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The wrist automatic blood pressure monitor LD-735,LD-752,LD-753 is intended for the non-invasive measurement of systolic and diastolic arterial blood pressure and pulse rate in adults (aged 15 and above).

The Wrist Automatic Blood Pressure Monitor is an automatic, non-invasive, blood pressure measurement device that is intended to measure the systolic and diastolic arterial blood pressure and pulse rate. The systolic and diastolic pressure are determined using the oscillometric method, where the cuff is inflated with a pump and deflates via an automatic electronic valve. During the inflation measurements, an electric pump within the main unit slowly inflates the wrist cuff, generating cuff pressure which is monitored and from which pulse waveform data is extracted. This waveform data is analyzed by software algorithms within the sensor to determine systolic pressure and diastolic pressure.

The Wrist Automatic Blood Pressure Monitor consists of two parts: main unit and the wrist cuff. The main unit is mainly composed of pump, valve, PCB, enclosure and LCD. The cuff, which is applicable to wrist circumference approximately between 12.5 and 20.5cm, includes the inflatable bladder and the nylon shell.

This device adopts the oscillometric technology with Fuzzy Algorithm to measure the arterial blood pressure and pulse rate. The cuff is wrapped around the arm and automatically inflated by the air pump. The sensor of the device catches weak fluctuation of the pressure in the cuff produced by extension and contraction of the artery of the arm in response to each heartbeat. The amplitude of the pressure waves is measured, converted in millimeters of the mercury column, and is displayed by digital value.

This FDA 510(k) clearance letter pertains to three models of wrist automatic blood pressure monitors (LD-735, LD-752, LD-753) submitted by HONSUN (Nantong) Co.,Ltd. The clearance is based on the substantial equivalence of these devices to a legally marketed predicate device, the Wrist Automatic Blood Pressure Monitor LD-737 (K131463).

The primary focus of the submission and the FDA's review is on demonstrating that the new devices do not raise new issues of safety or effectiveness compared to the predicate. The document thoroughly compares the technical characteristics and functions of the subject devices to the predicate.

Here's an analysis of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a separate, quantitative set of thresholds for clinical performance that the device must meet in a specific study. Instead, the "acceptance criteria" appear to be implicit in the compliance with recognized standards and the declared measuring accuracy specification. The study performed is a non-clinical bench testing comparison to the predicate device and compliance with relevant safety and performance standards.

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

The document explicitly states that "bench testing" was conducted. However, it does not provide any details on the sample size used for this testing or the specific data provenance (e.g., country of origin, retrospective/prospective). The testing mentioned is primarily related to compliance with various electrical, EMC, and environmental standards, as well as biocompatibility. For measuring accuracy, the statement merely re-iterates the specification as being the same as the predicate, suggesting that this specification was verified during the "bench testing" rather than proven with a new clinical study.

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

The document does not mention any human experts establishing ground truth for the "test set." The evaluation appears to be based on engineering and laboratory testing for compliance with technical standards and comparison to the predicate device's specifications. This is a blood pressure monitor, not an AI/imaging diagnostic device that would typically require expert ground truth labeling.

4. Adjudication Method for the Test Set

Since no human experts were involved in establishing ground truth for a test set in the traditional sense (e.g., for diagnostic accuracy), there was no adjudication method 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 MRMC comparative effectiveness study was done or is applicable to this device. This is a standalone medical device (blood pressure monitor), not an AI-based diagnostic tool intended to assist human readers or clinicians.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document outlines an assessment of non-clinical testing which included electrical safety, EMC, biocompatibility, and software verification/validation. The device itself is an "automatic blood pressure monitor," meaning its core function is to autonomously measure blood pressure. Therefore, the "bench testing" and compliance with standards like ISO 80601-2-30 (Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers) serve as the standalone performance evaluation for the device's accuracy and safety, without human intervention in the measurement process itself. The document states: "The performance tests demonstrate that the wrist automatic blood pressure monitor performs comparably to the predicate device that is currently marketed for the same intended use." This indicates a standalone performance assessment against established benchmarks (the predicate and relevant standards).

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the primary function of blood pressure measurement accuracy, the ground truth is implicitly defined by the measurement standards provided in ISO 80601-2-30, which typically refers to reference measurements from a calibrated clinical-grade sphygmomanometer (e.g., mercury sphygmomanometer). For other aspects, the ground truth for compliance is the relevant international and national standards (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety and EMC).

8. The Sample Size for the Training Set

Not applicable/Not mentioned. This device is a hardware-based blood pressure monitor using an "oscillometric method with Fuzzy Algorithm." While a "Fuzzy Algorithm" implies some form of computational processing, the document does not indicate that it is a machine learning or AI algorithm that requires a "training set" in the modern sense of deep learning or complex predictive modeling. The algorithm is a fixed part of the device's operation.

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

Not applicable/Not mentioned for the same reasons as #8. If the "Fuzzy Algorithm" involved a "training" or calibration phase during its development, the details are not provided in this regulatory document.

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