(29 days)
The AMPLIFE Digital Infrared Ear Thermometer, Model E100, is a Digital Infrared Ear Thermometer (without probe cover) using an infrared sensor to detect body temperature from the ear in the neonatal, pediatric and adult population used in the home setting.
The device is used without a probe cover.
The AMPLIFE Digital Infrared Ear Thermometer, Model E100 is a digital infrared Ear Thermometer (without probe cover) using an infrared sensor (thermopile) to measure eardrum temperature, then get a reading and display it on the LCD.
Its operation is based on measuring the natural thermal radiation emanating from the eardrum.
The AMPLIFE Digital Infrared Ear Thermometer, consists mainly of five parts:
- a) IR Thermopile Sensor
- b) ASIC
c) E2PROM IC
d) LCD and Blacklight - e) Kev2, Buzzer1
The provided text does not contain detailed acceptance criteria or a comprehensive study plan with the specific information requested in your prompt. This document is a 510(k) summary for a medical device (AMPLIFE Digital Infrared Ear Thermometer, Model E100), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical trial report with detailed acceptance criteria and performance metrics in the format you've requested for AI/machine learning models.
However, I can extract the information that is present and indicate what is missing:
Here's an attempt to answer your questions based only on the provided text, highlighting the limitations:
1. A table of acceptance criteria and the reported device performance
The document states compliance with ASTM E1965-98 for thermometry and IEC60601-1 and IEC60601-1-2 for medical electrical equipment safety. These standards contain specific performance criteria (e.g., accuracy, repeatability) for thermometers. However, the exact numerical acceptance criteria from these standards and the specific reported performance of the AMPLIFE device against those criteria are not explicitly detailed in the provided 510(k) summary. It only indicates that "bench testing contained in this submission supplied demonstrate that any differences in their characteristics do not raise any new questions of safety or effectiveness."
For example, ASTM E1965-98 specifies accuracy limits (e.g., ±0.2°C or ±0.3°C depending on the temperature range), but these are not directly presented in a table with the device's measured performance.
| Criterion Type | Acceptance Criteria (from referenced standards - not explicitly stated in doc) | Reported Device Performance (not explicitly stated in doc) |
|---|---|---|
| Accuracy | (e.g., per ASTM E1965-98, e.g., ±0.2°C or ±0.3°C) | "demonstrate that any differences... do not raise new questions of safety or effectiveness." |
| Clinical Bias | (Not specified/detailed) | Data was presented (no numerical value provided) |
| Clinical Uncertainty | (Not specified/detailed) | Data was presented (no numerical value provided) |
| Clinical Repeatability | (Not specified/detailed) | Data was presented (no numerical value provided) |
| Safety (Electrical) | (per IEC60601-1, IEC60601-1-2) | Compliance claimed |
2. Sample size used for the test set and the data provenance
- Sample size: The document states "Controlled human clinical studies were conducted," but the exact sample size (number of subjects/measurements) is not provided.
- Data provenance: The studies were "Controlled human clinical studies" conducted by "AMPLIFE clinical test protocol for infrared Ear Thermometer." The country of origin is not specified. The studies are implied to be prospective clinical studies as they were "conducted" for this submission.
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. For a thermometer, "ground truth" often refers to a reference thermometer reading (e.g., rectal thermometer or highly accurate laboratory thermometer) rather than expert consensus on interpretation. The document refers to "clinical bias, clinical uncertainty and clinical repeatability," implying comparison to a reference.
4. Adjudication method for the test set
This information is not provided. Given it's a thermometer measuring a specific physical value, a formal adjudication method (like 2+1 for image reviews) is less likely to be directly applicable compared to a direct comparison against a gold standard reference.
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
- MRMC study: No, an MRMC study was not conducted or described. This device is a standalone thermometer, not an AI-powered diagnostic image interpretation tool.
- Effect size for human readers with/without AI: This is not applicable as the device is not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Yes, the device's performance was evaluated in a standalone manner. The device "using an infrared sensor (thermopile) to measure eardrum temperature, then get a reading and display it on the LCD." The "temperature measurements algorithm and its fundamental scientific technology are identical to the predicate device." The "discussion of clinical tests performed" refers to "Controlled human clinical studies were conducted using the AMPLIFE Infrared Ear Thermometer E100." This suggests the device's readings were directly evaluated.
7. The type of ground truth used
The ground truth used would be a reference temperature measurement from an established and highly accurate method (e.g., rectal temperature, or a calibrated standard thermometer) against which the ear thermometer's readings ("clinical bias, clinical uncertainty and clinical repeatability") are compared. The exact method is not explicitly stated, but it's implied by the nature of thermometer testing.
8. The sample size for the training set
This is not applicable in the context of this device. This device is a traditional infrared thermometer, not an AI/machine learning model that undergoes a training phase. Its algorithm is based on established physical principles for infrared thermometry and is stated to be "identical to the predicate device."
9. How the ground truth for the training set was established
This is not applicable as there is no "training set" in the context of a traditional thermometer.
§ 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.