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510(k) Data Aggregation
(396 days)
This device is a non-sterile reusable, contact thermometer, intermittent determination of human body temperature through on the ear canal or forehead as the measurement site on people of all age. The ThermArt (Model IR-EFT) can be used in clinical and home environment.
The ThermArt (Model IR-EFT) is a hand-held, battery powered device designed to measure human body temperature. This Thermometer takes the body temperature the infrared energy emitted from the forehead skin or the ear canal. The Thermometer adopts gentle-touch, user friendly and non-invasive measurement design. It instantly displays the accurate reading of the body temperature with just a gentle touch.
The provided document is a 510(k) summary for the ThermArt (Model IR-EFT) clinical electronic thermometer, outlining its substantial equivalence to a predicate device (K190873). It details the device's characteristics, indications for use, and a comparison with the predicate device.
Regarding the acceptance criteria and the study that proves the device meets them, the document states that the evaluation was based on non-clinical data and adherence to voluntary standards. This suggests that performance was assessed through laboratory testing rather than a clinical study involving human patients in a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, or a standalone AI algorithm performance study.
Here's an attempt to extract and synthesize the information based on the provided text, addressing your points. Note that the document is focused on demonstrating substantial equivalence through non-clinical testing and adherence to standards, rather than proving a novel AI device's performance against human readers or a detailed statistical analysis of a clinical test set.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by adherence to established international and national standards for clinical electronic thermometers and general medical electrical equipment safety. The "reported device performance" is essentially that the device met the requirements of these standards.
| Acceptance Criteria (Defined by Standards) | Reported Device Performance |
|---|---|
| Accuracy (ASTM E1965): | - $\pm0.4°F/\pm0.2°C$ (95°F - 107.6 °F/35.0°C - 42°C) |
| - $\pm0.2°C$ (0.4°F) during 35.5°C ~42.0°C (95.9°F ~107.6°F) at 15°C ~35°C (59.0°F ~95.0°F) operating temperature range | - $\pm0.5°F/\pm0.3°C$ (outside this temperature range) |
| - $\pm0.3°C$ (0.5°F) for other measuring and operating temperature range (per predicate) | - Performed accuracy test according to ASTM E1965 and ISO 80601-2-56 and met the requirements. |
| Biocompatibility (ISO 10993-1, -5, -10): | - Performed Cytotoxicity, Skin irritation, Skin sensitization tests according to ISO 10993-1, -5, -10 and met the requirements. |
| - Evaluation and testing within a risk management process, in vitro cytotoxicity, irritation, and skin sensitization. | - The device's different materials (PC enclosure, glass & ABS probe for subject; ABS enclosure, Stainless steel & ABS probe for predicate) were found to be substantially equivalent in biocompatibility risk after testing. |
| Cleaning Validation: | - Performed cleaning validation according to the method in the instruction for use, and the validation result shows that the method of cleaning meets the cleaning requirements. |
| Medical Electrical Safety (ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11): | - Performed medical electrical safety tests according to these standards (including for home healthcare environment) and met the requirements. The different screen display types were addressed by these tests. |
| - General requirements for basic safety and essential performance, electromagnetic disturbances, and requirements for use in the home healthcare environment. | |
| Operating Environment (ISO 80601-2-56, ASTM E1965): | - Performed accuracy test according to the ISO 80601-2-56 and ASTM E1965, and met the requirements, despite differences in specified operating temperature and humidity ranges. |
| - Performance within specified temperature and humidity ranges. | |
| Transportation and Storage Conditions (ISO 80601-2-56, ASTM E1965): | - Performed accuracy test according to the ISO 80601-2-56 and ASTM E1965, and met the requirements, despite differences in specified transportation and storage conditions. |
| - Performance after transportation and storage within specified conditions. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of human patient data. The performance studies cited (e.g., ASTM E1965, ISO 80601-2-56) are non-clinical performance tests conducted to verify the device's technical specifications and accuracy under controlled conditions. This implies laboratory testing rather than a patient-based study.
- Sample Size: Not applicable in the context of a clinical test set. The testing was done according to the methodologies prescribed by the relevant standards (e.g., how many measurements, temperature points, etc., are required for accuracy testing).
- Data Provenance: Not applicable in the context of a clinical test set. The data originates from laboratory performance testing.
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 clinical electronic thermometer, and "ground truth" for temperature measurement is typically established by reference temperature standards and precise measurement instruments in a laboratory setting, not by human expert consensus or interpretation of images.
4. Adjudication Method for the Test Set
Not applicable, as "ground truth" was not established by human readers or experts requiring adjudication.
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 performed, nor is it relevant for this type of device. This medical device is a thermometer, not an AI-powered diagnostic imaging tool that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This question is not applicable to a clinical electronic thermometer. The device itself is the "algorithm" for temperature measurement, and its performance was evaluated through non-clinical testing against standards. There isn't a separate AI algorithm being assessed.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by reference temperature standards and precise measurement equipment used in laboratory settings as per the methodologies defined in standards like ASTM E1965 and ISO 80601-2-56. This is not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic tool would be.
8. The Sample Size for the Training Set
Not applicable. This is a traditional medical device (thermometer) and does not rely on machine learning or AI models that require a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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