(185 days)
The WiCap™ patient monitor is intended for the continuous or spot-check monitoring of carbon dioxide concentration of the expired (EtCO2) and inspired (FiCO2) breath and respiration rate (RR), and functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) measurements. Intended patient populations include: Adult, Pediatric, and Neonate patients. The device is for use in hospitals, healthcare facilities and clinics, nursing home facilities, and other healthcare environments. The WiCap™ patient monitor is to be used by trained healthcare providers.
The WiCap Patient Monitor is a device that monitors physiological parameters associated with carbon dioxide gas and pulse oximetry. The WiCap Patient Monitor is a multi-patient use non-sterile device. It utilizes embedded firmware. Patient applied parts are needed for physiological measurement and are provided via FDA cleared OEM accessories to the WiCap monitor. WiCap is intended to be used in hospitals, healthcare facilities and clinics, nursing home facilities, and other healthcare environments.
The WiCap Patient Monitor is designed for continuous or spot-check monitoring of EtCO2, FiCO2, respiration rate (RR), SpO2, and pulse rate (PR).
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Parameter | Acceptance Criteria (WiCap Monitor) | Reported Device Performance (WiCap Monitor) |
|---|---|---|
| Capnography | ||
| CO2, EtCO2, FiCO2 Range | 0 to 150 mmHg, 0 to 19.7% | 0 to 150 mmHg, 0 to 19.7% |
| CO2 Accuracy | 0 - 40 mmHg ± 2 mmHg | 0 - 40 mmHg ± 2 mmHg |
| 41 - 70 mmHg ± 5% of reading | 41 - 70 mmHg ± 5% of reading | |
| 71 - 100 mmHg ± 8% of reading | 71 - 100 mmHg ± 8% of reading | |
| 101 - 150 mmHg ± 10% of reading | 101 - 150 mmHg ± 10% of reading | |
| Above 80 breath per minute ± 12% of reading. Note: Gas temperature at 25°C. | Above 80 breath per minute ± 12% of reading. Note: Gas temperature at 25°C. | |
| Respiration Rate Range | 2 to 150 breaths per minute (bpm) | 2 to 150 breaths per minute (bpm) |
| Respiration Rate Accuracy | ± 1 breaths per minute (bpm) | ± 1 breaths per minute (bpm) |
| Flow Rate | 50 ml/min ±10 ml/min | 50 ml/min ±10 ml/min |
| Pulse Oximetry | ||
| SpO2 Measurement Range | 0-100% | 0-100% |
| SpO2 Accuracy (No Motion, Adult & Pediatric) | ± 2 digits (70%-100%) | Varies per sensor type (Typical specs: ± 2 digits for Adult & Pediatric No Motion 70%-100%) |
| SpO2 Accuracy (Motion, Adult & Pediatric) | ± 3 digits (70%-100%) | Varies per sensor type (Typical specs: ± 3 digits for Adult & Pediatric Motion 70%-100%) |
| SpO2 Accuracy (Low Perfusion, Adult & Pediatric) | ± 2 digits (70%-100%) | Varies per sensor type (Typical specs: ± 2 digits for Adult & Pediatric Low Perfusion 70%-100%) |
| SpO2 Accuracy (No Motion, Neonatal) | ± 3 digits (70%-100%) | Varies per sensor type (Typical specs: ± 3 digits for Neonatal No Motion 70%-100%) |
| SpO2 Accuracy (Low Perfusion, Neonatal) | ± 2 digits (70%-100%) | Varies per sensor type (Typical specs: ± 2 digits for Neonatal Low Perfusion 70%-100%) |
| Pulse Rate Range | 30 to 250 beats per minute (bpm) | 30 to 250 beats per minute (bpm) |
| Pulse Rate Accuracy (No Motion/Low Perfusion) | ± 3 digits | Varies per sensor type (Typical specs: ± 3 digits for No Motion/Low Perfusion) |
| Pulse Rate Accuracy (Motion) | ± 5 digits | Varies per sensor type (Typical specs: ± 5 digits for Motion) |
2. Sample size used for the test set and the data provenance:
- Capnography: The document does not explicitly state the sample size for the capnography accuracy testing or its provenance. However, the accuracy specifications (e.g., "Above 80 breath per minute ± 12%") imply testing across a range of physiological conditions.
- Pulse Oximetry:
- Sample Size: The number of subjects is not explicitly stated, but it mentions "healthy, non-smoking, light-to-dark-skinned subjects."
- Data Provenance: The SpO2 accuracy testing was conducted "during induced hypoxia studies... in an independent research laboratory." The location of this laboratory (country of origin) is not specified. The study was prospective in the sense that hypoxia was induced for the purpose of testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Capnography: Not mentioned.
- Pulse Oximetry: For SpO2 accuracy testing, the "ground truth" (reference standard) was arterial hemoglobin oxygen (SaO2) values determined from blood samples using a laboratory co-oximeter. This method does not involve human experts establishing ground truth in the traditional sense, but rather a validated clinical measurement device.
4. Adjudication method for the test set:
- Not applicable as the ground truth for the clinical study was established by objective measurements (laboratory co-oximeter for SpO2). For capnography, no specific adjudication method is mentioned.
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 MRMC comparative effectiveness study was done, as this device (WiCap Patient Monitor) does not involve human readers interpreting data in the way an imaging AI product would. It directly measures and reports physiological parameters.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance data presented is for the standalone performance of the WiCap Patient Monitor itself. It measures and displays real-time physiological data without requiring human interpretation that would be significantly enhanced or altered by AI assistance in the context of this device type. The clinical accuracy report for the pulse oximeter module and sensor demonstrated its standalone performance.
7. The type of ground truth used:
- Capnography: Not explicitly stated, but typically involves calibrated gas mixtures and/or comparison against a highly accurate reference capnograph.
- Pulse Oximetry: Arterial hemoglobin oxygen (SaO2) values determined from blood samples with a laboratory co-oximeter. This is considered a clinical reference standard.
8. The sample size for the training set:
- The document does not describe the use of a "training set" in the context of machine learning or AI algorithm development for the WiCap Patient Monitor. The device relies on established physiological measurement principles (NDIR infrared spectroscopy for capnography, spectrophotometry for pulse oximetry) rather than a deep learning model that would require a large training dataset. The OEM modules and their underlying algorithms would have been developed and validated by their respective manufacturers, but those specifics are not detailed here for the WiCap device itself.
9. How the ground truth for the training set was established:
- Not applicable, as no dedicated training set for a machine learning model is mentioned for the WiCap Patient Monitor. The "training" for such devices is typically in the form of engineering design, calibration, and validation against physical and physiological models and clinical reference standards by the OEM module manufacturers.
§ 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).