(640 days)
For the measurement of systolic and diastolic blood pressure and pulse rate in adult patients.
The SEIN SE-330 Wrist Blood Pressure Meter is a semi-automatic electronic device designed to measure blood pressure and pulse, and in which a compact wrist cuff is used in place of the standard wrist cuff. Inflation and deflation are accomplished through the use of a manual inflation bulb and solenoid valve respectively. Blood pressure and pulse are measured using the oscillometric method. A liquid crystal display of up to six digits is employed to record blood pressure and pulse. Power is supplied by two lithium batteries (size CR2032). Built-in memory allows the display of the previously measured blood pressure and pulse values for comparison to current measurements. An automatic power cut-off feature after one minute of non-use is built into the device to permit saving of energy. The measuring range of the device is 20-280 mmHg (pressure) and 40-200 pulses per minute with an accuracy of +3mmHg or 2% of the reading, whichever is greater, for the pressure and t5% of the reading for pulse. The dimensions of the SE-330 Blood Pressure Meter are 58 mm (W) and 70 mm (D) x 23.8 mm (H). The weight of the meter is approximately 110 g including two batteries. The wrist cuff dimensions are 314.7 mm (1) x 70 mm (w). Battery life for the device is approximately 150 measurements.
The provided text describes a 510(k) summary for a Digital Wrist Blood Pressure Meter, Model SE-330. It outlines the device's technical specifications and a study conducted for its approval. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ANSI/AAMI SP-10 1992 Guidance) | Reported Device Performance (Model SE-330) |
|---|---|
| Accuracy for Pressure | +3mmHg or 2% of the reading, whichever is greater |
| Accuracy for Pulse | +5% of the reading |
| Equivalency to cuff-stethoscope auscultatory method | Shown to be equivalent |
Note: The document states the device's measuring range is 20-280 mmHg (pressure) and 40-200 pulses per minute. While these are not explicitly termed "acceptance criteria" in the text, they define the operational limits of the device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 108 patients
- Data Provenance: The document states "A clinical trial... conducted on 108 patients," implying the data was collected prospectively for this study. The country of origin for the data is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document refers to the "cuff-stethoscope auscultatory method" as the comparator for determining blood pressure and pulse. This method typically involves trained medical professionals (e.g., doctors, nurses). However, the number of experts used to establish the ground truth for the test set and their specific qualifications (e.g., years of experience) are not specified in the provided text.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method for the test set. It mentions the "cuff-stethoscope auscultatory method" as the basis for comparison, which usually relies on direct measurement by a human observer. There is no mention of multiple experts or any reconciliation process (like 2+1 or 3+1).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study in the provided text. The study compares the device's performance against a standard manual method, not the improvement of human readers with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The study described is a standalone performance test of the device, comparing its measurements to the traditional cuff-stethoscope auscultatory method. The device itself is an "Automatic Digital Wrist Blood Pressure Meter," implying it operates without continuous human-in-the-loop adjustment for each reading, other than initial placement and activation. Therefore, this can be considered a standalone performance study for the device's measurement capabilities.
7. Type of Ground Truth Used
The type of ground truth used is the cuff-stethoscope auscultatory method for determining blood pressure and pulse. This is a clinically accepted, established method for blood pressure measurement, serving as the gold standard for comparison in this context.
8. Sample Size for the Training Set
The document does not mention a training set or its sample size. The description pertains to a clinical trial for performance evaluation against a standard, not the development or training of an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, this information is not applicable or not provided in the document.
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).