(437 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 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 the healthcare facility.
The provided text is a 510(k) summary for Vanguard Reprocessed Pulse Oximeter Sensors. While it asserts that the reprocessed devices perform as intended and are safe and effective, it does not contain detailed acceptance criteria or a study write-up with specific performance metrics, sample sizes, or ground truth establishment methods typically found in a clinical study report.
The document is a regulatory submission for substantial equivalence based on the technological characteristics and functional testing compared to a predicate device. It indicates that "Sterilization validations, and functional/performance and biocompatibility testing demonstrates that the reprocessed devices perform as intended and are safe and effective." However, it does not elaborate on the specific methodologies or results of these tests in a way that would allow for the construction of the requested table and detailed description.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: The document does not provide specific numerical acceptance criteria or performance metrics for the reprocessed pulse oximeter sensors beyond the general statement that they perform as intended and are safe and effective.
- Sample sized used for the test set and the data provenance: No sample sizes for testing are mentioned.
- Number of experts used to establish the ground truth...: Not applicable as no clinical study with ground truth establishment is described.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is a physical sensor, not an algorithm, so this is not applicable in the way it's framed for AI/algorithm performance.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable as it's not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
The "Test Data" section merely states: "Sterilization validations, and functional/performance and biocompatibility testing demonstrates that the reprocessed devices perform as intended and are safe and effective." This is a high-level summary and does not provide the granular information needed to describe acceptance criteria or a study that proves the device meets those criteria.
§ 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).