(261 days)
Famidoc Infrared Thermometers, models: FDIR-V2, FDIR-V4, FDIR-V5, FDIR-V6, FDIR-V7, FDIR-V9, FDIR-V9-3, FDIR-V10, FDIR-V15, are intended for intermittent measurement and monitoring of human body temperature by consumers in the home.
Famidoc Infrared FDIR series Thermometers are hand-held, reusable, battery operated devices, which can measure human body temperature in two ways.
- On forehead, the skin temperature on one's forehead.
- In ear, the tympanic temperature in one's ear.
The operation principle is based on Infrared Sensor technology. The IR sensor can output different signal when measuring different object temperature or in different ambient temperature, and the ASIC can turn the signal from IR Sensor to a digital value and display it on the LCD.
The subject devices (Models: FDIR-V2, FDIR-V4, FDIR-V6, FDIR-V6, FDIR-V7, FDIR-V9, FDIR-V9-3, FDIR-V10, FDIR-V15) are the same series in Famidoc. Their design principle, intended use, indications for use, material, control keys, software and the applicable standards are the same. The differences between them are appearance, some parameters (e.g. LCD size), and some minor functions (e.g. Voice function).
The provided document is a 510(k) summary for an Infrared Thermometer. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel AI/device.
Therefore, the requested information cannot be fully extracted as it pertains to a different type of device evaluation (e.g., for an AI/ML medical device).
However, I can provide what information is available in the document regarding performance and equivalence:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of numerical performance metrics for the thermometer's accuracy against a ground truth. Instead, it relies on conformance to standards.
| Acceptance Criteria (Inferred from standards conformance) | Reported Device Performance (from the document) |
|---|---|
| Conforms to ASTM E1965-98 (Standard Specification for Clinical Thermometers for Intermittent Determination of Patient Temperature) | The devices conform to applicable standards including ASTM E1965-98 |
| Conforms to IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | The devices conform to applicable standards including IEC 60601-1 |
| Conforms to IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility - Requirements and tests) | The devices conform to applicable standards including IEC 60601-1-2 |
| Substantial equivalence to predicate device (Famidoc Infrared Thermometer, model FDIR-V1, K052849) | "The subject devices and the predicate device are the same in design principle, intended use, functions, material and the applicable standards." |
| No new issues of safety and effectiveness due to appearance or minor functional differences | "But the tests in this submission provide demonstrate these differences do not raise new issue of safety and effectiveness." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on a specific "test set" in the context of clinical data for performance evaluation. The "tests in this submission" likely refer to bench testing for compliance with the mentioned standards (ASTM, IEC). No information on sample size, country of origin, or retrospective/prospective nature of data is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The evaluation is based on technical standards conformance and substantial equivalence, not a clinical study requiring expert ground truth assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided.
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 information is not applicable and not provided. This is an infrared thermometer, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This is a standalone medical device, but not one that employs an algorithm in the AI/ML sense where "standalone performance" against a human baseline would be relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" used for this type of device is typically established against calibrated reference thermometers and environmental conditions during testing for compliance with standards like ASTM E1965-98. The document does not specify the exact methods or type of ground truth beyond conformance to these standards.
8. The sample size for the training set
This information is not applicable and not provided. There is no mention of a "training set" in the context of machine learning, as this is a traditional medical device.
9. How the ground truth for the training set was established
This information is not applicable and not provided.
§ 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.