(28 days)
With the optional CeVox™ oximetry module connected to a compatible PulsioFlex oximetry probe, PulsioFlex measures oxygen saturation to assess oxygen delivery in adults.
PulsioFlex Monitoring System with Optional CeVox ™ Accessories
The provided text is a 510(k) premarket notification and does not contain detailed information about a study proving the device meets acceptance criteria. It mainly focuses on regulatory approval. Therefore, I cannot extract complete information for all the requested sections.
However, I can extract the acceptance criteria for oxygen saturation measurements from the "Indications for Use Statement" and state that no study details are provided in this document.
Here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
| Label | Unit | Lower Limit | Upper Limit | Acceptance Criteria (Accuracy) | Reported Device Performance |
|---|---|---|---|---|---|
| SO2 | % | 1 | 99 | ± 2% (Valid from 40-99%) | Not reported in this document |
| SvO2 | % | 1 | 99 | ± 2% (Valid from 40-99%) | Not reported in this document |
| ScvO2 | % | 1 | 99 | ± 2% (Valid from 40-99%) | Not reported in this document |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not provided in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not provided in this document.
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 as this is not an AI-assisted diagnostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is a standalone device measuring oxygen saturation. The document doesn't provide performance data from any study, standalone or otherwise.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not provided in this document. For oximetry, typically a co-oximeter is used as the reference standard (ground truth).
8. The sample size for the training set
Not applicable as this device is not described as having a training set (e.g., it is not an AI/ML model being trained).
9. How the ground truth for the training set was established
Not applicable.
§ 870.1435 Single-function, preprogrammed diagnostic computer.
(a)
Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.(b)
Classification. Class II (performance standards).