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TeleRPM Gen2 Blood Glucose Monitoring System is comprised of the TeleRPM Gen2 Blood Glucose Meter and the TeleRPM Blood Glucose Test Strips. TeleRPM Gen2 Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.

TeleRPM Gen2 Blood Glucose Monitoring System consists of TeleRPM Gen2 Blood Glucose Meter and the TeleRPM Blood Glucose Test Strips.

TeleRPM Control Solution, TeleRPM Lancing Device, TeleRPM Lancets are required for use but not included in meter box or test strips box and should be purchased separately. The TeleRPM Control Solution is for use with the above meter and test strip as a quality control check to verify that the meter and test strip are working together properly, and that the test is performing correctly. TeleRPM Lancing Device and TeleRPM Lancets are used for puncturing fingertip and then user can perform qlucose test with blood sample.

TeleRPM Gen2 Blood Glucose Monitoring System is designed to quantitatively measure the glucose concentration in fresh capillary whole blood from the fingertip. The glucose measurement is achieved by using the amperometric detection method. The test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip. The blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with glucose oxidase and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration value is reported in plasma equivalents and is displayed on meter screen.

The provided text primarily focuses on the substantial equivalence determination for the TeleRPM Gen2 Blood Glucose Monitoring System to a predicate device. While it mentions the general types of studies conducted (robustness, precision, linearity, user evaluation, interference, stability, flex studies, software, cybersecurity controls, and a clinical usability study), it does not provide detailed acceptance criteria or numerical performance data as requested for several of your points.

Based on the information available:

1. A table of acceptance criteria and the reported device performance:

The document broadly states that the device "met the FDA SMBG OTC Guidance and industry standards" and that "these devices performed as intended and met associated guidance documents and industry standards." Specific numerical acceptance criteria and reported device performance for each study (precision, linearity, interference, etc.) are not detailed in the provided summary. For the user evaluation (clinical study), it states "the clinical performance met the FDA SMBG OTC Guidance."

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

• User Evaluation (Clinical Study): The document mentions "All participants" were able to understand the labeling, use the system, and interpret results. However, the exact sample size for the clinical usability evaluation is not specified.
• Provenance: Not explicitly stated, but the company is located in Zhongshan, Guangdong, China. The testing location isn't specified, but it's reasonable to infer the studies were conducted by or on behalf of the manufacturer, likely in China or a region where they operate.

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

• This information is not provided in the summary. For a blood glucose monitoring system, the "ground truth" for glucose levels would typically be established by a laboratory reference method, not by experts adjudicating results.
• For the usability evaluation, the "ground truth" is about successful interaction with the device, which is assessed through user performance and observation, not expert consensus on a measurement.

4. Adjudication method for the test set:

• This information is not provided. For analytical performance, laboratory reference methods are used, not typically expert adjudication. For usability, the success of user interaction is observed and recorded.

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:

• This is not applicable to this device. A "Blood Glucose Monitoring System" measures blood glucose; it is not an AI-assisted diagnostic imaging device that involves "human readers." Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.

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

• The device performs a direct measurement of blood glucose. Its core function is a "standalone" algorithmic interpretation of the electrochemical reaction to display a glucose reading. This is its fundamental operation. There isn't a separate "human-in-the-loop" component in the direct glucose measurement process that would necessitate a distinction here.

7. The type of ground truth used:

• For analytical performance (precision, linearity, interference), the ground truth for blood glucose concentration would be established using a laboratory reference method (e.g., YSI analyzer). This is standard for blood glucose meter validation.
• For the usability evaluation, the "ground truth" assesses whether users can successfully operate the device and interpret results, which is based on direct observation and participant feedback.

8. The sample size for the training set:

• This device is a physical blood glucose meter and test strips relying on electrochemical principles, not a machine learning or AI model that requires a "training set" in the computational sense. Therefore, the concept of a training set sample size is not applicable here.

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

• As above, the concept of a training set is not applicable.

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This Blood Pressure Monitor is intended for use in measuring blood pressure and pulse rate in patients with arm circumferences from 16 to 36 cm (6.3 to 14.1 inch), 22 to 42cm (8.6 to 16.5 inch), 22 to 45cm (8.6 to 17.7 inch) or 40 to 52cm (15.7 to 20.5 inch).

Cuff model AC1636-01, arm circumference range is 16-36cm (6.3 to 14.1 inch), which is intended for children older than 3 years old or adults without conditions of diabetes, pregnancy, or preeclampsia.

Cuff model AC2245-021, arm circumference range is 2245cm (8.6 to 17.7 inch), which is intended for adult population or those who with conditions of diabetes, pregnancy, or pre-eclampsia. Cuff model AC2242-41 and cuff model AC4052-04, arm circumference range are 22-42cm (8.6 to 16.5 inch) and 4052cm (15.7 to 20.5 inch) respectively, which are intended for adults without conditions of diabetes, pregnancy, or pre-eclampsia.

It is intended indoor use only.

The Blood Pressure Monitor is designed to measure the systolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our 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 manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".

The main components of the Blood Pressure Monitor is the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 160mm and 520 mm, includes the inflatable bladder and polyester shell. The device consists of the microprocessor, the pressure sensor, the operation keys, the electromagnetic deflation control valve and the LCD.

The devices embed a Cellular Wireless network connections module that allows it to connect to receiving end. Once measurement is over, the LCD of device displays results, and the device will start to send out data such as systolic, diastolic, pulse rate, date and time by Wireless method and protocol.

Here is a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

Note: The exact numerical acceptance criteria for ANSI/AAMI/ISO 81060-2:2019 are not explicitly stated in the provided text, but the text confirms that the device fulfilled these criteria. Typically, Criterion 1 relates to the mean difference and standard deviation of differences, and Criterion 2 relates to the standard deviation of differences for individual subjects.

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

• Sample Size: 172 general adult subjects in total across two clinical studies.
  • First clinical study (AC2242-41): 86 subjects, with 258 datasets collected.
  • Second clinical study (AC4052-04): 86 subjects, with 258 datasets collected.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective clinical validation studies for the accuracy of the blood pressure monitor with the new cuff sizes.

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

The document does not explicitly state the number of experts or their qualifications for establishing the ground truth. However, blood pressure monitor clinical validation (like ISO 81060-2) typically involves multiple trained observers (e.g., two or three) to take reference blood pressure measurements using a validated sphygmomanometer (often mercury or validated auscultatory method) to establish the ground truth. These observers are usually trained clinical professionals.

4. Adjudication method for the test set

The document does not explicitly state the adjudication method. In ISO 81060-2 studies, ground truth is typically established by multiple observers (as mentioned above) taking simultaneous or nearly simultaneous measurements, and a consensus or average of these readings serves as the reference and deviations between observers are often within predefined limits.

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, an MRMC comparative effectiveness study involving human readers and AI assistance was not mentioned. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.

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

Yes, the clinical studies described evaluate the performance of the device itself in measuring blood pressure and pulse rate, without direct human intervention in the measurement process (beyond applying the cuff and initiating the measurement). The results (-0.02 ± 2.12 mmHg, etc.) represent the standalone performance of the algorithm.

7. The type of ground truth used

The ground truth was established by reference blood pressure measurements. In the context of ANSI/AAMI/ISO 81060-2, this typically refers to auscultatory measurements performed by human observers using a standardized reference sphygmomanometer.

8. The sample size for the training set

The document does not provide information regarding a separate training set. The clinical studies mentioned are validation studies (test sets) to prove the accuracy of the device against established standards. For an oscillometric blood pressure monitor, the algorithm itself is developed based on physiological models and extensive internal testing, not typically a separate "training set" in the machine learning sense that would be reported in this manner for a 510(k) submission.

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

As no training set is explicitly mentioned in the context of this 510(k) submission for an oscillometric BPM, how its ground truth was established is not provided. The "ground truth" discussed for these types of devices relates to the clinical accuracy validation against reference measurements, as detailed in point 7.

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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´) or 22cm to 42cm (about 834"-161/2"). It is intended for adult indoor use only.

Blood Pressure Monitor BBZ32-AA01 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, two types of cuffs have been clinically validated to be matched with the device, suitable for adults with arm circumference from 22cm~42cm. 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.

The Guangdong Transtek Medical Electronics Co., Ltd. Blood Pressure Monitor (BBZ32-AA01) underwent a clinical study to demonstrate its performance against established acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against the criteria outlined in ISO 81060-2:2018/Amd.1:2020 for non-invasive sphygmomanometers. The document does not explicitly present these as a table of "acceptance criteria," but rather as two validation criteria (Criterion 1 and Criterion 2) that the device must fulfill. The reported device performance is indicated as having fulfilled both these criteria.

Note: The exact numerical thresholds for acceptance for Criterion 1 and 2 from ISO 81060-2:2018/Amd.1:2020 are not explicitly stated in this document but are implied to have been met by the reported performance.

2. Sample Size and Data Provenance

• Test Set Sample Size: 86 qualified subjects.
• Data Provenance: The document does not explicitly state the country of origin but mentions the manufacturer is "Guangdong Transtek Medical Electronics Co., Ltd." in China. It is a prospective clinical study, as indicated by "The clinical study was performed on the device..."

3. Number of Experts and Qualifications

The document does not provide information on the number of experts used to establish the ground truth or their specific qualifications (e.g., radiologist with 10 years of experience). It only refers to "reference BPs" for comparison.

4. Adjudication Method

The document does not specify an adjudication method like 2+1 or 3+1 for establishing ground truth. The "reference BPs" suggest a gold standard measurement was used, but the process for ensuring its accuracy is not detailed.

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

No multi-reader multi-case (MRMC) comparative effectiveness study was done to assess human readers' improvement with or without AI assistance. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool.

6. Standalone Performance

Yes, a standalone performance study was done. The clinical study described evaluates the algorithmic (device) performance in measuring blood pressure and pulse rate without human-in-the-loop assistance for interpretation or adjudication of results.

7. Type of Ground Truth Used

The ground truth used was "reference BPs." This implies that the device readings were compared against highly accurate and established blood pressure measurements, likely obtained by a validated manual method (e.g., auscultatory method by trained professionals) or another highly accurate reference device.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This suggests the blood pressure monitor is likely based on an established oscillometric algorithm rather than a machine learning model that requires a dedicated training set.

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

Since no training set is mentioned (implying a rule-based or conventional algorithm rather than a machine learning model), the method for establishing ground truth for a training set is not applicable or detailed in this document.

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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") or 22cm to 42cm (about 8¾"-16½"). It is intended for adult indoor use only.

Blood Pressure Monitor TMB-2296-BT 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 HI-121H material. The two types of cuffs have been clinically validated to be matched with the device, suitable for adults with arm circumference from 22cm~42cm. 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.

The provided text describes the 510(k) submission for a Blood Pressure Monitor (Model TMB-2296-BT) and its substantial equivalence to a predicate device. The information focuses on regulatory compliance, non-clinical, and clinical performance data, primarily related to the accuracy of blood pressure and pulse rate measurements.

1. Table of Acceptance Criteria and Reported Device Performance

The main acceptance criteria for blood pressure monitors is typically defined by standards like ISO 81060-2. The document specifically states that the device was tested according to ISO 81060-2:2018/Amd.1:2020 and "fulfilled both validation criteria 1 and 2".

The ISO 81060-2 standard defines the following criteria:

• Criterion 1: The mean difference between the device readings and reference blood pressure (BP) measurements should be within ±5 mmHg, with a standard deviation of 8 mmHg or less.
• Criterion 2: For each subject, the difference between the device reading and the reference BP should be within 5 mmHg for at least 65% of the subjects, within 10 mmHg for at least 85% of the subjects, and within 15 mmHg for at least 95% of the subjects.

Here's a table summarizing the reported device performance against these generally accepted criteria (as defined by ISO 81060-2):

Note: The document states "fulfilled both validation criteria 1 and 2 of the ISO 81060-2:2018/Amd.1:2020," indicating that the device met the required statistical thresholds for accuracy. The provided mean differences and standard deviations are the direct results from the studies, demonstrating compliance with Criterion 1. While specific percentages for Criterion 2 are not listed, the statement of fulfillment confirms compliance.

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

• Sample Size:
  • Study 1: 88 qualified subjects. From these, 262 datasets were collected.
  • Study 2: 87 qualified subjects. From these, 259 datasets were collected.
• Data Provenance: Not explicitly stated regarding the country of origin. The studies are described as "clinical studies," implying a prospective design where the data was collected specifically for the validation.

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

The document does not provide details on the number or qualifications of experts for establishing ground truth. For blood pressure monitor validation according to ISO 81060-2, ground truth is established by multiple independent reference measurements, typically performed by trained observers using a mercury sphygmomanometer or a validated auscultatory device. The standard requires specific training and quality control for these observers, but their specific "qualifications" (e.g., as radiologists) are not applicable or mentioned. The primary focus is on the accuracy of the reference measurements, not expert interpretation.

4. Adjudication Method for the Test Set

The document does not explicitly describe an "adjudication method" in the context of expert review, as ISO 81060-2 validation primarily relies on direct comparison of the device's readings against a set of rigorously collected reference measurements. Multiple readings are taken per subject, and statistical analyses (mean difference, standard deviation) are applied directly to these comparative measurements, rather than requiring expert adjudication of "results" in the typical sense of image interpretation. The standard outlines specific procedures for simultaneous measurements by multiple observers to minimize bias in reference readings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI/CAD systems that assist human readers in interpreting medical images (e.g., detecting lesions). For a blood pressure monitor, the study evaluates the device's direct measurement accuracy against a gold standard, not its comparative effectiveness with or without human assistance in interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the clinical validation described in the document is a standalone performance study. The device, a blood pressure monitor, measures blood pressure and pulse rate directly and automatically. The reported performance metrics (mean difference, standard deviation) are of the device itself, without human intervention in the measurement process (beyond proper cuff placement and initiation of the measurement).

7. The Type of Ground Truth Used

The ground truth used was reference blood pressure measurements obtained through a validated clinical method (implied to be auscultatory or an equivalent gold standard method, as per ISO 81060-2) against which the automated device's readings were compared. This is a form of "outcomes data" in the sense of comparing the device's output to a clinically accepted reference measurement for the physiological parameter it is designed to measure.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" or its sample size. For a blood pressure monitor that uses an oscillometric method, the device's algorithm for determining BP values from oscillation waveforms is pre-programmed/calibrated. It's not typically a machine learning model that undergoes a 'training phase' on a distinct dataset in the way an AI image analysis algorithm would. The clinical studies described are for validation (test set performance) of the final device, not for training internal algorithms.

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

As noted in point 8, there is no mention of a traditional "training set" in the context of an AI/ML algorithm that would require a separate ground truth establishment for training. The ground truth for the device's internal calibration/oscillometric algorithm (if applicable) would have been established during its development and calibration phases, likely using established physiological models and comparisons to known accurate pressure measurements, but these details are not part of this 510(k) submission. The clinical studies establish the accuracy of the final, already "trained" or calibrated, device.

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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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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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This Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate with arm circumference ranging from 16cm to 36cm (about 6½"-14½"), 22cm to 32cm (about 8¾"-12½"), 22cm to 42cm (about 8¾"-16½") or 22cm to 45cm (about 8¾"-17¾").

The cuff with arm circumference range of 1636cm is intended for children older than 6 years old or adults. The cuffs with arm circumference range of 2232cm or 2242cm or 2245cm, which are intended for adult population.

It is intended indoor use only.

Blood Pressure Monitor TMB-2266 is designed to measure systolic pressure, diastolic pressure and pulse rate of population at or over 3 years old 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 16cm~45cm. The cuff is consisted of fabric and an inflatable bladder inside. For critical electronic components, there is medical witch 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.

The provided document describes the K232713 Blood Pressure Monitor, which is a digital monitor for measuring blood pressure and pulse rate. The information below is extracted from an FDA 510(k) summary concerning the device's substantial equivalence to predicate devices.

1. Acceptance Criteria and Reported Device Performance

The device's performance acceptance criteria are primarily derived from the ISO 81060-2 standard for non-invasive sphygmomanometers. The reported performance indicates that the device met these criteria.

2. Sample Size and Data Provenance for Test Set (Clinical Studies)

• Sample Sizes:
  • Study 1: 87 qualified subjects
  • Study 2: 86 qualified subjects
  • Study 3: 86 qualified subjects
  • Study 4: 102 qualified subjects (65 adults, 37 children aged 3-12)
• Data Provenance: The document does not explicitly state the country of origin. The studies are described as "clinical studies," implying they were prospective.

3. Number of Experts and Qualifications for Ground Truth Establishment

The document does not provide details on the number of experts or their specific qualifications for establishing the ground truth measurements during the clinical studies. However, for blood pressure monitor validation studies conforming to ISO 81060-2, trained observers are typically used to obtain reference blood pressure measurements using a validated auscultatory method.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). For ISO 81060-2 studies, it is common to have multiple observers simultaneously or sequentially measure blood pressure using a reference method, and their measurements (or an average) are used as the ground truth.

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

No information is provided about a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human interpretation.

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

Yes, the clinical studies describe the standalone performance of the blood pressure monitor, which operates autonomously to measure blood pressure and pulse rate (algorithm only). The studies evaluated the device's accuracy against a recognized reference standard (implied by ISO 81060-2).

7. Type of Ground Truth Used

The ground truth for the clinical studies was established through comparative measurements against a reference method, which for ISO 81060-2 studies typically involves simultaneous or sequential auscultatory measurements performed by trained observers.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. This is typical for medical device submissions that focus on the clinical validation of the final product and do not disclose details about internal development or machine learning training data.

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

The document does not provide information on how the ground truth for the training set was established, as details about the device's internal development and training are not part of this 510(k) summary.

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This Blood Pressure Monitor is intended for use in measuring blood pressure and pulse rate in patients with arm circumferences from 16 to 36 cm (6.3 to 14.1 inch) or 22 to 45cm (8.6 to 17.7 inch).

Cuff model AC1636-01, arm circumference range is 16-36cm (6.3 to 14.1 inch), which is intended for children older than 3 years old or adults without conditions of diabetes, pregnancy, or pre-eclampsia.

Cuff model AC2245-021, arm circumference range is 22-45cm (8.6 to 17.7 inch), which is intended for adult population or those who with conditions of diabetes, pregnancy, or pre-eclampsia.

It is intended indoor use only.

The Blood Pressure Monitor is designed to measure the systolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our 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 manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".

The main components of the Blood Pressure Monitor is the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 160mm and 450 mm, includes the inflatable bladder and polyester shell. The device consists of the microprocessor, the pressure sensor, the operation keys, the electromagnetic deflation control valve and the LCD.

The devices embed a Cellular Wireless network connections module that allows it to receiving end. Once measurement is over, the LCD of device displays results, and the device will start to send out data such as systolic, diastolic, pulse rate, date and time by Wireless method and protocol.

The provided text describes the acceptance criteria and study proving the device meets those criteria for a Blood Pressure Monitor.

Here's the breakdown of the information requested:

Acceptance Criteria and Reported Device Performance

The clinical performance acceptance criteria for this blood pressure monitor are based on the ISO 81060-2:2018/Amd.1:2020 standard, specifically Criterion 1 and Criterion 2. These criteria define the acceptable mean difference and standard deviation between the device readings and reference blood pressure measurements.

Table of Acceptance Criteria and Reported Device Performance

Detailed Reported Performance from Clinical Studies:

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • Total Clinical Study Subjects: 138 general adult subjects (aged 3-12 years for children and general adults), 90 diabetic patients, and 91 pregnant women.
   • First Clinical Study (AC1636-01): 261 datasets collected from 88 subjects (36 children and 52 adults)
   • Second Clinical Study (AC2245-021): 258 datasets collected from 86 subjects (general adults)
   • Third Clinical Study (diabetes): 268 valid BP dataset pairs collected from 90 diabetic patients
   • Fourth Clinical Study (pregnant): 270 valid datasets collected from 91 pregnant subjects
   • Data Provenance: Not explicitly stated, but typically clinical studies for regulatory submissions are prospective. The location (country of origin) is not mentioned in the provided text, but the manufacturer is based in China.

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

   • The document implies that the ground truth (reference blood pressure measurements) was established by standard clinical methods using a reference device or trained observers as required by ISO 81060-2:2018/Amd.1:2020. However, the exact number and qualifications of experts (e.g., radiologists, cardiologists) that would typically establish such ground truth in the context of blood pressure measurement (e.g., supervising the auscultatory method or reading a reference device) are not specified in the provided text. The standard usually requires trained observers for the reference measurements.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • The document does not explicitly state an adjudication method. For blood pressure measurement validation studies, this typically involves simultaneously taking measurements with the device under test and a calibrated reference device (or multiple trained observers using the auscultatory method). The ISO 81060-2 standard outlines the methodology for obtaining reference measurements, often involving multiple mercury sphygmomanometers and trained observers. No further details on adjudication are provided.

4. 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. This is a study to validate a blood pressure monitor, not an AI-assisted diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

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

   • Yes. The tests described are for the standalone performance of the blood pressure monitor, which uses an oscillometric algorithm to measure blood pressure without active human interpretation during the measurement process itself, beyond initiation and cuff placement. The performance data presented are for the device (algorithm) measuring blood pressure against a reference.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth was established by reference blood pressure measurements obtained from clinical studies, presumably following the methodology detailed in ISO 81060-2:2018/Amd.1:2020. This standard typically relies on simultaneously recording blood pressure using a validated reference method (e.g., auscultatory method by trained observers using mercury sphygmomanometers, or other validated reference devices) and comparing it to the device under test.

7. The sample size for the training set:

   • The document describes clinical validation studies (test sets) for the device. It does not provide information on the sample size used for the training set for the device's underlying algorithm development. Blood pressure monitors often use long-established algorithms, but if machine learning was used, the training set details are not provided.

8. How the ground truth for the training set was established:

   • Since details of a specific training set are not provided, information on how its ground truth was established is also not available in the provided text.

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The device is a digital monitor intended for use in measuring blood pressure and pulse rate. The device is intended to be used in a human adult population with an arm circumference of 9 inches (22 cm to 42 cm). The device is intended for indoor use.

The 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 upper arm. Our 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 manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "Oscillometric method".

When using the device, users will be able to monitor their blood pressure and their pulse rate. The device will give metrics about heart health:

• Systolic blood pressure
• Diastolic blood pressure
• Pulse rate

The device should be placed on the left upper arm during all the measurement duration. The measurement lasts between 30 seconds and 3 minutes depending on the selected mode by the user. The measurement can be longer if the user selects the triple measurement mode (three blood pressure measurements in a row to give an average).

Users will get an instant feedback after the measurement thanks to a LED matrix located on the tube part of the device.

WPM05 (BPM Connect)
The device synchronizes with Withings application and Withings server via Bluetooth or Wi-Fi connectivity.

WPM06 (BPM Connect Pro)
The device synchronizes with third-party applications by cellular, Wi-Fi or Bluetooth connectivity. On the mobile application, users have access to their historic and more contents around each metrics.

Here's a breakdown of the acceptance criteria and study information for the Blood Pressure Monitor (K223374), based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily refers to the relevant standards and states that the device meets them. It doesn't present a specific table of numerical acceptance criteria alongside the device's numerical performance for all parameters. However, it does highlight the performance specific to blood pressure and pulse measurement.

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

• Sample Size for Test Set (Clinical Data): 135 qualified healthy adult subjects.
• Data Provenance: The document does not explicitly state the country of origin. Given the manufacturer's location in China, it is highly probable the clinical study was conducted there. The study appears to be prospective as it involves "qualified healthy adult subjects" being tested.

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

The document does not specify the number of experts or their qualifications for establishing the ground truth in the clinical validation study. For ISO 81060-2 adherence, typically a specific protocol involving independent, trained observers (often physicians or technicians certified in blood pressure measurement) taking reference measurements with a validated mercury sphygmomanometer or auscultatory method is followed.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method. In the context of ISO 81060-2 clinical validation, ground truth is established through a standardized reference measurement method (e.g., auscultation by trained observers), and discrepancies are usually handled by comparing the device readings to these established reference readings. It's not a consensus-based adjudication in the same way an imaging study might be.

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

• No, an MRMC comparative effectiveness study was not done. This type of study (MRMC) is typically relevant for interpretative devices (e.g., AI for radiology) where human readers are making diagnoses. This device is a measurement device (blood pressure monitor), and its accuracy is validated against established reference measurement methods, not through human reader interpretation.

6. Standalone Performance

• Yes, a standalone performance study was done. The clinical data section explicitly states: "The device was tested to ISO 81060-2: 2018 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type." This standard specifically evaluates the accuracy of the automated device (algorithm only) against a reference standard.

7. Type of Ground Truth Used

• Clinical Ground Truth (Reference Standard Measurement): The ground truth was established through a standardized clinical reference measurement method, as prescribed by ISO 81060-2. This typically involves simultaneous or near-simultaneous measurements by trained observers using a validated reference sphygmomanometer (e.g., mercury or calibrated oscillometric device for reference) with the test device.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. While the device uses an "Oscillometric method" which is a "well-known technique in the market," the specific neural network or machine learning component that would require a distinct training set is not detailed. The oscillometric method itself relies on empirically derived algorithms and signal processing, often refined with large datasets, but these are usually part of the initial engineering and development, not explicitly detailed as a 'training set' in the 510(k) summary for such a device.

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

Since the document does not mention a distinct "training set" or explicit machine learning model in the context of the submission, it does not provide information on how the ground truth for a training set was established. The oscillometric method generally works by analyzing oscillations in cuff pressure during deflation to determine systolic, diastolic, and mean arterial pressure using proprietary algorithms derived from physiological principles and extensive validation studies over time.

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