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510(k) Data Aggregation
(90 days)
The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in adult, pediatric, and neonatal patients.
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.
The provided text describes a 510(k) summary for the Flexi-Stat SpO2 Sensor. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a detailed study description. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a comprehensive clinical study report with specific acceptance criteria.
Based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that the device was "found to be equivalent to predicate device accuracy claims." It does not provide specific numerical acceptance criteria (e.g., A_rms values, bias, precision) or the detailed performance metrics of the Flexi-Stat against those criteria. The predicate device's accuracy claims are not specified in this document.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific SpO2 accuracy (e.g., A_rms < X%) | "Equivalent to predicate device accuracy claims" |
| Specific pulse rate accuracy (e.g., ± Y bpm) | "Equivalent to predicate device accuracy claims" |
| Biocompatibility requirements | Conforms to established industry standards |
| Electrical safety requirements | Conforms to established industry standards |
| EMC testing requirements | Conforms to established industry standards |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "clinical hypoxia studies" but does not provide the number of subjects or data points used in these studies.
- Data Provenance: The studies were conducted in an "independent research lab." The country of origin of the data is not specified, but the submitter is Elekon Industries, USA, Inc., and the FDA is a US regulatory body, suggesting the studies likely occurred in the US. The studies are prospective in nature, involving "clinical hypoxia studies" where the device was compared to arterial blood samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable in this context. The ground truth for oxygen saturation (SpO2) measurements in this type of device comparison is typically established by a laboratory co-oximeter analyzing arterial blood samples, which is a gold standard measurement, not by expert interpretation of images or other subjective data.
- Qualifications of Experts: N/A.
4. Adjudication method for the test set:
Not applicable. The ground truth is established by a laboratory co-oximeter, which provides an objective measurement, not a subjective interpretation 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 a SpO2 sensor, which provides a direct physiological measurement, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the performance testing described for the Flexi-Stat SpO2 Sensor is a standalone performance assessment. The device itself (the sensor) provides the SpO2 and pulse rate measurements, which were then compared against a gold standard (arterial blood samples analyzed on a laboratory co-oximeter). There is no "human-in-the-loop" component for the measurement itself, beyond applying the sensor and operating the connected oximeter.
7. The type of ground truth used:
The ground truth used was arterial blood samples analyzed on a laboratory co-oximeter. This is considered a highly accurate and objective gold standard for measuring functional arterial oxygen saturation.
8. The sample size for the training set:
Not applicable. This device is a hardware sensor, and the performance testing described is for its accuracy in measuring SpO2 and pulse rate. The concept of a "training set" is typically relevant for machine learning or AI-based devices that learn from data. This device's operation is based on electro-optical principles, not an algorithm that requires a training set in the AI sense.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set in the context of this device.
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