(221 days)
EvieMED Ring is a wireless, non-invasive, and stand-alone pulse oximeter intended to be used for spot checking oxygen saturation of peripheral arterial hemoglobin (SpO2) and pulse rate of adult users with a condition that might benefit from monitoring. Only the Pulse Oximeter function of the EvieMED device provides medical data. The device is designed for use in a healthcare or home environment, during no motion conditions. It is not intended for critical care and out-of-hospital transport use and does not have alarms. It is available with a prescription and can aid in the diagnosis and treatment of health conditions.
The EvieWED Ring is a rechargeable noninyasive wearable is an open arrow design that allows for a snug fit and comfort during fluctuations in fluid retention and/or weight changes. There is an optical sensor that collects physiological signals and an app that processes the signals and provides spot SpO2 and pulse rate (PR) measurements during a spot check on a user's connected iOS phone. The ring is designed to be worn continuously and is waterproof, allowing the user to wear the device during handwashing, showering, and bathing without damaging the ring.
The EvieMED Ring is designed for accurate pulse oximeter readings inside of a clinical setting. The device is for a single user but can be used for many users, with the rechargeable battery in the ring and the charger expected to last 2 years or more. The device is not life-sustaining or life-supporting and does not include alarms. It is not indicated for use in motion or in conditions of low perfusion.
The device is supplied in a labeled box that includes a wearable, a charger, a USB-C cable, and a quick start guide. The ring is provided in common ring sizes (e.g., US 5 through US 12). Operation of the device depends on connection to the user's device running iOS 16.0 and above where the EvieWED Ring Mobile Application has been installed and registered, and a user-supplied AC adaptor is required for recharging the charger.
The provided text describes the acceptance criteria and the study conducted for the EvieMED Ring, a pulse oximeter. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy | +/- 3.5% over the range of 70 to 100% | Overall accuracy of 2.46% (for 816 pooled samples over the range of 70-100% SaO2) |
| Pulse Rate Accuracy | +/- 3 bpm over the range of 40 to 240 bpm | Not explicitly stated in the provided text for the study, but the specification is +/- 3 bpm. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Eleven (11) healthy young adults (3 male, 7 female). The text also mentions "4 rings/subject" and approximately "25 samples/subject" for a total of 816 pooled samples.
- Data Provenance: The study was conducted at an "independent lab" with subjects placed into "controlled hypoxia." This suggests a prospective, controlled clinical study. The country of origin is not explicitly stated but is implicitly within the US context given the FDA submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The text describes an "IRB-approved SpO2 accuracy study" where "SaO2 and test samples were taken" and "SaO2 data was compared to the test (SpO2) data." This strongly implies that arterial blood gas (SaO2) measurements were used as the gold standard/ground truth. There is no mention of human experts establishing ground truth for this type of accuracy study; it relies on the direct physiological measurement from arterial blood.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by direct physiological measurement (arterial blood gas) and statistical comparison, not expert consensus or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC study was not performed. This device is a standalone pulse oximeter, and the study focused on its accuracy compared to a physiological gold standard, not on human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, this was a standalone performance study. The device's SpO2 and pulse rate readings were directly compared to a reference measurement (SaO2 from arterial blood) without a human interpretation loop.
7. The Type of Ground Truth Used
The ground truth used was outcomes data / direct physiological measurement specifically, arterial blood gas (SaO2) measurements. Subjects were desaturated under controlled conditions, and their SaO2 was measured directly and compared to the device's SpO2 readings.
8. The Sample Size for the Training Set
The document does not specify a training set size. The described study is a clinical validation study on a test set, performed to demonstrate the accuracy of the device. For a device like a pulse oximeter, the core algorithm for SpO2 calculation is typically based on established biophysics and signal processing, often refined and designed during internal development rather than being "trained" on a large dataset in the machine learning sense, at least not in a way that would be detailed in a 510(k) summary focused on validation. If machine learning was used, the training data would be internal to the company and not usually disclosed in this summary.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a specific "training set" and its ground truth establishment are not described in this regulatory submission summary. The accuracy study described is a clinical validation (test set) study.
§ 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).