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510(k) Data Aggregation
(154 days)
The FT-100A Electronic thermometer is an Infrared thermometer which uses an infrared sensor to detect human body temperature of patients of all ages. It is intended to detect body temperature. The FT-100A is intended for home use.
The Universal Infrared Forehead Thermometer, Model FT-100A is a non-contact thermometer which infers temperature from the blackbody radiation emitted from the patient. Temperature is calculated from the knowledge of the amount of infrared energy emitted from the human body. The design consists of a lens to focus the infrared thermal radiation on to a detector, which converts the radiant power to an electrical signal that can be displayed in units of temperature after being compensated for ambient temperature. This permits temperature measurement from a distance without contact with the object to be measured.
The provided text describes the 510(k) premarket notification for the Infrared Forehead Thermometer, FT-100A. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a standalone study for the device's performance against specific statistical targets commonly seen in AI/ML medical devices.
However, I can extract information related to the device's accuracy and the clinical investigation performed.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for accuracy are implicitly derived from the comparison to the predicate device and the standards met. The table below combines the stated accuracy for the new device and the predicate, implying that the new device aims to meet or exceed the predicate's accuracy.
| Characteristic | Acceptance Criteria (implied from predicate/standards) | Reported Device Performance (FT-100A) |
|---|---|---|
| Accuracy (Body Mode) | ±0.2°C (±0.36°F) from 36.0°C (96.8°F) to 39.0°C (102.2°F)±0.3°C (±0.54°F) from 32.0°C (89.6°F) to 35.9°C (96.6°F) and from 39.1°C (102.4°F) to 43.0°C (109.4°F) (From Predicate) | FOR BODY MODE:± 0.2°C (±0.4°F) from 36.0°C (96.8°F) to 39.0°C (102.2°F)± 0.3°C (±0.5°F) from 32.0°C (89.6°F) to 35.9°C (96.6°F) and from 39.1°C (102.4°F) to 43.0°C (109.4°F)Clinical investigation demonstrated: "bias less than predicate device when compared to reference." This implies the FT-100A met or exceeded the accuracy of the predicate against the reference."clinical repeatability... statistically and clinically acceptable (less than 0.3 deg C or 0.58 deg F)." |
| Accuracy (Object Mode) | ± 1°C (±2°F) from 0°C (32°F) to 100°C (212°F) (From Predicate) | FOR OBJECT MODE:± 4°C (±7.2°F) from 0°C (32°F) to 4.9°C (40.8°F)± 1°C (±2°F) from 5.0°C (32°F) to 60.0°C (140.0°F)± 4°C (±7.2°F) from 60.1°C (140.1°F) to 100°C (199.9°F) |
| Clinical Repeatability | Defined in ASTM E1965-98 (Reapproved 2009) as "clinical acceptability" (not explicitly quantified for predicate, but implied by standard compliance). | "statistically and clinically acceptable (less than 0.3 deg C or 0.58 deg F)." |
| Compliance with Standards | ISO 80601-2-56:2009, ASTM E1965-98(Reapproved 2009) (and others for biocompatibility, electrical safety, EMC) | Passed all listed standards (ISO 10993-5, ISO 10993-10, ANSI/AAMI ES60601-1, IEC 60601-1-2, ISO 80601-2-56, ASTM E1965-98). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The text states, "A clinical investigation was performed to evaluate the clinical accuracy and clinical repeatability on the following three age groups: 0-12 months- <5 years, and 5 years and older." However, the exact number of subjects or measurements in the test set for this clinical investigation is not specified.
- Data Provenance: The document does not explicitly state the country of origin of the clinical data. It is a submission by a company in Hangzhou, China, but the location of the clinical trial is not mentioned. It is a prospective study, as it describes a "clinical investigation" that was "performed."
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 thermometer, and "ground truth" for temperature is established by a reference thermometer, not by expert interpretation. The reference was the "Reference SureTemp Plus Oral/Rectal and Axillary Contact Thermometer in the monitoring mode (K030580)."
4. Adjudication method for the test set
Not applicable, as ground truth is established by a reference thermometer, not by expert consensus where adjudication would be necessary.
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 medical device for measuring temperature, not an AI/ML diagnostic tool that involves human readers interpreting output.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in essence. The device (infrared thermometer FT-100A) measures temperature directly. The clinical investigation compared its readings to a reference thermometer. This is a "device only" performance evaluation, as there is no human-in-the-loop component for reading the thermometer itself.
7. The type of ground truth used
The ground truth for the clinical accuracy and repeatability study was established by a reference clinical thermometer: "Reference SureTemp Plus Oral/Rectal and Axillary Contact Thermometer in the monitoring mode (K030580)."
8. The sample size for the training set
Not applicable. This device is an infrared thermometer, not an AI/ML algorithm that requires a "training set" in the conventional sense. Its function is based on physical principles of infrared radiation detection, not on machine learning from a dataset.
9. How the ground truth for the training set was established
Not applicable (see point 8).
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