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510(k) Data Aggregation
(140 days)
The Electronic Thermometers are intended to measure the human body temperature under arm, and the devices are nonsterile, reusable for clinical or home use on people of all ages.
Electronic Thermometer, Model: AET-F331, AET-F332, AET-F334, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383
I'm sorry, but this document does not contain the information required to answer your request. The provided text is an FDA 510(k) clearance letter for an electronic thermometer. It details regulatory information, product codes, indications for use, and compliance requirements. However, it does not include any details about:
- Acceptance criteria and reported device performance related to a study. The document lists the device models and their intended use (measuring human body temperature under the arm), but no specific performance metrics or thresholds are mentioned.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study results.
- Standalone algorithm performance data.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This type of information, particularly regarding studies, performance data, and ground truth establishment, is typically found in the 510(k) submission itself (which often includes a "Truth in Labeling" section or performance testing reports), but it is not presented in the FDA's clearance letter.
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(409 days)
The Electronic Thermometers (AET-F101, AET-F221, AET-F241) are intended to measure human body temperature orally or under the arm. The devices are reusable for clinical or home use on people of all ages.
Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241
I am sorry, but the provided text is an FDA 510(k) clearance letter for an Electronic Thermometer. It does not contain information about the acceptance criteria, device performance, or any studies using AI or human readers. The document is a regulatory approval and does not detail the technical performance evaluation in the way requested in your prompt.
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(289 days)
The Electronic Thermometers(AET-E201, AET-E21, AET-E231, AET-E241, AET-E241, AET-E251, AET-E301, AET-E311) are intended to measure the human body temperature orally, or axillary, and the devices are non-sterile, reusable for clinical or home use on people of all ages.
Not Found
This is an FDA clearance letter for a medical device (Electronic Thermometer), not a study report. Therefore, the document does not contain the requested information regarding acceptance criteria and a study proving the device meets those criteria.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it has similar indications for use, technological characteristics, and safety and effectiveness. The FDA clearance process for a 510(k) often involves demonstrating compliance with recognized standards or conducting comparison testing against a predicate device, but the details of such testing (like specific acceptance criteria, sample sizes, ground truth, etc.) are typically found in the 510(k) submission itself, not in the clearance letter.
Therefore, I cannot provide the requested table and information based on the provided text.
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(129 days)
The Electronic Thermometer (XHF2001, XHF2002) is intended to measure the body temperature under the arm and to be used by consumers in household environments for the people of one month of age and above.
The Electronic Thermometer is hand-held, predictive, thermistor-based, stick themometer capable of measuring temperature. The thermometer uses a negative temperature coefficient thermistor embedded in a measurement tip that is in contact with the measurement site. As the themistor changes tem perature, the resistance of the thermistor also changes, which is measured by the thermometer and converted to a measurement of the temperature of the the thermometer.
This temperature, following the use of the predictive a lgorithm, is then displayed to theend user. Because the thermometer displays the measurement for the physiological site at which it is used, it does not need to convert this temperature via clinical offset.
The Electronic Thermometer comprises a probe which includes a thermistor for getting temperature signal, a buzzer for sounding effect, an build-in software for processing the target temperature digitally, battery compartment with cover, a LCD for displaying the temperature result and indicator information, and a Power (On/Off) switch key.
There are two models of Electronic Thermometer, XHF2002. The two models share same specification, main components (such as LCD, probe, electric circuit and CPU), the only differences are size and appearance.
The size XHF2001 is 105 x 22 x 12 mm, and the XHF2002 is 125 x 18 x 9.5 mm.
The provided document describes the 510(k) premarket notification for the Electronic Thermometer (XHF2001, XHF2002). The information regarding acceptance criteria and supporting studies is extracted and organized below.
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against the international standard ISO 80601-2-56: Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
| Acceptance Criteria (from ISO 80601-2-56 and ASTM E1112) | Reported Device Performance (XHF2001, XHF2002) |
|---|---|
| Accuracy | |
| $32 ~ 36.9°C (89.6°F~98.42°F) \pm 0.2°C$ | $32 ~ 36.9°C (89.6°F~98.42°F) \pm 0.2°C$ |
| $37 ~ 39°C (98.6°F~102.2°F) \pm 0.1°C$ | $37 ~ 39°C (98.6°F~102.2°F) \pm 0.1°C$ |
| $39.1 ~ 42.9°C (102.38°F~109.22°F) \pm 0.2°C$ | $39.1 ~ 42.9°C (102.38°F~109.22°F) \pm 0.2°C$ |
| Clinical Bias | Complies with ISO 80601-2-56 |
| Clinical Consistency | Complies with ISO 80601-2-56 |
| Clinical Repeatability | Complies with ISO 80601-2-56 |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: A total of 110 subjects were included in the clinical study. These were divided into three age groups:
- 1 month - 1 year (35 subjects)
- 1-5 years (35 subjects)
- Above 5 years (40 subjects)
The study also included both febrile and afebrile persons.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study data or whether it was retrospective or prospective. However, the sponsor and correspondent are based in China, suggesting the study likely took place in China. The "Controlled human clinical studies were conducted" implies a prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide details on the number or qualifications of experts used to establish the ground truth for the test set. The clinical study evaluated the device's performance against the requirements of ISO 80601-2-56, which typically involves comparing the device's readings to reference thermometer readings.
4. Adjudication Method for the Test Set
The document does not describe a specific adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The study focused on the standalone performance of the device against a standard.
6. Standalone Performance
Yes, a standalone performance study was conducted. The "Controlled human clinical studies were conducted on proposed device with predicates in accordance with ISO 80601-2-56." This involved evaluating the clinical bias, clinical consistency, and clinical repeatability of the proposed device.
7. Type of Ground Truth Used
The ground truth used for the clinical study was based on the requirements and methodologies outlined in ISO 80601-2-56. This standard typically involves comparing the electronic thermometer's readings to those of a highly accurate reference thermometer, often under controlled clinical conditions, to determine accuracy, bias, and repeatability.
8. Sample Size for the Training Set
The document does not mention a separate "training set" in the context of machine learning. The device described (Electronic Thermometer XHF2001, XHF2002) is a medical device that relies on a thermistor and a predictive algorithm, not a machine learning algorithm that typically requires a large training set in the sense of AI. The software verification and validation were conducted according to general guidance for software in medical devices, not specific to AI/ML training data.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a traditional machine learning "training set" in the context of this device, this question is not applicable. The "predictive algorithm" in the device is likely based on established physiological models and calibration rather than a trained AI model.
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(139 days)
Electronic Thermometer is intended for measuring and monitoring human body temperature orally and/or under arm for adult, pediatric and infant. It can be used in healthcare facility and home.
The proposed device, Electronic Thermometer, is a handheld device with battery power supply, intended for measuring and monitoring human body temperature orally and/or under arm for adult, pediatric and infant. It can be used in healthcare facility and home. There is no specific use of this device other than temperature measurements, including conversion of temperatures. The proposed device is available in two models, which are WT1 and WT2. Similarities between models: a. Both of them incorporate a temperature sensitive sensor b. Both of them can measure and monitor human body temperature under arm; C. Neither the WT1 nor WT2 has display function, the measured or monitored temperature will be transmitted to a mobile application, Temp Sitter, installed under iOS system via the blue tooth to display the measured and monitored temperature; Differences between models: a. WT1 has an automatic power on/off feature; b. WT1 can be used with an adhesive tape, which could be fix the thermometer under arm for measuring and monitoring; c. WT2 can be used with a designated probe cover; d. WT2 can be used for measurement of oral temperature.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Electronic Thermometer (Models WT1 and WT2), formatted as requested.
Electronic Thermometer (Models WT1 and WT2)
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, the acceptance criteria are generally established by compliance with recognized standards and the reported performance is directly stated in the comparison table.
| Acceptance Criteria Category | Specific Acceptance Criteria (from standards or implied) | Reported Device Performance (from comparison table) | Meets Criteria? |
|---|---|---|---|
| Accuracy | Not explicitly stated as a separate acceptance criterion, but implied by comparison to predicate. The standard ISO 80601-2-56 sets specific requirements for accuracy. The predicate device claims ±0.1°C within its operational range. | ±0.1°C (25.00°C | YES, claims higher accuracy in certain ranges than the predicate. Implied compliance with ISO 80601-2-56 suggests meeting its accuracy requirements. |
| Precision | Not explicitly stated, but common for medical thermometers. | 4 numeric digits displayed in 0.01 degree increments | YES (Matches predicate) |
| Response Time | Not explicitly stated as an acceptance criterion other than being "acceptable" and communicated in the user manual. The predicate device has a much faster response time. | 5 minutes | YES (Stated as acceptable, though slower than predicate) |
| Biocompatibility | Compliance with ISO 10993-5 and ISO 10993-10. | No Cytotoxicity, No Sensitization, Irritation-negligible | YES |
| Electrical Safety | Compliance with IEC 60601-1. | Complied with IEC 60601-1 | YES |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2. | Complied with IEC 60601-1-2 | YES |
| Range | Consistent with clinical thermometer use. | 25.00°C~45.00°C | YES (Wider than predicate) |
Notes on Acceptance Criteria: The document primarily relies on non-clinical testing against recognized national and international standards (ISO, IEC) to demonstrate substantial equivalence. The detailed accuracy claims are a performance specification that needs to be verified by testing.
2. Sample Size Used for the Test Set and the Data Provenance
The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no information about:
- Sample size used for the test set.
- Data provenance (e.g., country of origin, retrospective or prospective).
The "test set" in this context refers to non-clinical tests (e.g., biocompatibility testing, electrical safety testing, EMC testing), which are performed on device samples, not human participants or clinical data. The precise number of device units or samples used for each non-clinical test (e.g., for biocompatibility or electrical safety) is not specified in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable as no clinical studies were performed, and thus no clinical ground truth was established by experts for a test set. Non-clinical tests establish "ground truth" based on standard protocols, calibrated equipment, and laboratory measurements.
4. Adjudication Method for the Test Set
Not applicable as no clinical studies were performed. Adjudication methods are typically employed in clinical trials or studies where human readers/experts independently assess cases, and a process is needed to resolve discrepancies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an electronic thermometer, not an AI-assisted diagnostic tool involving human readers or interpretation of medical images/data. Therefore, an MRMC study is not relevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself is a standalone electronic thermometer. The performance described (accuracy, precision, response time) is for the device operating independently to measure temperature. There isn't an "algorithm" in the sense of AI or image processing, but the device's measurement functionality itself operates in a standalone manner to generate a temperature reading. The companion mobile application "Temp Sitter" serves for display and potentially trend monitoring, but the temperature measurement occurs directly by the physical device. The compliance with standards like ISO 80601-2-56 reflects this standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests that were performed:
- Accuracy and Response Time: Ground truth would be established using calibrated reference thermometers and temperature sources as per the methodologies outlined in ISO 80601-2-56 or similar standards.
- Biocompatibility: Ground truth is established by laboratory testing results (e.g., cell viability assays for cytotoxicity, skin patch tests for sensitization, observation of tissue reactions for irritation) against specified limits.
- Electrical Safety and EMC: Ground truth is established by laboratory measurements taken by specialized equipment as per the IEC standards.
8. The Sample Size for the Training Set
Not applicable as no AI or machine learning algorithm requiring a "training set" is mentioned or implied for this device.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set was used.
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(26 days)
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