(162 days)
The Transtek Blood Pressure Monitors intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22cm to 45cm (about 8¾"-17½").
The device can be used to detect irregular heartbeat.
It is intended for adult indoor use only.
Blood Pressure Monitor, Models LS802-GS is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".
The main components of the Blood Pressure Monitor is the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 450 mm, includes the inflatable bladder and nylon shell. The device consists of the microprocessor, the pressure sensor, the operation keys, the electromagnetic deflation control valve and the LCD.
The devices also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular pulse rhythm when the difference of the time intervals is over 25%.
The devices embed an LTE Wireless network connections module that allows it to connect to receiving end. Once measurement is over, the LCD of device displays results, and the device will start to send out data such as systolic, diastolic, pulse, date, time with Wireless method and protocol.
The provided text is a 510(k) Summary for a Blood Pressure Monitor, Model LS802-GS, seeking a Substantial Equivalence (SE) determination from the FDA. The performance data section primarily focuses on non-clinical testing and a clinical validation study against a specific standard for blood pressure monitors.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the blood pressure monitor, in terms of its core functionality, are implicitly derived from the ISO 81060-2: 2018 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type standard. This standard defines the accuracy requirements for automated blood pressure devices.
While the exact numerical acceptance criteria from ISO 81060-2: 2018 are not explicitly listed in a table, the document states:
"All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018, and the accuracy of subject device is better than predicate device."
This statement confirms that the device met the required accuracy limits of the standard.
Implicit Acceptance Criteria (from ISO 81060-2: 2018, as referenced):
| Measurement Parameter | Acceptance Criteria (from ISO 81060-2: 2018) | Reported Device Performance (as stated in document) |
|---|---|---|
| Systolic Blood Pressure Accuracy | Mean error and standard deviation of differences within specified limits of ISO 81060-2: 2018 | All data's mean error and standard deviation of differences for systolic pressure is not over the limits of ISO 81060-2: 2018. |
| Diastolic Blood Pressure Accuracy | Mean error and standard deviation of differences within specified limits of ISO 81060-2: 2018 | All data's mean error and standard deviation of differences for diastolic pressure is not over the limits of ISO 81060-2: 2018. |
| Pulse Rate Measurement | 40-199 beat/minute, ±5% (This is a general performance specification listed for the device, not explicitly tied to a clinical study acceptance criteria, but reflects expected performance) | 40-199 beat/minute, ±5% (as listed under "Blood Pressure Measurement" table) |
| Irregular Heartbeat Detection | Device can detect irregular heartbeat (functional claim, not quantified by the clinical study described) | Device can be used to detect irregular heartbeat. |
Note: The document references the standard but does not provide the specific numerical limits (e.g., mean difference +/- X mmHg, standard deviation Y mmHg) outlined in ISO 81060-2: 2018.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The clinical study tested the device on 85 qualified healthy adult subjects.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. However, a clinical validation study conducted to a specific ISO standard for device approval is typically a prospective study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. In clinical validation studies for blood pressure monitors following ISO 81060-2, ground truth is typically established by trained observers (often two or more) using a reference sphygmomanometer (e.g., mercury manometer or a validated electronic device) concurrently with the device being tested, in a blinded fashion. The "experts" would be these clinical observers.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. In clinical validation studies of blood pressure monitors, if multiple observers are used (common for ground truth), their readings are often compared, and discrepancies might require adjudication by a third observer or a predefined averaging method as per the standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study described is a clinical validation study against a standard (ISO 81060-2), which assesses the device's accuracy against a reference method, not how it improves human reader performance or diagnostic accuracy in an assisted workflow. This type of study is more common for imaging AI devices.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The clinical study described is a standalone performance evaluation of the device's algorithm. The ISO 81060-2 standard assesses the automated device's measurements (algorithm output) against a reference standard, effectively evaluating its performance without human intervention in the measurement process itself, beyond initiation.
7. The Type of Ground Truth Used
The ground truth for the clinical validation study was established by comparison with a reference standard as prescribed by ISO 81060-2: 2018. While not explicitly stated, this typically involves simultaneously recording blood pressure measurements from the test device and a validated reference method (e.g., using a double manometer setup with trained observers taking auscultatory readings or another clinically validated device). This is a form of empirical measurement ground truth, not expert consensus in the diagnostic sense, nor pathology or outcomes data.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set sample size or how it was used. This 510(k) summary focuses on the clinical validation of the final device, not the development or training of an underlying algorithm. For a blood pressure monitor based on the "oscillometric method," the "algorithm" is often a well-established signal processing technique, not necessarily a deep learning model that requires a large, annotated training set in the same way an AI imaging algorithm would.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned or implied for an AI/ML algorithm requiring such, this information is not applicable and not provided in the document. The oscillometric method relies on established physiological principles and signal processing, rather than a learned model from a "training set" of labeled data in the AI sense.
§ 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).