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The Transtek Blood Pressure Monitor intended for use in measuring blood pressure and heartbeat rate with a wrist circumference ranging from 13.5cm to 23cm. It is intended for adult, indoor use only.

Transtek Wrist Blood Pressure Monitor, TMB-2072 is designed to measure the systolic and diastolic blood pressure and heartbeat rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. 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 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 heartbeat rate, which is a wellknown technique in the market called the "Oscillometric method". Transtek Wrist Blood Pressure Monitor is single-mounted devices of the main unit and cuff unit. The preformed cuff unit, which is applicable to wrist circumference approximately between 13.5 and 23 cm, includes the inflatable bladder and nylon shell. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump and the electromagnetic deflation control valve. The subject device is powered by 3.7V Built-in rechargeable lithium-ion battery. The device also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular heartbeat when the difference of the time intervals is over 25%. Transtek Wrist Blood Pressure Monitor TMB-2072 embeds a Bluetooth module that allows it to connect to nearby BT receiving end. The mobile application displays results. And once measurement is over, the device will start transmission data by BT. Thus, users can receive, and display/storage, measurement data from TMB-2072 unit through their end devices that embedded BT module.

The provided text describes the 510(k) submission for the Transtek Wrist Blood Pressure Monitor (Model TMB-2072). Here's an analysis of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The primary clinical performance acceptance criteria for the blood pressure monitor are based on the ISO 81060-2:2018 standard for clinical validation of automated measurement type. While the specific numerical acceptance criteria (e.g., mean difference and standard deviation thresholds) are not explicitly stated in the document, the conclusion indicates that the device met these criteria.

Additional Performance Criteria (Non-Clinical):
The device also claims compliance with various non-clinical standards for electrical safety, electromagnetic compatibility, usability, and wireless testing. These are not presented in a table with specific acceptance values, but rather as statements of compliance.

2. Sample Size and Data Provenance

• Sample Size for the Test Set: 85 qualified healthy adult subjects.
• Data Provenance: The document does not explicitly state the country of origin for the clinical study data or whether it was retrospective or prospective. However, based on the manufacturer's location (Guangdong, China) and the submission's context, it's highly likely the study was conducted prospectively in China.

3. Number of Experts and Qualifications for Ground Truth

The document specifies that the clinical study was conducted according to ISO 81060-2:2018. This standard typically requires "reference blood pressure measurements obtained by two trained observers using a reference sphygmomanometer against which the automated device measurements are compared."

• Number of Experts: The document does not explicitly state the number of experts used to establish the ground truth. However, based on the adherence to ISO 81060-2, it would involve at least two trained observers (likely medical professionals or technicians specifically trained in auscultatory blood pressure measurement).
• Qualifications of Experts: Not specified in the document, but ISO 81060-2 mandates "trained observers." These observers would be qualified to perform accurate auscultatory blood pressure measurements.

4. Adjudication Method for the Test Set

The document does not explicitly describe an "adjudication method" in the context of expert consensus (like 2+1 or 3+1). For blood pressure measurement validation under ISO 81060-2, the ground truth is established by concurrent measurements from reference sphygmomanometers read by trained observers. The standard outlines specific methods for comparing the automated device readings against these observer readings. Discrepancies between the two observers' readings typically have pre-defined limits within the standard, and if these limits are exceeded, the measurements might be discarded or re-taken. This is more of a concordance assessment rather than adjudication to resolve differing opinions on a single diagnosis.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a standalone performance validation of the device against a reference standard (observers), not an assessment of human readers' improvement with or without AI assistance. The device in question is an automatic measuring device, not an AI-assisted diagnostic tool for interpretation by human readers.

6. Standalone Performance Study

Yes, a standalone performance study was done. The entire clinical study described, based on ISO 81060-2:2018, is a standalone (algorithm only without human-in-the-loop performance) assessment of the device's accuracy in measuring blood pressure. The device's measurements were compared directly to the reference measurements obtained by trained observers.

7. Type of Ground Truth Used

The type of ground truth used was expert consensus (from trained observers) using reference sphygmomanometers, as mandated by the ISO 81060-2:2018 standard. This is considered a gold standard for blood pressure measurement validation.

8. Sample Size for the Training Set

The document does not provide information on the sample size for a training set. This submission is for a medical device that measures blood pressure using the "Oscillometric method," which is a well-established technique. While the internal algorithms of such devices are developed and likely refined using data, the document focuses on the clinical validation of the final device, not the development data. Therefore, details about a "training set" in the context of, for instance, a deep learning AI model, are not applicable or provided here.

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

As noted above, information on a "training set" in the context of an AI model is not provided. For the clinical validation (test set) ground truth, it was established by trained human observers using reference sphygmomanometers following the protocols of ISO 81060-2:2018.

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Transtek Wrist Blood Pressure Monitor TMB-1014-BT is a digital monitor intended for use in measuring blood pressure and heartbeat rate in adult patient population with wrist circumference ranging from 13.5 cm to 21.5 cm (about 5 1/4 - 8 1/2 inches). This device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. Wrist Blood Pressure Monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension guideline of 135/85 mmHz. Transtek Wrist Blood Pressure Monitor, TMB-1014-BT is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Transtek Wrist Blood Pressure Monitor, TMB-1014-BT is designed to measure the systolic and diastolic blood pressure and heartbeat rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. 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 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 heartbeat rate, which is a well-known technique in the market called the "Oscillometric method". Transtek Wrist Blood Pressure Monitor is single-mounted devices of the main unit and cuff unit. The preformed cuff unit, which is applicable to wrist circumference approximately between 13.5 and 21.5 cm, includes the inflatable bladder and nylon shell. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD. The subject device is powered by two AAA alkaline batteries. The device also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular heartbeat when the difference of the time intervals is over 25%. Transtek Wrist Blood Pressure Monitor TMB-1014-BT embeds a Bluetooth module that allows it to connect to nearby BT receiving end. The LCD of device displays results. And once measurement is over, the device will start transmission data by BT. Thus users can receive, and display/storage, measurement data from TMB-1014-BT unit through their end devices that embedded BT module.

The provided document is a 510(k) summary for the TRANSTEK Wrist Blood Pressure Monitor Model TMB-1014-BT, which is a modification of a previously cleared device (TMB-1014). The key difference is the addition of a Bluetooth module. The document focuses on demonstrating substantial equivalence to the predicate device and does not contain a standalone study proving the device meets specific acceptance criteria for blood pressure measurement accuracy. Instead, it relies on the predicate device's performance and the argument that the added Bluetooth function does not affect the core measurement function.

Therefore, many of the requested details about a study evaluating the device's performance against acceptance criteria are not present in this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document references compliance with AAMI/ANSI SP10, which sets performance criteria for non-invasive blood pressure monitors. However, it does not explicitly state specific numerical acceptance criteria or report the device's performance against those criteria within this submission.

The document claims:

• "TMB-1014-BT conforms to the following standards: AAMI/ANSI SP10, Safety and performance characteristics"
• "All applicable performance tests have been done according with demands of FDA guidance document 'Non-Invasive Blood Pressure (NIBP) Monitor Guidance' FDA March 10, 1997."

This indicates that the device is expected to meet the AAMI/ANSI SP10 criteria, but the specific performance results are not provided in this 510(k) summary.

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

The document explicitly states: "Explanation: The cuff of TMB-1014-BT is identical to the predicate's cuff, and the new wireless function does not affect blood pressure monitor measurement function. Therefore we have not done the ISO10993 test and Clinical test."

This means:

• Sample size for the test set: Not applicable, as no new clinical test (involving a test set of human subjects) was performed for this modified device.
• Data provenance: Not applicable, as no new clinical data was generated for the TMB-1014-BT in this submission. The substantial equivalence relies on the predicate device's data and the non-impact of the modification.

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

Not applicable. No new clinical test was performed with a human test set. Establishing ground truth for blood pressure measurement typically involves simultaneous measurements by trained human observers using auscultation (e.g., two observers) or a reference device. Since no clinical study was conducted, this information is not available.

4. Adjudication Method for the Test Set

Not applicable. As no new clinical test was performed, there was no test set requiring adjudication.

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

No. This type of study is not relevant for a blood pressure monitor, which measures a physiological parameter rather than interpreting images or other complex data requiring multiple human readers.

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

The device is a standalone blood pressure monitor. However, the study referenced (compliance with AAMI/ANSI SP10) would be a performance study of the device itself, not an "algorithm-only" study in the typical AI/software sense where a human-in-the-loop comparison is the alternative. The entire device's accuracy is evaluated against a reference standard. The document states "All applicable performance tests have been done according with demands of FDA guidance document 'Non-Invasive Blood Pressure (NIBP) Monitor Guidance' FDA March 10, 1997," implying that such a standalone performance evaluation against accepted standards was done for the predicate device. No new standalone clinical performance study was done for this modified device.

7. The Type of Ground Truth Used

For the initial clearance of the predicate device (TMB-1014), the ground truth for blood pressure measurements would typically be established using a standard reference method, most commonly auscultation by trained observers with a mercury sphygmomanometer, in accordance with standards like AAMI/ANSI SP10. The document does not provide details on how the ground truth was established for the predicate device, only that the new device relies on the predicate's performance.

8. The Sample Size for the Training Set

Not applicable. This device is a traditional oscillometric blood pressure monitor, not an AI/ML-based device that would typically have a "training set" in the context of machine learning. The algorithms used are likely well-established signal processing techniques.

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

Not applicable, as there is no "training set" in the AI/ML sense for this device.

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This series of devices are digital monitors intended for use in measuring blood pressure and heartbeat rate in adult patient population with wrist circumference ranging from 13.5 cm to 21.5 cm (about 5 1/4 -- 8 1/2 inches).

This series of devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings.

The Wrist Blood Pressure Monitor compares average blood pressure results to pre-established AFIA (American Heart Association) hypertension guideline of 135/85 mmHg.

Transtek Wrist Blood Pressure Monitor, TMB-895, TMB-988, TMB-1014, TMB-1117 models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Transtek Wrist Blood Pressure Monitor, TMB-895, TMB-1014, TMB-1117 are designed to measure the systolic and diastolic blood pressure and heartbeat rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist.

Measurement method to define systolic and diastolic pressure is similar to the auscultatory melhod 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 heartbeat rate, which is a well-known technique in the market called the "Oscillometric method".

Transtek Wrist Blood Pressure Monitor is single-mounted device of the main unit and cuff unit. The preformed cuff unit, which is applicable to wrist circumference approximately between 13.5 and 21.5 cun, includes the inflatable bladder and nylon shell. All four models of the wrist blood pressure monitor use the same size of cuff. The subject devices consist of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve, and the LCD. The subject devices are powered by two AAA alkaline batteries.

The device also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular heartbeat when the difference of the time intervals is over 25%.

The provided text is a 510(k) summary for the Transtek Wrist Blood Pressure Monitor. It does not contain information about a specific study comparing the device's performance against acceptance criteria beyond the general statement that "performance testing and assessment proved that the subject devices are safe and effective."

The document primarily focuses on establishing substantial equivalence to a predicate device (Omron, MODEL HEM-609N, K042505) by comparing features and performance parameters.

However, based on the Accuracy section in "Table 1: The difference between Transtek Wrist Blood Pressure Monitors" and "Table 2: The difference between Transtek Wrist Blood Pressure Monitor and Predicate HEM 609N", we can infer the acceptance criteria for accuracy.

Here's an analysis of the available information:

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

Based on the "Accuracy" row in the provided tables, the acceptance criteria for accuracy are:

The Transtek devices report:

• 5°C~40°C: within ±3mmHg
• 0°C45°C (out of 5°C40°C): within ±5mmHg.
  The summary states this is "Similar" to the predicate, implying the predicate itself has a ±3mmHg accuracy. It also implicitly sets these as the performance criteria for the Transtek device. | 5°C40°C: within ±3mmHg
  0°C45°C (out of 5°C~40°C): within ±5mmHg |
  | Pulse Value/Rate | Similar to Predicate (Omron HEM-609N): Within ±5% of reading. | Within ±5% of reading |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The 510(k) summary only states that "performance testing and assessment proved that the subject devices are safe and effective" without detailing the methodology, sample sizes, or data provenance of these tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. For blood pressure monitors, ground truth is typically established by trained medical professionals using a reference standard like a mercury sphygmomanometer following a validated protocol (e.g., ISO 81060-2), but the details are not included here.

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

This information is not provided in the document.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this type of device (a wrist blood pressure monitor). This kind of study is typically used for medical imaging devices where human interpretation of images is a key component. This device directly measures physiological parameters.

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

Yes, the device is a standalone automaticsensing device. Its performance is evaluated based on its direct measurements without human intervention as part of the measurement process. The document implicitly refers to standalone performance through its accuracy claims.

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

The document does not explicitly state the type of ground truth. However, for blood pressure monitors, the ground truth for accuracy testing is typically established by simultaneous measurements using a validated reference standard (e.g., a mercury sphygmomanometer or an equivalent oscillometric device that has been rigorously validated, applied by trained observers) alongside the device under test. This is standard practice for blood pressure monitor validation.

8. The sample size for the training set

This information is not provided in the document. Blood pressure monitors developed using the oscillometric method usually involve algorithms trained and validated on a diverse set of real-world blood pressure readings. However, no details on "training sets" are mentioned in this 510(k) summary.

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

This information is not provided in the document, as no "training set" is explicitly mentioned for this device.

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