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510(k) Data Aggregation
(139 days)
G0 Blood Pressure Monitoring System (G0)
The Aktiia G0 Blood pressure monitoring system consists of a wrist worn monitor and an oscillometric cuff. The system is intended for measuring blood pressure and pulse rate based on using a Pulse Wave technique in adults aged from 22 to 59 years old with wrist circumference ranging from 14 cm to 21 cm following a calibration process (every 24 hours) using the oscillometric blood pressure cuff.
The Aktiia G0 Blood pressure monitoring system is intended for spot-checking of adult patients for home use.
The Aktiia G0 Blood Pressure Monitoring System measures blood pressure and pulse rate (spot check) based on the analysis of Photoplethysmography (PPG) signals. Aktiia G0 Blood Pressure Monitoring System consists of the following components:
- Bracelet
- Charger (for the Bracelet)
- Aktiia Init I1 (cuff)
- Mobile App
- Backend Software and Algorithm (in the Cloud)
The Aktiia G0 Blood Pressure Monitoring System hardware component, referred to as the bracelet, is responsible for PPG data acquisition on the user's wrist. It is composed of a data logging unit called the pod and of a detachable strap that is intended to secure the pod to the user's wrist. The pod uses the bracelet's electronics and PPG sensor. The bracelet's internal battery is located inside the pod and is recharged using a pin to USB docking station using a provided charger.
A calibration process (also referred to as initialization) is required prior to converting blood pressure values from optical data. This calibration process uses reference blood pressure values measured with an oscillometric blood pressure monitor (cuff) also referred to as Aktiia Init I1.
The Aktiia G0 Blood Pressure Monitoring System includes a mobile application for displaying data to the user and uses a cloud server referred to as the backend for data storage. The backend also hosts the algorithm which converts optical data generated by the bracelet into blood pressure and pulse rate data.
The FDA 510(k) clearance letter for the Aktiia G0 Blood Pressure Monitoring System (K250415) provides details on the acceptance criteria and the study conducted to prove the device meets these criteria.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The core acceptance criterion for blood pressure measurement accuracy for both the G0 System and the Aktiia Init I1 cuff is compliance with ISO 81060-2. For pulse rate, a specific RMSE threshold is provided.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Blood Pressure Accuracy: Complies with ISO 81060-2:2018 (for both G0 System and Aktiia Init I1 cuff) | "When comparing BP measurements of reference methods to the G0 Blood Pressure Monitoring System and the Aktiia Init I1 achieved the requirements of ISO 81060-2:2018 and accurately displayed blood pressure." |
| Pulse Rate Accuracy: RMSE ≤ 3 beats per minute (bpm) when compared to ECG readings. | Not explicitly stated if this threshold was met, but the study was designed to achieve it: "The primary endpoint required that the root mean square error (RMSE) of pulse rate measurements remain ≤3 beats per minute (bpm) when compared to ECG readings." The implication is that the primary endpoint was satisfied for clearance. |
2. Sample Sizes and Data Provenance
- Test Set Sample Size:
- Blood Pressure: The document states that "Clinical validations of blood pressure per ISO 81060-2:2018 were performed." ISO 81060-2:2018 generally requires a minimum of 85 subjects for accuracy testing, evenly distributed across specific blood pressure ranges. While the exact number isn't explicitly stated for the BP validation itself, the pulse rate study involved 85 participants, and it's highly likely that the blood pressure validation used the same or a very similar cohort given it was also a clinical investigation aiming for ISO compliance.
- Pulse Rate: 85 participants were included in the final dataset for the pulse rate validation study (NCT06565780), with 1273 simultaneous pulse rate measurements collected.
- Data Provenance: The study aimed for "a representative US population cohort," which implies the data originated from the United States. The study was a prospective clinical investigation (NCT06565780).
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number of experts or their specific qualifications for establishing the ground truth for the blood pressure measurements. However, for blood pressure, the ground truth reference method was double auscultation. This method inherently involves human observers (typically trained medical professionals) taking readings.
For pulse rate, the ground truth was an electrocardiogram (ECG), which is a gold standard instrumental measurement and does not inherently require expert human interpretation for establishing pulse rate.
4. Adjudication Method for the Test Set
- Blood Pressure: The ground truth was established by "double auscultation." This method typically involves two independent observers taking blood pressure readings, and potentially a third if there is a significant discrepancy. The document does not specify the exact adjudication protocol (e.g., 2+1, 3+1), but conformity to ISO 81060-2 implies a standardized, typically adjudicated, process for reference measurements.
- Pulse Rate: The ground truth was an ECG. Adjudication for instrumental measurements like ECG usually refers to the process of interpreting or reviewing the ECG waveform, but for simple pulse rate determination, the automated measurement from the ECG device is considered the ground truth. There is no mention of human adjudication for the ECG-derived pulse rate.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned for the Aktiia G0 Blood Pressure Monitoring System. The device is a "blood pressure monitoring system," not an interpretation device like an AI for medical imaging. The evaluation focuses on the accuracy of the device's measurements against established reference methods, not on how human readers' performance is improved by AI assistance in diagnosis or interpretation.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance evaluation was conducted. The clinical validation studies (ISO 81060-2 for BP, NCT06565780 for PR) assessed the accuracy of the Aktiia G0 system's measurements (algorithm output) against reference methods (double auscultation for BP, ECG for PR).
7. Type of Ground Truth Used
- Blood Pressure: Expert consensus via double auscultation (a highly standardized and accepted clinical method for reference blood pressure measurement).
- Pulse Rate: Instrumental data (electrocardiogram - ECG), which is considered a gold standard for heart rate measurement.
8. Sample Size for the Training Set
The document does not provide information regarding the sample size used for the training set of the algorithm. It only details the clinical validation (test) set.
9. How Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established. It only details the establishment of ground truth for the test set used in the clinical validation studies. Given that the algorithm is described as "Pulse-Wave Analysis (PWA)," it would conceptually involve matching optical signal data to simultaneously acquired reference blood pressure measurements (likely oscillometric cuff or arterial line) to train the model, but these specifics are not in the provided text.
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