(195 days)
Model 8004CB (Adhesive Version)
The 8004CB Single-Patient use, Non-Sterile, Disposable Regional Oximetry Sensor is intended for use as an absolute real-time adjunct monitor of hemoglobin oxygen saturation of blood underneath the sensor at cerebral and somatic sites. The sensor is for spot-checking and continuous monitoring of neonate, infant, and pediatric patients weighing less than 88 pounds (40 kilograms).. The sensor may be repositioned or replaced with another 8004CB sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long term care and mobile environments.
Model 8004CB-NA (Non-Adhesive Version)
The 8004CB-NA Non-Adhesive, Single-Patient use, Non-Sterile, Disposable Regional Oximetry Sensor is intended for use as an absolute real-time adjunct monitor of hemoglobin oxygen saturation of blood underneath the sensor at cerebral and somatic sites. The sensor is for spot-checking and continuous monitoring of neonate, infant, and pediatric patients weighing less than 88 pounds (40 kilograms). The sensor may be repositioned or replaced with another 8004CB-NA sensor without baseline reestablishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long term care and mobile environments. I
Model 7600 Regional Oximeter System
Nonin's non-invasive Model 7600 4- Channel Regional Oximeter System is intended for use as an absolute real-time adjunct monitor of hemoglobin oxygen saturation of blood underneath the sensor at cerebral and somatic sites. It is intended for spot-checking or continuous monitoring of adult, or neonate, infant and pediatric patients. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care and mobile environments.
Nonin's® EQUANOX Advance Neonatal/Pediatric Sensor 8004CB Series for use with the Model 7600 4-Channel Regional Oximeter System continuously monitors and records the mixed arterial/venous blood oxygen levels (rSO2) through non-invasive near-infrared spectroscopy of tissue under the sensors.
The 7600 system is comprised of three subsystems; sensor, patient oximetry device (pod) and display unit. The sensor allows light absorption measurements at various wavelengths in the near-infrared spectrum (approximately 700 to 900 nanometers). The sensor is sized appropriately for the patient population.
The sensors plug into the patient oximetry device (pod) which controls the light emitted from the sensor LEDs and measures the light returning via the sensor photodiodes. From these measurements, the 7600PA pod determines specific absorption values and calculates the rSO2 value. The pod then communicates the rSO2 readings and other data to the display unit. Up to 4 pods with attached sensors may be used with a single 7600 display unit.
The 7600 display unit displays real-time regional oximetry data. It is a battery-backed, mains-powered device equipped with audio and visual alarm indicators. Real-time data and playback output is accomplished through a Bluetooth transceiver module or serial RS-232 connection.
Here's an analysis of the provided text regarding the acceptance criteria and study for the EQUANOX Advance Neonatal/Pediatric Sensor 8004CB Series:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Absolute rSO2 accuracy (Arms) for 45% to 95% rSO2 | ±5.9% |
Note: The document explicitly states the accuracy specification as "absolute rSO2 accuracy (Arms*): 45% to 95% rSO2 ±5.9%." This serves as the acceptance criterion that the device aims to meet. The reported device performance matches this criterion, as the study was conducted to demonstrate this specific accuracy.
Study Details
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: 44 subjects
- Data Provenance:
- Country of Origin: Not specified in the provided text.
- Study Type: Prospective, controlled, multisite study.
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)
- The document does not mention the use of experts to establish ground truth in the traditional sense of image or clinical interpretation.
- Ground Truth Establishment: The ground truth for rSO2 (regional hemoglobin oxygen saturation) was established by comparing the sensor's measurements to actual SavO2 (arterial/venous hemoglobin oxygen) values. These SavO2 values were "determined from venous and arterial blood samples." This implies direct laboratory analysis of blood samples, which serves as the gold standard for oxygen saturation.
- Qualifications of Experts: Not applicable, as expert consensus on interpretation wasn't the method for ground truth. The ground truth was derived from direct physiological measurements (blood gas analysis).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/None. The "ground truth" was established through direct physiological measurement (blood gas analysis of SavO2), not through human interpretation or a scenario requiring adjudication of disparate expert opinions.
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
- No. This was not an MRMC comparative effectiveness study. The study focused on the standalone accuracy of the device itself against a physiological ground truth, not on how a human reader's performance might be augmented by the device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes. The study assessed the "absolute rSO2 accuracy" of the EQUANOX Advance Neonatal/Pediatric Sensor 8004CB Series with the Model 7600 Regional Oximeter System against a physiological ground truth (blood gas analysis). This is a standalone performance assessment of the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Physiological measurements from blood samples. Specifically, the "SavO2 (value determined from venous and arterial blood samples)" served as the ground truth. A model of 70% venous and 30% arterial blood was used for brain blood.
8. The sample size for the training set
- The document does not explicitly mention a separate "training set" or sample size for training. This typically indicates that the device's algorithms or parameters were either pre-developed, or the accuracy study itself demonstrated the device's performance without explicitly detailing an iterative training/validation process in this summary. For medical devices of this type, initial algorithm development often relies on internal data and testing, with the submission focusing on performance in a clinical validation set.
9. How the ground truth for the training set was established
- Not applicable, as a distinct training set with established ground truth is not described in this document.
§ 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).