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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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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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The Transtek Glass Body Fat Analyzer measure weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat, total body water percentage, bone mass, and muscle mass in generally healthy adults 18 years of age or older.

It is intended for use in the home/domestic setting only.

Transtek Glass Body Fat Analyzer uses BIA (Bioelectrical Impedance Analysis) technology which passes an electrical current through the body to estimate body fat mass, total body water, muscle mass and bone mass. The electrical current is low and may not be felt. The current passes freely through the fluids contained in muscle tissue, but encounters difficulty/resistance when it passes through fat tissue. This resistance of the fat tissue to the current is termed 'Bioelectrical Impedance', and is accurately measured by Glass Body Fat Analyzer LS203-B.

This method simultaneously calculates your personal weight, body fat, total body water, muscle mass and bone mass, giving you a more accurate reading of your overall health and fitness.

Transtek Glass Body Fat Analyzer GLS203-B embeds a Bluetooth module that allows it to connect to nearby BT receiving terminal. Once measurement is over, the LCD of device displays measurement results, and the device will start to send out measurement data to paired BT terminal at the same time. Thus users can receive, display, and storage measurement results from LS203-B unit through mobile BT terminal.

The provided text describes a 510(k) summary for the Transtek Glass Body Fat Analyzer Model LS203-B. However, it does not contain information about specific acceptance criteria or a study that proves the device meets those criteria in terms of performance metrics like accuracy, sensitivity, or specificity for its intended body composition measurements.

The document focuses on demonstrating substantial equivalence to a predicate device (TRANSTEK, Glass Body Analyzer, Model LS206-E, K123781) by highlighting that the only significant difference is the wireless communication technology (Bluetooth vs. RF). It asserts that this change does not raise new questions of safety and effectiveness, and therefore, no clinical performance testing was deemed necessary for the comparison of the two devices.

Here's a breakdown of what can be extracted and what is missing based on your request:

1. Table of acceptance criteria and the reported device performance

Not provided. The document states: "Explanation: The wireless function does not affect body analyzer measurement function. Therefore we have not done the Clinical test." This indicates that no specific performance metrics comparing the LS203-B to a gold standard were conducted or reported in this summary.

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

Not applicable/Not provided. No clinical performance test set or data provenance is mentioned. The only "tests" referred to are "bench tests," "risk management," and "design verification tests" for the modification.

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

Not applicable/Not provided. No ground truth establishment experts are mentioned because no clinical performance study was conducted.

4. Adjudication method for the test set

Not applicable/Not provided. No adjudication method is mentioned because no clinical performance study was conducted.

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

Not applicable. This device is a body composition analyzer, not an AI-assisted diagnostic imaging device requiring human reader interpretation in an MRMC study.

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

Not applicable/Not provided. While the device itself is a standalone measurement tool, the document doesn't present a study assessing its standalone performance against a clinical ground truth. It relies on the substantial equivalence to the predicate device, which presumably had established performance.

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

Not applicable/Not provided. No ground truth is mentioned in the context of a performance study for the LS203-B. Its substantial equivalence argument implies that the predicate device's performance, likely validated against some form of ground truth (e.g., DEXA or other established body composition methods for the predicate), is assumed to apply.

8. The sample size for the training set

Not applicable/Not provided. This document doesn't describe the development or training of an AI algorithm in the contemporary sense. It's an impedance-based device, and while it uses algorithms for calculation, it's not discussed in terms of a "training set" like a machine learning model.

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

Not applicable/Not provided. As there's no mention of a training set, there's no information on how its ground truth might have been established.

Summary of the Study (as described in the document):

The document describes a submission for a modified device (LS203-B) that is substantially equivalent to a predicate device (LS206-E). The "study" here is primarily a design control activity and substantial equivalence comparison, not a clinical performance validation of the LS203-B's accuracy in measuring body composition.

• Objective: To demonstrate that the modified device (LS203-B) is substantially equivalent to the predicate device (LS206-E) and does not raise new questions of safety and effectiveness.
• Key Finding: The only significant difference is the use of Bluetooth instead of RF for wireless data transmission.
• Conclusion: This modification does not impact the safety and effectiveness of the device, and therefore, no clinical performance tests were considered necessary for this 510(k) submission. The device is deemed substantially equivalent.

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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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The Transtek Body Fat Analyzer measure weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat, total body water percentage, bone mass, and muscle mass in generally healthy adults 18 years of age or older.

It is intended for use in the home/domestic setting only.

Transtek Body Fat Analyzer uses BIA (Bioelectrical Impedance Analysis) technology which passes an electrical current through the body to estimate body far mass, total body water, muscle mass and bone mass. The electrical current is low and may not be felt. The current passes freely through the fluids contained in muscle tissue, but encounters difficulty/resistance when it passes through fat tissue. This resistance of the fat tissue to the current is termed 'Bioelectrical Impedance', and is accurately measured by Transtek Body Fat Analyzer (GBF-1251-B, BF-1256-B, and GBF-1257-B).

This method simultaneously calculates personal body water, muscle mass, and bone mass, giving a more accurate reading of overall health and fitness. As well as being an analyzer, this device can be used as a conventional weight scale.

The Transtek Body Fat Analyzer embeds a Bluetooth (BT) 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 of Transtek Body Fat Analyzer unit through their end devices that embedded BT module.

Here's an analysis of the provided text regarding the Transtek Body Fat Analyzer and its acceptance criteria and study information:

Acceptance Criteria and Study Information for Transtek Body Fat Analyzer

Based on the provided 510(k) summary (K130311), here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or reported device performance metrics for body fat, total body water percentage, muscle mass, or bone mass estimation. Instead, it relies on demonstrating substantial equivalence to a predicate device and adherence to general safety and electrical standards.

The document primarily focuses on demonstrating that the Transtek Body Fat Analyzer (GBF-1251-B, BF-1255-B, BF-1256-B, GBF-1257-B) is substantially equivalent to the predicate device, Transtek Glass Body Fat Analyzer, Model GBF-950-D (K112932). The key argument for substantial equivalence is that the only significant difference is the addition of a wireless data communication function, which is an add-on and does not affect the safety and effectiveness of the body composition analysis function.

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

The document does not specify a sample size or provide details on a "test set" used for clinical validation of the body composition measurements. The assessment appears to rely on a demonstration of design control activities and performance tests focusing on adherence to electrical safety and electromagnetic compatibility standards, rather than a clinical trial with a defined test set for accuracy of body composition measurements.

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. (The submitter is from China, but there's no indication of where any testing data, if clinical, would originate).
• Retrospective/Prospective: Not specified.

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

Given that no explicit clinical test set for body composition accuracy is described, there's no information regarding experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

As no explicit clinical test set is described, no adjudication method is mentioned.

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

No MRMC comparative effectiveness study is mentioned in the provided document. The focus is on device equivalence, not on comparing human reader performance with or without AI assistance.

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

The device is a Body Fat Analyzer that directly measures and displays results. The concept of "standalone performance" in the context of an algorithm's output versus human interpretation (as often seen in imaging AI) is not applicable to this type of device based on the provided information. The device itself is the "algorithm" and produces the output for the user.

7. The Type of Ground Truth Used

The document does not specify a type of ground truth (e.g., pathology, outcomes data, expert consensus) for body composition measurements. The substantial equivalence argument implies reliance on the already accepted performance of the predicate device and adherence to relevant standards.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This implies that the device's algorithms for body composition measurement were either developed or previously validated, and this 510(k) focused on demonstrating equivalence and safety of the new wireless feature rather than re-validating the core body composition algorithms.

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

Since no training set is mentioned, there is no information on how its ground truth was established.

Summary of Study Information Gaps:

The K130311 summary for the Transtek Body Fat Analyzer primarily focuses on demonstrating substantial equivalence to an existing predicate device, particularly concerning the addition of a wireless data transmission function. It emphasizes compliance with general electrical safety (IEC60601-1), electromagnetic compatibility (IEC60601-1-2, FCC Part 15), and risk management (ISO14971) standards.

Crucially, the document does not provide details on specific clinical studies, test sets, sample sizes, or ground truth establishment related to the accuracy of the body composition measurements (body fat, water, muscle, bone mass). This is a common characteristic of 510(k) submissions where a device is deemed substantially equivalent to a predicate, and the modifications are considered not to raise new questions of safety or effectiveness regarding the core function. The assumption is that the predicate device's performance has already been established.

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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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The Transtek Glass Body Fat Analyzer measure weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat, total body water percentage, bone mass, and muscle mass in generally healthy adults 18 years of age or older. It is intended for use in the home/domestic setting only.

Transtek Glass Body Fat Analyzer uses BIA (Bioelectrical Impedance Analysis) technology which passes an electrical current through the body to estimate body fat mass, total body water, muscle mass and bone mass. The electrical current is low and may not be felt. The current passes freely through the fluids contained in muscle tissue, but encounters difficulty/resistance when it passes through fat tissue. This resistance of the fat tissue to the current is termed 'Bioelectrical Impedance', and is accurately measured by Glass Body Fat Analyzer LS206-E. This method simultaneously calculates your personal weight, body fat, total body water, muscle mass and bone mass, giving you a more accurate reading of your overall health and fitness. This scale stores the personal data of up to 4 users. As well as being an analyzer, this device can be used as a conventional weight scale. Transtek Glass Body Fat Analyzer LS206-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 results from LS206-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 Glass Body Fat Analyzer Model: LS206-E". It focuses on establishing substantial equivalence to a predicate device, the TRANSTEK Glass Body Fat Analyzer, Model GBF-950-D (K112932).

Crucially, the document explicitly states: "Explanation: The new wireless function does not affect body analyzer measurement function. Therefore we have not done the Clinical test." This means no clinical study was performed to demonstrate the device meets acceptance criteria related to its core measurement functions (body fat, total body water, muscle mass, bone mass). The focus of the submission and the performance tests summary is on the safety and effectiveness of the wireless function integration and compliance with electrical and EMI standards, not on the accuracy of the body composition measurements.

Therefore, I cannot provide acceptance criteria or a study proving the device meets those criteria for the body composition analysis function based on the given information.

However, based on the information provided, here's what can be inferred and stated regarding performance and testing related to the wireless functionality and general device safety:

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

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

The document does not mention a "test set" for body composition measurements or a clinical study. The tests performed were "bench tests" related to design control, risk management, and verification for the device modifications (primarily the wireless function) and compliance with relevant standards. No specific sample size or data provenance is mentioned for these engineering/safety 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)

Not applicable. As no clinical test was performed to establish performance for body composition measurements, there were no experts establishing ground truth for such a test set. The submission focuses on engineering and regulatory compliance.

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

Not applicable. No clinical test was performed for body composition measurements.

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

Not applicable. This device is a standalone body composition analyzer, not an AI-assisted diagnostic tool requiring human reader interpretation. No MRMC study was performed.

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

A "standalone" performance for the body composition analysis (BIA technology) is implied to be identical to the predicate device, K112932, as the new device's core measurement function is stated to be unchanged. The submission primarily addresses the standalone performance of the wireless communication module and its non-interference with the core function. No new standalone performance evaluation for the BIA algorithm itself was conducted for this submission.

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

For the body composition measurements, this information is not provided in the summary, as no new clinical study was conducted. It is assumed the predicate device established its performance against some form of ground truth (e.g., DEXA or other established methods), but details are not present here.

For the wireless functionality and safety aspects, the "ground truth" is compliance with engineering standards (IEC, FCC, ISO) and verification that the wireless module performs its intended data transmission without negatively impacting the existing device functions. This "ground truth" is established through bench testing and adherence to published standard requirements.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that involves a training set in the conventional sense for its core function. The device uses BIA technology, which is based on established biophysical principles and algorithms, not a trainable model from a large dataset.

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

Not applicable, as there is no training set for an AI-based algorithm described in this submission.

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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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