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This Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate with arm circumference ranging from 22cm to 32cm (about 8¾˜-12½´´), 22cm to 42cm (about 8% -16½"), 22cm to 45cm (about 8¾ -17¾ ") or 40cm to 52cm (about 15¾ -20½ "). It is intended for adult indoor use only.

Blood Pressure Monitor TMB-2287-B is designed to measure systolic pressure, diastolic pressure and pulse rate of adult by a non-invasive technique, with an inflatable cuff wrapped around the upper arm. 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 cuff. For the outer housing of the main unit, it's made of HIPS material. As for accompanying cuffs, five types of cuffs have been clinically validated to be matched with the device, suitable for population aged at or over three and with arm circumference from 22cm~52cm. The cuff is consisted of fabric and an inflatable bladder inside. For critical electronic components, there is medical switch power supply, 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.

With the use of software (including APP) and Bluetooth communication module, the wireless software function and hardware function are solely intended to transfer, store, convert formats, or display medical device data and results (blood pressure and pulse rate readings), without controlling or altering the functions or parameters of any connected medical devices, which is not be intended for active patient monitoring, therefore, based on the FDA guidance titled "Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices" (issued on September 28, 2022.), this software function is belong to Non-device-MDDS, and the hardware function is belong to Device-MDDS, they are not subject to FDA laws and regulations applicable to devices.

The provided text details the performance data for the Guangdong Transtek Medical Electronics Co., Ltd. Blood Pressure Monitor (TMB-2287-B), demonstrating its substantial equivalence to a predicate device. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

• Systolic BP: -0.77 ± 2.09 mmHg
• Diastolic BP: -0.08 ± 1.69 mmHg
  Study 2 (91 subjects): Mean differences between reference and device readings:
• Systolic BP: 0.2 ± 2.96 mmHg
• Diastolic BP: 0.76 ± 3.42 mmHg |
  | Blood Pressure Measurement Accuracy (ISO 81060-2:2018/Amd.1:2020, Criterion 2) | Study 1 (87 subjects): Mean differences between reference and device readings:
• Systolic BP: -0.77 ± 1.58 mmHg
• Diastolic BP: -0.08 ± 1.17 mmHg
  Study 2 (91 subjects): Mean differences between reference and device readings:
• Systolic BP: 0.2 ± 2.46 mmHg
• Diastolic BP: 0.76 ± 2.83 mmHg |
  | Biocompatibility (ISO 10993-1/5/10/23) | All patient contact parts meet the requirements. Testing included: Cytotoxicity, Sensitization, Irritation. |
  | Electrical Safety (IEC 60601-1, IEC 60601-1-11) | Compliance with IEC 60601-1 (General requirements for basic safety and essential performance) and IEC 60601-1-11 (Requirements for medical electrical equipment and systems used in the home healthcare environment). |
  | Electromagnetic Compatibility (EMC) (IEC 60601-1-2) | Compliance with IEC 60601-1-2. |
  | Automated Non-Invasive Sphygmomanometers (IEC 80601-2-30) | Compliance with this standard. |
  | Wireless (47 CFR Part 15, Subpart C & FDA Guidance "Radio Frequency Wireless Technology") | Compliance with 47 CFR Part 15, Subpart C, and the FDA Guidance for Radio Frequency Wireless Technology in Medical Devices. (Note: The wireless software and hardware functions are classified as Non-device-MDDS and Device-MDDS, respectively, due to their limited role in data transfer/storage without controlling device functions, and are not subject to FDA device regulations). |
  | Blood Pressure Measurement Range | 0 mmHg ~ 299 mmHg, within ±3 mmHg (0.4 kPa) for 5°C - 40°C. |
  | Pulse Rate Measurement Range | 40-199 beats/minute, ±5%. |

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

• Sample Size:
  • Study 1: 87 qualified subjects (258 datasets collected).
  • Study 2: 91 qualified subjects (272 datasets collected).
• Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. However, clinical validation reports typically involve prospective data collection for accuracy studies. The submitter is based in Zhongshan, Guangdong, China.

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

The document states that the clinical data was collected according to ISO 81060-2:2018/Amd.1:2020 which involves "reference BPs." While this standard requires comparisons to a reference measurement (typically auscultatory measurements by trained observers), the exact number and specific qualifications of the experts (e.g., medical professionals making the reference measurements) are not explicitly stated in the provided text.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for establishing the ground truth beyond stating that "reference BPs" were used in accordance with ISO 81060-2. This standard typically involves multiple observers taking reference measurements, and criteria are usually in place for discrepancies, but the specific method (e.g., 2+1, 3+1) is not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The studies described are clinical validation studies comparing the device's readings against a reference method, not studies comparing human reader performance with and without AI assistance.

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

Yes, the device itself is an automated non-invasive sphygmomanometer. The clinical validation, comparing the device's measurements to reference blood pressure readings, represents a standalone performance evaluation of the algorithm and hardware without human interpretation or intervention in the measurement process itself, beyond initial setup.

7. The Type of Ground Truth Used

The ground truth for the blood pressure measurement accuracy studies was established using reference blood pressure measurements, as required by the ISO 81060-2 standard. This typically involves auscultatory measurements performed by trained medical professionals.

8. The Sample Size for the Training Set

The document does not provide information regarding a training set or its sample size. This is a medical device clearance, not a submission for an AI/ML algorithm that typically requires separate training data. The device's underlying oscillometric algorithm would have been developed and refined, but the specific "training set" for that development is not part of this regulatory submission details.

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

As no "training set" is disclosed in the context of this regulatory document, there is no information on how its ground truth might have been established.

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