Search Results

The IDEAL LIFE BP-MANAGER™ is a non-invasive blood pressure monitor intended for the measurement of systolic and diastolic blood pressure and heart rate (pulse rate) using the oscillometric technique.

The IDEAL LIFE BP-MANAGER™ should be used in adults (individuals aged 18 and older) in a non-clinical environment such as in the home. The IDEAL LIFE BPMANAGER ™ should not be used on infants or children. The end user of this device should not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation. This device makes no interpretation, evaluation, medical judgeners or recommendations for treatment. Clinical judgment and experience are required for interpretation of information. This device is not intended as a substitute for reedical care.

The IDEAL LIFE POD™ is an optional accessory to the IDEAL LIFE BPMANAGER TM and is a transmitter that is intended to transmit data obtained by the IDEAL LIFE BP-MANAGER™ to the internet via common telephone lines from the user's home setting. The IDEAL LIFE POD™ is an optional accessory designed to ssist in the management of user information. This device makes no interpretation, evaluation, medical judgments or recommendations for treatment. Clinical judgment and experience are required to check or interpret information transmitted. This device is not intepded as a substitute for medical care.

The IDEAL LIFE BP-MANAGER™ is a single unit software-controlled device with a blood pressure cuff, and operation is automatic. The IDEAL LIFE BP-MANAGFER™ can bc used alone without any other accessories. Blood pressure and heart rate results are displayed on the screen of the IDEAL LIFE BP-MANAGER™. Up to 70 blood pressure readings are stored in the blood pressure computer processor. The device is not intended for self-diagnosis of discase and it is expected that individuals using the IDEAL LIFE BP-MANAGER™ will consult with a physician for interpretation of results.

If an individual desires automated graphical presentation of their blood pressure and heart rate data, the IDEAL LIFE POD™ may be purchased separately and used with the IDEAL LIFE BP-MANAGER™ as an optional accessory. The IDEAL LIFE POD™ is not required for operation of the IDEAL LIFE BP-MANAGER™ . The IDEAL LIFE POD™ is a simple transmitter (i.e., a wireless router) that is intended to transmit data obtained by the IDEAL LIFE BP-MANAGER™ to the internet via common telephone lines from the user's home setting.

The provided text describes the IDEAL LIFE BP-MANAGER™ and IDEAL LIFE POD™ devices. However, it does not contain specific acceptance criteria or detailed results from a study that definitively proves the device meets such criteria in a quantitative manner as requested in the input format.

Here's an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance:

The document states that the performance testing was conducted "in accordance with the guidance document entitled 'Non-Invasive Blood Pressure (NIBP) Monitor Guidance' dated March 10, 1997." This guidance document would contain the actual acceptance criteria (e.g., accuracy ranges for blood pressure measurements).

However, the provided text does not explicitly list these acceptance criteria or the specific reported device performance values (e.g., mean difference and standard deviation of blood pressure readings compared to a reference standard). It only provides a general statement: "Results of these tests confirm the appropriate performance of both the IDEAL LIFE BP-MANAGER™ and the IDEAL LIFE POD™."

Therefore, a table cannot be fully constructed from the provided text.

2. Sample size used for the test set and the data provenance:

The document mentions "performance testing in human volunteers" but does not specify the sample size for this test set. It also does not specify the country of origin of the data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document states that performance testing included "performance testing in human volunteers." For a blood pressure monitor, the ground truth is typically established by trained medical professionals using a reference blood pressure measurement method (e.g., auscultation with a sphygmomanometer). However, the document does not specify the number of experts used or their qualifications.

4. Adjudication method for the test set:

The document does not mention any adjudication method for the test set.

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:

This device is a blood pressure monitor and a data transmitter, not an AI-powered diagnostic tool requiring human interpretation of images or complex data. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device and was not mentioned.

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

The IDEAL LIFE BP-MANAGER™ is a standalone device for measuring blood pressure. The performance testing "in human volunteers" would inherently be a standalone performance evaluation of the algorithm's ability to measure blood pressure. However, the document does not explicitly label it as a "standalone" study in contrast to human-in-the-loop. The IDEAL LIFE POD™ is a data transmitter and doesn't have an "algorithm-only" performance in the sense of making medical judgments.

7. The type of ground truth used:

For the blood pressure measurements, the ground truth would typically be established by concurrent measurements using a validated reference method (e.g., auscultation by trained observers). While not explicitly stated as "ground truth," performance testing in human volunteers for a blood pressure monitor implies comparison against such a standard.

8. The sample size for the training set:

The document does not mention a training set or its sample size. Given the device's function as a blood pressure monitor, it's unlikely to have a "training set" in the context of machine learning. The device's calibration and algorithm development might have used a dataset, but it's not referred to as a "training set" in the provided text.

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

Since no training set is described, this information is not available.

In summary:

The provided document, a 510(k) summary, focuses on establishing substantial equivalence to predicate devices and generally stating that performance tests were conducted according to guidance. It lacks the specific quantitative details requested regarding acceptance criteria, sample sizes for testing, expert qualifications, or detailed study methodology. To obtain such information, one would typically need to refer to the full study reports that were submitted to the FDA, which are not included in this summary.

Ask a specific question about this device