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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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The Withings WBS01 Smart Body Scale is a body analyzer that measures weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat mass in generally healthy adults 18 years of age or older. It is intended for use in the home/domestic setting only.

WBS01 Smart Body Scale uses the BIA (Bioelectrical Impedance Analysis) technique. This method measures body composition by sending a low, safe electrical current through the body. 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 WBS01 Smart Body Scale.

WBS01 Smart Body Scale embeds a 802.11 (Wi-Fi) module that allows it to connect to the Internet. This module is a product add-on that is entirely independent from the body analyzer function, which does not rely on the wireless connection to carry out a bioelectrical impedance analysis and display its results. The scale uses this connectivity to offer users a complementary web and mobile interface to the scale's display, although users are instructed in the provided user manual that the only reference values are the measures displayed on the scale's display. By design. the body analysis and Wi-Fi functions never are enabled at the same time. The scale only connects to the Internet while no weight or bioelectrical impedance measures are being performed, and if a person steps on the scale while the Wi-Fi module is active, Wi-Fi immediately gets turned off therefore allowing the display and body analysis function to be enabled. The users profile details are stored locally in the scale so that they are immediately available when a bioelectrical impedance analysis needs to be performed. The scale without its Wi-Fi module is therefore an autonomous body fat analyzer, Wi-Fi functionality being a product add-on not being part of the body analyzer function and not affecting the safety and effectiveness of the body analyzer function in any way.

The provided text describes a 510(k) summary for the Withings WBS01 Smart Body Scale, which is a body analyzer that uses bioelectrical impedance analysis (BIA) to estimate body fat mass. The submission aims to demonstrate substantial equivalence to a predicate device, the TRANSTEK Glass Body Analyzer (Model: GBF-830).

However, the document does not contain a detailed study proving the device meets specific acceptance criteria with reported device performance values. It primarily focuses on comparing the proposed device to the predicate device and asserting substantial equivalence based on similar technology and intended use, with the main difference being the addition of Wi-Fi connectivity, which is described as not impacting the safety or effectiveness of the body analyzer function.

Therefore, many of the requested details about acceptance criteria, specific performance results, sample sizes, expert ground truth, and comprehensive study designs are not present in the provided text.

Here's a breakdown of what can and cannot be answered based on the provided document:

Acceptance Criteria and Study Information for Withings WBS01 Smart Body Scale

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document does not describe a clinical performance study using a "test set" in the traditional sense for evaluating body fat accuracy.
• Data Provenance: Not applicable, as a test set study with performance data is not described.

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

• Not applicable. No direct clinical performance study where expert ground truth was established for a test set is described in this 510(k) summary.

4. Adjudication method for the test set

• Not applicable. No test set requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and 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 that would involve human readers or MRMC studies.

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

• The device itself is a standalone algorithm/device for measuring body composition. However, the document does not describe a specific standalone performance study to quantify its accuracy against a gold standard (e.g., DEXA or underwater weighing). Instead, it relies on substantial equivalence to a predicate device. The "display results" are what the user sees, and these are presented as the "only reference values."

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

• Not explicitly stated for the proposed device's performance. For BIA devices, ground truth for body fat estimation typically involves methods like DEXA, underwater weighing, or MRI. The document does not mention the use of such a ground truth for testing the WBS01. It relies on the predicate device's established performance using BIA.

8. The sample size for the training set

• Not applicable. This document describes a medical device, not a machine learning model that would require a "training set" in the context of deep learning or advanced AI. The BIA technology itself is a well-established method using physics principles and calibrated algorithms, not a dynamically trained AI system.

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

• Not applicable, as there is no "training set" in the context of a machine learning algorithm being developed or presented in this submission. The BIA technology uses physical measurements and equations.

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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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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.

The TRANSTEK Glass Body Fat Analyzer uses BIA (Bio Impedance Analysis) technology which passes an electrical current through the body to estimate body fat mass, total body water and bone mass. The electrical current is small and may not be felt. Contact with the body is made via glass and stainless steel pads on the platform of the analyzer. This method simultaneously calculates your personal weight, body fat, total body water, bone mass and muscle mass, giving you a more accurate reading of your overall health and fitness. This scale stores the personal data of up to 4 or 8 users. As well as being an analyzer, this device can be used as a conventional scale.

The provided text describes a 510(k) premarket notification for the TRANSTEK Glass Body Fat Analyzer. However, the document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information regarding acceptance criteria, a specific study proving device performance against such criteria, sample sizes for test or training sets, ground truth establishment, expert involvement, or any multi-reader multi-case comparative effectiveness study.

The document states:
"The subject devices have all features of the predicate device, Transtek Glass Body Analyzer (Model GBF-950) except the new features and the power source voltage of the device. These differences do not affect the safety and effectiveness of the subject devices. BIA (Bioelectrical Impedance Analysis) technology is same as what is used in Glass Body Analyzer (Model GBF-950). Thus, the subject devices are substantially equivalent to the predicate devices."

This indicates that the submission relies on the established safety and effectiveness of the predicate device, rather than providing new performance data against specific acceptance criteria for the new models.

Therefore, I cannot populate the requested table and information based on the provided text.

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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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The Transtek Glass Body 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.

The TRANSTEK Glass Body Analyzer uses BIA (Bio Impedance Analysis) technology which passes an electrical current through the body to estimate body fat mass, total body water and bone mass. The electrical current is small and may not be felt. Contact with the body is made via glass and stainless steel pads on the platform of the analyzer. This method simultaneously calculates your personal weight, body fat, total body water, bone mass and muscle mass, giving you a more accurate reading of your overall health and fitness. This scale stores the personal data of up to 8 or 10 users. As well as being an analyzer, this device can be used as a conventional scale.

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets said criteria. However, based on the context of a 510(k) summary for a body composition analyzer, we can infer some general information and highlight what is missing.

The document states that the "TRANSTEK Glass Body Analyzer utilizes a "foot-to-foot" bioelectrical impedance analysis (BIA) technology to determine internal body composition" and that "BIA (Bioelectrical Impedance Analysis) technology is same as what is used in Scaleman Body Fat Scales (Model FS-148BW1)." This indicates that the primary "study" for acceptance is a demonstration of substantial equivalence to a predicate device already on the market (K083838, Scaleman Body Fat Scales).

Here's an attempt to answer your questions based on the provided text, while acknowledging the significant gaps in detail regarding a specific performance study:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The provided 510(k) summary does not contain any information about a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective). The assessment relies on the equivalence to a predicate device, implying that the predicate device's performance is an acceptable benchmark.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for a test set. Since a direct performance study is not detailed, the concept of expert-established ground truth for the device's accuracy isn't applicable in the provided information.

4. Adjudication Method

Not Applicable. No specific test set or ground truth establishment requiring adjudication is described in the provided text.

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

Not Applicable. The device is a direct measurement tool (body composition analyzer), not an AI-assisted diagnostic tool requiring human interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

6. Standalone (Algorithm Only) Performance Study

The provided text does not detail a standalone performance study where the algorithm's accuracy for body composition measurements was rigorously tested against a gold standard. The focus is on demonstrating that the BIA technology used is the same as the predicate device. While BIA itself is an "algorithm" to derive body composition from impedance, the document doesn't provide data on its standalone accuracy.

7. Type of Ground Truth Used

Not explicitly stated for the applicant device. For a body composition analyzer, common gold standards (ground truth) would include DEXA (Dual-energy X-ray absorptiometry) scans, hydrostatic weighing, or isotopic dilution methods. However, the document does not mention that this specific device was tested against such gold standards. Instead, the ground truth is implicitly tied to the accepted performance of the predicate device, which would have undergone such validation during its own clearance process.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This type of information would be relevant if the applicant device involved novel algorithms or machine learning requiring specific training data. Since the device relies on a known technology (BIA) and aims for substantial equivalence, a "training set" in the machine learning sense is not discussed.

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

Since no training set is discussed, the method for establishing its ground truth is not applicable/provided.

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