(324 days)
The pediatric Oxisensor, model D-20, is indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing between 10 and 50 kg.
The reprocessed ClearMedical/Nellcor D-20 Oxisensor is intended as a single patient use O transducer/accessory sensor to a Nellcor Oximeter system. The role of the sensor the acquisition of patient data which is used by the oximeter in the determination of functional oxygen saturation and pulse rate of pediatric patients. The D-20 oxisensor is used in conjunction with the Nellcor oximeter in a hospital environment where non-invasive monitoring of pulse oxygen hemoglobin saturation (SpO2) and pulse rate (PR) are required for patients with potentially abnormal pulmonary/circulatory function.
The ClearMedical/Nellcor Oxisensor is an accessory device to an oximeter monitoring system. The oximeter system is designed for the determination of functional oxygen saturering and pulse rate. 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) that serve as light sources and one photodiode that acts as a light detector. Both the LED's and photodiode are contained within a laminated envelope with an adhesive bandage for attachment to a patient. Attached to the laminated envelope is a sensor cable, which terminates in a connector element that connects to the oximeter.
Here's a breakdown of the acceptance criteria and study information based on the provided text, categorized as you requested. Please note that the document is a 510(k) summary, which often provides general statements of equivalence rather than a full, detailed study report. Therefore, some information, especially regarding specific statistical outcomes or detailed methodologies, might be inferred or not explicitly present.
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state quantitative acceptance criteria in a pass/fail format with exact numerical targets for all aspects. Instead, it emphasizes substantial equivalence to the predicate device in terms of safety and performance. The performance is reported as meeting this substantial equivalence.
| Acceptance Criterion (Inferred from substantial equivalence) | Reported Device Performance |
|---|---|
| Functionality in optical sensitivity of the optical diodes | ClearMedical devices demonstrated "equality in safety and performance" when compared to the predicate device. Assumed to be met as part of "Technological Characteristics of ClearMedical/Nellcor Oxisensor Compared with the Nellcor Oxisensor." |
| Continuity of sensor circuitry | ClearMedical devices demonstrated "equality in safety and performance" when compared to the predicate device. Assumed to be met as part of "Technological Characteristics of ClearMedical/Nellcor Oxisensor Compared with the Nellcor Oxisensor." |
| Comparative non-invasive Co-Oximetry and Oximetry data (SpO2 and Pulse Rate accuracy) | ClearMedical devices demonstrated "equality in safety and performance" based on "specific bench and non-invasive clinical testing." This implies that the reprocessed device's SpO2 and pulse rate measurements were comparable to the predicate device and within acceptable clinical ranges. The device is intended for "determination of functional oxygen saturation and pulse rate." |
| Infection control methodology | ClearMedical devices demonstrated "equality in safety and performance." Given it's a reprocessed single-use device, this would involve validation of the reprocessing method to ensure sterility and prevent cross-contamination. |
| Fit/attachment | ClearMedical devices demonstrated "equality in safety and performance." The sensor uses an "adhesive bandage for attachment to a patient" and serves "to align the optical sensors and retain the sensor to a patient digit." This implies the reprocessed device fits as intended. |
| Connector function | ClearMedical devices demonstrated "equality in safety and performance." The sensor terminates in a "molded PVC connector element that connects to the oximeter." This implies the reprocessed device's connector is compatible and functions correctly with the oximeter. |
| Overall safety and performance | "For all established indicators of substantial equivalence, the ClearMedical devices demonstrated equality in safety and performance." The device is intended for "non-invasive monitoring of pulse oxygen hemoglobin saturation (SpO2) and pulse rate (PR) are required for patients with potentially abnormal pulmonary/circulatory function" in a hospital environment for patients weighing between 10 and 50 kg. |
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 for test set: Not explicitly stated. The document refers to "specific bench and non-invasive clinical testing" but does not provide details on the number of subjects or cases included in these tests.
- Data provenance: Not explicitly stated. Clinical testing implies prospective data collection, but the location (country of origin) is not mentioned.
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. For oximeters, ground truth for SpO2 is typically established via arterial blood gas (Co-Oximetry) measurements, but the specifics of how this was performed (number of experts, their qualifications, or who performed the reference measurements) are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided in the document. Adjudication methods are more common in studies involving subjective interpretation (e.g., radiology reads). For objective measurements like oximetry, statistical comparison to a reference standard is typically used rather than adjudication.
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
- This is not applicable (N/A). The device is an oximeter sensor, which provides objective physiological measurements (SpO2 and pulse rate) and does not involve human "readers" interpreting images or data that could be augmented by AI. The device functions as a transducer for an oximeter system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable (N/A). The device itself is a sensor (hardware component), not an algorithm. Its performance is measured in conjunction with an oximeter system. The "algorithm" here would be inherent in the oximeter's processing of the sensor's signals, not a standalone AI application. The document describes the sensor's function as "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."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The document mentions "Comparative non-invasive Co-Oximetry and Oximetry data." For oximeters, the gold standard for measuring arterial oxygen saturation is arterial blood gas analysis (Co-Oximetry). Therefore, it is highly likely that this was the type of ground truth used for the "non-invasive clinical testing" to validate SpO2 accuracy. Pulse rate ground truth would typically come from an ECG or manual palpation.
8. The sample size for the training set
- This information is not provided and is likely not relevant in the context of this device. The device is a reprocessed hardware sensor. Its "performance" is based on its physical and electrical properties, and its ability to produce signals comparable to the predicate device. It is not an AI/ML algorithm that requires a distinct "training set" in the conventional sense. The "training" here would be the quality control and reprocessing procedures, and the "validation" would be the bench and clinical testing described.
9. How the ground truth for the training set was established
- This is not applicable (N/A) for the reasons stated in point 8. There is no "training set" in the AI/ML context for this hardware device.
§ 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).