(127 days)
Belun Ring BLR-100 is a non-invasive and stand-alone pulse oximeter, intending for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients through index finger in hospital and home environment. It is not intended for single-use and out-of-hospital transport use.
The proposed device Belun Ring BLR-100 is a non-invasive and stand-alone pulse oximeter, which can detect and display the measured oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate in hospital and home environment.
The proposed device consists of two parts: Ring and Cradle.
The Ring is intended to be worn on the bottom of index finger. The Cradle collects data from the ring and translates it into text and graph for the user.
Using spectrophotometric methodology, the proposed device measures oxygen saturation by illuminating the skin and measuring changes in light absorption of oxygenated (oxyhemoglobin) and deoxygenated blood (reduced hemoglobin) using two-wavelengths light: 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 palmar side of the proximal phalanx of the index finger and the sensor is being place along the radial artery. The system uses a customized dual CPU design. It consists of two main platforms: the Ring is responsible for signal pre-conditioning, data post-processing (SPO2/PR algorithm), parameters calculation and sensor interfacing, while the Cradle takes care of the user interface including display output and button user input.
The system includes two embedded software, namely Ring firmware and Cradle firmware. The software systems work in conjunction with Ring and Cradle. The two platforms (Ring and Cradle) are connected via "Connectivity software module". The communication protocol is proprietary which provides a reliable and fast communication.
Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from predicate device SONOSAT-W01T) | Reported Device Performance (Belun Ring BLR-100) |
|---|---|---|
| SpO2 Measurement Range | 70% ~ 100% | 70% ~ 100% |
| SpO2 Accuracy | ± 2% | ± 2% (from bench testing) |
| PR Measurement Range | 25 bpm ~ 250 bpm | 30 bpm ~ 250 bpm |
| PR Accuracy | ± 3 bpm | ± 2 bpm or ± 2%, whichever is larger |
Note: The provided text primarily compares the proposed device to a predicate device and a reference device, rather than explicitly stating acceptance criteria for the proposed device itself. The "Acceptance Criteria" column above is derived from the performance specifications of the predicate device (SONOSAT-W01T) which the proposed device aims to be substantially equivalent to. The "Reported Device Performance" for SpO2 and PR accuracy directly reflect the findings from the non-clinical bench testing.
2. Sample size used for the test set and the data provenance
- Clinical Study: The document states that the clinical test was conducted following ISO80601-2-61:2011, clause 201.12.1. This standard requires at least 10 healthy adult volunteers (male and female). However, the exact number of subjects used in the clinical study for the Belun Ring BLR-100 is not explicitly stated in the provided text.
- Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective, though a clinical test following a standard like ISO80601-2-61 implies a prospective study design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- The ground truth for the clinical study was established using CO-Oximetry by analyzing arterial blood samples. This method is considered a direct and objective measure of arterial oxygen saturation (SaO2), serving as the "gold standard." Therefore, the ground truth was not established by a panel of human experts in this context.
4. Adjudication method for the test set
- Not applicable, as the ground truth was based on objective laboratory measurements (CO-Oximetry) rather than subjective expert assessment.
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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The Belun Ring BLR-100 is a pulse oximeter that directly measures physiological parameters (SpO2 and pulse rate) and does not involve human readers interpreting images or data via an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance evaluation was done. Both non-clinical (bench testing) and clinical studies (against CO-Oximetry) evaluated the device's performance in measuring SpO2 and pulse rate without active human intervention in the interpretive process. The device provides direct measurements.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the clinical study, the ground truth for SpO2 accuracy was established using CO-Oximetry analysis of arterial blood samples.
- For pulse rate accuracy, the non-clinical bench testing used a functional tester as the ground truth.
8. The sample size for the training set
- The document describes a medical device for measuring SpO2 and pulse rate, not an AI or machine learning algorithm in the typical sense that would require an extensive "training set" of data for learning and model development. The algorithm for calculating SpO2 and pulse rate from light absorption is based on established spectrophotometric principles and is likely pre-programmed and calibrated, rather than "trained" on a large dataset. Therefore, a specific training set sample size is not mentioned as it's not applicable in the context of this device's underlying technology as described.
9. How the ground truth for the training set was established
- As explained in point 8, the concept of a "training set" in the context of an AI/ML algorithm is not directly applicable here. The device uses spectrophotometric methodology, which is based on known physical principles and calibrated against direct measurements (like SaO2 from CO-Oximetry) during its development and manufacturing, rather than a data-driven training process in the AI sense.
§ 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).