(135 days)
Belun Ring BLR-100C is a non-invasive and stand-alone pulse oximeter, intended to be used for spot-checking and/or 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. It is not intended for single-use and out-of-hospital transport use.
The proposed device Belun Ring BLR-100C is a non-invasive and stand-alone pulse oximeter, which can detect, display and transfer the measured oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate in hospital and home environment.
The proposed device consists of two parts: A Ring and a Cradle.
The Ring, which is of a smooth and a light design and is easy to be worn and taken off, is intended to be worn on the base of the index finger. It provides comfortable and accurate measurements with the Cradle in the spot-checking mode or without the Cradle in the recording mode. The Cradle collects data from the Ring and translates the data into text and graph which can be easily understood by the user. It also exports the collected data via USB port to a host such as computer or mobile equipment for recording data transfer and review. They usually outside of patient environment, which is remote from the patient. There is no wireless function in this device.
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 is using a customized dual CPU design to realize the functions. 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 a display for output and a button for input.
The system includes two embedded software, namely the Ring firmware and the Cradle firmware. It is modularized and provides high stability. The software systems work in conjunction with the Ring and the 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.
The provided document is a 510(k) premarket notification for the Belun Ring BLR-100C, a pulse oximeter. It primarily focuses on demonstrating substantial equivalence to a predicate device (Belun Ring BLR-100) and a reference device (Nonin 3150 WristOx2).
Here's an analysis to extract the requested information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a "table of acceptance criteria" in a pass/fail format alongside reported device performance for the BLR-100C. Instead, it relies heavily on comparing the BLR-100C's specifications to its predicate device (BLR-100) and a reference device (Nonin 3150 WristOx2). The implicit acceptance criterion is that the BLR-100C's performance specifications are substantially equivalent to or within acceptable limits of the predicate/reference devices, and it meets relevant international standards.
For SpO2 and PR accuracy, which are key physiological measurements for an oximeter, the document lists specifications that can be interpreted as de facto acceptance criteria based on its comparison with predicate devices.
| Acceptance Criteria (Based on comparison with predicate/reference) | Reported Device Performance (Table 1, Proposed Device BLR-100C) |
|---|---|
| SpO2 Measurement Range: 70% ~ 100% | 70% ~ 100% |
| SpO2 Accuracy: ± 2% | ± 2% |
| PR Measurement Range: 30 bpm ~ 250 bpm | 30 bpm ~ 250 bpm |
| PR Accuracy: ± 2 bpm or ± 2%, whichever is larger | ± 2 bpm or ± 2%, whichever is larger |
| Data Average (Spot checking mode): Similar to predicate (8s) | 8s |
| Data Average (Recording mode): Similar to reference (e.g., 1s for Recording mode) | 1s |
| Data Update Period (Spot checking mode): Similar to predicate (≤20s) | ≤20s |
| Data Update Period (Recording mode): Similar to reference (e.g., 1s) | 1s |
| Compliance with: IEC 60601-1-2:2014, IEC 60601-1-11:2015, IEC 60601-1:2005 + a1:2012, ISO 80601-2-61:2011 | Tested in accordance with these standards |
| Software Validation: Compliance with FDA guidance | In compliance with Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices from FDA |
| Biocompatibility: Demonstrated equivalence to predicate | BLR-100C used same materials as BLR-100, tests performed for K180174 (predicate) are applicable. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily relies on non-clinical (bench) testing and the clinical study data from its predicate device (Belun Ring BLR-100, K180174).
- The text states: "BLR-100C is using the same PCB assembly (PCBA), materials for mechanical parts and bill-of-material as predicate device BLR-100 (K180174) except that the firmware, a resistor value on a PCB and an adhesive tape model have been changed such that "data collection and recording" function can be added in BLR-100C. Hence, the proposed device Belun Ring BLR-100C is verified in bench studies to meet the specifications fulfilled by the cleared predicate Belun Ring BLR-100 (K180174)."
- And: "Hence, the clinical study of predicate BLR-100 remains valid for BLR-100C."
Therefore, the sample size and data provenance for the clinical validation of the BLR-100C are those of the predicate device, BLR-100. This specific 510(k) document (K191417) does not provide details about the sample size, country of origin, or whether the predicate's study was retrospective or prospective. It simply states the clinical data for the BLR-100 is considered valid for the BLR-100C.
For the non-clinical bench tests performed on the BLR-100C itself, sample sizes are not explicitly mentioned, but these would typically involve a smaller number of devices to verify specific functionalities and meet technical standards.
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)
This information is not provided in the document. As the clinical validation relies on the predicate device's study, details about ground truth establishment, including the number and qualifications of experts, would be found in the 510(k) submission for Belun Ring BLR-100 (K180174), not in K191417.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Similar to point 3, details about the adjudication method for clinical ground truth would be found in the K180174 submission.
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 MRMC study was done or reported as part of this 510(k). This device is a pulse oximeter, not an AI diagnostic imaging tool where MRMC studies are typically applicable. It provides direct physiological measurements (SpO2 and pulse rate) and does not involve "human readers" or "AI assistance" in the sense of image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is a standalone oximeter in terms of its direct measurement capability. The "algorithm" for SpO2 and PR calculation is embedded within the device (Ring firmware). The performance assessment of the BLR-100C (and its predicate) against the reference method (e.g., co-oximetry, which would represent the "ground truth") intrinsically represents its standalone algorithmic performance. The document states it is for "spot-checking and/or data collection and recording."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For oximeters, the gold standard for measuring arterial oxygen saturation (SaO2) is typically laboratory co-oximetry performed on arterial blood samples. While not explicitly stated in this document, it is standard practice for pulse oximeter clinical studies to use co-oximetry as the ground truth. The document references ISO 80601-2-61:2011, which specifies requirements for pulse oximeters, and typically mandates such validation.
8. The sample size for the training set
This document describes a medical device, not a machine learning/AI algorithm that typically has a distinct "training set" and "test set." The "development" or "calibration" of such a device's algorithm would be part of its initial design and verification, which might involve a set of data, but it's not referred to as a "training set" in the machine learning sense here because this is a traditional, deterministic device. Details of any data used during the initial development/calibration of the BLR-100 or its core technology are not provided in this 510(k).
9. How the ground truth for the training set was established
As per point 8, the concept of a "training set" in the context of an ML/AI model with ground truth establishment is not directly applicable to this traditional medical device. Any calibration or verification data used during the device's original development (for the predicate device BLR-100) would have likely used co-oximetry as a reference, but these details are not in this document.
§ 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).