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The TRULYL Infrared thermometer TET-351 is intended for the intermittent measurement of human body temperature from the auditory canal and from the forehead for people of all ages used in the home setting. The non-contact thermometer detects infrared heat from the forehead at distance of about 1-2cm.

The TRULYL Infrared thermometer TET-351 is a hand-held, battery powered device designed to measure the body temperature through receiving infrared energy radiation via the ear canal or forehead. The thermometer has the capability to measure temperature via forehead temperature mode or ear temperature mode, and the temperature is directly shown on the LCD display. The results measured by TET-351 can also be transmitted to APP to record and display through Bluetooth.

This is an infrared thermometer (TET-351) that measures human body temperature from the auditory canal and forehead. The device is intended for home use for people of all ages.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the standard ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature. While the document states that the clinical study demonstrated compliance, it does not explicitly list the specific numerical acceptance criteria (e.g., accuracy limits) from ASTM E1965-98 within the provided text, nor does it provide detailed numerical results for the device's performance against those criteria beyond a general statement of compliance.

However, the comparison table with the predicate device does offer some insight into the accuracy specification, which would likely be the basis of the acceptance criteria:

Note: The "Different" note here implies that while the general accuracy ranges are similar, there might be slight variations in the specified temperature ranges where the higher accuracy applies. The report states that the clinical study demonstrated compliance with ASTM E1965-98 (Reapproved 2016), which would inherently define the specific acceptance criteria for accuracy.

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

• Sample Size for Test Set: A minimum of 150 subjects.
  • 1/3 children
  • 1/3 adults
  • The remaining 1/3 (implicitly infants) are not explicitly stated but are covered by the age categories: "Infants---newborn to one year; Children--- greater than one to five years; Adults--- greater than five years old."
• Data Provenance: The document does not explicitly state the country of origin of the data. It refers to "This clinical study" without specifying the location.
• Retrospective or Prospective: Not explicitly stated, but the description "This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation" strongly suggests a prospective study.

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

This information is not provided in the document. The study involves measuring patient temperature, which typically involves comparing the device's readings against a highly accurate reference thermometer (e.g., rectal or oral core temperature measurement, depending on the standard). The role of "experts" as ground truth adjudicators in the sense of image interpretation is not directly applicable here.

4. Adjudication Method for the Test Set

This information is not explicitly provided in the context of "adjudication" as it might apply to subjective assessments. For temperature measurement studies, the ground truth is typically established by measurements from a validated reference device, not by expert consensus or adjudication. The study design is described as "randomization, simple blind homologous control, pairing design," but this refers to the overall study methodology rather than a specific ground truth adjudication process.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted in the traditional sense of evaluating human readers with and without AI assistance, as this device is a standalone thermometer, not an AI-powered diagnostic imaging tool.

6. Standalone (Algorithm Only) Performance

A standalone performance study was done. The entire clinical study for the Infrared Thermometer TET-351 is a standalone performance evaluation, as it assesses the accuracy of the device itself (algorithm + hardware) against a reference standard in patients.

7. Type of Ground Truth Used

The ground truth implicitly used for clinical accuracy assessment for thermometers is a reference temperature measurement obtained from a highly accurate clinical reference device (e.g., glass thermometer, electronic thermometer, or other gold-standard method for core body temperature measurement). The standard ASTM E1965-98 outlines how these reference measurements should be obtained. The document does not explicitly state the specific reference method used, but it's central to the standard's methodology.

8. Sample Size for the Training Set

This information is not provided. As this is a medical device and not an AI/ML imaging algorithm that requires a separate training set, the concept of a "training set" in this context is not directly applicable for the device's primary function of temperature measurement. Any internal calibration or algorithm development would have been done prior to the clinical validation.

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

Given that this is an infrared thermometer and not an AI/ML imaging algorithm, a separate "training set" with established ground truth in the AI sense is not applicable. The device's underlying physics and calibration would be based on established temperature measurement principles.

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Truly Automatic Arm Blood Pressure Monitor DB series, Models DB66-1, DB68 are a series devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.

The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected.

The devices' feature include Bluetooth function to transmit data to an external Bluetooth device with wireless communication.

Automatic Arm Blood Pressure Monitor DB series, Models DB66-1, DB68 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 Truly Automatic Arm Blood Pressure Monitor DB series 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 340 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 and the LCD.

The devices 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 pulse rhythm when the difference of the time intervals is over 25%.

The devices embed a Bluetooth 4.0 Wireless network connections module that allows it to connect to nearby receiving end. Once measurement is over, the LCD of device displays results, and the device will start to send out data such as systolic, diastolic, pulse, date, time with Wireless method and protocol.

Here's an analysis of the provided text to fulfill your request, focusing on the acceptance criteria and the study that proves the device meets them.

The document describes the submission of a "Truly Automatic Arm Blood Pressure Monitor" (Models DB66-1, DB68) for 510(k) clearance, asserting its substantial equivalence to a predicate device (DB62, K161846).

Acceptance Criteria and Reported Device Performance

The core acceptance criteria for a non-invasive blood pressure monitor are its accuracy for both pressure and pulse readings. The document refers to compliance with ISO 81060-2:2013, which sets the standards for clinical validation of automated sphygmomanometers.

Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The document states:

"Testing Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intend use. The following tests were performed on the device. Compliant to the standard of ISO 81060-2: Second Edition 2013-05-01 Non-invasive sphygmomanometers- Part 2: Clinical validation of automated measurement type. The results of this clinical investigation show that the required limits for mean difference and standard deviation are fulfilled by the subject device."

This directly indicates that a clinical validation study, adhering to the ISO 81060-2 standard, was performed, and the device successfully met its requirements.

Detailed Information about the Study:

Given the provided text, some of the requested information is not explicitly detailed. However, based on common practice for ISO 81060-2 clinical validation studies for blood pressure monitors, we can infer some aspects and state what is present in the document.

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

• See table above. The document explicitly states the device's accuracy for pressure (± 3mmHg) and pulse (± 5%), and confirms "the required limits for mean difference and standard deviation are fulfilled by the subject device" according to ISO 81060-2.

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

• Sample Size: The document does not specify the exact sample size. However, ISO 81060-2 typically requires a minimum of 85 subjects for clinical validation. It can be assumed that the study met this minimum requirement to claim compliance.
• Data Provenance (Country of origin, retrospective/prospective): The document does not explicitly state the country of origin or if the study was retrospective or prospective, but clinical validation studies for regulatory submission are almost invariably prospective in nature.

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

• The document does not specify the number or qualifications of experts. For oscillometric blood pressure devices validated against ISO 81060-2, ground truth (reference blood pressure) is established by two trained observers using a mercury or auscultatory sphygmomanometer following a specific protocol. These observers are trained to accurately read the reference device.

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

• The document does not explicitly state the adjudication method. For ISO 81060-2, the ground truth is typically established by two independent observers taking simultaneous readings. If their readings differ by more than a specified amount, a third measurement (or a different method of reconciliation) might be employed, though two simultaneous, blinded observers are standard for the reference method.

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:

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools (e.g., radiology AI), not for a standalone non-invasive blood pressure monitor. The device is measuring a physiological parameter directly, not interpreting complex medical images for human assistance.

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

• Yes, in essence, this was a standalone performance test. The clinical validation per ISO 81060-2 assesses the accuracy of the automated device (algorithm + hardware) against a reference standard (manual auscultatory method). While a human applies the cuff and initiates the measurement, the device's measurement process itself is automated ("algorithm only" in the context of its function).

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

• The ground truth was established by simultaneous auscultatory measurements performed by trained observers using a reference sphygmomanometer (typically mercury or validated aneroid) on the contralateral arm or simultaneously on the same arm if protocol allows, per ISO 81060-2. This is the "expert consensus" of blood pressure measurement via a gold standard clinical method.

8. The sample size for the training set:

• The document does not provide information on a training set sample size. For medical devices primarily validated through performance testing against an ISO standard (like blood pressure monitors), the term "training set" in the context of machine learning (AI development) isn't directly applicable in the same way. The device's underlying "oscillometric method" is a long-established algorithm, not typically a deep learning model requiring a large training dataset in the same vein as image classification AI. The development of the algorithm might involve internal data, but it's not described here.

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

• As noted above, the concept of a "training set" with ground truth in the AI sense isn't directly applicable or described for this traditional medical device. The "ground truth" for the validation (test set) study was established through the gold-standard auscultatory method by trained observers. If any internal algorithm refinement involved data, it would likely follow similar principles of comparison to expert-measured reference values.

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Truly Automatic Arm Bluetooth Blood Pressure Monitor DB series, Models DB62, DB63, DB85 are a series devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.

The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected.

The devices' feature include Bluetooth function to transmit data to an external Bluetooth device with wireless communication.

Truly Automatic Arm Bluetooth Blood Pressure Monitor DB series, Models DB62, DB63, DB85 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 Truly Automatic Arm Blood Pressure Monitor DB series 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 340 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 and the LCD. The subject devices are powered by four AA alkaline batteries.

The devices 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 pulse rhythm when the difference of the time intervals is over 25%.

The devices embed a Bluetooth 4.0 Wireless network connections module that allows it to connect to nearby receiving end. Once measurement is over, the LCD of device displays results, and the device will start to send out data such as systolic, diastolic, pulse, date, time with Wireless method and protocol.

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

Device Name: Automatic Arm Bluetooth Blood Pressure Monitor (Models DB62, DB63, DB85)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the ISO81060-2 Standard. The reported device performance refers to the results of the clinical study.

Note on Criterion 2: The document provides a table for Maximum permissible standard deviation, Sm, as a function of mean error, xn. The reported Std for Criterion 2 (2.56 mmHg for systolic and 2.10 mmHg for diastolic) would need to be compared against the values in this table based on the reported mean errors (2.5 mmHg for systolic and 1.8 mmHg for diastolic) to explicitly confirm conformance. However, the study directly states, "Through clinical research, we can convinced that the clinical device is safe and effective," implying these values met the standard.

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

• Sample Size: 85 subjects.
• Data Provenance: The clinical study was conducted in a hospital. This suggests prospective data collection in a clinical setting, likely in the country of origin of the manufacturer (China), though not explicitly stated.

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

• Number of Experts: Two doctors.
• Qualifications of Experts: The document states "Simultaneous and blinded blood pressure determinations were performed by two doctors." Their specific qualifications (e.g., years of experience, specialization) are not detailed beyond "doctors."

4. Adjudication Method for the Test Set

• Adjudication Method: Implicitly, a simultaneous and blinded comparison against a standard mercury sphygmomanometer (reference standard) with two doctors performing the determinations. This suggests that the readings from the two doctors on the reference standard formed a consensus or averaged ground truth against which the device was compared. The document does not specify a formal adjudication process like "2+1" or "3+1" for resolving discrepancies between the two doctors, but rather implies their measurements constituted the reference.

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

• Was a MRMC study done? No, a MRMC comparative effectiveness study was not done. The study focused on the accuracy of the device against a gold standard, not on how human readers' performance improved with or without AI assistance.

6. Standalone Performance Study

• Was a standalone study done? Yes, the clinical study performed was a standalone study of the algorithm's performance. The device itself (Automatic Arm Bluetooth Blood Pressure Monitor) is the "algorithm only" in this context, as it automatically measures and displays blood pressure readings without a human-in-the-loop directly interpreting raw signals. Its performance was measured against the reference standard.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth was established using a standard mercury sphygmomanometer as a reference standard, with simultaneous and blinded blood pressure determinations performed by two doctors. This is a form of expert consensus/reference measurement, widely accepted for blood pressure monitor validation.

8. Sample Size for the Training Set

• Sample Size for Training Set: The document does not provide information regarding a specific training set or its sample size. This is common for devices that use established physiological measurement principles (like the oscillometric method for blood pressure) rather than complex machine learning models that require explicit training on large datasets for regulatory submission. The "oscillometric method" itself is a well-known technique.

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

• How Ground Truth for Training Set Was Established: As no specific training set is mentioned, the method for establishing its ground truth is not applicable/not provided in this document. The device operates based on the "oscillometric method," which is a pre-established principle rather than a continuously learning algorithm requiring a dedicated, labeled training set like many AI/ML devices.

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The Truly TET-350 TET-370 is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal , pediatric and adult population used in the home setting.

Truly Infrared Ear Thermometer TET-350 TET-360 TET-370

The provided document is a 510(k) summary for an Infrared Ear Thermometer. It does not contain a study report or detailed information about acceptance criteria and device performance based on a study.

Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on the device's classification, substantial equivalence to a predicate device, and regulatory approval. It does not include specific performance data or study details.

To answer your request, a study report detailing performance metrics would be necessary.

Ask a specific question about this device

Ask a specific question about this device