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To measure systolic and diastolic blood pressure and pulse rates of adults using wrist cuff and oscillometric method.

Full Auto Wrist Blood Pressure Monitor (Models BP1600, BP1650, BP1700 and BP1750) 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. The user interface panel of the device has power button, memory button and liquid crystal display ("LCD") for displaying systolic pressure, diastolic pressure and pulse rate. The device has memory capacity to store 10, 20, 60 and 90 most recent measurement results (respectively for BP1600, BP1650, BP1700 and BP1750). The device measures blood pressure through the use of an automatic inflating cuff. Pressurization is automatically governed. If the initial inflation pressure (180mmHg) is inadequate for measurement, i.e. Iower that the patient's systolic pressure, the pump will automatically re-pressurize to a preset level (30 mmHg) above the initial level. Symbols in the LCD indicate pressurization status at all times. The cuff automatically deflates with stepwise pressure drop of 5~6 mmHg per 2 pulses during blood pressure measurement.

This 510(k) premarket notification (K071523) by GENEXEL-SEIN, INC. for the Full Auto Wrist Digital Blood Pressure Monitor (Models BP1600, BP1650, BP1700, and BP1750) references substantial equivalence to a predicate device (K012054) rather than providing specific acceptance criteria and a standalone study for the new device. The provided text indicates that the performance of the new device is "Identical" to the predicate device. Therefore, the details about acceptance criteria, specific performance metrics, and the study proving compliance are derived from the overall claim of substantial equivalence and the listed characteristics.

Given the information provided, a direct table of acceptance criteria with reported device performance of the new device in a standalone study is not explicitly present. The submission relies on the established safety and effectiveness of the predicate device.

Here's an analysis based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that the "Performance" of the new device is "Identical" to the predicate device (510(k) # K012054). Therefore, the implied acceptance criteria would be those met by the predicate device, and the reported performance is that it matches the predicate. Specific numerical criteria are not provided for the new device in isolation.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a new, separate clinical study with a test set conducted for this 510(k) submission (K071523). Instead, it claims substantial equivalence based on the technological characteristics being identical or similar to the predicate device. Details on sample size or data provenance for a test set for the new device are therefore not provided. It's implied that the predicate device would have undergone such testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

As no specific test set study for K071523 is described, there's no information about the number or qualifications of experts used to establish ground truth.

4. Adjudication Method for the Test Set

Since no specific test set study for K071523 is described, there's no information about an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study is mentioned for this device. Blood pressure monitors typically do not involve multi-reader multi-case studies, as their function is to provide an objective measurement.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

The document does not describe a standalone performance study for the K071523 device. The basis for clearance is substantial equivalence to a predicate device, meaning its performance characteristics are considered to be effectively the same as the predicate, which would have undergone performance validation. The device itself is an automated measurement system, so "algorithm only" performance would be synonymous with its standalone performance.

7. Type of Ground Truth Used

For blood pressure monitoring devices, the "ground truth" for accuracy studies typically involves comparison against a reference standard, such as auscultatory measurement by trained observers using a mercury sphygmomanometer or an invasive arterial line. However, the document does not specify the ground truth method for this submission, instead relying on the predicate device's validation.

8. Sample Size for the Training Set

This submission does not discuss a training set, as it is not a machine learning or AI-based device in the common sense that would require a distinct training and test set with ground truth labeling for its development. It's a medical device with an oscillometric measurement algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this device does not describe a machine learning training set in the context typically seen for AI/ML devices.

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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":

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.

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To measure of systolic and diastolic blood pressure and pulse rates of adults using wrist cuff and oscillometric method.

Full Auto Wrist Digital Blood Pressure Monitor, SE-312

Based on the provided text, the document is a 510(k) clearance letter for the "Full Auto Wrist Digital Blood Pressure Monitor, SE-312" (K012054). This type of document from the FDA primarily focuses on establishing "substantial equivalence" to a predicate device, rather than requiring a detailed study demonstrating device performance against specific acceptance criteria for this particular device.

Therefore, most of the requested information regarding acceptance criteria and performance studies is not present in these documents. The 510(k) process typically relies on comparisons to already-cleared devices to demonstrate safety and effectiveness.

However, I can extract the following:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as pass/fail metrics for this specific device. The entire 510(k) process implies acceptance if substantial equivalence to a legally marketed predicate device is demonstrated for the stated indications for use.
• Reported Device Performance: Not explicitly enumerated in a performance table in these documents. The clearance is based on the comparison to a predicate device, assuming similar performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The document does not describe a specific test set or clinical study for this device's performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No test set or ground truth establishment process is described for this device in these documents.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. 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 blood pressure monitor, not an AI-assisted diagnostic tool. An MRMC study is not relevant here and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This device is a physical diagnostic monitor, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable for this device. The concept of "ground truth" as used for AI/diagnostic algorithms doesn't apply directly to a blood pressure monitor submission in this context. Substantial equivalence relies on comparing the device's design and operating principle to a predicate, and potentially some basic performance data if presented, but not typically a complex ground truth dataset.

8. The sample size for the training set

• Not applicable. This isn't an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

• Not applicable. This isn't an AI/machine learning device that requires a training set or ground truth for it.

In summary: The provided 510(k) documents grant clearance based on substantial equivalence to a predicate device. They do not contain the details of a de novo clinical study with explicit acceptance criteria and performance data for the "Full Auto Wrist Digital Blood Pressure Monitor, SE-312." Such detailed performance studies are typically found in the 510(k) submission itself (which is not provided) and would compare the device's accuracy against a recognized standard (e.g., AAMI, BHS protocol for blood pressure devices).

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