Search Results

The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >20 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 rigid, spring-loaded clip. The sensor cable is terminated in a DB-9 style connector, with an adapter cable for Datex-compatible models.

The provided document describes a 510(k) summary for the Flexi-Stat SpO2 Sensor, indicating its substantial equivalence to a predicate device for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring. However, the document does not contain detailed information regarding acceptance criteria or a specific study that proves the device meets those criteria in a format that allows for the extraction of all the requested information.

Here's an analysis of what can and cannot be extracted from the provided text, based on your questions:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not explicitly stated. The document mentions "clinical hypoxia studies" but does not provide the number of subjects or data points.
• Data Provenance:
  • Country of Origin: Not specified. It mentions studies conducted "in an independent research lab," but the location of this lab is not given.
  • Retrospective or Prospective: Not specified, but "clinical hypoxia studies" typically imply a prospective design where the device is tested on subjects under controlled conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The "ground truth" was established by "arterial blood samples analyzed on a laboratory co-oximeter," which implies laboratory personnel or medical professionals were involved in sample collection and analysis, but their qualifications are not detailed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable/not specified. For an SpO2 sensor, the "ground truth" is typically a direct physiological measurement (co-oximetry) rather than an interpretation requiring adjudication among human experts.

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

• MRMC Comparative Effectiveness Study: No. This type of study is not relevant for an SpO2 sensor, which provides direct physiological measurements rather than aiding human readers in interpreting images or complex data. The device itself is a measurement tool, not an AI-assisted diagnostic aid for interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Yes, in terms of the device's measurement accuracy. The clinical hypoxia studies directly compared the Flexi-Stat's measurements to the co-oximeter’s results, indicating its performance as a standalone measurement device. There is no "human-in-the-loop" aspect to analyze beyond a clinician using the device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: Arterial blood samples analyzed on a laboratory co-oximeter. This is a direct physiological measurement and considered the gold standard for arterial oxygen saturation.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/not specified. The device is a traditional electro-optical sensor, not an AI/ML algorithm that requires a "training set" in the machine learning sense. Its design and calibration would be based on engineering principles and physiological models, not data-driven training.

9. How the ground truth for the training set was established

• How Ground Truth for Training Set was Established: Not applicable. As mentioned, this is not an AI/ML device that uses a "training set" with established ground truth in the typical sense.

Summary of what the document implies about the study:

The document indicates that Elekon Industries, USA, Inc. conducted "clinical hypoxia studies in an independent research lab" where the Flexi-Stat SpO2 Sensor was "compared to arterial blood samples analyzed on a laboratory co-oximeter." The conclusion was that the device was "found to be equivalent to predicate device accuracy claims." This suggests a prospective, controlled clinical study designed to assess the accuracy of the SpO2 sensor against a gold standard (co-oximetry) under varying oxygen saturation levels induced by hypoxia. However, specific details such as the number of subjects, the range of SpO2 values tested, the statistical methods used, or the actual accuracy data (e.g., bias, precision, A-rms values) are not provided in this summary. The assessment focuses on demonstrating substantial equivalence to a predicate device, rather than detailing the full performance characteristics of the new device.

Ask a specific question about this device