(339 days)
The intended use of the TidalWave Sp (Models 710/715) is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia / recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care. Separate airway adapters are provided for pediatric/adult and neonatal/pediatric use.
The Tidal Wave Models 710/715 handheld combined pulse oximeter/capnograph are designed for continuous, non-invasive monitoring of carbon dioxide and functional oxygen saturation. Oxygen saturation is measured with ratiometric technique using red and infrared absorbance of oxy- and deoxyhemoglobin and pulse rate is measured using the time between successive pulses. Carbon dioxide is measured on-airway using an infrared absorption (IR) technique. The airway adapters and O2 saturation sensors are already legally marketed as accessories to the Model 610 and Model 510 monitors, respectively. The TidalWave Sp monitor is a microprocessor based data acquisition system consisting of CO2 and SpO2 measurement, control circuitry and a high speed serial interface. The monitor uses SRAM for data storage and an EEPROM to store system parameters. The firmware resides in a PROM. The operations performed by the TidalWave Sp monitor include data acquisition, parameter calculation, zeroing, heater control and corrections to the CO2 signal for N2O, O2 and barometric pressure.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Tidal Wave Sp, Models 710/715 device. It's important to note that the provided document is a 510(k) summary (K032971) which focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed study report with all the specific data points requested in your prompt. Therefore, some of the information you asked for may not be explicitly stated or not applicable in this type of submission.
Acceptance Criteria and Device Performance for Tidal Wave Sp, Models 710/715
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly list quantitative acceptance criteria in a formal table like a performance specification. Instead, it states that "inter-device comparison studies were conducted to establish the TidalWave Sp accuracy and to ensure that the sensors meet their currently published accuracy specifications with the specified predicate devices."
The key performance indicators are implied to be accuracy for CO2 measurement and accuracy for SpO2 and pulse rate measurement.
| Performance Metric | Acceptance Criteria (Implied/General) | Reported Device Performance |
|---|---|---|
| CO2 Measurement Accuracy | Accuracy comparable to predicate devices (Tidal Wave Model 610, CO2SMO Model 7100). Meet currently published accuracy specifications. | Achieved through "inter-device comparison studies" against predicate devices. The document implies that the device's accuracy meets or is equivalent to the established accuracy of the predicate devices, as it states the device operates on "infrared absorption (IR) technique for monitoring CO2" which "have endured and evolved in the clinical setting for over two decades." and is based on "its response to a known concentration of CO2 is stored in the monitor at the factory." |
| SpO2 and Pulse Rate Measurement Accuracy | Accuracy comparable to predicate devices (Spot Check Model 510). Meet currently published accuracy specifications for sensors. | Achieved through "inter-device comparison studies" against predicate devices. Explicitly states: "The Models 710/715 use the identical SpO2 and pulse rate software algorithms to process the information from the sensor as the predicate device, Model 510 Pulse Oximeter, cleared under K924626." |
| Functional Equivalence | Same intended use, patient population, and environments of use as predicate devices. | Demonstrated through comparison of product features, labeling, and promotional literature, and confirmed by testing to accepted industry standards. (This is a general statement from the summary, not a specific performance metric about accuracy). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes (number of patients or measurements) used for the "inter-device comparison studies."
- Data Provenance: Not explicitly stated, but the submission is from Respironics Novametrix, Inc. in Wallingford, CT, USA. Given the context of a 510(k) submission to the FDA, it is highly likely that the testing was conducted in a controlled environment, potentially with healthy volunteers or clinical patients. The studies were retrospective in the sense that they were comparing the new device's performance against established predicate devices rather than observing real-world outcomes over a long period.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the summary. For devices like pulse oximeters and capnographs, the "ground truth" for accuracy is typically established by using highly accurate, calibrated reference measurement devices (e.g., co-oximeters for SpO2, calibrated gas analyzers for CO2) rather than expert consensus.
4. Adjudication Method for the Test Set
This is not applicable and not mentioned. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers interpret medical images or clinical data, and their interpretations need to be reconciled to establish a ground truth. For objective physiological measurements like CO2 and SpO2, adjudication by experts is not the standard method for establishing ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not conducted or reported. MRMC studies are primarily relevant for AI-powered diagnostic tools interpreting complex medical data where human readers are involved. This device is a physiological monitor providing objective measurements, not an interpretative AI tool that assists human readers.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance evaluation of the device's algorithms was implied and conducted as part of the "inter-device comparison studies." The device's SpO2 and pulse rate algorithms are explicitly stated to be "identical" to the predicate device (Model 510 Pulse Oximeter). The CO2 algorithm is based on established IR absorption linearity and factory calibration to known concentrations. The "accuracy" reported for these measurements is inherently the standalone performance of the device's algorithms and sensors against reference standards.
7. Type of Ground Truth Used
Based on the description of the devices (pulse oximeter/capnograph):
- For CO2: Ground truth would typically be established using calibrated gas analyzers with known CO2 concentrations. The document mentions "the photodetector's response to a known concentration of CO2 is stored in the monitor at the factory," implying calibration against such standards.
- For SpO2: Ground truth would typically be established using laboratory co-oximetry (or similar invasive arterial blood gas analysis) which is considered the gold standard for measuring fractional oxygen saturation in blood.
- For Pulse Rate: Ground truth would likely be established using simultaneous ECG monitoring or other highly accurate cardiac rhythm detection methods.
8. Sample Size for the Training Set
This information is not provided and is largely not applicable in the context of this device. The Tidal Wave Sp is described as a traditional physiological monitor, not an AI/machine learning device that relies on a "training set" in the modern sense. Its algorithms are based on established biophysical principles (infrared absorption, light absorption by hemoglobin) and fixed factory calibrations, not statistical learning from a large dataset.
9. How Ground Truth for the Training Set Was Established
As there is no "training set" in the context of modern AI/ML for this device, this question is not applicable. The device's operational parameters and calibration are set at the factory based on known physical properties and reference standards (e.g., known CO2 concentrations, specific light absorption properties of hemoglobin).
§ 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).