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Belun Ring BLR-200 is a wireless, non-invasive and stand-alone pulse oximeter intended to be used for spot-checking and/or continuous data collection and recording of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients through index finger in 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-200 consists of two parts: a Ring, and a host program. The Ring, which has smooth and light design and is easy to wear and take off, is intended to be worn on the bottom of index finger providing comfortable and accurate measurements. To make the Optical module appropriately contact with the soft part of the finger, the Ring arm is designed to be changeable for fitting different sizes of fingers. The Ring transfers the collected data to host via Bluetooth low power technology. The host program translates the collected data into text and graph which can be easily interpreted by the user.

The system consists of two main platforms, namely Ring and host. It includes one embedded software and one host program, namely Ring firmware embedded in Ring and Belun Ring Management (BRM) executed in host respectively. The Ring is responsible for signal acquisition, data processing, parameters calculation (SpO2/PR algorithm), sensor interfacing and data storage. The host is for data display, data export and user interface. The system is modularized, and the communication protocol is proprietary. The system is secured with cybersecurity measures.

This document is a 510(k) summary for the Belun Ring BLR-200. It doesn't contain a detailed study report that proves the device meets specific acceptance criteria with reported device performance, sample sizes, expert qualifications, or details about standalone or MRMC studies.

However, based on the provided text, I can infer some information about how the device's accuracy was tested and the general approach to demonstrating substantial equivalence.

Here's an attempt to answer your questions based on the available information:

1. A table of acceptance criteria and the reported device performance

The document mentions that "The SpO2 and pulse rate accuracy of proposed device have also been tested on healthy subjects and compared with the predicate device in hypoxia tests." However, it does not explicitly state specific acceptance criteria (e.g., A_rms value for SpO2 accuracy) or provide the reported device performance values for these tests. It only states that the device was tested for accuracy.

Therefore, a table cannot be constructed with the detailed information you requested.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document states that accuracy was tested "on healthy subjects" for hypoxia tests. It does not specify the number of subjects used for the test set.
• Data Provenance: Not explicitly stated. The applicant is based in Hong Kong, but the location of the hypoxia tests is not mentioned. It is implied to be prospective since it describes testing performed on "healthy subjects."

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. For pulse oximetry accuracy during hypoxia tests, the ground truth is typically established by an arterial blood gas co-oximeter reading, not by human experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable in the context of pulse oximetry accuracy testing against a reference standard (e.g., arterial blood gas co-oximeter). Adjudication methods are more commonly used when human interpretation of data is being assessed.

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

There is no indication of an MRMC comparative effectiveness study involving human readers or AI assistance in this document. The device is a standalone pulse oximeter.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance assessment was done. The document states:

• "The SpO2 and pulse rate accuracy of proposed device under low perfusion and motion conditions have been tested against functional tester."
• "The SpO2 and pulse rate accuracy of proposed device have also been tested on healthy subjects and compared with the predicate device in hypoxia tests."

These describe assessments of the device's (algorithm's) performance in isolation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the hypoxia tests, the ground truth for SpO2 and pulse rate accuracy is implicitly established by a reference method, typically a co-oximeter measurement from arterial blood samples. This is the standard for pulse oximeter accuracy testing.

8. The sample size for the training set

This information is not provided. The document primarily focuses on demonstrating substantial equivalence through testing of the final device, not on the developmental or training phases of its algorithms.

9. How the ground truth for the training set was established

This information is not provided.

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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:

Study Details:

1. 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.

2. 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.

3. Adjudication Method for the Test Set:

   • Not applicable as the ground truth for SpO2 was established by CO-Oximetry, which is a direct measurement.

4. 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.

5. 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.

6. 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.

7. 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.

8. How Ground Truth for the Training Set Was Established:

   • Not applicable, as information about a training set is not provided.

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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.

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.

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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

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.

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