(168 days)
The Rainbow Resposable Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, methemoglobin saturation (SpMet), and/or total hemoglobin (SpHb). The Rainbow Resposable Sensors are indicated for use with adult and pediatric patients during no motion conditions and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The Rainbow Resposable Sensors are fully compatible sensors for use with Masimo Rainbow SET and Masimo Rainbow SET compatible pulse CO-Oximeter monitors. They represent a design change to the Masimo Rainbow Adhesive Sensors in the K0801659 filing.
The Rainbow Resposable Sensors have the similar intended use/indications for use and performance specifications as the Rainbow Adhesive Sensors in the K0801659 filing. The main difference is that the entire Rainbow Adhesive Sensor is single-patient use. However for the Rainbow Resposable Sensor, the tape assembly is single-patient use and the emitter/detector/cable assembly is detachable from the tape assembly. This emitter/detector/cable assembly is reusable. Also, the Rainbow Resposable Sensors are not indicated for the measurement of carboxyhemoglobin saturation and motion conditions.
Here's an analysis of the provided text, outlining the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Measurement | Acceptance Criteria (Accuracy) | Reported Device Performance (Accuracy) | Conditions |
|---|---|---|---|
| Arterial Oxygen Saturation (SpO2) | ± 3% (for 60-80% range) | ± 3% | No Motion |
| Arterial Oxygen Saturation (SpO2) | ± 2% (for 70-100% range) | ± 2% | No Motion |
| Arterial Oxygen Saturation (SpO2) | ± 2% (for 70-100% range) | ± 2% | Low Perfusion |
| Pulse Rate | ± 3 bpm | ± 3 bpm | No Motion |
| Pulse Rate | ± 3 bpm | ± 3 bpm | Low Perfusion |
| Methemoglobin (SpMet) | ± 1% (for 1-15% range) | ± 1% | No Motion |
| Total Hemoglobin Concentration (SpHb) | ± 1 g/dL (for 8-17 g/dL) | ± 1 g/dL | No Motion |
2. Sample Size Used for the Test Set and Data Provenance:
The document states: "Clinical studies for the Rainbow Resposable Sensors are similar to those of the Rainbow Adhesive Sensors, resulting in the following sensor specifications for adult and pediatric patients."
- Sample Size (Test Set): The specific sample sizes for the clinical studies are not provided in this document. It only mentions "adult and pediatric patients."
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only states "Clinical studies for the Rainbow Resposable Sensors are similar to those of the Rainbow Adhesive Sensors," implying that new studies were conducted, making them likely prospective, but this is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. For non-invasive oximetry, the "ground truth" for SpO2 is typically established by arterial blood gas (ABG) analysis, not by human experts. The document does not specify how ground truth was established for the other parameters (SpMet, SpHb, Pulse Rate), but it's generally based on direct measurement or established clinical methods.
4. Adjudication Method for the Test Set:
This information is not applicable/provided. As mentioned above, ground truth for oximetry is usually based on direct physiological measurements (like ABG) rather than expert adjudication of images or clinical assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
This information is not applicable/provided. This device is a sensor for direct physiological measurement, not an AI-powered diagnostic tool requiring human reader interpretation or MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The entire performance assessment described is for the device in a standalone capacity (sensor and its associated algorithm performing measurements). So, yes, a standalone performance assessment was done. The listed accuracy specifications represent the device's performance directly.
7. The Type of Ground Truth Used:
The document doesn't explicitly state the type of ground truth used for each measurement. However, based on the nature of the device:
- SpO2: Highly likely to be established using arterial blood gas (ABG) analysis, which is the gold standard for arterial oxygen saturation.
- Pulse Rate: Likely established using a reference ECG (electrocardiogram) or direct palpation/auscultation with a stopwatch in a controlled setting.
- SpMet and SpHb: Likely established using co-oximetry from arterial blood samples (different from functional SpO2), which are laboratory-based measurements.
8. The Sample Size for the Training Set:
The document does not specify a training set size. While the device utilizes algorithms, this submission focuses on the performance of the product, not the development or training of its underlying algorithms. Clinical studies are typically test sets to validate the final device.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided in the document, as it does not detail the algorithm development or training process.
§ 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).