(77 days)
The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring. The Flexi-Stat SpO2 Sensor is indicated for use in patients weighing >30 kg.
The Flexi-Stat(tm) SpO2 Sensor is an electro-optical sensor that functions 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 a durable finger clip housing. The sensor cable is terminated in a DB-9 style connector, with an adapter cable for Datex-compatible models.
Here's a breakdown of the acceptance criteria and study information for the Elekon Flexi-Stat SpO2 Sensor, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria/Outcome Demonstrated | Reported Device Performance |
|---|---|---|
| Accuracy (SpO2) | Equivalent to predicate device accuracy claims. | "found to be equivalent to predicate device accuracy claims." |
| Biocompatibility | Conformance with established industry standards. | Performed; conformance demonstrated. |
| Electrical Safety | Conformance with established industry standards. | Performed; conformance demonstrated. |
| EMC (Electromagnetic Compatibility) | Conformance with established industry standards. | Performed; conformance demonstrated. |
| Intended Use | Continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring. For patients weighing >30 kg. | Device is indicated for this use. |
| Principle of Operation | Uses the same theory and principle of operation as predicate device. | Confirmed. |
| Design Characteristics | Equivalent to predicate devices in terms of safety and effectiveness. | Confirmed by testing and accuracy claims. |
Study Details
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The text mentions "clinical hypoxia studies" without specifying the number of subjects.
- Data Provenance: Clinical hypoxia studies conducted in an independent research lab. The country of origin is not specified, but the submission is from Elekon Industries, USA, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. However, the ground truth was "arterial blood samples analyzed on a laboratory co-oximeter," implying that experts in laboratory co-oximetry would have been involved in analyzing these samples.
4. Adjudication method for the test set:
- Not applicable. The ground truth was established through direct comparison with arterial blood samples analyzed on a co-oximeter, not through expert consensus requiring adjudication.
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:
- Not applicable. This device is an SpO2 sensor, not an AI-assisted diagnostic tool for which MRMC studies are typically performed. The study focused on the sensor's accuracy compared to a reference standard.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The performance testing described is standalone for the device. The Flexi-Stat SpO2 sensor's readings were compared directly to the ground truth from arterial blood samples without human interpretation being part of the device's measurement process, though human operators would connect and read the oximeter display. The focus was on the sensor's accuracy.
7. The type of ground truth used:
- Reference Standard: Arterial blood samples analyzed on a laboratory co-oximeter. This is considered a gold standard for blood oxygen saturation measurement.
8. The sample size for the training set:
- Not applicable / Not specified. This device is a physiological sensor, not a machine learning algorithm that typically requires a distinct training set. The performance testing validates its function.
9. How the ground truth for the training set was established:
- Not applicable. As a non-AI physiological sensor, there isn't a "training set" in the machine learning sense. The ground truth for performance evaluation was established by comparing sensor readings to concurrently drawn and analyzed arterial blood samples using a laboratory co-oximeter.
§ 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).