(15 days)
This device is an over the counter device, and is indicated for use to measure systolic and diastolic pressure and pulse rate of adults by the individual, in a home care environment, using wrist cuff and oscillometric method of measurement.
Full Auto Wrist Digital Blood Pressure Monitor SE-311 is intended to measure systolic and diastolic pressure and pulse rate of adults in a home care environment using wrist cuff and oscillometric method of measurement.
There are no contraindications; the subject device may be employed in the care of normotensive, hypertensive, or hypotensive patents.
The user interface panel of SE-311 has power button, time button, time button, user button, memory button and liquid crystal display ("LCD") for displaying systolic pressure, diastolic pressure, pulse rate, time, date and user. SE-311 has memory capacity to store the 180 most recent measurement results for four users and the function to transmit the measured data to PC through RS232C cable.
The patient is responsible for applying the cuff, for initiating the measurements sequence by pressuring the "Power" button, and for recording results. The patient cannot alter bleed-down rate.
All system functions are preprogrammed. The user is cautioned in the instruction manual aqainst attempting any programming or other modification.
No special training beyond basic ability to follow instruction is required. Since the products are designed for home use, detailed instructions on avoidance of practices that adversely affect the accuracy of measurements are included in the instruction manual.
The provided text is a 510(k) summary for the Sein Electronics Co., Ltd. Full Auto Wrist Digital Blood Pressure Monitor SE-311. This summary focuses on demonstrating substantial equivalence to a predicate device (SE-312) rather than presenting a standalone study with detailed acceptance criteria and performance data from a new clinical trial.
Therefore, much of the requested information regarding a specific study to prove the device meets acceptance criteria, such as sample sizes, expert qualifications, adjudication methods, MRMC studies, or detailed ground truth methodologies, cannot be extracted from the provided text. The submission's primary argument for safety and effectiveness is based on the device being "safe and effective as the predicate device cited above" due to "identical" or "similar" technological characteristics.
Here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria (e.g., specific accuracy ranges for blood pressure measurements) for the SE-311 and then report the SE-311's performance against these criteria. Instead, it claims "Performance: Identical" to the predicate device (SE-312).
Here's a table based on the provided "Summary comparing technological characteristics with predicate device":
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (SE-311) |
|---|---|
| Indicatio ns for use (Identical to SE-312) | Identical |
| Target population (Identical to SE-312) | Identical |
| Design (Similar to SE-312) | Similar |
| Materials (Identical to SE-312) | Identical |
| Performance (Identical to SE-312) | Identical |
| Sterility (Not Applicable for SE-312) | Not Applicable |
| Biocompatibility (Identical to SE-312) | Identical |
| Mechanical safety (Identical to SE-312) | Identical |
| Chemical safety (Not Applicable for SE-312) | Not Applicable |
| Anatomical sites (Identical to SE-312) | Identical |
| Human factors (Similar to SE-312) | Similar |
| Energy used and/or delivered (Identical to SE-312) | Identical |
| Compatibility with environment and other devices (Identical to SE-312) | Identical |
| Where used (Identical to SE-312) | Identical |
| Standards met (Identical to SE-312) | Identical |
| Electrical safety (Identical to SE-312) | Identical |
| Thermal safety (Identical to SE-312) | Identical |
| Radiation safety (Not Applicable for SE-312) | Not Applicable |
2. Sample size used for the test set and the data provenance
- Sample size for the test set: Not provided. The submission focuses on comparing technological characteristics to a predicate device, not on presenting a new clinical study with a test set of patients.
- Data provenance: Not provided, as there's no mention of a specific clinical study for the SE-311 in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. The submission does not describe a clinical study where experts established ground truth for a test set.
4. Adjudication method for the test set
- Not applicable/Not provided. No test set or adjudication method is described.
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. This device is a digital blood pressure monitor, not an AI-assisted diagnostic tool. An MRMC study is not relevant here, and no such study is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device performs measurements automatically using the oscillometric method. Its standalone performance is inherently what is being described as "identical" to the predicate. However, detailed results of such a standalone performance test are not provided in this summary. The user applies the cuff and initiates the measurement, but the measurement itself is automated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated for the SE-311. For blood pressure monitors, ground truth typically involves simultaneous or near-simultaneous measurements using a recognized reference standard (e.g., mercury sphygmomanometer with auscultation by trained observers) following established protocols (e.g., ISO, AAMI standards). Since the performance is claimed to be "Identical," it's implied that the predicate device (SE-312) adhered to such ground truth methods, and the SE-311 is expected to do the same.
8. The sample size for the training set
- Not applicable/Not provided. This is not an AI/machine learning device that would typically have a "training set" in the context of data-driven model development.
9. How the ground truth for the training set was established
- Not applicable/Not provided, as there is no training set described for an AI/machine learning model.
§ 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).