(180 days)
This device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used at home.
The Thermo Buddy Ear Thermometer is a hand held instrument that measures body temperature through the opening of the auditory canal. Operation is based on measuring the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces.
The provided document is a 510(k) premarket notification for the "Thermo Buddy Ear Thermometer, Model TB-100." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting new clinical trials to establish acceptance criteria and device performance in the same way a PMA (Premarket Approval) would.
Therefore, the document does not contain the information requested regarding acceptance criteria and the detailed study that proves the device meets those criteria, as typically found in clinical efficacy studies. The information provided primarily asserts the device's technological characteristics and intended use are similar to predicate devices.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance derived from a study on the device itself.
- Sample sizes used for a test set, data provenance, number of experts for ground truth, or adjudication methods for a specific study conducted for this device.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study, effect sizes, or human reader improvement with AI.
- Details on a standalone algorithm performance study.
- The type of ground truth used, sample size for training, or how ground truth was established for a training set.
The summary states: "The Thermo Buddy Ear Thermometer has the same general design and performance characteristics as the predicate devices from Braun and Omron. The main difference is the physical size, shape and weight. The Thermo Buddy Ear Thermometer has the same intended use, general design and incorporates similar materials and components, hence should therefore raise no new questions of safety and effectiveness. This submitter concludes that the Thermo Buddy Thermometer is therefore substantially equivalent to the predicate devices 'Braun Thermoscan IRT3020' and the 'Omron Gentletemp Instant Ear Thermometer MC-509'."
This indicates that the "proof" of meeting acceptance criteria is through demonstrating equivalence to already approved predicate devices, rather than through an independent clinical study that would generate the specific data points requested in your prompt.
§ 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.