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510(k) Data Aggregation
(176 days)
Biobeat Platform-2 and BB-613WP Patch
The Biobeat Platform-2 is a wireless noninvasive remote monitoring system intended for use by healthcare professionals for spot check collection of physiological data in home and healthcare settings. This can include, functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, blood pressure, respiration rate (RRp), hemodynamic parameters (stroke volume, cardiac output), and body temperature.
The Biobeat Platform-2 tracks changes in blood pressure based on Pulse Wave Transit Time (PWTT) which is obtained utilizing pulse measurements from the integrated SpO2 sensor, following a calibration process using an FDA-cleared oscillometric blood pressure monitor.
The Biobeat Platform-2 is intended for spot-checking and tracking changes of adult patients in hospitals, clinics, long-term care, and at home. The data from the Biobeat Platform-2 are intended for use by healthcare professionals as an aid to diagnosis and treatment. The device is not intended for use on critical care patients.
The Biobeat Platform-2 includes a sensor device that is attached to the patient's chest to collect physiological data for later review by their healthcare provider. The device consists of a light source (LEDs), thermistors and sensor array on the backside of the device. The LEDs transmit light into the subject's skin and part of this light is reflected from the tissue and detected by a photo-diode. This allows measurement of arterial oxygenation, pulse rate, change in blood pressure, stroke volume, cardiac output, and respiration rate. Body temperature is measured by the thermistors. Data is transmitted to a gateway via Bluetooth and then uploaded to the cloud. From the cloud, data is transmitted and presented in a web application for review by a healthcare professional. The device does not contain any alarms.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The document doesn't explicitly list "acceptance criteria" in a separate table with specific numerical targets for each parameter. However, it states the device aims for equivalent performance to its predicate devices and provides accuracy statements for certain physiological parameters. For the new parameters (Stroke Volume (SV) and Cardiac Output (CO)), the acceptance criterion is implicitly demonstrated by the Bland-Altman analysis showing acceptable Limits of Agreement (LOA) against a reference method.
Here's an attempt to structure the information into a table, inferring the acceptance criteria from the performance data and comparisons to predicate devices:
Table of Acceptance Criteria and Reported Device Performance
| Parameter / Metric | Acceptance Criteria (Implicitly from Predicate Comparison or Performance Data) | Reported Device Performance | Study that Proves Device Meets Acceptance Criteria |
|---|---|---|---|
| Functional Oxygen Saturation (%SpO2) | Accuracy (Arms): ±2% | Not explicitly re-tested for Biobeat Platform-2, relied on K212153. | K212153 (Primary Predicate Device study data) |
| Pulse Rate (PR/HR) | Accuracy (Arms): ±3% | Not explicitly re-tested for Biobeat Platform-2, relied on K212153. | K212153 (Primary Predicate Device study data) |
| Blood Pressure (BP) | Accuracy: ±5 mmHg | Not explicitly re-tested for Biobeat Platform-2, relied on K212153. | K212153 (Primary Predicate Device study data) |
| Respiration Rate (RRp) | No specific accuracy stated, but "measured by analyzing cyclic variations in the photoplethysmogram due to respiration." | Not explicitly re-tested for Biobeat Platform-2, relied on K212153. | K212153 (Primary Predicate Device study data) |
| Body Temperature | No specific accuracy stated. | Not explicitly re-tested for Biobeat Platform-2, relied on K212153. | K212153 (Primary Predicate Device study data) |
| Cardiac Output (CO) | Bland-Altman LOA to reference method (Fick, TD) within 30%. | Bland-Altman analysis showed LOA to the Fick method and TD within 30%. | Clinical Validation Data (90 patients, 80/77/82 included in final analysis) |
| Stroke Volume (SV) | Implicitly covered by Cardiac Output (CO) validation, as it's a hemodynamic parameter measured through the same new algorithm. | Implicitly covered by CO validation. | Clinical Validation Data (90 patients, 80/77/82 included in final analysis) |
| Software Validation | Per FDA guidance, General Principles of Software Validation; Final Guidance for Industry and FDA Staff (January 11, 2002) | "The new software elements have been documented and validated per FDA guidance." | Software validation per FDA guidance |
Study Details for New Features (Stroke Volume & Cardiac Output)
1. Sample sizes used for the test set and the data provenance:
* Sample Size:
* 90 patients recruited.
* 80 patients included in the final analysis comparing PPG device and Fick method.
* 77 patients included in the final analysis comparing TD with Fick method.
* 82 patients included in the final analysis comparing PPG with TD.
* Data Provenance:
* Country of Origin: Not explicitly stated, but the company address is in Petah Tikva, Israel. Based on the Clinical Validation Data section, it seems to be from a clinical site where patients underwent right heart catheterization.
* Retrospective or Prospective: The study states, "Comparison was performed retrospectively, after completion of the measurement phase." However, subjects were "recruited" and "simultaneously attached" to devices, which suggests prospective data collection followed by retrospective analysis. The description indicates a prospective collection design for the "test set."
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* This information is not provided in the text. The ground truth was established by objective medical methods (indirect Fick method and thermodilution), not subjective expert assessment.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* None. The ground truth was established by objective reference measurements (Fick method and thermodilution, and a comparison between PPG and TD), not by human expert adjudication of images or data.
4. 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. This was not an MRMC study. The study focused on the accuracy of the device's measurements against established clinical reference methods, not on human reader performance with or without AI assistance. The device output is physiological data for healthcare professionals to aid diagnosis and treatment, not an AI interpretation for a human reader to validate.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Yes. The clinical validation data presents the performance of the Biobeat device's algorithm (PPG device) in measuring cardiac output and comparing it to the reference methods (Fick and Thermodilution). This is a standalone algorithm performance evaluation.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Objective Clinical Reference Standards:
* Indirect Fick method
* Thermodilution (TD)
* These are considered "gold standard" or highly accurate methods for measuring cardiac output in a clinical setting.
7. The sample size for the training set:
* This information is not provided in the text. The document describes clinical validation for the test set, but not the training of the algorithms. It only states that a "new algorithm, derived from the existing photoplethysmogram, was added for measuring stroke volume and cardiac output."
8. How the ground truth for the training set was established:
* This information is not provided in the text. Given the new algorithm for SV/CO was "derived from the existing photoplethysmogram," it's possible it was developed using internal data and/or existing physiological models. The document focuses on the validation of this algorithm.
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(259 days)
Biobeat Platform, BB-613WP Patch
The Biobeat Platform is a wireless nonitoring system intended for use by healthcare professionals for spot check collection of physiological data in home and healthcare settings. This can include, functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, blood pressure, respiration rate (RRp), and body temperature.
The Biobeat Platform tracks changes in blood pressure based on Pulse Wave Transit Time (PWTT) which is obtained utilizing pulse measurements from the integrated SpO2 sensor, following a calibration process using an FDA-cleared oscillometric blood pressure monitor.
The Biobeat Platform is intended for spot-checking changes of adult patients in hospitals, clinics, long-term care, and at home. The Biobeat Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment. The device is not intended for use on critical care patients.
The Biobeat Platform and the BB-613WP Patch sensor include a device that is attached to the patient's chest to collect physiological data for later review by their healthcare provider. The device consists of a light source (LEDs), thermistors and sensor array on the backside of the LEDs transmit light into the subject's skin and part of this light is reflected from the tissue and detected by a photo-diode. This allows measurement of arterial oxygenation, pulse rate, change in blood pressure, and respiration rate. Body temperature is measured by the thermistors. Data is transmitted to a gateway via Bluetooth and then uploaded to the cloud. From the cloud, data is transmitted and presented in a web application for review by a healthcare professional. The device does not contain any alarms.
Here is an analysis of the acceptance criteria and study information for the Biobeat Platform, BB-613WP Patch, based on the provided FDA 510(k) summary:
Analysis of Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary provides accuracy specifications for several physiological parameters. These can be considered the acceptance criteria for those parameters. The document states that the clinical validations showed the Biobeat Platform met the pre-specified efficacy requirements and performed in a manner substantially equivalent to the predicate devices. Therefore, the reported device performance is indicated to be within these accuracy ranges.
| Parameter | Acceptance Criteria (Accuracy) | Reported Device Performance (Implied) |
|---|---|---|
| Oxygen Saturation (SpO2) | ±2% | Within ±2% |
| Pulse Rate (PR) | ±3% | Within ±3% |
| Blood Pressure (BP) | ±5 mmHg | Within ±5 mmHg |
| Respiration Rate (RRp) | ±3 RPM | Within ±3 RPM |
| Body Temperature | ±0.3 °C | Within ±0.3 °C |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Clinical validations of respiration rate and body temperature were performed to evaluate the efficacy of the new parameters." However, it does not explicitly state the sample sizes for these clinical test sets.
The data provenance is not specified. It does not mention the country of origin of the data, nor whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide information on the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method
The document does not specify any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of an MRMC comparative effectiveness study or any effect size for human reader improvement with AI assistance. This device is an automated physiological data collection system, not an AI-assisted diagnostic imaging tool that typically involves human readers.
6. Standalone Performance Study (Algorithm Only)
The document implies a standalone performance study. It states that the device "uses the same algorithm to compute SpO2 and pulse rate and to compute and track changes in blood pressure. Therefore, these signals' evaluation testing, which was submitted in K190792, remains applicable to the subject device." For respiration rate and body temperature, "Clinical validations... were performed to evaluate the efficacy of the new parameters." This indicates that the device's algorithms were evaluated for their ability to measure these parameters against a reference, which constitutes a standalone performance evaluation.
7. Type of Ground Truth Used
The type of ground truth used for the clinical validations of respiration rate and body temperature is not explicitly stated. However, for physiological monitoring devices, the ground truth is typically established using:
- Reference medical devices: Often, highly accurate, clinically accepted devices (e.g., a spirometer for respiration rate, a core body temperature probe for temperature, or an invasive blood pressure monitor for BP) are used as the "ground truth" during validation studies.
- Given the "clinical validation" claim, it's highly probable these reference measurements were taken directly from human subjects.
The document mentions that the device tracks blood pressure "following a calibration process using an FDA-cleared oscillometric blood pressure monitor." This suggests that an FDA-cleared oscillometric device serves as the reference for BP calibration.
8. Sample Size for the Training Set
The document does not provide information on the sample size used for any training set. It primarily discusses performance data (validation testing) rather than aspects of model training. It mentions "a new algorithm, derived from the existing photoplethysmogram, was added for measuring respiration rate (RRp)." This implies an algorithm was developed, but details on its training are absent.
9. How Ground Truth for the Training Set Was Established
Since information on a training set or its sample size is not provided, there is no information on how ground truth for a training set was established.
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(148 days)
BB-613WP
The BB-613 WP is a wrist-worn or skin attached device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO₂) and pulse rate.
The BB-613WP can also track changes in blood pressure based on Pulse Wave Transit Time (PWTT) which is obtained utilizing pulse measurements from the integrated SpO2 sensor, following a calibration process using oscillometric blood pressure monitor.
The BB-613WP is intended for spot-checking of adult patients in hospitals, clinics, long-term care, and home use.
The BB-613WP consists of a light source (LEDs) and sensor array on the backside of the device. The device is available in two versions, a watch version and an adhesive patch version. The LEDs transmit light into the subject's skin and part of this light is reflected from the tissue and detected by a photo-diode. The integrated display is used to display the blood saturation, pulse rate results and changes in blood pressure following calibration. These results are displayed on the LCD screen for the watch version and/or displayed on a mobile application installed on the user's phone. The display also shows symbols that show if there was no signal as well as well as battery status.
I am unable to provide a detailed table of acceptance criteria and reported device performance for blood pressure measurement, as the provided text doesn't contain a specific table or detailed numerical results for blood pressure accuracy from the clinical studies. The text only states that the device "achieved the requirements of the ISO 81060-2:2013 and accurately displayed blood pressure" and lists an accuracy of "±5 mmHg" in the comparison table, but doesn't specify if this is a mean absolute difference (MAD) or part of a defined acceptance criteria.
However, I can extract the available information from the provided text for other aspects of your request.
Analysis of Acceptance Criteria and Study Details for BioBeat Technologies Ltd.'s BB-613 WP (K190792)
Based on the provided 510(k) summary, the BB-613 WP is a wrist-worn or skin-attached device that measures and displays functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, and tracks changes in blood pressure based on Pulse Wave Transit Time (PWTT).
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Stated or Implied) | Reported Device Performance | Notes |
|---|---|---|---|
| SpO2 Accuracy | ±2% (Implied by comparison to predicate K181006) | Not explicitly stated for BB-6613WP, but claimed to be derived from K181006 performance as the algorithm is the same. K181006 SpO2 accuracy: ±2%. | The text states: "The device contains the same sensor unit and uses the same algorithm to compute SpO2 and pulse rate. Therefore, the SpO2 and pulse rate testing submitted in K181006 remains applicable to both models of the subject device." |
| Heart Rate (HR) Accuracy | ±3% (Implied by comparison to predicate K181006) | Not explicitly stated for BB-6613WP, but claimed to be derived from K181006 performance as the algorithm is the same. K181006 HR accuracy: ±3%. | Same as SpO2, performance is based on the predicate device due to identical sensor and algorithm. |
| Blood Pressure (BP) Accuracy (tracking changes) | "achieved the requirements of the ISO 81060-2:2013" and "accurately displayed blood pressure." (Specific numerical criteria of this ISO standard are not provided in the document, but typically involve mean difference and standard deviation). A comparison table lists "±5 mmHg" for accuracy. | "achieved the requirements of the ISO 81060-2:2013 and accurately displayed blood pressure." The comparative table lists "±5 mmHg" for accuracy of blood pressure. Specific statistical results (e.g., mean difference, standard deviation per ISO 81060-2:2013) are not detailed in this summary. | The ±5 mmHg value in the comparison table is likely the criterion they aimed to meet as per the ISO standard, rather than a specific reported result from the study. The phrasing in the performance data section confirms compliance with the standard without providing exact numerical results. |
| Software Validation | Compliance with FDA guidance | Performed | |
| EMC Testing | Compliance with IEC 60601-1-2:2014 | Performed | EMC testing unique to activated Bluetooth feature was also performed. |
| Biocompatibility | Cytotoxicity, sensitization, and irritation per ISO 10993 | Performed | |
| Safety Events | Absence of safety events during studies (Implied) | "during the studies, there were no safety events, showing the BB-613WP to be a safe device for use." |
2. Sample Size Used for the Test Set and Data Provenance
- SpO2 and Pulse Rate: The summary states that the SpO2 and pulse rate testing submitted for the predicate device (BB-613, K181006) remains applicable. Therefore, the sample size and data provenance for these parameters would be from the K181006 submission, which is not detailed in the provided document.
- Blood Pressure (PWTT):
- Clinical Tests: Conducted per ISO 80601-2:2013. The sample size for this clinical validation is not explicitly stated in the provided document.
- Animal Tests: An animal model study was performed in a swine model to evaluate the efficacy of the BB-613WP to detect blood pressure. The specific number of animals is not stated.
- Data Provenance (Clinical): The document does not specify the country of origin of the clinical data nor whether it was retrospective or prospective. It just states "Clinical validations of blood pressure per ISO 80601-2:2013 were performed."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- SpO2 and Pulse Rate: Ground truth related to the predicate device, not detailed here.
- Blood Pressure (PWTT):
- Clinical Tests: Not explicitly stated how the ground truth was established beyond referencing "reference devices" and compliance with ISO 81060-2:2013. The ISO standard itself outlines requirements for comparing a non-invasive blood pressure monitor to a reference measurement (often invasive arterial pressure or another validated non-invasive device). It doesn't mention expert consensus for establishing ground truth directly but relies on established measurement methods.
- Animal Tests: Gold standard device was used for systolic and diastolic blood pressure measurements. No mention of human experts for ground truth establishment.
4. Adjudication Method (for the test set)
- SpO2, Pulse Rate, Blood Pressure: No adjudication method is described in the provided text for any of the performance studies.
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 conducted or described for this device. This device is a measurement device, not an AI-assisted diagnostic imaging tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, for the blood pressure measurement, the clinical validation and animal tests assess the standalone performance of the device's algorithm in measuring or tracking blood pressure changes against a reference standard. The device "accurately displayed blood pressure" and results were compared between "reference devices" and the BB-613WP.
7. The type of ground truth used
- SpO2 and Pulse Rate: Not explicitly stated for BB-613WP, relies on predicate. Typically, oximetry ground truth in clinical studies involves arterial blood gas analysis for SpO2.
- Blood Pressure (PWTT):
- Clinical Tests: Comparison to "reference devices" as per ISO 81060-2:2013. This typically involves validated oscillometric blood pressure monitors or, less commonly for this type of device, invasive arterial pressure. The method for establishing ground truth is not explicitly stated as expert consensus, pathology, or outcomes data, but rather a comparison to established measurement techniques outlined in the ISO standard.
- Animal Tests: Comparison to a "gold standard device" for systolic and diastolic blood pressure measurement.
8. The sample size for the training set
- The document does not provide any information regarding a training set size. This suggests that the blood pressure algorithm might have been developed and internally validated using data not specified in this public summary, or the algorithm development process was not detailed as part of this 510(k) submission. For SpO2 and HR, the algorithms are reused from a previous device.
9. How the ground truth for the training set was established
- As no information on a training set or its sample size is provided, there is no information on how ground truth for a training set was established.
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