(61 days)
The SenTec Digital Monitor System (comprising the SenTec Digital Monitor, V-Sign™ Sensor and Accessories) is indicated for continuous noninvasive monitoring. The SenTec Digital Monitor System is indicated for use in hospital type realities, includes intra-hospital transport environments, and clinical supervision, home environments. The SenTec Digital Monitor System is for prescription use only.
The V-Sign™ Sensor, model VS-A/P, is indicated for use with the Sentec Digital Monitor when continuous noninvasive carbon dioxide tension, oxygen saturation and pulse rate monitoring are required for adult through pediatric patients.
SenTec's Ear Clip, model EC-A/P, is intended for use with the V-Sign™ Sensor when continuous, non-invasive carbon dioxide tension, oxygen saturation and pulse rate monitoring are required. The Ear Clip is for single-patient use and is indicated for patients weighing 30 kg or more, using exclusively the ear lobe as the monitoring site. The use of the SenTec Ear Clip is contraindicated for patients whose ear-lobes are very small (resulting in inadequate sensor application).
Caution: Federal law restricts this device to sale by or on the order of a physician.
The Sentec Digital Monitor System (SDMS) is a device consisting of a stand-alone monitor, a digital sensor, a connecting cable, and accessories for sensor application and maintenance. The SDMS is designed for the continuous noninvasive measurement of cutaneous carbon dioxide partial pressure (PCO2), functional oxygen saturation (SpO2) and pulse rate (PR), using a single, digital sensor (V-Sign™ Sensor).
The V-Sign™ Sensor combines within one digital sensor the technology to measure cutaneous PCO2 with the optical elements (LED, photodetector) needed for pulse oximetry. The PCO2 measurement of the V-Sign™ Sensor is based on a Stow-Severinghaus type PCO2 sensor. The V-Sign™ Sensor slightly raises the temperature at the monitoring site to achieve the cutaneous PCO2 measurement. Safe temperature is achieved using two independent measurement and control systems. The sensor is applied to the patient's ear lobe using SenTec's single patient use Ear Clip and a thin layer of Sensor Gel.
The Sentec Digital Monitor (SDM) is equipped with an integrated calibration unit, the Docking Station, allowing an automatic PCO2 sensor calibration that begins when the V-Sign™ Sensor is stored in the Docking Station. This ensures that the V-Sign™ Sensor is continuously ready to use.
The V-Sign Disposable Set provides a straight-forward preparation of the V-Sign™ Sensor - with the ease of 4 "Push-and-Turn" procedures, all necessary steps to exchange the sensor's membrane are performed.
The Sentec Digital Monitor System (SDMS) is intended for continuous non-invasive monitoring of cutaneous partial pressure of carbon dioxide (PCO2), functional oxygen saturation (SpO2), and pulse rate (PR).
Here's a breakdown of the acceptance criteria and study information:
1. Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list quantitative acceptance criteria in a table format. However, it indicates that the device met specified requirements based on various tests. For the purpose of this response, I infer the performance from the statements made about the device's functionality and comparison to predicate devices, and the successful completion of testing.
| Metric / Test Item | Acceptance Criteria (Inferred from statements) | Reported Device Performance |
|---|---|---|
| Electrical, Mechanical, Environmental Safety | Compliance with applicable standards (e.g., electrical safety, EMC, shock, vibe, temp/humidity) and FDA Guidance Document: Cutaneous Carbon Dioxide | "The device passed all tests." |
| Biocompatibility | Compliance with ISO 10993-1.997 for contact materials | "All materials met Biocompatibility requirements." |
| Pulse Rate Accuracy (Bench Test) | Pulse rate values within +/- 3 digits of a laboratory pulse rate simulator (Implied standard for pulse oximeters) | "The Sentec Digital Monitor System measured pulse rate values within ±3 digits of a laboratory pulse rate simulator." |
| SpO2 Accuracy (Clinical Study) | Reported saturation values meet specified accuracy requirements (Specific numeric criteria not provided, but implies equivalence to predicate devices and acceptable clinical performance). | "The clinical studies show that the reported saturation values from the Sentec Digital Monitor System meet specified accuracy requirements." (The study involved "progressive induced hypoxia against arterial hemoglobin oxygen determined from and the PCO samples with a CO-Oximeter as reference.") This implies that the SpO2 measurements were compared to a gold standard (CO-Oximeter) during hypoxia, and the device performed acceptably. The precise accuracy range (e.g., +/- X%) is not explicitly stated in the summary, but the successful conclusion suggests it met predefined benchmarks. |
| PCO2 Performance (Clinical Study) | Support for the performance of transcutaneous PCO2 (Implied equivalence to predicate devices and acceptable clinical performance). | "The clinical study data furthermore support the performance of the PCO samples with a CO-Oximeter as reference." While less specific than SpO2, this indicates the PCO2 measurement from the device was compared against a reference (PCO samples with a CO-Oximeter as reference) and found to be performing as expected for its intended use. The specific accuracy for PCO2 is not quantified in this summary. |
| Overall Safety and Effectiveness | Safe, effective, and performs as intended as a combination of predicate devices | "The clinical and non-clinical testing performed demonstrates that the Sentec Digital Monitor System is safe, effective and performs as intended comparable to that of your company and the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document only states "healthy adult volunteer subjects" were used for the clinical studies. No specific number is provided.
- Data Provenance: The data is prospective, generated from clinical studies with healthy adult volunteers. The country of origin is not explicitly stated, but the manufacturer is Sentec Inc. located in Switzerland.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for SpO2 and PCO2 measurements was established using objective measurement devices (CO-Oximeter and direct PCO samples), not human expert consensus.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by direct measurement from reference devices/methods, not through expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is a monitor, not an AI for interpretation, so improvements in human reader performance with AI assistance are not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described are essentially standalone performance evaluations of the device (monitor and sensor) against reference standards. The results demonstrate the device's accuracy and performance independent of human interpretation or interaction other than operation.
7. The Type of Ground Truth Used
- For SpO2 and PCO2: Objective physiological measurements using a CO-Oximeter and direct PCO samples.
- For Pulse Rate: Laboratory pulse rate simulator.
- For Safety: Compliance with national and international standards.
8. The Sample Size for the Training Set
Not applicable. The Sentec Digital Monitor System is a sensing device, not an AI/ML algorithm that requires a "training set" in the conventional sense. Its underlying technology is based on established biophysical principles (2-wavelength SpO2 measurement, PCO2 electrode technology) and not on learned patterns from a large dataset. Calibration is mentioned, but this is a technical adjustment using known references, not a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of AI/ML for this device. The device uses an integrated calibration unit (Docking Station) for daily PCO2 sensor calibration, which relies on known gas values for accurate measurements.
§ 868.2480 Cutaneous carbon dioxide (PcCO2) monitor.
(a)
Identification. A cutaneous carbon dioxide (PcCO2) monitor is a noninvasive heated sensor and a pH-sensitive glass electrode placed on a patient's skin, which is intended to monitor relative changes in a hemodynamically stable patient's cutaneous carbon dioxide tension as an adjunct to arterial carbon dioxide tension measurement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA.” See § 868.1(e) for the availability of this guidance document.