(342 days)
Accessory to pulse oximeter for the purpose of continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring.
SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The optical components are housed in soft pad with a clear window. The sensor cable is terminated in a connector that couples with the corresponding monitor.
Here's a breakdown of the acceptance criteria and study information for the Tenacore Holdings, Inc. SpO2 Sensor:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| SpO2 Accuracy (ARMS) | Acceptability within ±3% |
| Pulse Rate Accuracy | Verified (claimed to be equivalent to predicate device) |
2. Sample Size Used for the Test Set and Data Provenance
The exact sample size for the clinical hypoxia studies is not explicitly stated in the provided text.
- Data Provenance: Clinical hypoxia studies were conducted in an independent research lab. The data is prospective as it involved conducting new studies. The country of origin is not specified, but given the submission to the FDA, it is likely the studies were conducted in the US or in a manner compliant with US regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- The document does not specify the number of experts used to establish ground truth or their qualifications.
- The ground truth for SpO2 accuracy was established by comparing the subject sensors to arterial blood samples analyzed on a laboratory co-oximeter. This implies the co-oximeter itself provides the "ground truth," rather than human experts interpreting results.
4. Adjudication Method for the Test Set
- The document does not mention any adjudication method for the test set. The comparison was directly against objective measurements from a laboratory co-oximeter for SpO2 and likely a reference standard for pulse rate.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret images. For an SpO2 sensor, the performance is measured against objective physiological parameters.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, a standalone performance assessment was done. The performance data explicitly states, "Subject sensors were compared to arterial blood samples analyzed on a laboratory co-oximeter and found to be equivalent to predicate device accuracy claims." This indicates the device's accuracy was assessed directly without human interpretation influencing the measurement.
7. The Type of Ground Truth Used
- SpO2 Accuracy Ground Truth: Achieved by arterial blood samples analyzed on a laboratory co-oximeter. This is an objective, gold-standard physiological measurement.
- Pulse Rate Accuracy Ground Truth: The text states, "Bench testing was performed to verify pulse rate accuracy." While not explicitly stated, this would typically involve comparing the device's pulse rate reading against a known, highly accurate reference standard (e.g., an ECG or a precision pulse generator).
8. The Sample Size for the Training Set
- The provided document does not mention a training set or its sample size. This is typical for a medical device like an SpO2 sensor where performance is based on physical principles and calibration, not a machine learning algorithm that requires extensive data for training.
9. How the Ground Truth for the Training Set Was Established
- As no training set is mentioned (or generally applicable to this type of device), this question is not applicable.
§ 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).