(717 days)
The Hygia Health Services Reprocessed Nellcor Oxisensor is used as a non-invasive method to provide continuous SpO2 monitoring and pulse rate.
The Hygia Health Services Oxisensors are non-invasive probes used to provide continuous SpO2 monitoring and pulse rate. The probes contain a dual wavelength light emitting diode (LED), and an optical photodiode sensor which are housed in a pad which attaches to the patient using adhesive material. The LED emits red and infrared light in alternate pulses, governed by the Oximeter instrument. The photodiode sensor responds to the light and generates a current that is interpreted by the Oximeter instrument. The Oximeter instrument interprets the different amounts of each light type (red and infrared) from the output of the photodiode and interprets the information and displays a reading. The sensor operates without any type of tissue penetration, electrical contact, or heat transfer to the patient. The sensors use optical means to determine the light absorption of functional arterial hemoglobin.
The provided document is a 510(k) summary for a reprocessed medical device, specifically pulse oximeter sensors, and does not contain the detailed information typically found in a study report for device performance against specific acceptance criteria. The document focuses on demonstrating substantial equivalence to a predicate device.
Therefore, it is not possible to fully answer your request with the provided input.
However, based on the available information, I can extract the following:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a tabular format. It generally states that "Biocompatibility and performance/functional testing demonstrate that the devices are equivalent and are safe and effective for their intended use." and "Functional testing, cleaning validation, and biocompatibility testing demonstrates that the reprocessed devices perform as intended and are safe and effective."
The "performance" referred to here is likely in comparison to the predicate device, aiming for substantial equivalence rather than meeting specific numerical targets for accuracy, sensitivity, or specificity.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document lists "Functional testing, cleaning validation, and biocompatibility testing" but does not detail the methodology, sample sizes, or data provenance for these tests.
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)
This information is not provided in the document. The concept of "ground truth" as typically used in the context of diagnostic device studies (like those involving image interpretation or disease detection) is not directly applicable to the functional testing of a reprocessed pulse oximeter sensor as described here. The focus is on the device's ability to measure SpO2 and pulse rate, which would be compared to established measurement methods, not expert interpretation of a diagnostic outcome.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. As mentioned above, the type of testing described does not typically involve adjudication in the way diagnostic algorithm studies do.
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
This information is not applicable/provided. The product is a physical reprocessed medical device (pulse oximeter sensor), not an AI algorithm or a diagnostic tool that involves human readers interpreting results. Therefore, an MRMC study with AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The product is a physical sensor, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
As explained in point 3, the concept of "ground truth" in the diagnostic sense is not directly applicable. For a pulse oximeter, the "ground truth" for its measurements (SpO2 and pulse rate) would typically be established by highly accurate, reference measurement techniques (e.g., arterial blood gas analysis for oxygen saturation) run concurrently with the device being tested. The document does not specify the ground truth methods used for their functional testing.
8. The sample size for the training set
This information is not applicable/provided. The device is a reprocessed physical sensor, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided for the reasons stated in point 8.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).