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HX-461 is intended for used by adults to measure the systolic and diastolic blood pressure and pulse rate and transfer medical device data electronically to the designated health care center through internet website. HX-461 enables user reqistration for user-specific data management, and provides blood pressure measurement function. It can receive blood pressure, blood qlucose and body fat measurement values by connecting with respective measurement instruments supporting Bluetooth connection, or by docking a blood glucose meter on its back. In addition, HX-461 supports wired/wireless communication with a designated person including video communication.. It has three size of cuff for blood pressure measurement. User chooses the cuff depending on their arm circumference.

HX-461 applies the oscillometric method to measure patient blood pressure. It is composed of blood pressure module, cuff, LCD touch pad control panel and CPU processer based on Window CE to operate the blood pressure module. Patient can easily operate the device with the touch pad using the cuff installed in the device. Operator can control by touch screen based on SEERSTECHNOLOGY CO., LTD.'s software. It has unique communication function that can get the medical information from other blood pressure meter, blood glucose meter and body fat measurement device using bluetooth module and wire connector. HX-461 has a wire and wireless internet function.

The provided text is a 510(k) summary for the HX-461 Auto Blood Pressure Meter. This type of regulatory document typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed study results against specific, quantitatively defined acceptance criteria for a novel device.

Based on the provided text, here's an analysis of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a table format. Instead, it relies on a comparison to predicate devices, asserting that the HX-461's specifications and performance are "same as functional and effective as the legally marketed predicate device."

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

The document does not provide information on the sample size used for a test set or the data provenance (e.g., country of origin, retrospective/prospective). The assessment appears to be based on "investigation for function and effectiveness" by comparing the new device directly to the predicate device.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document does not mention the use of experts to establish ground truth.

4. Adjudication Method:

The document does not describe any adjudication method.

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

The document does not mention an MRMC study. The comparison is between the HX-461 and predicate blood pressure monitors, not a comparison of human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance:

The document does not provide standalone performance data for an algorithm. The HX-461 is a blood pressure measurement device, not an AI-driven diagnostic algorithm in the context typically associated with standalone performance studies.

7. Type of Ground Truth Used:

The document does not explicitly mention a specific type of ground truth beyond the "comparison results" demonstrating functional and effective equivalence to the predicate devices. For blood pressure monitors, ground truth typically involves a reference measurement method (e.g., auscultation with a manometer) against which the automated device is validated. However, such details are not in this summary.

8. Sample Size for the Training Set:

The document does not mention a training set or its sample size. This is expected as the HX-461 is a hardware device, not an AI model that typically requires a training set.

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

As there is no mention of a training set, the document does not describe how ground truth for a training set was established.

Summary based on the provided text:

The 510(k) summary for the HX-461 Auto Blood Pressure Meter primarily focuses on demonstrating substantial equivalence to existing predicate devices (UA-789 & UA-767PBT). The "study" referenced is a qualitative comparison of the device's function and effectiveness against these predicates. It does not provide detailed quantitative acceptance criteria, performance metrics, sample sizes for testing or training, or information about expert ground truth establishment commonly found in studies evaluating novel diagnostic algorithms.

The key statement regarding performance is: "Comparison results demonstrate that the specifications and performance of the device are same as functional and effective as the legally marketed predicate device." This implies that the HX-461's performance is acceptable because it matches that of already cleared devices.

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