(168 days)
Belun Ring BLR-100X is a wireless, non-invasive and stand-alone pulse oximeter intended to be used for continuous data collection and recording of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients through index finger in hospital and home environment for up to ten hours, during no motion and motion conditions, and for patients who are well or poorly perfused. It is not intended for single-use and out-of-hospital transport use and does not have alarms.
Belun Ring BLR-100X is a wireless, non-invasive and stand-alone pulse oximeter intended to be used for continuous data collection and recording of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients through index finger in hospital and home environment for up to ten hours, during no motion and motion conditions, and for patients who are well or poorly perfused. It is not intended for single-use and out-of-hospital transport use and does not have alarms. The proposed device consists of three parts: A Ring, a Cradle and a Host program. The Ring is intended to be worn on the base of the index finger. It provides comfortable and accurate measurements without the Cradle in the recording mode. The soft part of the Ring is designed to be changeable for fitting different sizes of fingers. The Cradle collects data from the Ring and charges up the Ring. It transfers the collected data to host via an attached USB cable or Bluetooth low power technology. The host program translates the data into text and graph which can be easily understood by the user. Using spectrophotometric methodology, the proposed device measures oxygen saturation by illuminating the skin and measuring changes in the light absorption of oxygenated (oxyhemoglobin) and deoxygenated blood (reduced hemoglobin) using light of two wavelengths: red and infrared. The ratio of absorbance at these wavelengths is calculated and calibrated against direct measurements of arterial oxygen saturation (SaO2) to establish the pulse oximeter's measurement of functional oxygen saturation of arterial hemoglobin (SpO2). The sensor of the Ring should be placed on the palmar side of the proximal phalanx of the index finger and along the radial artery. The system consists of three main platforms. Ring is responsible for signal acquisition, data processing, parameters calculation (SpO2/PR algorithm), sensor interfacing and user interface. Cradle takes care of the data storage, data transfer and user interface. Host program is for data export and user interface. The system includes two embedded software and one host program, namely the Ring firmware, the Cradle firmware and the Belun Ring Management.
Acceptance Criteria and Device Performance:
| Parameter | Acceptance Criteria | Reported Device Performance (Belun Ring BLR-100X) |
|---|---|---|
| SpO2 Accuracy | ± 3% (bench testing) | ± 2.7% (bench testing) |
| Not explicitly stated for clinical, but implied by ARMS meeting required specification | Accuracy Root Mean Square (ARMS) met required specification (clinical study) | |
| Pulse Rate (PR) Accuracy | ± 2.5 bpm or ± 2%, whichever is larger (bench testing) | ± 2.5 bpm or ± 2%, whichever is larger (bench testing) |
| SpO2 Measurement Range | 70%~100% | 70%~100% |
| PR Measurement Range | 30 bpm ~ 250 bpm | 30 bpm ~ 250 bpm |
| Data Average | Recording mode: 8s | Recording mode: 8s |
| Data Update Period | Recording mode: 8s | Recording mode: 8s |
Study Details:
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Sample Size and Data Provenance:
- Test Set (Clinical Study): The document does not explicitly state the sample size used for the clinical test set. It only mentions the purpose of the study was to evaluate SpO2 accuracy during steady state/non-motion conditions.
- Data Provenance: The document does not explicitly state the country of origin or whether the clinical data was retrospective or prospective.
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Number of Experts and Qualifications for Ground Truth (Test Set):
- Ground Truth for SpO2: Arterial blood samples assessed by CO-Oximetry.
- The document does not mention the number of experts or their qualifications for establishing the ground truth from the CO-Oximetry results, as CO-Oximetry is a direct measurement method.
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Adjudication Method for the Test Set:
- Not applicable as the ground truth for SpO2 was established by CO-Oximetry, which is a direct measurement.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study was focused on the standalone accuracy of the device.
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Standalone Performance:
- Yes, a standalone performance study was done for the algorithm. The clinical test evaluated the SpO2 accuracy performance of the Belun Ring BLR-100X as a standalone device.
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Type of Ground Truth Used:
- For the clinical study, the ground truth for SpO2 accuracy was established using arterial blood samples assessed by CO-Oximetry.
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Sample Size for the Training Set:
- The document does not provide information regarding a specific training set or its sample size. The focus is on the validation of the device's performance through bench and clinical testing.
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How Ground Truth for the Training Set Was Established:
- Not applicable, as information about a training set is not provided.
§ 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).