(84 days)
The Blood Pressure Monitor is a digital monitor in measuring blood pressure and pulse rate with a wrist circumference ranging from 13.5cm to 21.5cm (about 51/3"-81/2"). It is intended for adult indoor use only.
Blood Pressure Monitor TMB-2285-BT is designed to measure systolic pressure, diastolic pressure and pulse rate of adult population by a non-invasive technique, with an inflatable cuff wrapped around the wrist. The method to define systolic and diastolic pressure is similar to auscultatory method, though it uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alternations of cuff pressure into electrical signals. Based on analysis of these signals, the systolic and diastolic blood pressure is defined, and the pulse rate is calculated. This is an extensively used technique applied in blood pressure monitors, also known as "oscillometric method". The main components of the Blood Pressure Monitor include main unit and wrist cuff. For the outer housing of the main unit, it's made of ABS material. The cuff model is WC1321-04, suitable for adults with wrist circumference of 13.5cm to 21.5cm. The cuff is consisted of fabric and an inflatable bladder inside. For critical electronic components, there is PCB, thermistor, pressure pump, motor, release valve and pressure sensor. The device also enjoys a function of detecting irregular pulse rate. When measurements were performed, the monitor will record all pulse intervals and calculate the average. If two or more pulse intervals were recorded, and the difference between each interval and the average is larger than ±25% of the average; or if four or more pulse intervals were recorded, and the difference between each interval and the average is larger than ±15% of the average, the irregular pulse symbol will be displayed along with measurement results. An embedded Bluetooth wireless connection module in the device allows it to connect with matching receiving ends. When a measurement is done, the results will be displayed on LCD, and the measured data will be transferred to the APP via Bluetooth.
Acceptance Criteria and Device Performance for Transtek Blood Pressure Monitor (K233130)
Based on the provided FDA 510(k) summary for the Transtek Blood Pressure Monitor (K233130), the device's acceptance criteria and the study proving it meets these criteria are outlined below.
Please note: The document primarily focuses on demonstrating substantial equivalence to a predicate device through adherence to recognized standards and clinical validation. Specific "acceptance criteria" in the sense of predefined thresholds for performance metrics derived from an AI/ML model are not explicitly detailed as this is a traditional medical device (blood pressure monitor) clearance, not an AI/ML software as a medical device (SaMD). The acceptance criteria are therefore inferred from compliance with the relevant industry standards, particularly ISO 81060-2 for clinical accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Criterion) | Reported Device Performance (Result and Metric) |
|---|---|
| Clinical Accuracy (ISO 81060-2:2018/Amd.1:2020) | |
| Criterion 1: Mean difference between device reading and reference for SBP/DBP. | SBP: -0.27 ± 3.18 mmHg (Mean ± Standard Deviation) |
| DBP: -0.80 ± 2.51 mmHg (Mean ± Standard Deviation) | |
| Criterion 2: Mean difference between device reading and reference for SBP/DBP. | SBP: -0.27 ± 2.60 mmHg (Mean ± Standard Deviation) |
| DBP: -0.80 ± 2.06 mmHg (Mean ± Standard Deviation) | |
| Biocompatibility (ISO 10993-1/5/10/23) | All tests (Cytotoxicity, Sensitization, Irritation) passed. |
| Electrical Safety (IEC 60601-1, IEC 60601-1-11) | Compliance confirmed. |
| Electromagnetic Compatibility (IEC 60601-1-2) | Compliance confirmed. |
| Performance - Non-Invasive Sphygmomanometers (IEC 80601-2-30) | Compliance confirmed. |
| Wireless (47 CFR Part 15, Subpart C & FDA Guidance) | Compliance confirmed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 258 datasets collected from 86 subjects.
- Data Provenance: Not explicitly stated, but given the company's location (Guangdong, China), it is highly probable the study was conducted retrospectively or prospectively within China. The document does not specify if the data was retrospective or prospective, but clinical validation studies are typically prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth. For blood pressure monitors, the "ground truth" (reference BPs) in clinical validation is typically established by trained technicians or clinicians using validated reference methods (e.g., auscultatory method with mercury manometer) according to the ISO 81060-2 standard.
4. Adjudication Method for the Test Set
The document does not mention an explicit adjudication method for the test set. Given the nature of blood pressure measurement validation according to ISO 81060-2, the comparison is typically against a reference measurement performed by trained personnel using a standardized method, not a consensus of multiple independent human readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed. This type of study is more common for diagnostic imaging AI algorithms where the AI assists human readers. For a standalone blood pressure monitor, the primary evaluation is its direct accuracy against a reference standard.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance study was done. The clinical data presented (mean differences and standard deviations) directly assesses the device's accuracy in measuring blood pressure and pulse rate without human-in-the-loop assistance for the measurement process itself, beyond the initial setup for obtaining the reference readings. The device is intended for over-the-counter use, implying standalone operation.
7. Type of Ground Truth Used
The ground truth used was reference blood pressure measurements obtained from subjects, likely using a validated auscultatory method as per the ISO 81060-2 standard (often involving two observers for accuracy). The document refers to "reference BPs."
8. Sample Size for the Training Set
The document does not provide information regarding a specific "training set" or its size. This device is a traditional non-invasive blood pressure monitor, not an AI/ML-based device that typically undergoes a separate model training phase. The "study" described is a clinical validation study for accuracy, which serves as the test set for the device's performance.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set in the context of an AI/ML algorithm for this traditional blood pressure monitor, this question is not applicable. The device's underlying "algorithm" (oscillometric method) is a well-established engineering principle, not a data-trained AI model requiring a separate ground-truth-established training set. The clinical validation proves the accuracy of this established method as implemented in the device.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).