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The Compact Blood Pressure Monitor is 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 device is reusable and intended for home use on adults.

The Compact Blood Pressure Monitor, model BD204 is designed to measure systolic and diastolic blood pressure and pulse rate of an individual adult by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Rather than using the ausculatory method, which employs either an aneroid gauge or mercury manometer with a stethoscope to determine systolic and diastolic pressure, the device uses the oscillometric method, wherein an electronic semiconductor - sensor in the cuff determines the measurements. The sensor converts minute alterations in cuff pressure to electrical signals, by analyzing the amplitude of those signals systolic and diastolic pressure and pulse rates are calculated. The device analyses the signals and displays the results immediately.

Analysis of Thermor Limited Digital Blood Pressure Monitor (K122810)

The provided documentation describes a 510(k) application for the Thermor Limited Compact Digital Blood Pressure Monitor, model BD204. This application focuses on demonstrating substantial equivalence to a predicate device (LD 578) rather than an independent de novo safety and effectiveness study. Therefore, much of the requested information regarding detailed acceptance criteria and a standalone study is not explicitly provided in the typical format one would expect for a novel device.

The core of this submission relies on showing that the new device, BD204, is substantially equivalent to the predicate device, LD 578, which has already been cleared by the FDA (K061279). This means that the acceptance criteria for this application are largely met by demonstrating that the modifications made do not negatively impact the safety or effectiveness, and that the performance specifications remain identical to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a substantial equivalence submission, the explicit "acceptance criteria" for a new device's performance are not outlined as such. Instead, the acceptance is based on maintaining the performance of the predicate device. The document states:

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

The document does not explicitly state a sample size for a test set conducted specifically for the BD204 device to establish its own performance. The application relies on the established performance of the predicate device (LD 578) and the demonstration that the minor modifications to BD204 do not alter this performance.

The statement "The accuracy of this monitor has been validated to the European Hypertension Society protocol" refers to the oscillometric technology in general and, by extension, the predicate device. It is not clear if new clinical data was generated for the BD204. If any data was collected, its provenance (country of origin, retrospective/prospective) is not mentioned.

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

As no specific new clinical "test set" for the BD204's performance is detailed in the provided text, there is no information available regarding the number of experts, their qualifications, or their role in establishing ground truth for the BD204. The substantial equivalence argument bypasses the need for a new ground truth establishment process for the re-submitted device.

4. Adjudication Method for the Test Set

Given the lack of a specific test set described for the BD204, there is no information available regarding an adjudication method.

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

There is no mention of an MRMC comparative effectiveness study in the provided document. This type of study is typically used for diagnostic imaging devices where human interpretation plays a significant role. Blood pressure monitors have a direct numerical output, making an MRMC study less relevant. The focus here is on the accuracy of the device's measurement.

6. Standalone Performance Study (Algorithm Only)

The document states: "The algorithm used to determine the blood pressure values and the software codes are unchanged from the predicate model." The predicate device's underlying oscillometric technology "has been validated to the European Hypertension Society protocol."

While this indicates that the algorithm's performance was evaluated previously (for the predicate device), likely in a standalone manner, the specifics of that standalone study (e.g., sample size, detailed methodology) are not provided within this document for the BD204. The current submission's "performance testing" focuses on electrical, mechanical, and environmental compliance, not a new clinical accuracy study of the algorithm itself.

7. Type of Ground Truth Used for the Test Set

For the original validation of the oscillometric technology (and by extension, the predicate device), the "European Hypertension Society protocol" would typically involve comparison against a gold standard reference method, such as a manual auscultatory measurement performed by trained observers. The "ground truth" would be these reference blood pressure readings. However, no specific details are provided about how this was applied to a test set for the BD204 in this document.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for any training set. This is because the device relies on a well-established oscillometric algorithm (unchanged from the predicate) rather than a newly developed AI algorithm that typically requires a large training set.

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

Similarly, since there's no mention of a "training set" in the context of an AI/ML algorithm development, this information is not applicable and not provided in the document. The oscillometric method is a deterministic algorithm, not a learning-based one in the modern sense of AI/ML. The "ground truth" for calibrating such a method would have been established during the initial development and validation of the oscillometric technology, likely through comparison with reference measurements (e.g., auscultation).

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