Search Results
Found 27 results
510(k) Data Aggregation
(369 days)
The Digital Thermometer is intended to measure body temperature orally, rectally and under the arm (armpit). The devices are reusable in a clinical or home use setting on people of all ages, including children under the age of 8 with adult supervision.
Digital Thermometer
The provided text is a 510(k) clearance letter from the FDA for a Digital Thermometer. It does not contain the specific technical details, acceptance criteria, or study results that would typically be found in a performance study report.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, not on the detailed scientific evidence of performance against specific acceptance criteria.
Ask a specific question about this device
(152 days)
The digital thermometer is intended for the measurement and monitoring of human body temperature through or axillary as the measurement site on people of all ages by doctor or user in the hospital or home.
Digital Thermometer, Model T28, T28L
The provided document is an FDA 510(k) clearance letter for a Digital Thermometer, Model T28, T28L. This device is a standard medical instrument for measuring body temperature and does not involve AI or complex algorithms requiring extensive studies as described in the prompt's request.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML-driven medical devices, are not applicable to this specific product.
Here's a breakdown based on the characteristics of the device and the provided document:
1. A table of acceptance criteria and the reported device performance
- Not applicable in the context of AI/ML performance. For a digital thermometer, acceptance criteria would typically involve accuracy, precision, response time, and environmental operating limits, as defined by international standards (e.g., ISO 80601-2-56 for clinical thermometers). These technical performance specifications are usually provided in the device's design and testing documentation submitted to the FDA, but they are not detailed in this clearance letter. The letter confirms substantial equivalence, implying these technical specifications meet regulatory requirements.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for AI/ML performance. For a digital thermometer, testing would involve physical measurements on a range of test subjects or using calibrated thermal sources, not a "test set" of data in the AI sense. The document does not provide details on the sample sizes for these physical performance tests or their provenance.
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. "Ground truth" in the context of expert consensus is not relevant for a digital thermometer. Accuracy is typically validated against highly calibrated reference thermometers (e.g., in a metrology lab) or in clinical trials against established methods, not by expert consensus on data interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are used to resolve disagreements among multiple experts interpreting complex data, which is not relevant for the direct measurement function of a digital thermometer.
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 not an AI-assisted diagnostic tool. An MRMC study is completely irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not have an "algorithm only" component that operates independently for diagnosis or prediction. It's a measurement device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the context of expert consensus/pathology/outcomes data. For a digital thermometer, the "ground truth" for its accuracy and performance testing would be highly accurate reference measurements from certified calibration equipment or established clinical comparison methods, not subjective expert assessment.
8. The sample size for the training set
- Not applicable. This device does not use machine learning, therefore, there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, there is no ground truth to establish for it in this context.
In summary: The FDA 510(k) clearance letter for the Digital Thermometer, Model T28, T28L, indicates a device that does not leverage AI/ML algorithms. Therefore, the detailed questions about acceptance criteria, study design, and ground truth establishment specific to AI-driven devices are not applicable to the information provided in this document. The clearance signifies that the device has demonstrated substantial equivalence to a legally marketed predicate device based on its intended use and conventional performance standards for clinical thermometers.
Ask a specific question about this device
(223 days)
The Digital Thermometer QT001 is intended to measure the human body temperature in armpit, orally or rectally, and the device is reusable for clinical or home use on people of all ages.
The digital thermometer QT001 is hand held device which can measure human body's temperature at the site of armpit, orally or rectally, the device is reusable for clinical or home use on people of all ages. The results can be displayed on LCD. The QT001 has only one operating mode: direct mode. The digital thermometer measures temperatures of human body by placing the probe tip into the armpit, oral, rectum directly with the measuring time about 3 minutes. The digital thermometer consists of a temperature sensor, low power consumption integrated circuit(IC),LCD display and buzzer. The resistance of sensor changes with temperature and the IC converts the resistance to frequency and calculates the temperature according to the relation of resistance and frequency. The calculated temperature is displayed on the LCD. The thermistor sensor(Type:503F) reacts to temperature. In different temperature, the thermistor has a different resistance value. The essence of temperature measurement is actually measuring the resistance of the sensor, usually is to change the resistance into voltage or current and other analog signals, and digital signals, and then the processor converts the signals to the corresponding temperatures. QT001 has several functions, such as beep alarm, unit switchable, low battery detection, memories, backlight, auto power off functions.
Here's a breakdown of the acceptance criteria and study information for the Digital Thermometer (Model QT001), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard Requirement) | Reported Device Performance (Model QT001) | Verdict/Comment |
|---|---|---|
| Measurement Range | $32.0~42.9 °C (89.6°F ~ 109.2°F)$ | Meets ASTM E1112:00 and ISO 80601-2-56 requirements |
| Accuracy | $±0.1°C, 34.0°C-42.0°C (±0.2°F, 93.2°F-107.6°F)$$±0.2°C$ under $34.0°C$ or over $42.0°C$ ($±0.4°F$ under $93.2°F$ or over $107.6°F$) | Meets ASTM E1112:00 and ISO 80601-2-56 requirements |
| Display Resolution | $0.1 °C/0.1 °F$ | Identical to predicate device |
| Operating Range (Temperature) | $5°C-40°C (41°F -104°F)$ | Meets IEC60601-1 and ISO 80601-2-56 requirements |
| Operating Range (Relative Humidity) | $15%RH-95%RH$ | Meets IEC60601-1 and ISO 80601-2-56 requirements |
| Operating Range (Atmospheric Pressure) | $70kPa-106kPa$ | Meets IEC60601-1 and ISO 80601-2-56 requirements |
| Storage & Transport Temp. | $-20℃~55℃ (-4°F ~ 131°F)$ | Meets IEC60601-1 and ISO 80601-2-56 requirements |
| Storage & Transport Relative Humidity | $15%RH-95%RH$ | Meets IEC60601-1 and ISO 80601-2-56 requirements |
| Storage & Transport Atmospheric Pressure | $50kPa-106kPa$ | Meets IEC60601-1 and ISO 80601-2-56 requirements |
| Measurement Time | Approximate 3 minutes | Performance test conducted and meets ISO 80601-2-56 |
| Safety (Electrical) | Complied with IEC 60601-1 | Verified with standard |
| EMC | Complied with IEC 60601-1-2 | Verified with standard |
| Biocompatibility | Complied with ISO 10993-5 and ISO 10993-10 | Verified with standard |
| Performance Standard | Complied with ISO 80601-2-56:2017/AMD 1:2018 and ASTM E1112:00(2018) | Verified with standards |
| Software Life Cycle Processes | Complied with IEC 62304:2006+AMD1:2015 | Verified with standard |
| Home Healthcare Environment | Complied with IEC60601-1-11:2015 | Verified with standard |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "performance testing shows the subject device complies with standard ISO 80601-2-56," and "performance test was conducted in accordance with ISO 80601-2-56." and "software verification and validation were conducted". These standards, particularly ASTM E1112:00 and ISO 80601-2-56, define methodologies and requirements for testing clinical thermometers, which would inherently involve a test set of measurements. However, the specific number of subjects, measurements, or the origin of this data is not detailed in this summary.
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. For a clinical thermometer, the "ground truth" for temperature measurements would typically be established by highly accurate reference thermometers or methods in a controlled laboratory setting, rather than human experts in the way AI/radiology studies utilize them.
4. Adjudication Method for the Test Set:
This information is not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessment. For a device like a digital thermometer measuring a physical parameter against a standard, the "adjudication" is inherent in the comparison to the reference standard's reading and the pass/fail criteria of the specified accuracy.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation and reader variability, such as medical imaging AI. The Digital Thermometer is a standalone measurement device; its performance is not evaluated in terms of how it "improves" human reader performance.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a standalone study was done. The entire "Test Summary" section describes the non-clinical tests conducted on the Digital Thermometer (Model QT001) to demonstrate its compliance with various international standards (ASTM E1112-00, IEC 60601-1, ISO 80601-2-56, etc.). This inherently means the device's performance was evaluated independently without human intervention influencing its measurement accuracy.
7. The Type of Ground Truth Used:
The ground truth used for calibration and accuracy verification is the readings from highly accurate reference thermometers or validated temperature sources that meet the requirements of the specified standards (e.g., ASTM E1112-00, ISO 80601-2-56). These standards outline the methods for generating and comparing measurements against known, precise temperatures.
8. The Sample Size for the Training Set:
The document does not mention a training set in the context of machine learning or AI models. This device is a traditional digital thermometer based on a thermistor and embedded firmware for calculation, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a machine learning model or a training set, the establishment of ground truth for a training set is not applicable to this device described in the submission. The device's functionality relies on established physics and pre-programmed algorithms, not learned patterns from data.
Ask a specific question about this device
(389 days)
DT007 Digital Thermometer is intended for the measurement of human body temperature by doctors or customers in the hospital or at home. It can be used for axillary, oral temperature measurement at home, and used for axillary, oral and rectal temperature measurement in the hospital. The rectal body temperature measurement cannot be used for multi-patient use at home. The product is reusable and provided nonsterile. The device is intended for use on people of all ages.
DT008 Digital Thermometer is intended for the measurement of human body temperature by doctors or customers in the hospital or at home. It can be used for axillary, oral temperature measurement at home, and used for axillary, oral and rectal temperature measurement in the hospital. The rectal body temperature measurement cannot be used for multi-patient use at home. The product is reusable and provided nonsterile. The device is intended for use on people of all ages.
The basic principle of Digital Thermometer is that a change in thermistor resistance is caused by a change in temperature. The device measure body temperature by using a direct mode. The resistance is measured by a microcontroller unit, so that changes in temperature will correspond to changes in resistance. And the temperature value is displayed on the LCD screen. The device can be used for axillary, oral in the home, and used for axillary, oral and rectal temperature measurement in the hospital. The device is reusable and provided non-sterile. The device is intended for use on people of all ages. The probe cover is required when measuring the oral or rectal temperature, but not when measuring the axillary temperature.
The Digital Thermometer includes two models: DT007 and DT008. The differences of these two models are in appearance, PCB layout, external dimension and weight. All of them have the same function and they have the following basic functions:
- Data displayed on LCD
- Automatic stop (energy saver)
- Small, convenient, easy to use
The provided text describes the acceptance criteria and a study for a Digital Thermometer (Models DT007, DT008). Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are generally implied by conformity to specific standards and the stated "Measuring Accuracy". The reported device performance is presented in the comparison table with the predicate device and the non-clinical test summary.
| Acceptance Criteria (Implied by Standards) | Reported Device Performance (Subject Device) |
|---|---|
| Measuring Accuracy: To meet requirements of ASTM E1112 and ISO 80601-2-56. | * $32.0^\circ C \sim 35.9^\circ C \pm 0.2^\circ C$ |
| * $36.0^\circ C \sim 39.0^\circ C \pm 0.1^\circ C$ | |
| * $39.1^\circ C \sim 42.9^\circ C \pm 0.2^\circ C$ | |
| Electromagnetic Compatibility & Electrical Safety: Compliance with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11. | Tested in compliance with ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-2:2014, and IEC 60601-1-11:2015. |
| Biocompatibility: Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10 for human body contacting material. | Same human body contacting material as cleared device K163603; safety demonstrated in K163603 submission, complying with ISO 10993-1, ISO 10993-5 and ISO 10993-10. |
| General Performance: Compliance with ISO 80601-2-56 and ASTM E1112 for body temperature measurement. | Tested in compliance with ISO 80601-2-56:2017+A1:2018 and ASTM E1112-00 (Reapproved 2011). |
| Software Verification: Compliance with FDA guidance "Guidance for the Content of Premarket Submissions for Software in Medical Devices" (May 11, 2005). | Software documentation provided in accordance with FDA guidance "Guidance for the Content of Premarket Submissions for Software in Medical Devices" issued May 11, 2005. |
| Operating Environment Condition: Ambient temperature, relative humidity, pressure altitude. | Ambient temperature: $5^\circ C \sim 40^\circ C$ ($41^\circ F \sim 104^\circ F$); Relative humidity: $\le 85%$; Pressure altitude: 700hPa to 1060hPa. (Passed performance tests; no adverse impact on safety/effectiveness) |
| Storage Condition: Storage temperature, storage humidity, pressure altitude. | Storage temperature: $-20^\circ C \sim 55^\circ C$ ($-4^\circ F \sim 131^\circ F$); Storage humidity: $\le 95%$; Pressure altitude: 700hPa $\sim$ 1060hPa. (Passed performance tests; no adverse impact on safety/effectiveness) |
| Response Time: Sufficient response time for temperature measurement. | 30s. (Passed performance tests; no adverse impact on safety/effectiveness) |
| Auto-off Time: Sufficient for intended use. | 10 mins. (Sufficient for intended user to obtain temperature data; no adverse impact on safety/effectiveness) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "performance test" against standards like ASTM E1112 and ISO 80601-2-56. These typically involve rigorous testing of multiple units under controlled conditions. However, the specific sample size of devices tested and the number of measurements taken for these performance tests are not explicitly stated in the provided text. The document also does not provide details on data provenance (country of origin, retrospective/prospective).
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 applicable as the device is a digital thermometer, and the "ground truth" for temperature measurements is established against traceable reference standards and methods as defined by the performance standards (e.g., ASTM E1112, ISO 80601-2-56), not by human expert consensus or interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for a digital thermometer as its performance is objectively measured against physical standards, not through expert adjudication of subjective interpretations.
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 information is not applicable as the device is a digital thermometer and does not involve AI assistance or human reader interpretation for its primary function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to a digital thermometer in the context of diagnostic AI algorithms. The device itself is solely responsible for measuring temperature, and its performance is evaluated in a "standalone" manner (i.e., the device itself without human intervention affecting the measurement accuracy).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance evaluation of the digital thermometer is based on established metrological standards and reference temperatures as outlined in the technical standards ASTM E1112 and ISO 80601-2-56. These standards define the acceptable deviation from a true reference temperature.
8. The sample size for the training set
This information is not applicable as the digital thermometer is a hardware device with embedded firmware for measurement, not a machine learning or AI algorithm that requires a "training set" in the conventional sense.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as #8.
Ask a specific question about this device
(208 days)
The AOJ-25 series Digital Thermometer (except AOJ-25B) are designed as reusable battery-operated electronic device, and intended for the measurement of oral, armpit and rectal temperature for people of all ages at home.
The AOJ-25B is intended to measure temperature rectally only for people of all ages at home as well. The device is reusable.
The digital thermometer is designed as hand-held device which can measure human body's temperature orally, axillary (under the arm), or rectally. The results can be displayed on LCD.
The digital thermometers have several functions, such as beep indication, °C and °F unit switchable, low battery detection, memories, three-color backlight, auto automatic power off functions.
The device is a predictive digital thermometer. Users only need 10 seconds for quick reading, and will display the temperature value on the screen.
The provided FDA 510(k) K213485 submission describes the acceptance criteria and the study that proves the Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E meets these criteria.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
The submission primarily focuses on the clinical accuracy of the thermometer as a key performance criterion, referencing the ISO 80601-2-56 standard.
| Acceptance Criteria (from ISO 80601-2-56) | Reported Device Performance |
|---|---|
| Clinical accuracy of the subject device is at least the same as that of the reference device. | Demonstrated to be accurate within ±0.1°C as claimed in the manual. |
| No single measurement error exceeding the allowable limit. | Achieved with 99% confidence. Includes a reference device comparison. |
Note: The document also mentions other performance aspects like electrical safety, EMC, and biocompatibility, which are met through compliance with relevant IEC and ISO standards. However, specific "acceptance criteria" and "reported performance" are not detailed in a table format for these aspects within the provided text, beyond stating compliance.
2. Sample size used for the test set and the data provenance
- Sample Size: A minimum of 90 subjects were used for the clinical accuracy study.
- Data Provenance: The document does not explicitly state the country of origin. It indicates a "clinical study" was conducted, referring to it as a "randomization, simple blind homologous control, pairing design of clinical investigation." It is implied to be a prospective study due to the nature of a clinical investigation outlined by the standard.
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 used to establish the ground truth. It states that a "reference device is introduced as required by the standard," implying that the ground truth for temperature measurements during the clinical study was established by this validated reference device, not by human expert interpretation.
4. Adjudication method for the test set
The document mentions a "simple blind homologous control, pairing design of clinical investigation." This suggests a comparative design with a reference device. It does not describe an explicit adjudication method involving multiple human readers for differing interpretations, as the ground truth is based on the objective measurement of temperature by a reference device according to the standard.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. This device is a digital thermometer, not an imaging device requiring human interpretation of clinical images. The study focuses on the accuracy of the temperature measurement itself, not on human readers' interpretation of output.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the clinical accuracy study for the digital thermometer is essentially a standalone performance evaluation of the device in measuring temperature. While the device is used by a human, the performance measured is the accuracy of the device's output against a reference, not its performance in assisting human decision-making or interpretation.
7. The type of ground truth used
The ground truth for the clinical accuracy study was established by a reference device as required by the ISO 80601-2-56 standard. This reference device is used to measure the body temperature against which the subject device's measurements are compared.
8. The sample size for the training set
The document does not provide information about a separate "training set" or its sample size. For medical devices like digital thermometers, the development process typically involves calibration and validation against known standards, which is distinct from the machine learning "training set" concept often associated with AI/ML devices. The "clinical study" described serves as the validation of the final algorithm's accuracy.
9. How the ground truth for the training set was established
As there is no mention of a traditional machine learning training set, the concept of establishing ground truth for it is not applicable here. The device's underlying "algorithm" (firmware) related to temperature measurement would be calibrated and developed based on the physical principles of thermistor resistance and validated through bench testing and the described clinical study against a precise reference thermometer.
Ask a specific question about this device
(127 days)
Ask a specific question about this device
(267 days)
The digital thermometer intended for the measurement and monitoring of human body temperature by users for home use. It can be used for axillary measurement and oral measurement.
The digital thermometer is an electronic thermometer using a thermistor to measure human body temperature for people of all ages. The digital thermometer are designed to be non-sterile, reusable clinical thermometers intended for the determination of human body temperature by contact the sensing probe with patient's axillary and oral. The measurement duration is less than 1 minute. The device has a storage function in which the last measured value is automatically stored after measurement is successfully completed. This device is designed for people of all ages to use at home. There is BF applied part. No special protection against the use in the environment of ignitable gases.
The provided text is a 510(k) summary for a digital thermometer (Models T103, T104). It describes the device, its intended use, comparison to a predicate device, and the testing performed to demonstrate substantial equivalence.
Here's an analysis to extract the requested information, specifically focusing on the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document references compliance with several international and industry standards, including specific performance requirements related to temperature measurement accuracy. The acceptance criteria are implicit in these standards, and the reported performance is that the device "Pass[es]" the tests and "complies with the applicable requirements."
| Acceptance Criteria (Standard Reference & Description) | Reported Device Performance |
|---|---|
| ISO 80601-2-56: 2017 & ASTM E1112-00 (2008) - Performance Testing (Laboratory & Clinical Accuracy) - Displayed temperature range - Laboratory accuracy - Ambient conditions for operation and storage - Identification, marking, and documents - Clinical accuracy and repeatability for axillary and oral measurements | Pass "The T103 and T104 digital thermometer complies applicable requirements of ISO 80601-2-56 and ASTM E1112 including displayed temperature range, laboratory accuracy, ambient conditions for operation and storage, identification, marking and documents." "The subject complies with the applicable requirements set forth in the referenced performance standards." "The methods and criteria of clinical accuracy and repeatability testing had been clinically assessed to meet the requirements of clinical accuracy per the referenced standards." |
| IEC 60601-1: 2005/A1: 2012 - Electrical Safety Testing - General requirements, protection against electrical hazards, mechanical hazards, excessive temperatures, hazardous situations, fault conditions, and constructions. | Pass "The subject complies with the applicable requirements set forth in the referenced electric safety standard." "The digital thermometer complies with to applicable IEC 60601-1 requirements..." |
| IEC 60601-1-2: 2014 - EMC Testing - Radiated emission test, electrostatic discharge immunity test, radiated RF electromagnetic field immunity test, power frequency magnetic field immunity test. | Pass "The subject complies with the applicable requirements set forth in the referenced EMC standard." "The digital thermometer complicable IEC 60601-1-2 requirements..." |
| IEC 60601-1-11: 2015 - Electrical Safety for Medical Devices in Home Healthcare Environment | Pass "The subject complies with the applicable requirements set forth in the referenced IEC 60601-1-11:2015." "For lay person, the IEC 60601-1-11 was performed and the thermometer is accordance with applicable requirements." |
| IEC 60601-1-6 Edition 3.1 2013-10 - Usability | Pass "The subject complies with the applicable requirements set forth in the referenced IEC 60601-1-6:2010+A1:2013." "Usability testing was completed in accordance with IEC 60601-1-6 and the digital thermometer is complied with the applicable requirements of standard." |
| ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2010 - Biocompatibility Testing - Cytotoxicity, Sensitization, and Irritation for patient-contacting materials (cap and outer shell). | Pass "The subject complies with the applicable requirements set forth in the referenced biological evaluation standards." "Biocompatibility of patient-contacting materials (cap and outer shell) was performed according to ISO 10993-1/5/10..." |
| Software Verification and Validation (according to "Guidance for the content for premarket submissions for software contained in medical devices") | "Software verification and validation report in accordance with 'Guidance for the content for premarket submissions for software contained in medical devices'." (Implicitly "Pass" as part of the overall acceptance for substantial equivalence.) |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: For clinical accuracy and repeatability testing, the study involved 150 subjects, divided into three age groups of 50 subjects each: infants (0-1 year), children (1-5 years), and adults (>5 years).
- Data Provenance: The document does not explicitly state the country of origin for the clinical data or whether it was retrospective or prospective. However, given the manufacturer is based in China and the nature of a 510(k) submission, it is likely that the testing (including clinical) was conducted in a controlled, prospective manner to meet regulatory requirements, potentially in China or a region where the standards are applicable.
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 used to establish the ground truth for the clinical accuracy and repeatability testing. It simply states that "The methods and criteria of clinical accuracy and repeatability testing had been clinically assessed to meet the requirements of clinical accuracy per the referenced standards." For a digital thermometer, the ground truth for temperature measurement is typically established by highly accurate reference thermometers or alternative validated methods under controlled clinical conditions, rather than expert consensus in the way image-based diagnoses might be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not mention any adjudication method for the test set. Given the nature of a digital thermometer measuring a physiological parameter (body temperature), adjudication by multiple readers is not typically applicable in the same way it would be for interpreting medical images. The "ground truth" for temperature measurement would be derived from a highly accurate 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 study is for a digital thermometer, which is a direct measurement device, not an AI-powered diagnostic tool that assists human readers. Therefore, the concept of human readers improving with or without 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, the primary performance evaluation for this digital thermometer is its standalone performance in measuring body temperature. This means its accuracy and repeatability are assessed directly against established standards (ISO 80601-2-56 and ASTM E1112) without human interpretation affecting the device's reading. The user simply reads the displayed temperature.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the clinical accuracy and repeatability testing for the digital thermometer would be highly accurate reference temperature measurements obtained through methods specified by the referenced standards (ISO 80601-2-56 and ASTM E1112). These standards outline precise methods for temperature measurement validation, often using known stable temperature baths or highly calibrated reference thermometers. It's not based on expert consensus, pathology, or outcomes data in the way a diagnostic imaging AI would be.
8. The sample size for the training set
This document does not specify a training set sample size. Digital thermometers are hardware devices that perform a direct physical measurement using a thermistor and convert it to a digital display. They are not typically "trained" in the same way a machine learning algorithm would be. Their performance is inherent in their design, calibration, and manufacturing consistently across units.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of an AI/machine learning algorithm for this device. The device's performance is driven by its engineering and adherence to established physical principles and manufacturing tolerances, validated against standards using the test set described.
Ask a specific question about this device
(333 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Measurement Accuracy: | |
| 35.0 ~ 39.0°C | +/- 0.1°C |
| The rest (outside 35.0-39.0°C) | +/- 0.2°C |
| Response Time: | 60s |
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.
Ask a specific question about this device
(121 days)
The Digital Thermometer DMT-4756 is intended to measure the human body temperature in regular mode orally, rectally or under the arm, and the device is reusable for clinical or home use on people of all ages, including children under 8 with adult supervision.
The digital thermometer DMT-4756 is hand held device which can measure human body's temperature orally, axillary (under the arm), and rectally. The results can be displayed on LCD. The flexible tip is foldable,when the flexible tip folded, DMT-4756 is used to measure human body's temperature rectally, while the flexible tip unfolded, it is used to measure temperature orally and axillary (under the arm). The digital thermometer have several functions,such as beep alarm,unit switchable, low battery detection,memories,backlight,auto power off functions. DMT-4756 is a predictive digital thermometer. Users only need 10 seconds for predictive quick read and 30 seconds for final temperature readings.
This document is a 510(k) summary for the Joytech Healthcare Co., Ltd. Digital Thermometer, Model DMT-4756. It outlines the device's characteristics, its comparison to a predicate device, and the testing conducted to demonstrate its substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Test | Acceptance Criteria (from predicate or standard) | Reported Device Performance (DMT-4756) |
|---|---|---|
| Accuracy (Temperature) | ±0.1°C between 35.5°C to 42.0°C (±0.2°F, 95.9°F-107.6°F) ±0.2°C under 35.5°C or over 42.0°C (±0.4°F under 95.9°F or over 107.6°F) | Identical to predicate device. Clinical performance test protocol and data analysis conducted in accordance with ISO 80601-2-56. "The test report showed the clinical performance of the subject device complied with the requirement of ISO 80601-2-56." |
| Measurement Range | 32.0°C~43.9°C (89.6°F-111.0°F) | Identical to predicate device. |
| Display Resolution | 0.1 °C/0.1 °F | Identical to predicate device. |
| Measurement Time | Predicate: Approximate 5 ~ 10s | DMT-4756: 10s Predictive read, 30s Final read. "Performance test including clinical test shows the subject device complies with performance standard." |
| Predictive Mode | Predicate: Optional | DMT-4756: Yes (has this function). "Performance test including clinical test shows the subject device complies with performance standard." |
| Construction (Foldable Probe) | Predicate: Flexible Digital Thermometer | DMT-4756: The probe is foldable into the body of the thermometer. "Performance testing shows the subject device complies with standard ISO 80601-2-56." |
| Biocompatibility | Comply with ISO 10993-5 and ISO 10993-10 | Complied with ISO 10993-5 and ISO 10993-10. "Biocompatibility test and performance bench test met the requirements in the standards." |
| Electrical Safety | Complied with IEC 60601-1 / AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012, ISO 80601-2-56:2017, ASTM E1112:00(Reapproved 2011) | Complied with IEC 60601-1 / AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012, ISO 80601-2-56:2017, ASTM E1112:00(Reapproved 2011). "Performance testing was conducted to validate and verify that Digital Thermometer, DMT-4756 met all requirements of related international standards, including electrical safety... Results of these tests demonstrate compliance to the requirements of the below consensus standards." |
| Electromagnetic Compatibility (EMC) | Complied with IEC 60601-1-2:2014 | Complied with IEC 60601-1-2:2014. "Performance testing was conducted to validate and verify that Digital Thermometer, DMT-4756 met all requirements of related international standards, including ... EMC... Results of these tests demonstrate compliance to the requirements of the below consensus standards." |
| Home-used medical equipment requirements | Complied with IEC 60601-1-11:2015 | Complied with IEC 60601-1-11:2015. "Performance testing was conducted to validate and verify that Digital Thermometer, DMT-4756 met all requirements of related international standards... Results of these tests demonstrate compliance to the requirements of the below consensus standards." |
| Software Validation | "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005 | "The software/firmware verification and validation was provided in accordance with the 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,' dated May 11, 2005." |
2. Sample size used for the test set and the data provenance:
- Sample Size: 450 subjects for the clinical tests. These were divided into three groups:
- 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 or whether the data was retrospective or prospective. It only mentions "The clinical tests were conducted on the DMT-4756 for each measurement site." Without further information, it's not possible to determine the geographical origin of the subjects. The description of the test as "clinical tests were conducted" implies a prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The clinical performance was evaluated against the requirements of ISO 80601-2-56, which are standards for clinical thermometers.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe any adjudication method. The clinical performance was evaluated against a standard (ISO 80601-2-56) rather than against expert consensus on individual cases.
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 information is not applicable. The device is a digital thermometer, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This information is not applicable in the context of a digital thermometer. The device itself is standalone in its function of measuring temperature. The clinical tests evaluate the device's accuracy in direct measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the clinical tests, the ground truth is implicitly established by the performance standard ISO 80601-2-56. This standard defines the acceptable accuracy limits for clinical body temperature measurement devices. The study aimed to show that the device's readings fell within these established accuracy criteria.
8. The sample size for the training set:
- This information is not applicable. This is a traditional medical device (digital thermometer) and does not involve machine learning or AI models that require a separate "training set" in the conventional sense. The device's calibration and internal algorithms are developed through engineering and testing, not by training on a dataset of patient readings.
9. How the ground truth for the training set was established:
- This information is not applicable, as there is no "training set" for an AI model in this context.
Ask a specific question about this device
(260 days)
Digital Thermometer (models TM-2011, TM-3002, TM-3102) intended for the measurement and monitoring of human body temperature by users for home use. It can be used for axillary measurement and oral measurement.
Digital Thermometers comprises a thermistor for getting temperature signal, a reference resistor for comparing the resistance of the thermistor, an ASIC for processing the target temperature digitally, and a LCD for displaying the temperature. The design principle of thermometer is based on thermosensor and ASIC technology. A thermistor is used as thermosensor. 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. There is buzzing noise occurs when the device turns on and when the measurement is completed (for model TM-3002 and TM-3102 only.
The provided document describes the 510(k) premarket notification for a Digital Thermometer. It includes a summary of tests performed to demonstrate safety and performance.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document refers to adherence to specific standards rather than explicitly listing acceptance criteria with numerical targets in a table against which the device performance is reported. However, the "Remark" column in the comparison table indirectly indicates that the device meets the criteria by stating "SE" (Substantially Equivalent) or by providing explanations if there are differences.
| Acceptance Criteria (Standard Reference) | Reported Device Performance (Compliance) |
|---|---|
| Electrical safety (IEC 60601-1) | Complied |
| Electromagnetic compatibility (IEC 60601-1-2) | Complied |
| Biocompatibility (ISO 10993-1, -5, -10) | Complied |
| Usability (IEC 62366) | Complied |
| Particular Requirements for Basic Safety and Essential Performance of Clinical Thermometers for Body Temperature Measurement (ASTM E1112-00) | Complied |
| Basic Safety and Essential Performance of Clinical Thermometers for Body Temperature Measurement (ISO 80601-2-56) | Complied |
| Software verification and validation (FDA Guidance for Content of Premarket Submissions for Software Contained in Medical Devices) | Complied |
| Measurement Accuracy | ±0.1°C, 37.0°C ~ 39.0°C ±0.2°C, 35.0°C ~ 36.9°C, 39.1°C ~ 42.0°C ±0.3°C, 32.0°C ~ 34.9°C, 42.1°C ~ 43.0°C (At 25°C) |
| Measurement Speed | 45s |
Note 1: The document states that "Although there is a little difference between the 'measurement accuracy' and 'Measurement Speed', the subject device accuracy is compliance with ISO 80601-2-56 and ASTM E 1112 requirements. So, the difference of accuracy will not raise any safety of effectiveness issue." This implies that the specific performance values meet the acceptance criteria defined by these standards.
2. Sample size used for the test set and the data provenance
- Sample Size for Clinical Tests: 240 subjects were evaluated for the clinical tests performed on Model TM-3102.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions that the clinical performance test protocol and data analysis were conducted "in accordance with the requirement of ISO 80601-2-56."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a digital thermometer, and the ground truth for temperature measurement is typically obtained directly from the device's reading or a reference standard, not through expert interpretation of images or other subjective data. No experts were used to establish ground truth in the context of diagnostic interpretation.
4. Adjudication method for the test set
Not applicable, as this is a digital thermometer and not an AI/imaging device requiring expert adjudication for ground truth. The performance is assessed against physical standards and clinical 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 is a standalone medical device (digital thermometer), not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was done. The "Test Summary" and "Discussion of Clinical Tests Performed" sections describe various lab bench tests and clinical tests to evaluate the safety and performance of the device itself (Models TM-2011, TM-3002, TM-3102) against established standards (e.g., IEC 60601-1, ISO 80601-2-56, ASTM E1112-00). This indicates the algorithm (or the device's internal processing) only performance was assessed.
7. The type of ground truth used
The ground truth for the clinical performance tests (temperature measurements) would primarily be the actual body temperature measurements obtained through a reference standard or the device's readings compared against such standards, as required by ISO 80601-2-56 and ASTM E1112-00 for clinical electronic thermometers.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set. Its functionality is based on established thermistor and ASIC technology.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
Ask a specific question about this device
Page 1 of 3