(591 days)
Reprocessed Pulse Oximeter Sensors are intended for use when continuous external monitoring of arterial oxygen saturation and pulse rate are required.
The reprocessed pulse oximeter sensor is an electro-optical sensor that uses an optical means to determine the light absorption of functional arterial hemoglobin. The sensor contains three optical components: two light emitting diodes (LED's) that serve as light sources, and one photodiode, that acts as a light receiver. The oximeter sensor is positioned so that the LED's and photodiode oppose one another across the tissue. The sensor is connected via cable to a pulse oximeter, which provides continuous non-invasive, self-calibrated measurements of both oxygen saturation of functional hemoglobin and pulse rate. Please note that this submission only pertains to the sensor. It does not pertain to the pulse oximeter or connecting cable.
The provided document is a 510(k) summary for SterilMed's reprocessed pulse oximeter sensors. It outlines the device's description, intended use, and claims of substantial equivalence to predicate devices. However, the document does not contain the detailed study information required to answer your specific questions regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot provide a complete answer with the requested details from the text. The document states that "Representative samples of reprocessed sensors underwent bench testing and a clinical study to verify functional characteristics," but it does not elaborate on these studies' methodologies, results, or specific acceptance criteria met.
Here's a breakdown of what can be extracted and what is missing:
What can be inferred from the document:
- Device Name: SterilMed Reprocessed Nellcor Pulse Oximeter Oxisensor II Sensor N-25 and N-25LF
- Intended Use: "Reprocessed Pulse Oximeter Sensors are intended for use when continuous external monitoring of arterial oxygen saturation and pulse rate are required."
- Predicate Device: Nellcor Oxisensors™ (compatible with Nellcor N-200 pulse oximeter, K863784).
- Study Types Mentioned: Bench testing and a clinical study were performed to verify functional characteristics. Process validation testing was done for cleaning, sterilization, and packaging. Manufacturing includes visual and functional testing.
- Conclusion: The reprocessed sensors are "substantially equivalent" to predicate devices based on functional design, materials, indications for use, and construction methods.
What is missing from the document and therefore cannot be provided:
- A table of acceptance criteria and the reported device performance: The document states that testing was done to "verify functional characteristics which are substantially equivalent to the predicate devices'," but it provides no specific performance metrics or thresholds for acceptance.
- Sample size used for the test set and the data provenance: No details about the number of devices or subjects in the clinical study or bench testing are given, nor is the origin of the data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. Given the nature of pulse oximetry, the "ground truth" for oxygen saturation would typically come from arterial blood gas analysis, not expert consensus on images.
- Adjudication method for the test set: Not mentioned.
- 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 is not applicable to a reprocessed pulse oximeter sensor, which is a hardware device for direct measurement, not an AI interpretation tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable as it's not an AI algorithm. Its performance is inherent to the device itself.
- The type of ground truth used: While not explicitly stated, for a pulse oximeter, the ground truth for oxygen saturation would typically be obtained through methods like arterial blood gas analysis.
- The sample size for the training set: Not applicable and not mentioned, as this is a device reprocessing submission rather than an AI/machine learning model.
- How the ground truth for the training set was established: Not applicable and not mentioned.
In summary, the provided text confirms that studies were conducted to demonstrate substantial equivalence, but it lacks the granular details requested regarding acceptance criteria, specific performance results, and study methodologies.
§ 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).