(133 days)
The sensor is indicated for use in continuous noninvasive arterial oxygen saturation and pulse rate monitoring.
Oximeter sensors are used with compatible pulse oximeters to noninvasively continually monitor oxygen saturation and pulse rate. The primary components of the sensors are light-emitting diodes (red and infrared LED) and a photosensor. These components are embedded within a taping system to wrap the sensor around a patient's finger, foot or hand so that the LED and photosensor are directly opposite each other. As light is emitted and received across the vascular bed, the rates of absorption at the two wavelengths vary depending upon the ratios of oxygenated and deoxygenated hemoglobin within the blood. The pulse oximeter detects the changes in absorption and utilizes an algorithm to calculate the corresponding pulse rate (beats/minute) and percent arterial oxygen saturation.
Vanguard receives previously used pulse oximeter sensors from healthcare facilities; cleans, reworks, (replaces the tape [all patient-contacting materials]), inspects, tests, repackages and sterilizes the devices; and returns them to a healthcare facility.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
The provided text does not specify numerical acceptance criteria for performance (e.g., accuracy, precision). Instead, it states that the testing "demonstrates that the reprocessed devices perform as intended and are safe and effective." The performance is implicitly demonstrated by showing that the reprocessed sensors are "essentially identical to the original equipment manufacturer (OEM) devices" and that "No changes are made to the electro-optical components; the reprocessed sensors possess equivalent technological characteristics."
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Perform as intended | Demonstrated |
| Safe and effective | Demonstrated |
| Equivalent technological characteristics to OEM devices | Possesses equivalent technological characteristics, no changes to electro-optical components. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for performance testing of the reprocessed pulse oximeter sensors, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). It broadly mentions "cleaning, sterilization, and packaging validations, and performance and biocompatibility testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The type of device (reprocessed pulse oximeter sensors) typically relies on measurable physical parameters rather than expert interpretation for performance evaluation.
4. Adjudication method for the test set
This information is not provided. Given the nature of pulse oximetry performance testing, adjudication methods typically seen in image or data interpretation studies (like 2+1 or 3+1 for consensus) would not be applicable.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. This type of study is typically relevant for interpretative devices (e.g., AI in radiology), not for a device like a reprocessed pulse oximeter sensor, which directly measures physiological parameters. This device does not involve AI or human interpretation in its core function.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable. A pulse oximeter sensor is a hardware device for measurement. While it contains an algorithm to calculate pulse rate and SpO2 from collected data, the "standalone" performance here refers to the device's ability to accurately measure these parameters. The evaluation confirms that the reprocessed device functions equivalently to the original device, which inherently means its embedded algorithm (unchanged) performs as expected. The study likely involved comparing readings from the reprocessed sensor against a reference standard, not assessing an algorithm in isolation from the hardware.
7. The type of ground truth used
The document does not explicitly state the type of ground truth used for specific performance metrics. However, for pulse oximetry, the ground truth would typically be established by a reference method for arterial oxygen saturation and pulse rate, such as co-oximetry for SaO2 and ECG for heart rate, or tightly controlled hypoxic studies. The phrase "performance testing" implies comparison to such established standards.
8. The sample size for the training set
This information is not applicable and not provided. As a reprocessed hardware device with an existing, unchanged algorithm, there is no "training set" in the context of machine learning or AI algorithm development.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the same reasons as 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).