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K Number
K100016
Device Name
AVITA SCANEO INFRARED EAR THERMOMETER, MODEL TS7
Manufacturer
AVITA CORPORATION
Date Cleared
2010-03-04

(59 days)

Product Code
FLL
Regulation Number
880.2910
Type
Special
Panel
HO
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The AViTA Scanéo Infrared Ear Thermometer (Model no. TS7) is infrared thermometers intended for the intermittent measurement of human body temperature by people of all ages in the home.

Device Description

Not Found

AI/ML Overview

This document is an FDA 510(k) clearance letter for the AViTA Scanéo Infrared Ear Thermometer. It does not contain information about the acceptance criteria or the study details you've requested.

The letter states that the device is substantially equivalent to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to a device already on the market. However, it does not provide the specific performance data, study design, or expert qualifications that would typically be found in a clinical study report or a more detailed submission summary.

Therefore, I cannot extract the following information from the provided text:

  1. A table of acceptance criteria and the reported device performance: This document only provides the device's name and its intended use, but no performance metrics or specific criteria it met.
  2. Sample size used for the test set and the data provenance: Not mentioned.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
  4. Adjudication method for the test set: Not mentioned.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned. This type of study is more common for diagnostic imaging AI, not typically for thermometers.
  6. If a standalone performance (algorithm only without human-in-the-loop performance) was done: Not mentioned.
  7. The type of ground truth used: Not mentioned.
  8. The sample size for the training set: Not mentioned.
  9. How the ground truth for the training set was established: Not mentioned.

§ 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.