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The BP-2BHO Digital Blood Pressure Monitor is a device intended to measure the systolic, diastolic and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.

The BP-2BHO Digital Blood Pressure Monitor is designed to measure the systolic, diastolic and pulse rate of an individual by using a non-invasive technique which an inflatable curr is wrapper als manufactory of the upper arm. Our technique which an infiatable curr is wrapper als similar to the auscultatory method but uses an electronic capactive sensor rather than stethoscope and mercury manonical. - no onnalyzing those signals to define the cuff pressure to electrical signals, by andryzing the subscripmarket so called "oscillometric method".

The MicroLife Automatic Blood Pressure Monitor, Model BP-2BHO, was evaluated for both non-clinical and clinical performance to demonstrate its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not explicitly state the sample size used for the test set or training set.
The data provenance (e.g., country of origin, retrospective/prospective) for the clinical study is not specified in the provided text.

3. Number of Experts and Qualifications for Ground Truth Establishment

The document does not specify the number of experts used to establish ground truth for the test set or their qualifications. The clinical testing was performed according to ANSI/AAMI SP-10-1992, which typically involves comparison against reference measurements from trained observers.

4. Adjudication Method

The document does not describe the adjudication method used for the test set.

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

No multi-reader multi-case (MRMC) comparative effectiveness study evaluating the improvement of human readers with AI vs. without AI assistance was reported. The device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.

6. Standalone Performance Study

Yes, a standalone performance study was done for the device. The clinical testing against ANSI/AAMI SP-10-1992 demonstrates the algorithm-only performance of the MicroLife Automatic Blood Pressure Monitor.

7. Type of Ground Truth Used

For the clinical study, the ground truth was established by comparison to the "National Standard for Electronic or Automated Sphygmomanometers" (ANSI/AAMI SP-10-1992). This standard outlines procedures for accuracy testing, typically involving simultaneous measurements by the device and a trained human observer using a reference method (e.g., auscultation with a mercury sphygmomanometer). Therefore, the ground truth would be best described as expert consensus/reference method (as defined by the standard).

8. Sample Size for the Training Set

The document does not specify the sample size for the training set.

9. How Ground Truth for the Training Set was Established

The document does not provide details on how the ground truth for the training set was established. The device utilizes an "oscillometric method" based on a software algorithm to determine blood pressure. This implies that the algorithm itself might have been developed using various data, but the specifics of that development and ground truth establishment for training are not described in this summary.

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The BP-2BIO Digital Blood Pressure Monitor is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.

The BP-2BIO Digital Blood Pressure Monitor is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a noninvasive technique which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressures is similar to the auscultatory method but uses an electronic capacitive pressure sensor rather than stethoscope and mercury manometer. The sensor converts tiny alteration in cuff pressure to electrical signals; by analyzing those signals to define the systolic, diastolic and calculating pulse rate is a well known technique in the market so called "oscillometric method".

The MicroLife Manual Blood Pressure Monitor, Model BP-2BIO, has shown to meet acceptance criteria through various tests, primarily guided by the ANSI/AAMI SP-10-1992 "National Standard for Electronic or Automated Sphygmomanometers".

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify the sample size for the clinical test set used for the ANSI/AAMI SP-10-1992 standard. It also does not mention 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 Qualifications

The document does not provide information regarding the number of experts used to establish the ground truth for the test set or their qualifications. The ANSI/AAMI SP-10-1992 standard typically mandates specific protocols for clinical validation, often involving trained human observers using mercury sphygmomanometers as a reference, but these details are not present in this submission.

4. Adjudication Method for the Test Set

The document does not describe the adjudication method used for the test set.

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

An MRMC comparative effectiveness study was not performed or reported in this submission. The evaluation focuses on the standalone performance of the device against a standard and its substantial equivalence to a predicate, not on human-AI collaboration.

6. Standalone Performance Study

Yes, a standalone study was performed. The "Discussion of Clinical Tests Performed" section explicitly states: "ANSI/AAMI SP-10-1992 'National Standard for Electronic or Automated Sphygmomanometers' testing was performed. All relevant sections were addressed and testing conducted. The BP-2BIO met all relevant requirements of this standard." This indicates an evaluation of the algorithm's performance in determining blood pressure and pulse rate without human-in-the-loop assistance during the measurement process itself.

7. The Type of Ground Truth Used

Based on the reference to ANSI/AAMI SP-10-1992, the ground truth for blood pressure measurements would typically be established by expert auscultation using a mercury sphygmomanometer, considered the gold standard for non-invasive blood pressure measurement at the time. This standard defines precise protocols for comparing automated device readings against human-observed readings by trained professionals.

8. The Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. This device appears to be a traditional medical device (hardware with embedded software for signal processing) rather than an AI/ML-driven device that requires a separate "training set" in the modern sense. The software's accuracy is improved by a "split slope resolution" that maps to the sensor's output, a calibration approach rather than a machine learning training process.

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

As no "training set" is explicitly mentioned in the context of machine learning, there is no information on how ground truth for such a set would have been established. The device relies on a "well known oscillometric method" and a software interface designed to optimize accuracy against the sensor's output through calibration, rather than learning from a diverse dataset.

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The Pro Check™ Digital Pacifier Thermometer, is a non-sterile, re-usable clinical thermometer intended for the determination of oral body temperature in infants to children five years of age.

The Pro Check™ Digital Pacifier Thermometer, is a battery-powered, liquid crystal display device using a thermometer embedded in the nipple. The patient contact portion is composed of medical silicone rubber. The body is of ABS plastic. This device is reusable and no components are disposable. This device is not intended for use with other sheaths or devices.

The Pro Check™ Digital Pacifier Thermometer relies on previously performed clinical testing for predicate devices (Pasi-Temp Pacifier Digital Thermometer and Basis® Temp Pacifier Digital Thermometer) to demonstrate substantial equivalence. Therefore, the information provided focuses on the predicate devices' performance.

Acceptance Criteria and Reported Device Performance

Study Details (Inferred from Predicate Device Information)

Since the Pro Check™ Digital Pacifier Thermometer directly references clinical testing from its predicate devices, the specifics below apply to those predicate devices and are attributed to the Pro Check™ by reference.

• Sample size used for the test set and the data provenance: Not explicitly stated in the provided document. The document only mentions "Clinical testing previously performed."
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not explicitly stated.
• 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: Not applicable. This device is a digital thermometer, not an AI-assisted diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a standalone thermometer, meaning its performance is measured directly, not as an algorithm assisting human interpretation. The clinical testing likely evaluated its accuracy in measuring temperature.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated, but for a thermometer, the ground truth would typically be a highly accurate reference thermometer (e.g., a calibrated laboratory thermometer) against which the device's temperature readings are compared.
• The sample size for the training set: Not applicable, as this is a traditional medical device not employing machine learning that requires a training set.
• How the ground truth for the training set was established: Not applicable.

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