(146 days)
OxiMax Adult: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients > 30 kg.
OxiMax Pediatric: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients 10 - 50 kg.
OxiMax Infant: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients between 3 kg and 20 kg.
OxiMax Neonate: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients foot if 40 kg.
The ReNy Medical Reprocessed OxiMax Sensors are accessory devices to an oximeter monitoring system. The oxisensor is designed as a transducer for the transmission of electrical signals from the oximeter to the patient and the return of patient modified signals back to the oximeter for analysis and display of patient information. The sensor contains three optical components; two light emitting diodes (LEDs) serve as light sources and one photodiode acting as a light detector LED and sensor are contained in a laminated envelope provided with an adhesive bandage for attachment a patient. A sensor package is attached to a cable terminated in a multi-pin connector that plugs into the oximeter.
The provided text describes a 510(k) summary for ReNu Medical's Reprocessed OxiMax Sensors, which are oximetry sensors. The submission focuses on demonstrating substantial equivalence to predicate devices, particularly regarding safety and effectiveness.
Here's an analysis of the provided text in relation to your questions, focusing on what is explicitly stated:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly provide a table of acceptance criteria with corresponding device performance metrics in numerical form. It broadly states that:
- "Reprocessed OxiMax Sensors were tested to demonstrate functional characteristics by bench testing and in vivo clinical studies."
- "Bench testing was performed to determine pulse rate accuracy using an OxiTest 7 simulator. Varying environmental conditions and physical tests were performed for temperature and humidity."
- "Clinical studies in vivo were performed on both Adult and Neonate subjects to demonstrate accuracy of SpO2 in the reprocessed sensors."
While it mentions "pulse rate accuracy" and "accuracy of SpO2," it does not specify what the acceptance thresholds for these accuracies were, nor does it provide the measured performance values for the reprocessed sensors.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size: The document states "Clinical studies in vivo were performed on both Adult and Neonate subjects," but it does not provide specific sample sizes for these subject groups.
- Data provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given they are "in vivo clinical studies," they were likely prospective.
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 studies mentioned are clinical, implying direct measurement rather than expert interpretation of data. For oximetry sensors, "ground truth" for SpO2 accuracy would typically come from a co-oximetry blood gas analyzer, not expert consensus on images or other subjective data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable to the type of device and study described. Oximetry sensor accuracy is typically determined by comparing the device's readings to a reference standard (e.g., co-oximetry), not through human adjudication of ambiguous cases.
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
- MRMC study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic imaging devices where human interpretation is a key component. The ReNu Medical device is an oximetry sensor, a physiological measurement device, not an AI diagnostic tool that assists human readers.
- Effect size of human reader improvement: Therefore, this information is not applicable and not provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Yes, the described "bench testing" and "in vivo clinical studies" focus on the performance of the reprocessed sensors themselves, indicating a standalone assessment of the device's accuracy. This is not an "algorithm only" performance as the device is hardware, but it evaluates the device's output independently.
- Without human-in-the-loop: The accuracy measurements (pulse rate and SpO2) are direct device outputs, not dependent on human interpretation in the sense of a human-in-the-loop system for AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the specific ground truth method, but for oximetry sensors, the established scientific method for "accuracy of SpO2" in clinical studies involves:
- Inducing a range of oxygen saturations in subjects.
- Simultaneously measuring arterial oxygen saturation using a co-oximeter (a laboratory device that directly measures different hemoglobin species from arterial blood samples).
- Comparing the sensor's readings to the co-oximeter's readings. This is the accepted "gold standard" for blood oxygen saturation measurement.
For "pulse rate accuracy," the ground truth would typically be derived from an ECG monitor.
8. The sample size for the training set
This information is not applicable as the device is a reprocessed medical sensor, not an AI/ML algorithm that requires a training set. The "reprocessing" involves cleaning, testing, and sometimes replacing components, but it does not involve machine learning model training.
9. How the ground truth for the training set was established
This information is not applicable for the same reason 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).