(34 days)
The ION HEALTH USB INSTA-SCAN THERMOMETER is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages and for use in the home. It also available to detect object's surface temperature including human skin.
The ION HEALTH USB INSTA-SCAN THERMOMETER is characterized by measuring human body temperature in the ear canal. It utilizes infrared technology to measure either infrared energy emitted from the eardrum and surrounding tissues when making a temperature measurement.
This device, the ION HEALTH USB INSTA-SCAN THERMOMETER, is cleared under a 510(k) and demonstrates substantial equivalence to a predicate device, the FORA IR17 Ear Thermometer, model TD-1117 (K083299). Therefore, the study presented primarily focuses on establishing this substantial equivalence rather than independent performance criteria.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" for the ION HEALTH USB INSTA-SCAN THERMOMETER. Instead, it relies on demonstrating substantial equivalence to a predicate device that has already met such criteria. The "reported device performance" is essentially that it matches the performance of the predicate.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (as compared to Predicate) |
|---|---|
| Same performance characteristics as predicate device (FORA IR17 Ear Thermometer, TD-1117) | "ION HEALTH USB INSTA-SCAN THERMOMETER has the same performance characteristics as the predicate device." |
| System accuracy comparable to predicate device | "A comparison of system accuracy performance demonstrated that the ION HEALTH USB INSTA-SCAN THERMOMETER... and the currently marketed FORA IR17 Ear Thermometer... are substantially equivalent." |
| Performance, safety, and effectiveness equivalent to predicate device | "Software verification and validation, performance and safety tests confirmed that the performance, safety and effectiveness of the ION HEALTH USB INSTA-SCAN THERMOMETER are equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance
The document does not provide details on the sample size used for any specific test set, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective) for the comparison study. It only states that a "comparison of system accuracy performance" was done.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The study's focus is on comparing the new device to a predicate, not on generating novel ground truth through expert consensus.
4. Adjudication method for the test set
This information is not provided in the document.
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. The device is an electronic thermometer, not an AI-assisted diagnostic tool that involves human readers interpreting output. Therefore, an MRMC study and effects on human reader performance are 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 "study" described is a comparison of this device's performance against another standalone electronic thermometer (the predicate). The performance evaluated is the device's inherent measurement capabilities. So, in essence, the "study" assesses standalone performance by comparing it to another standalone device.
7. The type of ground truth used
The document does not explicitly state the "ground truth" used for the performance comparison. However, given it's a thermometer comparison, the implicit ground truth for accuracy studies of thermometers typically involves:
- Reference thermometers or calibrated temperature sources: These would represent the "true" temperature against which both devices are measured.
- Clinical measurements: In a clinical validation, the "true" body temperature might be established using gold-standard methods (e.g., rectal temperature, core body temperature) against which the ear thermometer readings are compared.
The document only states "system accuracy performance" was compared, implying such a reference method would have been used in the predicate's original clearance and presumably for this comparison too, even if not detailed here.
8. The sample size for the training set
This information is not applicable as the device is not an AI/machine learning algorithm requiring a "training set." It's a sensor-based electronic device.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of 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,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.