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Infrared Forehead Thermometer is intended for the intermittent measurement and monitoring of forehead temperature. The device is indicated for use by people of all ages in the home.

The Infrared Forehead Thermometer, model FR200 is a hand-held forehead thermometer and it is intended for the non-contact intermittent measurement and monitoring of forehead temperature which is based on the infrared energy emitted from the forehead. It is indicated for use by people of all ages in the home. After measurement, the temperature is directly shown on the LCD display so that the users can quickly get measurement results after properly scanning the forehead.

The provided document is a 510(k) summary for an Infrared Forehead Thermometer (Model FR200). It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets general acceptance criteria for a novel AI/software medical device.

Therefore, much of the requested information regarding acceptance criteria and study details for an AI/software device is not available in this document because it pertains to a different type of medical device (a thermometer) and regulatory pathway (substantial equivalence of a hardware device incorporating standard technology).

However, I can extract the information that is present and point out where the requested information is absent or not applicable given the context.

Here's a breakdown of what can be inferred or directly stated from the document:

Device Type: Infrared Forehead Thermometer (hardware device, not an AI/software image analysis device).
Regulatory Pathway: 510(k) - demonstrating substantial equivalence to a predicate device.

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

The document does not provide a general table of "acceptance criteria" for an AI/software device, as it is a thermometer. However, it does list performance specifications and testing standards that serve as benchmarks for this type of device.

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

• Test Set Sample Size: For the Clinical Accuracy study, the document states: "a clinical study was carried out on 160 subjects for all ages of population" (Page 7) and "consisting of 180 subjects, of which 60 subjects are infants, 60 subjects are children and the rest 60 subjects are adults" (Page 8). There is a discrepancy in the total number of subjects (160 vs 180). Assuming 60 per age group (infants, children, adults), 180 seems more consistent.
• Data Provenance: Not explicitly stated (e.g., country of origin, specific hospitals). The study is described as a "randomization, simple blind homologous control, pairing design of clinical investigation" (Page 8), indicating it was a prospective study specifically conducted for this submission.

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

Not applicable/available. This device is a thermometer. Its "ground truth" for temperature measurement is typically established by comparing readings against a reference thermometer (e.g., a rectal thermometer or other highly accurate standard) in a clinical setting, not through expert consensus on images. The document refers to meeting "acceptance criteria of the clinical study protocol" for repeatability, which would involve quantitative comparisons to a reference.

4. Adjudication method for the test set

Not applicable/available. Adjudication methods (e.g., 2+1, 3+1) are typically used for subjective assessments, like image reading, where multiple experts interpret data. For a thermometer, objective measurement comparisons are used.

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 is not an AI-assisted diagnostic device. It's a standalone thermometer.

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

Yes, in essence. The device functions as a "standalone" measurement tool. Its performance is evaluated intrinsically (how accurately it measures temperature), not in conjunction with human interpretation of complex data. The clinical accuracy study assesses the device's direct measurement capability.

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

For "Clinical Accuracy," the ground truth would be established by simultaneous measurements using a recognized reference standard thermometer (e.g., a rectal thermometer, an oral thermometer, or a highly accurate laboratory-grade thermometer) according to the ASTM E1965-98 and ISO 80601-2-56 standards. The document doesn't explicitly name the reference method used within the clinical study, but these standards prescribe such methods. It's an objective, quantitative comparison rather than subjective consensus.

8. The sample size for the training set

Not applicable. This is a traditional infrared thermometer, not an AI/machine learning model that requires a "training set."

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

Not applicable. As above, no training set for an AI model.

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The subject device intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual in hospitals, hospital-type facilities and home environments by using a non-invasive oscillometric technique with a single upper arm cuff (22-42 cm).

The device detects the appearance of irregular heart beats during measurement and gives a warning signal with readings.

The Subject device is not intended to be diagnostic device.

Combei Blood Pressure Monitor are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper 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 pulse rate, which is a well-known technique in the market called the "oscillometric method".

The main components of the Blood Pressure Monitor are 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 220 and 420 mm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve, Bluetooth tranismiision (optional) and the LCD. The subject devices are powered by four AA alkaline batteries or adatpter. 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 irreqular pulse rhythm when the difference of the time intervals is over a specified range.

The provided document contains information about the acceptance criteria and study that proves the device meets the acceptance criteria. Here's a summary of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states compliance with ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. This standard outlines the acceptance criteria for blood pressure monitor accuracy. While the specific numerical acceptance criteria (e.g., mean difference and standard deviation between the device and reference for systolic and diastolic blood pressure) are not explicitly detailed in the provided text, the document indicates that the results showed the accuracy of the blood pressure monitor is "within acceptable scope specified in ISO 81060-2."

From the "SE Comparison" table, the reported device accuracy is:

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

• Sample size for the test set: 85 patients
• Data provenance: Not explicitly stated, but the study was conducted as a "clinical investigation" for regulatory submission, implying prospective data collection. The manufacturer is Shenzhen Combei Technology Co., Ltd. from China, so the study was likely conducted in China.

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

The document mentions that "The manual Mercury Sphygmomanometer was used as a reference device" and that a "Same arm sequential method was adopted during the clinical testing." For non-invasive sphygmomanometer validation studies following ISO 81060-2, ground truth is typically established by trained observers using a reference manual sphygmomanometer. However, the exact number of experts/observers and their specific qualifications (e.g., radiologist with 10 years of experience) are not provided in this document.

4. Adjudication method for the test set:

The document states "Same arm sequential method was adopted during the clinical testing" using a manual Mercury Sphygmomanometer as a reference. This method involves taking simultaneous or sequential measurements by both the device under test and the reference method. For validation against ISO 81060-2, typically multiple observers take readings, and their readings are often averaged or adjudicated for the reference measurement. However, the specific adjudication method (e.g., 2+1, 3+1, none) is not explicitly detailed in the provided text.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on validating the accuracy of the automated blood pressure monitor against a manual reference standard, not on comparing human readers with and without AI assistance.

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

Yes, a standalone study was done. The clinical investigation described in section 8 (Brief discussions of clinical tests) evaluates the automated blood pressure monitor's performance directly against a reference device, without human interpretation of the device's output influencing the measurement. It's an algorithm-only (device-only) performance evaluation.

7. The type of ground truth used:

The type of ground truth used was measurements from a manual Mercury Sphygmomanometer, which serves as the reference standard for blood pressure measurement in accordance with ISO 81060-2.

8. The sample size for the training set:

The document does not provide information on the sample size for the training set. The clinical study mentioned (85 patients) is for validation/testing, not for training the algorithm. As a medical device that measures blood pressure using well-established oscillometric principles, it's possible that the core algorithm does not rely on a large, distinct "training set" in the same way a machine learning-based diagnostic algorithm would, or that such training data was internal to development and not disclosed in the 510(k) summary.

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

As no information is provided on a training set, the method for establishing its ground truth is also not mentioned.

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The subject device is intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual in hospitals, hospital-type facilities and home environments by using a non-invasive oscillometric technique in which an inflatable cuff(size: 12.5-21.5cm(4.9-8.5in) is wrapped around the single wrist.

The Subject device is not intended to be diagnostic device.

The Subject device is battery driven automatic non-invasive Blood Pressure Monitor. It consists of the Main Control Unit, LCD and attachments. The device can automatically complete the inflation, deflation and BP measurement, which intended to measure the diastolic, systolic blood pressures and pulse rate for an adult individual via the oscillometric technique.

The wrist style utilizes an inflatable cuff that is wrapped around the single wrist; the cuff circumference is limited to: 12.521.5cm(4.98.5in).

Here's an analysis of the provided text to fulfill your request:

Acceptance Criteria and Study for the Digital Blood Pressure Monitor-Wrist Style

The provided 510(k) summary indicates that the device was evaluated against the ISO 81060-2:2013 Non-invasive sphygmomanometers Part 2: Clinical validation of automated measurement type standard. This standard defines the acceptance criteria for accuracy in automated non-invasive sphygmomanometers.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Based on ISO 81060-2:2013)

*Note: The document states "The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2," but it does not provide the specific mean differences or standard deviations obtained from the clinical study.

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

• Sample Size (Test Set): Eighty-seven (87) patients. This consisted of 36 males and 51 females.
• Data Provenance: Not explicitly stated, but given the manufacturer (Shenzhen Combei Technology Co., Ltd. in China) and the submission date, it is highly likely that the data originates from China. The study is described as a prospective clinical investigation since patients participated in the study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: The document states that a "manual Mercury Sphygmomanometer was used as a reference device." This implies that the ground truth measurements were obtained by trained human operators using this reference device. However, the exact number of experts/operators and their specific qualifications (e.g., "physician with X years of experience," "trained technician") are not specified in the provided text.

4. Adjudication Method

• Adjudication Method: The document mentions a "Same arm sequential method" was adopted. This method typically involves taking measurements simultaneously or in rapid succession on the same arm by both the test device and the reference device. It does not explicitly describe an adjudication method for discrepancies between multiple readers, as the ground truth seems to be established by one or more operators using the reference manual device. Therefore, a specific adjudication method like "2+1" or "3+1" is not applicable or not specified in this context.

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

• Was an MRMC study done? No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI systems where human readers interpret medical images with and without AI assistance. This document describes a clinical validation for a blood pressure monitor, focusing on its accuracy against a reference standard.
• Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as no MRMC study was conducted.

6. Standalone Performance Study (Algorithm Only)

• Was a standalone performance study done? Yes, the clinical investigation described is essentially a standalone performance study of the algorithm within the device. The study directly compares the device's measurements against a reference standard (manual mercury sphygmomanometer) without human intervention in the device's measurement process, beyond initiating the measurement.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth was established by measurements obtained using a manual Mercury Sphygmomanometer as a reference device. This is considered an expert-derived reference standard as it relies on trained human operators properly using a calibrated, recognized reference instrument.

8. Sample Size for the Training Set

• Sample Size (Training Set): The document does not specify the sample size for any training set. Blood pressure monitors like this typically do not involve machine learning models that require explicit "training sets" in the same way AI algorithms for image analysis do. Their algorithms are usually based on established oscillometric principles and calibrated during manufacturing. Therefore, this question is likely not applicable to the device described.

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

• How Ground Truth for Training Set was Established: Not applicable, as no specific "training set" or explicit machine learning training process is described or implied for this type of device in the document.

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The subject device intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual in hospitals, hospital-type facilities and home environments by using a non-invasive oscillometric technique in which an inflatable cuff (size: 2232cm(8.712.6in) is wrapped around the single upper arm. The Subject device is not intended to be diagnostic device.

The Subject device is battery driven automatic non-invasive Blood Pressure Monitor. It consists of the Main Control Unit, LCD and attachments. The device can automatically complete the inflation, deflation and BP measurement, which intended to measure the diastolic, systolic blood pressures and pulse rate for an adult individual via the oscillometric technique. The Automatic Upper Arm style utilizes an inflatable cuff that is wrapped around the upper arm; the cuff circumference is limited to: 22cm32cm (8.7in12.6in).

The document is a 510(k) Pre-market Notification for a Digital Blood Pressure Monitor. It describes the device's characteristics, intended use, and comparison to a predicate device. The clinical validation data provided is specifically for demonstrating the accuracy of the blood pressure monitor.

Here's an analysis of the provided text to answer your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for accuracy are based on ISO 81060-2:2013, which specifies the requirements for clinical validation of automated non-invasive sphygmomanometers. The document states that the device's accuracy is "within acceptable scope specified in ISO 81060-2."

While ISO 81060-2 provides specific statistical criteria (mean difference and standard deviation of differences between the device and reference measurements), the document does not explicitly list these numerical criteria or the exact calculated performance metrics but rather makes a summary statement of compliance.

However, a "Substantial Equivalence Comparison" table (Table 1) provides the following for the subject device and predicate device:

Note: The accuracy characteristic listed as "Pressure: ±3mmHg; Pulse: ±5%" for the subject device seems to be a design specification or internal target, rather than reported clinical performance data resulting from the ISO 81060-2 study. The ISO standard specifies a statistical method to declare accuracy, not a simple range. The statement under section 9 "Brief discussions of clinical tests" that "The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2" is the key clinical performance outcome. Without the specific numerical results (mean difference and standard deviation) from the ISO 81060-2 test, a precise performance table cannot be constructed from this document.

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

• Sample Size for Test Set: Eighty-seven (87) patients.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as a "clinical investigation," which implies prospective data collection for this purpose.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

• For blood pressure accuracy studies following ISO 81060-2, "experts" in the traditional sense of image interpretation for AI are not typically involved in establishing ground truth.
• Ground Truth: The ground truth for blood pressure measurements is established by a manual Mercury Sphygmomanometer as the reference device, with measurements performed by trained personnel according to the standard. The document states: "The manual Mercury Sphygmomanometer was used as a reference device."

4. Adjudication Method for the Test Set

• Adjudication Method: The document describes a "Same arm sequential method" for the clinical testing. This is a specific protocol for comparing automated blood pressure readings to a reference standard, not an adjudication method in the context of multiple human readers for AI. It implies direct comparison of measurements taken immediately after each other.

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

• No, an MRMC comparative effectiveness study was not done. This study is for the clinical validation of a blood pressure monitor's accuracy against a standard, not an AI-assisted diagnostic device where human reader improvement would be measured.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, in essence. The validation described is for the device (the automated blood pressure monitor) itself, which functions as a standalone algorithm (oscillometric technique) to measure blood pressure without human interpretation of complex data (like medical images). It's comparing the device's automated readings to a reference standard.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth was established using a manual Mercury Sphygmomanometer as the reference device. This falls under the category of a reference standard method (a gold/silver standard where applicable) for physiological measurements.

8. The Sample Size for the Training Set

• Not Applicable/Not Provided: This document describes the clinical validation of a physical medical device (blood pressure monitor), not an AI/machine learning model where a distinct "training set" would be used for algorithm development. The device's underlying oscillometric algorithm is presumably developed and optimized by the manufacturer using internal methods, but this document does not detail that process or any "training set."

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

• Not Applicable/Not Provided: As mentioned above, this document does not refer to a training set for an AI model. The "ground truth" for the device's function is inherent in its design and the physical principles of oscillometry, calibrated and validated against established standards.

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