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The Blood Pressure Monitor is a digital monitor in measuring blood pressure and pulse rate with a wrist circumference ranging from 13.5cm to 21.5cm (about 51/3"-81/2"). It is intended for adult indoor use only.

Blood Pressure Monitor TMB-2285-BT is designed to measure systolic pressure, diastolic pressure and pulse rate of adult population by a non-invasive technique, with an inflatable cuff wrapped around the wrist. The method to define systolic and diastolic pressure is similar to auscultatory method, though it uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alternations of cuff pressure into electrical signals. Based on analysis of these signals, the systolic and diastolic blood pressure is defined, and the pulse rate is calculated. This is an extensively used technique applied in blood pressure monitors, also known as "oscillometric method". The main components of the Blood Pressure Monitor include main unit and wrist cuff. For the outer housing of the main unit, it's made of ABS material. The cuff model is WC1321-04, suitable for adults with wrist circumference of 13.5cm to 21.5cm. The cuff is consisted of fabric and an inflatable bladder inside. For critical electronic components, there is PCB, thermistor, pressure pump, motor, release valve and pressure sensor. The device also enjoys a function of detecting irregular pulse rate. When measurements were performed, the monitor will record all pulse intervals and calculate the average. If two or more pulse intervals were recorded, and the difference between each interval and the average is larger than ±25% of the average; or if four or more pulse intervals were recorded, and the difference between each interval and the average is larger than ±15% of the average, the irregular pulse symbol will be displayed along with measurement results. An embedded Bluetooth wireless connection module in the device allows it to connect with matching receiving ends. When a measurement is done, the results will be displayed on LCD, and the measured data will be transferred to the APP via Bluetooth.

Acceptance Criteria and Device Performance for Transtek Blood Pressure Monitor (K233130)

Based on the provided FDA 510(k) summary for the Transtek Blood Pressure Monitor (K233130), the device's acceptance criteria and the study proving it meets these criteria are outlined below.

Please note: The document primarily focuses on demonstrating substantial equivalence to a predicate device through adherence to recognized standards and clinical validation. Specific "acceptance criteria" in the sense of predefined thresholds for performance metrics derived from an AI/ML model are not explicitly detailed as this is a traditional medical device (blood pressure monitor) clearance, not an AI/ML software as a medical device (SaMD). The acceptance criteria are therefore inferred from compliance with the relevant industry standards, particularly ISO 81060-2 for clinical accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 258 datasets collected from 86 subjects.
• Data Provenance: Not explicitly stated, but given the company's location (Guangdong, China), it is highly probable the study was conducted retrospectively or prospectively within China. The document does not specify if the data was retrospective or prospective, but clinical validation studies are typically prospective.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth. For blood pressure monitors, the "ground truth" (reference BPs) in clinical validation is typically established by trained technicians or clinicians using validated reference methods (e.g., auscultatory method with mercury manometer) according to the ISO 81060-2 standard.

4. Adjudication Method for the Test Set

The document does not mention an explicit adjudication method for the test set. Given the nature of blood pressure measurement validation according to ISO 81060-2, the comparison is typically against a reference measurement performed by trained personnel using a standardized method, not a consensus of multiple independent human readers.

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

An MRMC comparative effectiveness study was not performed. This type of study is more common for diagnostic imaging AI algorithms where the AI assists human readers. For a standalone blood pressure monitor, the primary evaluation is its direct accuracy against a reference standard.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was done. The clinical data presented (mean differences and standard deviations) directly assesses the device's accuracy in measuring blood pressure and pulse rate without human-in-the-loop assistance for the measurement process itself, beyond the initial setup for obtaining the reference readings. The device is intended for over-the-counter use, implying standalone operation.

7. Type of Ground Truth Used

The ground truth used was reference blood pressure measurements obtained from subjects, likely using a validated auscultatory method as per the ISO 81060-2 standard (often involving two observers for accuracy). The document refers to "reference BPs."

8. Sample Size for the Training Set

The document does not provide information regarding a specific "training set" or its size. This device is a traditional non-invasive blood pressure monitor, not an AI/ML-based device that typically undergoes a separate model training phase. The "study" described is a clinical validation study for accuracy, which serves as the test set for the device's performance.

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

As there is no mention of a training set in the context of an AI/ML algorithm for this traditional blood pressure monitor, this question is not applicable. The device's underlying "algorithm" (oscillometric method) is a well-established engineering principle, not a data-trained AI model requiring a separate ground-truth-established training set. The clinical validation proves the accuracy of this established method as implemented in the device.

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XM-01 Automatic Electronic Blood Pressure Monitor is a home use digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 13.5 cm to 19.5 cm.

The device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

XM-01 Automatic Electronic Blood Pressure Monitor is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. This is a home use device.

Measurement method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury nmometer. With a sensor, the microprocessor converts tiny alterations in cuff pressure to electrical signals, and analyze those signals to define the systolic and diastolic blood pressure and calculating heartbeat rate, which is a well-known technique in the market called the "Oscillometric method". The sensor also detect pulse rate at the same time.

XM-01 Automatic Electronic Blood Pressure Monitor achieves its function by integrating a single-mounted device hardware to a mobile application software, which is downloadable to a mobile device such as Apple or Android phone. As the hardware itself does not include a LCD or other display components, it is necessary for the device hardware to communicate with mobile devices containing the supporting software to constitute a complete blood pressure measurement system. This communication is realized through an embedded Bluetooth module.

The single-mounted device hardware is composed of the main unit and cuff unit. The cuff unit, which is applicable to wrist circumference approximately between 13.5 and 19.5 cm, includes the inflatable bladder and nylon/cotton/PVC shell. The main unit consists of the microprocessor, pressure sensor, pump, the electromagnetic deflation control valve and the battery. The subject device is powered by a 3.7V/400mAH lithium battery. The battery can be re-charged by either a DC5V 500mA charger or a USB cable.

The mobile application, downloadable to mobile devices such as Apple IOS or Android phone, receives measurement results from the single mounted device. The mobile App allows the test results to be displayed on the mobile devices (such as cell phone) for user review. It also transmits the data to the database in remote server for storage and future retrieval.

The provided document describes the XM-01 Electronic Automatic Blood Pressure Monitor and its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device conforms to ISO 81060-2: Non-invasive sphygmomanometers -- Part 2: Clinical investigation of automated measurement type. This standard outlines the acceptance criteria for the clinical accuracy of automated non-invasive sphygmomanometers. While the document mentions adherence to the standard, it does not explicitly report the specific acceptance criteria outlined in ISO 81060-2 or the device's numerical performance against those criteria (e.g., mean difference and standard deviation between device and reference measurements for systolic and diastolic pressure).

Therefore, a table of specific numerical acceptance criteria and the device's reported performance against them cannot be fully constructed from the provided text. The document only generally states that "XM-01 Automatic Electronic Blood Pressure Monitor conforms to the following standards:" and lists ISO 81060-2.

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

The document mentions adherence to ISO 81060-2. This standard typically requires a minimum number of subjects for clinical validation studies. However, the specific sample size used for the actual clinical investigation mentioned in the submission is not explicitly stated in the provided text.

The data provenance (e.g., country of origin, retrospective or prospective) for the clinical investigation is not explicitly stated. The manufacturer is based in China, which might suggest the study was conducted there, but this is not confirmed.

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

The document states that the device's measurement method is similar to the auscultatory method. In clinical validation studies for blood pressure monitors, the "ground truth" is typically established by trained observers (experts) using a mercury sphygmomanometer or highly accurate reference method.

However, the number of experts used to establish the ground truth for the test set and their specific qualifications (e.g., "radiologist with 10 years of experience") are not explicitly stated in the provided text. ISO 81060-2 generally requires at least two trained observers.

4. Adjudication method for the test set

In the context of blood pressure monitor validation studies using the auscultatory method, an adjudication method usually refers to how discrepancies between multiple observers' readings are resolved. For instance, if two observers' readings differ by more than a certain threshold, a third observer might be involved.

The adjudication method used for the test set is not explicitly stated in the provided text. Although adherence to ISO 81060-2 is mentioned, the specific details of the clinical investigation are not given.

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

The XM-01 Automatic Electronic Blood Pressure Monitor is a standalone device for measuring blood pressure and pulse rate. It integrates hardware with a mobile application to display results. There is no indication in the document that an AI component is involved in interpreting the blood pressure measurements, nor is there any mention of human readers or a multi-reader multi-case (MRMC) comparative effectiveness study. The device's function is to measure and display, not to provide diagnostic interpretations that would involve human readers.

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

Yes, a standalone performance evaluation was done. The entire premise of this 510(k) submission is for the XM-01 Automatic Electronic Blood Pressure Monitor as a standalone device. The relevant standard for this standalone performance is ISO 81060-2, which specifies the clinical investigation of automated measurement type sphygmomanometers. This standard dictates that the automated device's measurements are compared against a reference standard (typically auscultation by trained observers), thus evaluating the device's accuracy in a standalone manner.

The document states: "XM-01 Automatic Electronic Blood Pressure Monitor conforms to the following standards: ... ISO 81060-2. Non-invasive sphygmomanometers -- Part 2: Clinical investigation of automated measurement type." This indicates that a standalone performance study, compliant with ISO 81060-2, was conducted.

7. The type of ground truth used

For blood pressure monitors evaluated under ISO 81060-2, the standard ground truth for blood pressure measurements is typically expert auscultation (manual measurement by trained observers using a mercury sphygmomanometer or equivalent reference device). This is implied by the adherence to ISO 81060-2.

8. The sample size for the training set

The document does not explicitly mention a "training set" in the context of machine learning or AI. Rather, the device uses an "Oscillometric method" where a "microprocessor converts tiny alterations in cuff pressure to electrical signals, and analyze those signals to define the systolic and diastolic blood pressure and calculating heartbeat rate." This is a well-established technique that typically uses fixed algorithms rather than a dynamically trained AI model. Therefore, a separate "training set" for an AI algorithm is not applicable or mentioned for this device.

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

As there is no explicit mention of a "training set" for an AI algorithm, or any machine learning training process, the method for establishing its ground truth is not applicable based on the provided text. The device relies on a "well-known technique in the market called the 'Oscillometric method'," which operates on established physiological principles and algorithms, likely without a separate learning phase requiring a "training set" with ground truth in the AI sense.

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