(102 days)
The Nellcor® DuraMax® reusable oximetry sensor is indicated when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing 40 kg or more.
The DuraMax is a reusable sensor, sized appropriately to fit the digit of a pediatric or adult patient weighing 40 kg or more.
The DuraMax sensor consists of an internal frame containing the optical components and flexible circuit encapsulated in a synthetic, latex-free rubber overmold.
The DuraMax sensor plug contains a memory chip carrying information about the sensor which the oximeter needs for correct operation, including Advanced Signal Evaluation, Intention and data set revision, and sensor model. The DuraMax sensor is compatible with Nellcor and other monitors incorporating either Nellcor R-Cal or OxiMAX (DigiCal) oximetry technology.
Nellcor® DuraMax® Reusable Oximetry Sensor
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly state quantitative acceptance criteria in a table format. However, it indicates adherence to the ISO 9919:2005 standard and states that "Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications." The implicit acceptance criterion, therefore, is conformance to the accuracy and precision specifications outlined in ISO 9919:2005 for pulse oximeters. The submission concludes that the device meets these requirements.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Conformance with ISO 9919:2005 for accuracy and precision specifications for pulse oximeters | "Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications." |
| No new questions of safety or effectiveness compared to predicate device | "The technological characteristics of the DuraMax sensor and the results of testing do not raise new questions of safety or effectiveness when compared to the legally marketed predicate device." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The submission states that "Human... tests were performed to support the determination of substantial equivalence" and that "Human oxygenation evaluations were conducted." However, the document does not specify:
- The exact sample size used for the human test set.
- The country of origin of the data.
- Whether the study was retrospective or 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 submission. The submission mentions "Human oxygenation evaluations," which implies direct physiological measurements rather than expert review of data. In the context of pulse oximetry, the "ground truth" for oxygen saturation is typically established through co-oximetry measurements of arterial blood samples. Expert review for ground truth establishment is not typically the primary method for this type of device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the submission. Given that the ground truth for oxygen saturation is usually established by direct or highly accurate indirect physiological measurements (e.g., co-oximetry), a multi-reader adjudication method would not be applicable in the traditional sense for the device's primary function.
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 comparing human readers with and without AI assistance was not done. The DuraMax® sensor is an oximetry sensor, not an AI-powered diagnostic device that assists human readers in case interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device itself is a passive sensor that provides data (oxygen saturation and pulse rate) to an oximeter; it does not contain a standalone "algorithm" in the sense of an AI-driven component. The "Advanced Signal Evaluation" and "Intention and data set revision" are mentioned as information carried by the sensor's memory chip, indicating internal processing logic for signal quality, but this is part of the integrated system and not a standalone algorithm evaluated independently for diagnostic performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For oxygen saturation measurements, the ground truth is typically established using arterial co-oximetry, where arterial blood samples are analyzed to determine actual oxygen saturation (SaO2). The submission states "Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications," which strongly implies comparison against a gold standard for oxygen saturation, most commonly co-oximetry.
8. The sample size for the training set
The submission does not mention a distinct "training set" for the device, as it is a hardware sensor rather than a machine learning model that requires training. The development and verification process for such a device would involve design, bench testing, and human testing for performance validation.
9. How the ground truth for the training set was established
As there is no mention of a "training set" in the context of a machine learning model, this question is not applicable. The ground truth for performance validation (the human oxygenation evaluations) would have been established through methods like co-oximetry as described in point 7.
§ 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).