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The Welch Allyn ProBP 2000 Digital blood pressure device is intended for use in measuring blood pressure and heart rate in patients at least 3 years of age or older with arm circumferences between 15 cm to 55 cm (approximately 5.9 to 21.7 inches).

The Welch Allyn ProBP 2000 automatically measures systolic and diastolic pressure and pulse rate. The device is intended to be used by clinicians and medically qualified personnel.

Contraindications:

This device is not intended for use on neonates, infants, or children under the age of 3 years. The effectiveness of this device has not been established in pregnant, including pre-eclamptic, patients.

The device 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 arm.

This device is designed for professional use, in other words, it is a professional BP device that only for trained users such as nurses, clinicians, and medically qualified personnel.

The measurement method for determining the systolic and diastolic pressure is similar with the ausculatory 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. This well-known technique for measuring blood pressure is called the "Oscillometric method".

The device includes the main unit and cuff unit. The main unit consists of the microprocessor, the pressure sensor, the operation key, the pump, the electromagnetic deflation control valve and the LCD. ABS is the plastic used in the outer housing. The device comes with one standard Reusable-11 Welch Allyn FlexiPort cuff. Other size cuffs can be ordered as needed for arm circumferences ranging from 15cm to 55cm. This device is equipped with the same wireless radio (Bluetooth) as supplied with the predicate device cleared in K161886, TMB-1591-A.

The subject device does not incorporate any software to support the BT wirelessly transmit function. In other word, ProBP 2000 has BT module but disabled the Bluetooth functionality. And Welch Allyn does not provide an application to receive data utilizing BT

The subject device does not have any externally-facing electronic interfaces.

Here's a summary of the acceptance criteria and study information for the Welch Allyn ProBP 2000 Digital Blood Pressure Device, based on the provided text:

Acceptance Criteria and Reported Device Performance

The device's accuracy was validated according to ISO 81060-2:2013, which specifies acceptance criteria for automated non-invasive sphygmomanometers. The core requirement is that "All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2:2013."

While the exact numerical limits of the ISO standard are not explicitly stated in the document, the report confirms that the device met these requirements.

Study Information

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

   • Test Set Sample Size: 88 qualified healthy subjects.
   • Subject Demographics:
     • Age: 3-12 years (35 pediatric) & 12-75 years (53 adults / adolescents)
     • Gender: 39 males & 49 females
     • Racial/Ethnic Background: Any
   • Data Provenance: The document does not explicitly state the country of origin where the clinical validation study was conducted, nor does it specify if the data was retrospective or prospective. Given it's a clinical validation study for a new device, it is highly likely to be a prospective study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   The document does not specify the number of experts or their qualifications for establishing ground truth, as is typical for blood pressure device clinical validation studies. ISO 81060-2 usually involves simultaneous measurements by trained observers using a mercury sphygmomanometer as the reference standard, rather than a panel of "experts" in the sense of image review or diagnostic interpretation.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   The document does not describe a specific adjudication method. For blood pressure device validation, the standard approach involves two or more trained observers performing simultaneous auscultatory measurements alongside the automated device, with discrepancies resolved according to the standard's protocol (e.g., if a certain difference is exceeded, a third observer might be involved, or the measurement discarded).

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, an MRMC comparative effectiveness study was not done. This device is a standalone blood pressure measurement device and does not involve AI assistance for human readers/clinicians in diagnostic interpretation.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Yes, the clinical validation described is a standalone performance study. The device's algorithm measures blood pressure and heart rate without human interpretation being part of the measurement process itself. The study compared the device's readings directly to a reference standard (auscultatory measurement) to assess its accuracy.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The ground truth was established through a reference standard method, which, for blood pressure devices, typically involves simultaneous auscultatory measurements performed by trained observers using a reference sphygmomanometer (e.g., mercury sphygmomanometer), as per the requirements of ISO 81060-2.

7. The sample size for the training set:
   The document does not explicitly state the sample size for the training set. It mentions the device uses an "oscillometric algorithm" and that the algorithm's accuracy "has been validated through bench testing including testing to the blood pressure standard, IEC 80601-2-30." It also states, "The oscillometric algorithm in the device measures pulse heights at various cuff pressures throughout the cycle. Those pulse heights are used to build a patient specific pulse envelope as taught by standard oscillometric technique." This suggests general physiological principles and established oscillometric techniques are used, rather than a specific algorithm trained on a large, labeled dataset in the way a modern AI algorithm might be.

8. How the ground truth for the training set was established:
   As there is no explicit mention of a training set in the context of a machine learning model, the concept of "ground truth for the training set" as it applies to AI algorithms doesn't directly apply here. The algorithm is based on well-established oscillometric principles for blood pressure measurement rather than being "trained" on a specific dataset in the modern AI sense. The development of such algorithms typically involves engineering and physiological understanding, and refinement through extensive testing (including bench and clinical testing as mentioned) against reference methods.

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Transtek Blood Pressure Monitor TMB-1591-A, Welch Allyn Blood Pressure Device RPM-BP100SBP and H-BP100SBP are digital monitors intended for use in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 15 cm to 54 cm (about 6-21 inches).

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

Contraindications:

This device is contraindicated for any person who is connected to a wearable or implantable electronic device or instrument, such as a pacemaker or defibrillator.

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

Blood Pressure Monitor TMB-1591-A, Welch Allyn Blood Pressure Transtek Device RPM-BP100SBP and H-BP100SBP 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 arm. The three devices are the same except brand name, model number and the layout of labeling.

Measurement method to define systolic and diastolic pressure is similar to the ausculatory 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".

These devices also compare 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%.

These devices include the main unit and cuff unit. The main unit consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD. ABS is used to outer housing of the main unit. The three preformed cuff units, which are applicable to arm circumference between 15-24cm, 22-42cm and 40-54cm to meet different population's need. The subject device is powered by four AA alkaline batteries or by a DC 6V 1AA adapter.

These devices embed a Bluetooth module that allows it to connect with nearby BT receiving terminal (such as iphone, ipad). Once measurement is over, the LCD of device displays results. And the device will start to transmit data to the pair-up BT terminal automatically. Thus users can display, manage and storage measurement data more easily.

The requested information is related to an automated non-invasive sphygmomanometer (blood pressure monitor), not an AI device. Therefore, some of the questions, particularly those related to experts, ground truth methods for AI, MRMC studies, and separate training/test sets for AI, are not directly applicable.

However, I can extract the information relevant to the clinical validation of this medical device, which is typically a performance study comparing the device's measurements against a reference standard.

Here's the breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

The clinical validation was performed against the standard AAMI/ANSI/ISO 81060-2:2013, which specifies acceptance criteria for automated non-invasive sphygmomanometers. While the document states that the device "meet the requirements of AAMI/ANSVISO 81060-2:2013," it does not explicitly list the numerical acceptance criteria or the specific reported device performance values (e.g., mean difference and standard deviation of blood pressure measurements).

Table of Acceptance Criteria and Reported Device Performance:

Note: The document confirms compliance with the standard but omits the specific numerical results. To get the exact acceptance criteria and the device's measured performance (mean differences, standard deviations), one would need to consult the AAMI/ANSI/ISO 81060-2:2013 standard itself and the detailed clinical validation report, which is not provided here.

Study Information (Clinical Validation)

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

   • Sample Size: Not explicitly stated in the provided text. The AAMI/ANSI/ISO 81060-2:2013 standard typically requires a minimum of 85 subjects for clinical validation.
   • Data Provenance: Not explicitly stated. Clinical studies are generally prospective.

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

   • For blood pressure monitors, the "ground truth" is typically established by trained human observers using a reference sphygmomanometer (e.g., mercurial or auscultatory method) alongside the device under test. This usually involves multiple observers.
   • Number of Experts: Not explicitly stated, but the AAMI/ANSI/ISO 81060-2:2013 standard usually mandates at least two trained observers.
   • Qualifications: Not explicitly stated. The standard requires observers to be clinically trained and experienced in auscultatory blood pressure measurement. (e.g., physicians, nurses, or trained technicians).

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

   • For blood pressure validation, adjudication typically involves averaging readings between multiple observers or using a third observer in cases of significant discrepancy, as per the AAMI/ANSI/ISO 81060-2:2013 protocol.
   • Adjudication Method: Not explicitly stated in the document, but the AAMI/ANSI/ISO 81060-2:2013 standard outlines a specific protocol for how observer readings are to be collected and compared to obtain the reference blood pressure.

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:

   • Not Applicable. This is a blood pressure monitor, not an AI device. Therefore, MRMC studies involving human readers and AI assistance are not relevant here.

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

   • Yes, effectively. The "standalone" performance in this context refers to the device's ability to accurately measure blood pressure on its own, which is what the clinical validation (AAMI/ANSI/ISO 81060-2:2013) assesses against a human-obtained reference. This study evaluates the device's performance without a human interpreting its output in the same way an AI output would be interpreted.

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

   • Expert Reference Measurement: The ground truth for a non-invasive sphygmomanometer is established by simultaneous or carefully timed measurements by trained human observers using a validated reference method (e.g., auscultation with a mercury sphygmomanometer or validated aneroid device).

7. The sample size for the training set:

   • Not Applicable. As this is not an AI device, there isn't a "training set" in the machine learning sense. The device's calibration and internal algorithms are developed during its engineering phase, which is distinct from a clinical validation study used for regulatory approval.

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

   • Not Applicable. See point 7. The device's internal algorithms are based on established oscillometric principles and refined through engineering and calibration processes, not a "training set" with ground truth in the AI context.

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Transtek Blood Pressure Monitor LS802-B, LS805-B, and TMB-1018-BT are digital monitors intended for use in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 22 cm to 42 cm (about 9-17 inches).

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

These Blood Pressure Monitor compare average blood pressure results to pre-established AHA (American Heart Association) hypertension guideline of 135/85 mmHg.

Transtek Blood Pressure Monitor, LS802-B, LS805-B, and TMB-1018-BT are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Transtek Blood Pressure Monitor, LS802-B, LS805-B and TMB-1018-BT 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 arm.

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 Blood Pressure Monitor is single-mounted devices of the main unit and cuff unit. ABS is jused to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 22cm and 42cm, 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 four AA/AAA alkaline batteries or by a DC 6V 400mA adapter.

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 Blood Pressure Monitor LS802-B, LS805-B and TMB-1018-BT embed a Bluetooth module that allows it to connect with nearby BT receiving terminal. Once measurement is over, the LCD of device displays results. And the device will start to transmit data to the paired BT terminal. Thus users can receive, display, and storage measurement data of Transtek Blood Pressure Monitor unit through their terminal devices that embedded BT module.

The provided text describes a 510(k) submission for a blood pressure monitor, focusing on substantial equivalence to a predicate device. It contains very limited information regarding the performance study that would typically establish acceptance criteria and device performance. The device is a "TRANSTEK Blood Pressure Monitor" (Models: LS802-B, LS805-B, and TMB-1018-BT).

Here's an analysis based on the provided text, highlighting what is present and what is missing:

Acceptance Criteria and Device Performance Study for TRANSTEK Blood Pressure Monitor

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a table of acceptance criteria or specific reported device performance metrics for blood pressure measurement accuracy. It primarily focuses on the substantial equivalence of the new models to a predicate device, with the key difference being the use of Bluetooth instead of RF for wireless data transmission.

The document states compliance with standards, notably:

• AAMI/ANSI/IEC 80601-2-30, Safety and performance characteristics
• ISO 14971, Risk management to medical devices

Compliance with AAMI/ANSI/IEC 80601-2-30 would imply that the device meets the performance requirements for blood pressure monitors as outlined in that standard. This standard typically defines accuracy requirements (e.g., mean difference and standard deviation of blood pressure readings compared to a reference method). However, the specific results from a study demonstrating this compliance are not presented in this document.

The document states: "All required design control activities have been implemented and 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 performance testing was conducted, but the results are not explicitly detailed.

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

The document does not specify the sample size used for any clinical or performance test set related to blood pressure measurement accuracy.

It also does not mention the data provenance (e.g., country of origin, retrospective or prospective) for any clinical data because it explicitly states that a clinical test for blood pressure measurement accuracy was not done for this submission.

The document includes the following crucial statement: "Explanation: The wireless coexistence tests provide to demonstrate the reliability of wireless connection and wireless coexistence of BT data communication function. Meanwhile the BT data communication function does not affect blood pressure monitors' measurement function. Therefore we have not done the Clinical test."

This indicates that the submission relies on the substantial equivalence of the core measurement technology to the predicate device (TRANSTEK, Blood Pressure Monitor, Model LS802-E, K123780), and the performance of the blood pressure measurement function itself was not re-evaluated clinically for this specific submission.

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

Since a clinical test for blood pressure measurement accuracy was not conducted for this submission (as stated in the document), there is no information provided regarding experts or ground truth establishment for a clinical test set.

4. Adjudication Method for the Test Set

As no clinical test set for blood pressure measurement accuracy was established for this submission, there is no information regarding an adjudication method.

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

• No MRMC multi-reader comparative effectiveness study was done. This device is an automated blood pressure monitor, not an imaging or diagnostic device that typically involves human readers interpreting results. The comparison is between automated measurements and a "reference" (likely auscultatory or invasive arterial pressure, as per NIBP standards), not between human readers.
• Therefore, no effect size for human readers improving with AI vs. without AI assistance is applicable or reported.

6. Standalone (Algorithm Only) Performance

The device itself is a standalone algorithm-based device for measuring blood pressure using the oscillometric method. The discussion implies that the basic measurement function (algorithm for detecting systolic and diastolic pressure) is identical to the predicate device. However, specific standalone performance metrics are not reported in this summary. The focus of the current submission is the change in wireless transmission technology.

7. Type of Ground Truth Used

For non-invasive blood pressure monitors, the "ground truth" in performance studies typically involves comparison with either:

• Auscultatory measurements performed simultaneously by trained observers using a mercury sphygmomanometer, often with double or triple auscultation for observer bias reduction.
• Invasive arterial pressure monitoring (intra-arterial catheter), considered the most accurate reference but less common for routine device validation.

Given the statement that an AAMI/ANSI/IEC 80601-2-30 compliant test would be expected, the ground truth would likely be established through one of these methods at the time the predicate device (K123780) was validated. For this submission, no new ground truth was established for blood pressure measurement accuracy, as no clinical test was performed.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set for the device's algorithms. As the device uses the "oscillometric method," which is a well-established technology, the core algorithm was likely developed and validated prior to the predicate device's clearance. The current submission is for a modification (Bluetooth) to an already cleared device.

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

The document does not describe how the ground truth for any training set was established. This information would typically be part of the original development and validation of the oscillometric algorithm, which predates this specific 510(k) submission.

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Transtek Blood Pressure Monitor LS802-E is a digital monitor intended for use in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 22 cm to 42 cm (about 9 - 17 inches).

This device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. The Blood Pressure Monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension guideline of 135/85 mmHg.

Transtek Blood Pressure Monitor, LS802-E is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Transtek Blood Pressure Monitor, LS802-E 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 arm.

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 Blood Pressure Monitor is single-mounted devices of 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 22cm and 42 cm. includes the inflatable bladder and nylon shell. The device consists of the microprocessor, the pressure sensor, the operation keys, the purnp, the electromagnetic deflation control valve and the LCD. The subject device is powered by four AA alkaline batteries or by a DC 6V 400mA adapter.

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 Blood Pressure Monitor LS802-E embeds a Wireless network connections module that allows it to connect to nearby receiving end (such as specific equipment that named Bridge) which is connected to the Internet. Once measurement is over, the LCD of device displays results. And the device will start to send out data. The Bridge receive / storage, and transmission data to Internet server. Thus users can receive, and display/storage, measurement data from LS802-E unit through their end devices (e.g. PC, cellular, tablet) that connected Internet.

The provided text describes a 510(k) premarket notification for the TRANSTEK Blood Pressure Monitor, Model LS802-E. This submission focuses on demonstrating substantial equivalence to a predicate device (TRANSTEK, Blood Pressure Monitor, Model LS-802, K120058), particularly highlighting an added wireless data communication function and a change in cuff surface materials.

Here's an analysis of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states, "The new wireless function does not affect blood pressure monitor measurement function. Therefore we have not done the Clinical test." This indicates that the core blood pressure measurement performance, which would typically involve clinical validation against acceptance criteria for accuracy (e.g., AAMI/ANSI SP10 for blood pressure accuracy), was not re-evaluated clinically for this specific submission because the change was deemed not to impact the measurement function. The substantial equivalence relies on the predicate device's prior clinical validation for blood pressure accuracy.

2. Sample Sizes and Data Provenance

• Test Set (Clinical Data for Blood Pressure Accuracy): Not applicable for this specific submission. The document explicitly states that no clinical test was performed due to the nature of the modifications (wireless function and cuff material). The clinical performance data for blood pressure accuracy would have been established for the predicate device (K120058). The document does not provide details on the sample size or data provenance for the predicate device's clinical validation.
• Other Performance Tests (Bench Tests): "Bench tests have been done" for design control activities, risk management, and design verification tests. No specific sample sizes for these bench tests are mentioned. Data provenance is implied to be from the manufacturer's internal testing.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Not applicable for a clinical test in this submission. For the predicate device's blood pressure accuracy validation, ground truth would typically be established by trained professionals using a reference method (e.g., auscultation by multiple observers). However, no details are provided for the predicate device's study.

4. Adjudication Method (Test Set)

• Not applicable for a clinical test in this submission. For the predicate device's blood pressure accuracy validation, a common adjudication method for clinical studies would involve multiple observers (e.g., two observers with a third to adjudicate discrepancies). No details are provided for the predicate device's study.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is typically for AI-assisted diagnostic devices to measure the improvement in human reader performance. The device here is a blood pressure monitor, and the changes are related to wireless transmission and cuff material, not AI-assisted interpretation.

6. Standalone (Algorithm Only) Performance Study

• A standalone study for the blood pressure measurement algorithm was implicitly done for the predicate device to establish its accuracy. However, for this submission (LS802-E), because the core measurement algorithm was unchanged, a new standalone study was not performed. The new elements (wireless and cuff material) do not involve an "algorithm only" performance that would typically be evaluated in a standalone study for diagnostic AI.

7. Type of Ground Truth Used (Test Set)

• Not applicable for a clinical test in this submission. For the predicate device's blood pressure accuracy validation, the ground truth would have been based on reference blood pressure measurements, typically performed by trained operators using a validated method (e.g., auscultation with a mercury sphygmomanometer).

8. Sample Size for the Training Set

• Not applicable. This device does not appear to involve machine learning or AI algorithms that would require a "training set" in the conventional sense for diagnostic image analysis or similar applications. The device uses the "oscillometric method" which is a well-known, established technique based on signal analysis, not a learned model from a large training dataset.

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

• Not applicable, as there is no mention of a training set for a machine learning model.

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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 arm circumference ranging from 22 cm to 42 cm (about 9 - 17 inches). These devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings. The Blood Pressure Monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension guideline of 135/85 mmHg. Transtek Blood Pressure Monitor, LS-802, TMB-1018, TMB-1018-A, TMB-1112, and TMB-1112-A models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Transtek Blood Pressure Monitor, LS-802, TMB-1018, TMB-1018-A, TMB-1112 and TMB-1112-A 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 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 heartbeat rate, which is a well-known technique in the market called the "Oscillometric method". Transtek Blood Pressure Monitor is single-mounted devices of 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 22 and 42 cm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor can use the same two size of cuff (22 - 32cm, or 22 -42cm). Product package will contains only one cuff and which size is decide by business requirement. The device consists 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 four AAA or AA alkaline batteries or by a DC 6V 400mA adapter. 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%.

Here's a breakdown of the acceptance criteria and study information for the Transtek Blood Pressure Monitor, based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria for the Transtek Blood Pressure Monitor models (LS-802, TMB-1018, TMB-1018-A, TMB-1112, TMB-1112-A) are based on their accuracy for pressure and heartbeat rate, as well as the measurement range. The reported performance for all these models is identical.

Note: The document states that "These differences do not affect the safety and effectiveness of the subject devices," implying that the performance reported meets the necessary standards for substantial equivalence to the predicate device.

Study Information

The provided 510(k) summary is for a premarket notification submission for substantial equivalence. It primarily focuses on comparing the new devices to a legally marketed predicate device (Transtek Blood Pressure Monitor, Model TMB-986, K101681). This type of submission generally relies on comparison to a predicate device that has already established its safety and effectiveness through prior studies (which are not detailed in this document).

Therefore, many of the requested details about a specific clinical study (like sample size for test sets, ground truth establishment for a training set, MRMC studies) are not typically included in this type of 510(k) summary as they refer to a primary clinical validation study. The document does not describe an independent clinical study performed specifically for these new models to prove they meet the stated acceptance criteria beyond asserting their similarity in features and performance specifications to the predicate device.

However, based on the context of blood pressure monitor regulation, devices of this type are generally validated against established standards (e.g., ISO 81060-2 or AAMI standards) which often involve clinical studies. If such a study were conducted, these are the details that would usually be provided:

1. Sample size used for the test set and the data provenance: Not explicitly stated for these specific models. For blood pressure monitor validation studies (e.g., following ISO 81060-2), a typical sample size would be around 85 subjects with specific demographic and blood pressure range distributions. Data provenance would likely be from a clinical setting, potentially in China (country of the manufacturer) or another region where the validation study was conducted, and it would be prospective.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. For blood pressure monitor validation, ground truth (reference blood pressure measurements) is typically established by trained clinical observers (e.g., physicians, nurses, or technicians) using a standardized auscultatory method, often with mercury sphygmomanometers, following strict protocols. Usually, at least two independent observers are involved for each measurement series.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not explicitly stated. In blood pressure monitor validation studies, if multiple observers are used for ground truth, their readings are compared. Differences beyond a certain threshold often require a third observer or a predefined averaging/exclusion rule.
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: Not applicable. These are standalone blood pressure monitors and do not involve human readers interpreting results with or without AI assistance in the way a diagnostic imaging AI would. They provide direct readings.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, indirectly. The performance specifications mentioned are for the device itself (algorithm and hardware combined) to measure blood pressure. The "oscillometric method" is an algorithmic approach. The comparison to the predicate device implies that the standalone performance is considered similar and acceptable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For blood pressure monitors, the ground truth for accuracy validation is typically expert consensus/clinical reference measurements obtained using a validated auscultatory method (e.g., using a mercury sphygmomanometer by trained observers).
7. The sample size for the training set: Not applicable and not mentioned. These devices use the "oscillometric method," a well-established technique that generally doesn't involve a separate "training set" in the context of deep learning AI. The underlying algorithms are developed and refined based on engineering principles and physiological data, not typically machine learning training on a large dataset for each new model.
8. How the ground truth for the training set was established: Not applicable, as no dedicated training set in the AI sense is described. The "ground truth" for the development of the oscillometric method itself would stem from extensive physiological studies and comparisons to direct arterial pressure measurements or established auscultatory methods.

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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 arm circumference ranging from 22 cm to 42 cm (about 9 - 17 inches).

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

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

Transtek Blood Pressure Monitor, TMB-986, TMB-987, and TMB-995 models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Transtek Blood Pressure Monitor, TMB-986, TMB-987, and TMB-995 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 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 heartbeat rate, which is a well-known technique in the market called the "Oscillometric method".

Transtek Blood Pressure Monitor is single-mounted devices of 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 22 and 42 cm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor can use the same two size of cuff (22 - 32cm, or 22 - 42cm). Product package will contains only one cuff and which size is decide by business requirement. The device consists 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 four AAA or AA alkaline batteries or by a DC 6V 400mA adapter.

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%.

This looks like a 510(k) submission for a non-invasive blood pressure monitor. Here's an analysis of the acceptance criteria and the study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

• Within ±0.4kpa / 3mmHg (at 15℃ to 25℃)
• Within ±0.65kpa / 5mmHg (at 10℃ to 40℃, out of 15℃ to 25℃) |
  | Accuracy (Heartbeat Rate) | Predicate: Within ±5% of reading | Transtek: Within ±5% of reading |
  | Cuff Inflation | Automatic inflation with air pump | Automatic inflation with air pump |
  | Deflation of Pressure | Deflation rate controlled by an active electronic control valve (4-11 mmHg/s) | Automatic air release |
  | Measurement Perimeter of Upper Arm | 22cm42cm | 22cm42cm |
  | Operating Voltage | DC 6V | DC 6V |
  | Operating Environment (Temperature) | 10℃40℃ | 10℃40℃ |
  | Operating Environment (Relative Humidity) | 30-80% | ≤80% |
  | Operating Environment (Barometric Pressure) | 10580 kPa (790-600 mmHg) | 10580 kPa (790-600 mmHg) |
  | Transport and Storage Environment (Temperature) | -20℃60℃ | -20℃60℃ |
  | Transport and Storage Environment (Relative Humidity) | 1095% | 1093% |

Note: The document explicitly states that the Transtek devices' accuracy for pressure and heartbeat rate are "similar" to the predicate device (HEM 780N3), implying they meet the predicate's acceptance criteria. The specific numerical values for temperature ranges and humidity are slightly different but considered "similar."

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

The provided document does not contain details about a specific clinical study conducted for the Transtek Blood Pressure Monitor models TMB-986, TMB-987, and TMB-995 regarding the sample size, data provenance (country of origin, retrospective/prospective), or the specific methodology used to validate the accuracy.

The submission relies heavily on demonstrating substantial equivalence to the OMRON Automatic Blood Pressure Monitor, Model HEM 780N3 (K061822). The "Performance Tests" section vaguely mentions "Biocompatibility, Electromagnetic Compatibility and Electrical Safety" tests, which are typically bench/engineering tests, not clinical performance studies.

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 document. As there's no detailed clinical study described, there's no mention of experts establishing ground truth. For blood pressure monitors, ground truth is typically established using a reference standard like a mercury manometer or another validated oscillometric device, with measurements taken by trained technicians.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

A MRMC comparative effectiveness study was not done or at least not described in this submission. This type of study is more common for imaging devices where human interpretation is a critical component and AI is introduced to assist. For a blood pressure monitor, the performance is primarily based on the accuracy of its direct measurements against a reference standard.

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

A standalone performance study of the algorithm's measurement accuracy would have implicitly been done as part of the overall device validation (to ensure it meets the accuracy criteria). However, the document does not detail a specific standalone study separate from the overall device performance claim, nor does it explicitly state the methodology for such a study. The "Oscillometric method" is a known technique, and the device's accuracy is reported, which implies direct measurement capability.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for validating the Transtek device's accuracy. However, for blood pressure monitors of this type, the established ground truth for accuracy testing typically involves:

• Reference standard measurements: Usually performed by trained professionals using a validated auscultatory method (e.g., using a mercury sphygmomanometer or another clinically validated device) against which the test device's readings are compared. This is implied by the accuracy criteria (e.g., ±3mmHg).

8. Sample Size for the Training Set

The document does not provide any information regarding a training set. This is not surprising as these blood pressure monitors typically rely on established "Oscillometric method" algorithms rather than deep learning models that require extensive training data. The algorithms are usually developed based on physiological principles and validated through clinical testing rather than machine learning training.

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

Since no training set is mentioned (as per point 8), the method for establishing its ground truth is also not applicable/provided.

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