(247 days)
The V-TRUST Handheld Pulse Oximeter is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adults.
This device with reusable SpO2 sensor accessories is indicated for non-invasive spot checking or continuous monitoring.
The V-TRUST Handheld Pulse Oximeter is a light weight, portable and non-invasive pulse oximeter designed for use in measuring and displaying functional arterial oxygen saturation and pulse rate for adults during no motion based on the principle of spectrophotometry.
The V-TRUST Handheld Pulse Oximeter uses the same fundamental technology with the predicate device, 503 Pulse Oximeter. The SpO₂ and pulse rate software algorithms, interference-filtering software, and alarming system are identical to the software in the legally marketed predicate device cleared under K911124, with minor changes that do not raise new questions of safety or efficacy.
The V-TRUST Handheld Pulse Oximeter is allowed to link individual Solaris Compatible Reusable Adult SpO2 Finger Sensor (K061931) only. Solaris finger sensors are electro-optical sensors which function without skin penetration, electrical contact, or heat transfer. The sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter device.
Here's a breakdown of the acceptance criteria and study information for the V-TRUST Handheld Pulse Oximeter:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Proposed Device Specifications) | Reported Device Performance (as tested) |
|---|---|---|
| SpO2 measurement range | 0% to 100% | Not explicitly stated as meeting this, but accuracy tested within 70% to 100%. |
| SpO2 Accuracy | 70% to 100%: within ± 2% | Equal to or less than 2% |
| Pulse Rate Measurement Range | 30 to 250 BPM | Not explicitly stated as meeting this, but accuracy tested. |
| Pulse Rate Accuracy | ± 1 bpm | Within ± 1 bpm |
| Display | LED (light-emitting diode) | LED (light-emitting diode) (Implicitly met as a design characteristic) |
| Power button | Yes | Yes (Implicitly met as a design characteristic) |
| SpO2 % display | Yes | Yes (Implicitly met as a design characteristic) |
| Pulse amplitude indicator | Yes | Yes (Implicitly met as a design characteristic) |
| Pulse rate display | Yes | Yes (Implicitly met as a design characteristic) |
| Low battery indicator | Yes | Yes (Implicitly met as a design characteristic) |
| Sensor error indicator | Yes | Yes (Implicitly met as a design characteristic) |
| Sensor connector port | Yes | Yes (Implicitly met as a design characteristic) |
| Alarm | Yes | Yes (Implicitly met as a design characteristic) |
| Storage condition | -4°F to 122°F (-20°C to 50°C), below 95%, non-condensing | -4°F to 122°F (-20°C to 50°C), below 95%, non-condensing (Same as specification) |
| Operating condition | 32 °F to 113 °F (0 °C to 45 °C) | 32 °F to 113 °F (0 °C to 45 °C) (Same as specification) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 10 healthy subjects (5 males and 5 females).
- Data Provenance: Not explicitly stated (e.g., country of origin), but the study was a "hypoxia study" conducted in adherence to ISO 9919:2005, implying a controlled clinical environment. It is a prospective study because subjects were tested during no motion to determine accuracy against an ABG analyzer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number of experts used or their qualifications for establishing the ground truth. It mentions that the ground truth for SpO2 and heart rate was determined "against the artery blood gas (ABG) analyzer in hospital," implying a gold standard measurement rather than expert consensus on visual interpretation.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by an objective medical device (ABG analyzer) rather than expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is a standalone pulse oximeter, not an AI-assisted diagnostic tool that would typically involve human readers. The study compared the device's performance against a gold standard and a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The study evaluated the accuracy of the V-TRUST Handheld Pulse Oximeter's measurements (SpO2 and heart rate) directly against a clinical gold standard (ABG analyzer) and a predicate device, without involving human interpretation of the device's output.
7. The Type of Ground Truth Used
The ground truth used for SpO2 was established by an artery blood gas (ABG) analyzer in a hospital setting. For heart rate, the ground truth was also established through comparison against the ABG analyzer and the predicate device. This represents an objective, clinically accepted gold standard.
8. The Sample Size for the Training Set
The document does not provide information on a training set or its sample size. This is typical for a device like a pulse oximeter, where the fundamental technology (spectrophotometry) and algorithms are well-established and not based on a machine learning model that requires explicit "training data" in the same sense as an AI diagnostic tool. The software algorithms are stated to be "identical to the software in the legally marketed predicate device cleared under K911124."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no specific training set for a machine learning model is mentioned or implied. The device's software algorithms are inherited from the predicate 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).