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Digital Thermometers are intended for the measurement and monitoring of human body temperature by doctor or consumers in the hospital or home.

It can be used for axillary measurement, oral measurement and rectal measurement.

Digital Thermometers comprises a thermistor for getting temperature signal, a reference resistor for comparing the resistance of the thermistor, a buzzer for sounding effect, an ASIC for processing the target temperature digitally, and a LCD for displaying the temperature result. The design principle of thermometer is based on thermos sensor and ASIC technology. A thermistor is used as thermos sensor. The ASIC gets the sensor's signal from human body, then processes the signal and calculates the result, after that displays the temperature result by a LCD.

The application describes a Digital Thermometer (Models: BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318) intended for measuring and monitoring human body temperature.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Measurement Accuracy" and "Response Time" listed and are identical to the predicate device. The performance is reported as meeting these criteria, asserting substantial equivalence.

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

The document states, "The whole product and manufacturing used for the Digital thermometer are identical to those of the predicate device... All hardware and software of the subject device are based on that of the predicate device (K172508), since no new testing is presented in the submission."

This indicates that no new test set or data provenance information is provided for the subject device (K193621). The substantial equivalence argument relies on the predicate device's prior testing and the assertion of identical components and manufacturing.

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 as no new testing data for the subject device is presented.

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

This information is not provided in the document as no new testing data for the subject device is presented.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable as the device is a digital thermometer, not an AI-assisted diagnostic tool requiring human interpretation.

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

The device itself is a standalone thermometer. The performance criteria (accuracy and response time) inherently describe its standalone performance. However, there's no dedicated study for the subject device's standalone performance described as separate from the predicate's established performance.

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

For a digital thermometer, the ground truth for performance testing is typically established using calibrated reference thermometers or environmental conditions to provide a known, accurate temperature for comparison. This document relies on the testing performed for the predicate device, which would have used such ground truth. Specific details on the ground truth for the predicate are not provided in this summary, but the listed standards (IEC 80601-2-56, ASTM E1112-00) dictate how such ground truth is established for clinical thermometers.

8. The sample size for the training set:

This information is not applicable/not provided as the device is not an AI/ML device that requires a training set.

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

This information is not applicable/not provided as the device is not an AI/ML device that requires a training set.

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Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.

Automatic Upper Arm Blood Pressure Monitor is designed to measure the systolic, diastolic and pulse rate of an individual by using a non-invasive technique which an inflatable cuff is wrapped around upper arm. Our method to define systolic and diastolic pressures is similar to the auscultatory method but using an electronic capacitive pressure sensor rather than stethoscope and mercury manometer. The sensor converts tiny alteration in cuff pressure to electrical signals; by analyzing those signals to define the systolic, diastolic and calculating pulse rate is a well-known technique in the market so called "oscillometric method". The device also has low voltage indication, which will be triggered when the battery is low.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Automatic Upper Arm Blood Pressure Monitor (Models: BA-801X, BA-802X, BA-803X, BA-805X, BA-806X, BA-811X, BA-812X, BA-813X, BA-821X, BA-822X, BA-823X, BA-826X, BA-818, BA-819)

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document states: "The whole product and manufacturing used for the Automatic Upper Arm Blood Pressure Monitor are identical to those of the predicate device, which were demonstrated to conform with the following standards: ... AAMI / ANSI / ISO 81060-2 Second Edition, Non-Invasive Sphygmomanometers Part 2: Clinical Validation of Automated Measurement Type. (Cardiovascular)."

However, the document does not directly provide the sample size or data provenance (e.g., country of origin, retrospective/prospective) for the clinical validation of the subject device itself. Instead, it refers to prior validation of the predicate devices. To get this information, one would need to consult the 510(k) submissions for predicate devices K153552 and K172895, as the subject device is deemed "substantially equivalent" to them based on these prior validations.

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

The document refers to the AAMI / ANSI / ISO 81060-2 standard for clinical validation. This standard typically involves trained observers (often medical professionals) to perform auscultatory blood pressure measurements, which serve as the ground truth.

However, the specific number of experts and their qualifications for the predicate device studies (which this device relies upon) are not explicitly stated in this 510(k) summary. The standard implicitly dictates the methodology for such experts to ensure accuracy.

4. Adjudication Method for the Test Set:

The document refers to the AAMI / ANSI / ISO 81060-2 standard. This standard specifies a rigorous methodology for obtaining reference blood pressure measurements, often including:

• Utilizing trained observers.
• Taking multiple consecutive measurements.
• Calculating the average of these measurements as the reference.
• Potentially discarding outlying measurements.

However, the specific adjudication method (e.g., 2+1, 3+1, none) used in the predicate device studies is not detailed in this 510(k) summary. One would need to refer to the original validation reports for the predicate devices.

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:

This device is an Automatic Upper Arm Blood Pressure Monitor and does not involve AI assistance for human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable and was not performed. The device takes direct measurements.

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

Yes, the device is an "Automatic Upper Arm Blood Pressure Monitor," indicating it operates in a standalone manner to measure blood pressure and pulse rate without continuous human interpretation or input during the measurement process. The clinical validation, by referring to AAMI / ANSI / ISO 81060-2, assesses the device's accuracy in autonomously taking these measurements against a reference standard.

7. The Type of Ground Truth Used:

The ground truth for blood pressure measurement, as stipulated by standards like AAMI / ANSI / ISO 81060-2, is typically established by trained observers using a validated reference method, such as auscultatory blood pressure measurement performed by healthcare professionals. This involves a mercury sphygmomanometer or an equivalent calibrated non-invasive device, with readings taken by at least two independent observers.

8. The Sample Size for the Training Set:

The document states: "All hardware and software of the subject device are based on that of the predicate device K153552 and K172895 since no new testing is presented in the submission." This implies that no new training set was explicitly created or used for the subject device beyond what was used for the predicate devices.

The text does not provide details on the training set or its size for the development of the oscillometric algorithm in either the subject device or its predicates. Blood pressure monitors using the oscillometric method are typically developed and calibrated by engineering teams using various physiological data and signal processing techniques. The "training" here refers more to the engineering development and calibration process rather than a machine learning training set with annotated data.

9. How the Ground Truth for the Training Set was Established:

As mentioned above, the development of an oscillometric blood pressure monitor involves engineering development and calibration. The "ground truth" during this development phase would typically involve:

• Reference blood pressure measurements: Using highly accurate, invasive (e.g., intra-arterial) or highly precise non-invasive (e.g., mercury sphygmomanometer with trained observers) methods during the development and calibration of the oscillometric algorithm.
• Physiological models and simulations: To refine the algorithm's ability to interpret oscillometric waveforms.
• Extensive testing against a range of patient populations: To ensure the algorithm performs robustly across different physiological conditions.

However, specific details on the ground truth establishment for the training set (developmental calibration) are not provided in this 510(k) summary. Such details would typically be part of the manufacturer's internal design and development files. The 510(k) summary primarily focuses on the clinical validation against established standards for regulatory approval.

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Automatic Wrist Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 13.5 cm~19.5 cm.

Automatic Wrist Blood Pressure Monitor is a battery driven automatic non-invasive blood pressure meter. It can automatically conduct the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at wrist within its claimed range and accuracy via the Oscillometry technique. The device also has low voltage indication, which will be triggered when the battery is low.

The provided document is a 510(k) summary for an Automatic Wrist Blood Pressure Monitor (K193628). It addresses the safety and effectiveness of the device by establishing substantial equivalence to a predicate device (K151281).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the subject device (Automatic Wrist Blood Pressure Monitor, K193628) has the same performance specifications as the predicate device (AGE Automatic Wrist Blood Pressure Monitor, K151281). The acceptance criteria are implicit in the predicate device's performance, as the subject device claims "substantial equivalence" based on these matching specifications.

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

The document mentions validation against standard AAMI / ANSI / ISO 81060-2 Second Edition, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type. This standard outlines clinical validation requirements for non-invasive sphygmomanometers. While the document does not explicitly state the sample size used for this specific validation for the subject device, it implies that this standard was followed.

It also notes that the predicate device similarly conformed to this standard. For blood pressure monitors, clinical validation studies typically involve a specific number of subjects (e.g., at least 85 subjects as per ISO 81060-2:2018 requirements), with measurements taken by trained observers against a reference standard.

The data provenance is not explicitly stated as retrospective or prospective for the subject device's validation, but adherence to a clinical validation standard like ISO 81060-2 usually implies prospective data collection for the clinical study. The country of origin of the data is not specified for the clinical validation.

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

The document does not directly state the number of experts or their qualifications for establishing the ground truth specifically for the subject device. However, compliance with ISO 81060-2 dictates the methodology for obtaining reference blood pressure measurements for clinical validation. This standard typically requires:

• A minimum of two trained observers (experts) to simultaneously obtain reference measurements using a calibrated auscultatory method.
• These observers need to meet specific training and accuracy criteria as outlined in the standard. While "radiologist with 10 years of experience" is not the relevant qualification here, the experts would be trained clinical professionals (e.g., physicians, nurses, or technicians) skilled in auscultatory blood pressure measurement.

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

The document does not explicitly state the adjudication method. However, for clinical validation studies adhering to ISO 81060-2, the standard typically requires simultaneous auscultatory measurements by two trained observers. Discrepancies between the two observers that exceed a certain threshold usually necessitate a third observer, or the exclusion of that measurement. This is a form of 2+1 adjudication, or a similar method for ensuring accuracy of the reference standard.

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 an Automatic Wrist Blood Pressure Monitor, which is a standalone measurement device, not an AI-assisted diagnostic tool that would involve human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.

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

Yes, implicitly. The device is an "Automatic Wrist Blood Pressure Monitor." Its core function is to automatically measure blood pressure and pulse rate without human intervention beyond placing the cuff and initiating the measurement. The validation against ISO 81060-2 is a clinical validation of the device's accuracy in a standalone capacity (i.e., comparing its automated readings to a reference standard).

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

The ground truth used for validating blood pressure monitors in accordance with ISO 81060-2 is expert auscultatory measurements (manual auscultatory method performed by trained observers) taken simultaneously or in quick succession with the device's measurements. This serves as the reference standard against which the automated device's readings are compared.

8. The sample size for the training set:

The document does not explicitly mention a "training set" or its sample size. For traditional medical devices like blood pressure monitors, while there is internal development and calibration, the term "training set" in the context of machine learning algorithms (as often seen with AI devices) is not typically used or disclosed in this type of regulatory submission. The focus is on the clinical validation of the final product.

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

As no explicit "training set" is discussed in the context of the device's regulatory submission in the provided text, the method for establishing its ground truth is not detailed. The primary regulatory focus for substantial equivalence is the clinical validation (test set) against established standards using expert auscultatory measurements as ground truth.

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Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.

Automatic Upper Arm Blood Pressure Monitor is designed to measure the systolic, diastolic and pulse rate of an individual by using a non-invasive technique which an inflatable cuff is wrapped around upper arm. Our method to define systolic and diastolic pressures is similar to the auscultatory method but using an electronic capacitive pressure sensor rather than stethoscope and mercury manometer. The sensor converts tiny alteration in cuff pressure to electrical signals; by analyzing those signals to define the systolic and calculating pulse rate is a well-known technique in the market so called "oscillometric method". The device also has low voltage indication, which will be triggered when the battery is low.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Automatic Upper Arm Blood Pressure Monitor:

This document is a 510(k) Summary for a medical device called "Automatic Upper Arm Blood Pressure Monitor" (Model: BA-815, BA-816) by DONGGUAN E-TEST TECHNOLOGY CO., LTD. It's a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

Crucially, this document states: "All hardware and software of the subject device are based on that of the predicate device (K172895), since no new testing is presented in the submission." This means that the acceptance criteria and performance data presented implicitly refer to the predicate device, as the subject device is deemed identical.

Acceptance Criteria and Reported Device Performance

The device is a non-invasive blood pressure monitor. The performance criteria are defined by the standard AAMI / ANSI / ISO 81060-2 Second Edition, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type.

Study Details (Based on the predicate device's compliance with AAMI / ANSI / ISO 81060-2)

Since "no new testing is presented in the submission" and the subject device is identical to the predicate, the compliance is based on the predicate device's clinical validation to AAMI / ANSI / ISO 81060-2 Second Edition. This standard outlines the requirements for clinical validation studies for automated non-invasive sphygmomanometers. The details below are inferred requirements from that standard, as the specific clinical study report is not provided in this 510(k) summary.

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

   • Sample Size: The AAMI / ANSI / ISO 81060-2 standard generally recommends a minimum of 85 participants for clinical validation studies, with a balanced distribution across age groups, genders, and blood pressure ranges (normotensive, hypertensive, hypotensive) to ensure robustness. The document does not explicitly state the sample size used in the predicate's study.
   • Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Clinical validation studies according to AAMI are typically prospective in nature, conducted in a controlled clinical environment.

2. 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):

   • The AAMI / ANSI / ISO 81060-2 standard requires at least two trained observers (experts) to perform simultaneous auscultatory measurements using a mercury sphygmomanometer as the reference standard (ground truth). These observers should be blinded to each other's readings and to the device under test.
   • The standard typically requires observers to be medically trained professionals (e.g., physicians, nurses) with demonstrated proficiency in indirect blood pressure measurement. Specific years of experience are not explicitly stated in the general overview of the standard but implied through training and certification. The document does not explicitly state the number or qualifications of experts for the predicate's study.

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

   • The AAMI / ANSI / ISO 81060-2 standard outlines specific protocols for comparing the automated device readings against the auscultatory measurements. If the two observers' readings differ by more than a predefined threshold, a third observer ("2+1") or a repeat measurement might be required to establish the ground truth or resolve discrepancies.
   • The document does not explicitly state the adjudication method used for the predicate's study, but a standard compliant study would have such a method.

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 type of study is relevant for imaging analysis or diagnostic aids where human interpretation is assisted by AI. This device is an automated blood pressure monitor; it does not involve human "readers" or AI assistance for interpretation in the same way an imaging system would. It provides direct numerical outputs for blood pressure and pulse rate.

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

   • Yes, a standalone study was done. The clinical validation per AAMI / ANSI / ISO 81060-2 is fundamentally a standalone clinical performance study. The automatic blood pressure monitor operates on its own, providing measurements, and its performance is compared directly against the reference standard (auscultatory method). There is no "human-in-the-loop" for the device's measurement process itself, although human interaction is required to apply the cuff and initiate the measurement.

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

   • The ground truth used for validating the accuracy of non-invasive blood pressure monitors under AAMI / ANSI / ISO 81060-2 is simultaneous auscultatory measurement performed by trained human observers using a mercury sphygmomanometer. This is considered the clinical reference standard for indirect blood pressure measurement.

7. The sample size for the training set:

   • Since no new testing was performed for the subject device and it is stated that "All hardware and software of the subject device are based on that of the predicate device," there is no specific mention of a training set for the subject device or for the predicate device's original validation. Automated blood pressure monitors are often developed and calibrated using internal data, but the AAMI validation focuses on clinical performance rather than a 'training/test' split akin to machine learning models. If the device uses a machine learning algorithm, the training set details would typically be proprietary and not disclosed in a 510(k) summary (unless it directly impacts the safety and effectiveness and needs specific validation).

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

   • As there's no explicitly mentioned "training set" in the context of this 510(k) summary, the method for establishing its ground truth is not provided. For the initial development and calibration of such a device, ground truth would likely be established through a combination of simulated physiological signals and clinical data obtained using reference methods like direct intra-arterial measurements or auscultatory measurements.

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