ground truth" would relate to its manufacturing specifications and performance against those specifications (e.g., a calibrated oxygen analyzer to verify purity, pressure gauges, timers). The document does not detail this.
8. The sample size for the training set
Not applicable. This device is not an AI/ML system that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. See point 8.
Summary of available information:
- Indications For Use: The device is intended for use in supplying pressurized oxygen to fill oxygen cylinders for patients' ambulatory use. It is intended to provide 93% (± 3%) oxygen.
- Predicate Devices: CHAD Therapeutics Total O2 Delivery System (K013472 & K971889). The substantial equivalence determination likely relied on comparisons to the performance and safety profiles of these predicates, rather than extensive new clinical studies detailed in this summary.
To obtain the detailed acceptance criteria and study data for this device, one would typically need to consult the full 510(k) submission, which often includes more extensive testing reports (e.g., engineering test reports, biocompatibility, electrical safety, performance testing against specifications). The provided summary is a high-level regulatory document.
§ 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).