(99 days)
The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring 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 adhesive film. The sensor cable is terminated in a DB-9 style connector, with an adapter cable for Datexcompatible models.
Here's a summary of the acceptance criteria and study information for the Elekon Flexi-Stat SpO2 Sensor based on the provided 510(k) submission:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinically equivalent to predicate devices (Nellcor, BCI, Datex, Envitec sensors) in terms of safety and effectiveness. | "Performance testing was conducted during clinical hypoxia studies conducted in an independent laboratory. In these studies, accuracy of the Flexi-Stat was compared to arterial blood samples analyzed on a laboratory co-oximeter and found to be equivalent to predicate device accuracy claims." |
| Biocompatibility | Conformed to established industry standards. |
| Electrical Safety | Conformed to established industry standards. |
| EMC Testing | Conformed to established industry standards. |
Note: The document does not provide specific numerical targets for SpO2 accuracy (e.g., standard deviation or root mean square error) within a defined range. Instead, it refers to equivalence to predicate device accuracy claims.
Study Details:
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "clinical hypoxia studies" without specifying the number of subjects or data points.
- Data Provenance: The studies were conducted in an "independent laboratory." The country of origin is not specified but given the submitter is "Elekon Industries, USA, Inc." it's likely they were conducted in the USA or a region with comparable regulatory standards. The study appears to be prospective, involving induced hypoxia, rather than retrospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified for SpO2 accuracy. The ground truth for SpO2 accuracy was established by "arterial blood samples analyzed on a laboratory co-oximeter." There is no mention of experts interpreting these co-oximeter results; rather, the co-oximeter itself provides the objective measurement.
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Adjudication method for the test set:
- Not applicable. The ground truth was based on objective laboratory measurements (co-oximetry) of arterial blood samples, not subjective assessments requiring expert adjudication.
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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, which provides a direct physiological measurement, not an AI-assisted diagnostic tool that requires human interpretation.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is a standalone device in the sense that its performance, as an accessory to a pulse oximeter, is evaluated based on its direct measurements compared to a gold standard (co-oximetry), without requiring a human-in-the-loop to interpret its output for the accuracy study. The sensor outputs a numerical SpO2 value.
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The type of ground truth used:
- Objective measurement (Laboratory Co-Oximetry): Arterial blood samples were analyzed on a laboratory co-oximeter to provide the gold standard for arterial oxygen saturation.
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The sample size for the training set:
- Not applicable. As a medical device (sensor) that measures a physiological parameter, there is no "training set" in the machine learning sense for the core SpO2 measurement algorithm itself, which is based on established electro-optical principles. The performance testing focuses on validation.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set in the context of this device's SpO2 measurement function.
§ 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).