(68 days)
Continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >10 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 ear clip housing. The sensor cable is terminated in a DB-9 style connector.
This document describes the Flexi-Stat SpO2 Ear Sensor, an accessory to a pulse oximeter, and its clearance for market based on substantial equivalence to a predicate device. This is primarily a descriptive summary of the device and its testing rather than a detailed study report. Therefore, specific details typically found in a robust study publication are limited.
Here's an attempt to extract the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a detailed "reported device performance" table with numerical metrics beyond the general statement of equivalence. It states that the device was found to be "equivalent to predicate device accuracy claims." The predicate device is the Nellcor Dura-Y ear sensor (K944760). Without the predicate device's specific accuracy claims, it's impossible to quantify the acceptance criteria or performance from this document alone.
| Feature / Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy | Equivalent to predicate device accuracy claims (Nellcor Dura-Y ear sensor K944760) | "found to be equivalent to predicate device accuracy claims" based on comparison to arterial blood samples analyzed on a laboratory co-oximeter during clinical hypoxia studies. |
| Pulse Rate Accuracy | Not specified (implied to be within acceptable limits for a pulse oximeter accessory) | "validated using bench testing with a pulse rate simulator." |
| Biocompatibility | Conformance with established industry standards | "performed to demonstrate conformance with established industry standards." |
| Electrical Safety | Conformance with established industry standards | "performed to demonstrate conformance with established industry standards." |
| EMC (Electromagnetic Compatibility) | Conformance with established industry standards | "performed to demonstrate conformance with established industry standards." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the 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 explicitly stated, though Elekon Industries, USA, Inc. is located in Torrance, CA, USA. The clinical studies were conducted in an "independent research lab," the location of which is not specified.
- Retrospective or Prospective: "Clinical hypoxia studies" implies a prospective study design, as subjects would be intentionally exposed to hypoxic conditions for the purpose of the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in the context of this device. The ground truth for SpO2 accuracy was established by comparing the device readings to "arterial blood samples analyzed on a laboratory co-oximeter." This is a direct physiological measurement, not an expert consensus on interpreting images or clinical signs.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was based on objective laboratory co-oximetry measurements of arterial blood samples. There was no need for expert adjudication of subjective assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document describes the performance testing of a medical device (SpO2 ear sensor), not an AI algorithm. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The SpO2 Ear Sensor itself is the "algorithm" (or the sensing and output component). Its performance in determining SpO2 and pulse rate was evaluated directly against a gold standard (co-oximetry for SpO2, pulse rate simulator for pulse rate) in a standalone manner, without requiring human interpretation of its raw output. The pulse oximeter to which it connects would then display these values, but the sensor's accuracy is evaluated independently.
7. The Type of Ground Truth Used
- For SpO2 Accuracy: "Arterial blood samples analyzed on a laboratory co-oximeter." This is considered a physiological measurement/outcome data, which is a gold standard for blood oxygen saturation.
- For Pulse Rate Accuracy: "Bench testing with a pulse rate simulator." This is a simulated/bench-test ground truth.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware sensor, not a machine learning algorithm that requires a training set. Its "training" is in its design and manufacturing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a hardware sensor.
§ 870.2710 Ear oximeter.
(a)
Identification. An ear oximeter is an extravascular device used to transmit light at a known wavelength(s) through blood in the ear. The amount of reflected or scattered light as indicated by this device is used to measure the blood oxygen saturation.(b)
Classification. Class II (performance standards).