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The Dual Mode Infrared Thermometer (Model DM-IR200) is intended for the intermittent measurement and monitoring of human body temperatures. It is for non-professional use by consumers at home. The ear canal mode is indicated for use by people above one year old and the skin/forehead mode is indicated for use by people of all ages.

Device Description

The Dual Mode Infrared Thermometer (Model DM-IR200) is a hand-held, non-sterile, reusable, battery powered device designed to measure human body temperature via one of two body sites: the ear canal or skin of the forehead. The DM-IR200 thermometer utilizes infrared technology to measure the natural thermal infrared energy emitted from the surface of the forehead or from the eardrum tissue.

AI/ML Overview

Based on the provided text, the device in question is a Dual Mode Infrared Thermometer (Model DM-IR200), which measures human body temperature. The information focuses on its clinical accuracy and comparison to predicate devices, rather than an AI-powered diagnostic tool. Therefore, many of the requested criteria (e.g., ground truth for AI training, MRMC study, expert qualifications for AI ground truth) are not applicable to this type of medical device's approval process as described in the document.

Here's a breakdown of the available information regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are primarily defined by adherence to relevant standards and demonstrated clinical accuracy.

Acceptance Criteria (Standard / Metric)	Reported Device Performance (Model DM-IR200)
Conformity to ASTM E1965 (Standard specification for infrared thermometers for intermittent determination of patient temperature)	Conforms to ASTM E1965
Conformity to IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)	Conforms to IEC 60601-1
Conformity to IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility)	Conforms to IEC 60601-1-2
Conformity to ISO 10993-1 (Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process)	Conforms to ISO 10993-1
Conformity to ISO 10993-5 (Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity)	Conforms to ISO 10993-5
Conformity to ISO 10993-10 (Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization)	Conforms to ISO 10993-10
Conformity to IEC 62304 (Medical device software - Software life cycle processes)	Conforms to IEC 62304
Conformity to ISO 14971 (Medical devices – Application of risk management to medical devices)	Conforms to ISO 14971
Measurement Accuracy (as per ASTM E1965)	± 0.4°F / ± 0.2°C (This is listed in the comparison table with predicate devices, implying it as an expected performance characteristic.)
Clinical Bias (as per ASTM E1965)	Did not exceed 0.06°C
Uncertainty of Clinical Bias (as per ASTM E1965)	Did not exceed 0.02°C
Clinical Repeatability (as per ASTM E1965)	0.1°C
Substantial Clinical Agreement with Predicate Devices	Demonstrated substantial clinical agreement.
Substantial Clinical Repeatability between proposed device and predicate devices	Demonstrated substantial clinical repeatability.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: 105 subjects.
Data Provenance: The document does not specify the country of origin of the data. It states "A clinical study was performed...". It can be inferred that this was a prospective study, as it describes the performance of the device rather than retrospective analysis of existing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. For a thermometer, "ground truth" for temperature measurement in a clinical study is typically established by comparing the device's readings to a validated reference thermometer or core body temperature measurement methods, not by expert interpretation like in diagnostic AI. The document states "The clinical accuracy of the proposed device was evaluated by determining two kinds of errors in accordance with requirements of ASTM E1965 - clinical bias with stated uncertainty and clinical repeatability." This implies a quantitative, objective comparison to a reference, not expert consensus.

4. Adjudication method for the test set

Not Applicable. As the "ground truth" for a thermometer is a quantitative measurement against a standard, adjudication by multiple readers/experts is not relevant.

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 not an AI-powered diagnostic device used in conjunction with human readers. The study was to determine the thermometer's accuracy.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a hardware device (thermometer), not an algorithm. Its performance is inherent in its design and measurement capabilities.

7. The type of ground truth used

The ground truth for this clinical study was established through comparison to a reference method (likely a highly accurate, calibrated clinical thermometer or other core body temperature measurement) as defined by ASTM E1965 standards. The objective was to measure "clinical bias" and "clinical repeatability" against this reference. The study also compared its performance to predicate devices.

8. The sample size for the training set

Not Applicable. This is a traditional medical device, not an AI/ML model that requires a "training set."

9. How the ground truth for the training set was established

Not Applicable. See point 8.

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