(176 days)
Infrared Ear Thermometer (InnoTherm ICT-100 and InnoTherm ICT-200) is intended for an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population.
Infrared Ear Thermometer offers easy, safe, accurate and fast temperature measurement in the ear. Temperature is more accurate core body temperature than other site of the body, since the eardrum shares blood vessels with the temperature control center in the brain (hypothalamus). Therefore, variations in body temperature are reflected sooner and more accurately in the ear than at the other sites on the body. Infrared Ear Thermometer is more convenient and safer than an oral thermometer, as it is unaffected by factors such as talking, eating, drinking and smoking.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document provided does not contain a specific table of acceptance criteria for performance metrics (e.g., accuracy against a standard thermometer). Instead, it primarily focuses on comparing features and functionality to a predicate device and states that "Test results support the conclusion that actual device performance satisfies the design intent."
However, we can infer some key specifications and compare them to the predicate device, which implicitly serves as a benchmark for acceptability.
| Feature | Acceptance Criteria (Implied by Predicate - K011059) | Reported Device Performance (InnoTherm ICT-100, ICT-200) |
|---|---|---|
| Measurement Temp Range | 34.0 ~ 42.2 ℃ (93.2 ~ 108 °F) | 32.0 ~ 43.0 ℃ (89.6 ~ 109.4 °F) |
| Ambient Range | 10 ~ 40 ℃ (50 ~ 104 °F) | 16.0 ~ 40.0 ℃ (93.2 ~ 108 °F) |
| Storage Range | -20 ~ 50 ℃ (-4 ~ 122 °F) | -10 ~ 41 ℃ (14 ~ 105.8 °F) |
| Display Type | LCD | LCD |
| Activation | Scan button | Scan button |
| Battery Type | CR2032 * 1 pcs | CR2032 * 1 pcs |
| Classification | thermometer, electronic, clinical (Class II), 21 CFR 880.2910 | thermometer, electronic, clinical (Class II), 21 CFR 880.2910 |
| Intended Population | Neonatal, pediatric, and adult population | Neonatal, pediatric, and adult population |
| Intended Use Setting | Auditory canal, used in the home setting | Auditory canal (no specific mention of home setting limitation) |
Note: The reported device performance generally meets or slightly expands upon the predicate's ranges for temperature measurements. The "Ambient range" and "Storage range" show variations, but the document doesn't explicitly state these as "acceptance criteria" against which the new device was measured; rather, they are presented as comparative specifications. The overall conclusion is "substantially equivalent," implying these differences are acceptable.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Testing was performed according to 'Harmonized Standard and ASTM'." It does not specify:
- The exact sample size used for the test set.
- The country of origin of the data.
- Whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For a clinical thermometer, ground truth would typically be established by comparison to a highly accurate reference thermometer, not necessarily by human experts.
4. Adjudication Method for the Test Set
This information is not provided in the document. As mentioned above, for a clinical thermometer, adjudication by experts for ground truth is not typically applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. This type of study is more common for diagnostic imaging devices where human interpretation plays a significant role. For a simple electronic thermometer, the objective is to measure temperature accurately, which is typically validated through direct comparison to a reference standard, not through reader studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was done. The document focuses on the device itself and its ability to measure temperature. The testing performed "according to 'Harmonized Standard and ASTM'" would assess the device's accuracy and performance independently.
7. The Type of Ground Truth Used
The document implies that testing was done against "Harmonized Standard and ASTM," which would mean the device's measurements were compared against established reference standards (e.g., highly accurate standard thermometers or controlled temperature environments) as defined by those standards. It is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. This device is an infrared ear thermometer, a hardware device that directly measures a physical property (temperature). It does not use algorithms that require a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this type of device.
§ 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.