NPAC MULTI-USE EAR THERMOMETER, MODELS TD 600,610,620,630,602,612,622,632, TN 600,610,620,630,602,612,622,632, TS 600,6

• K Number: K030126
• Device Name: NPAC MULTI-USE EAR THERMOMETER, MODELS TD 600,610,620,630,602,612,622,632, TN 600,610,620,630,602,612,622,632, TS 600,6
• Manufacturer: NORM PACIFIC AUTOMATION CORP.
• Date Cleared: 2003-02-07 ( 24 days)
• Product Code: FLL
• Regulation Number: 880.2910
• Type: Special
• Panel: HO
• Reference & Predicate Devices: N/A

Intended Use

For intermittent measurement of body temperature in patients of all ages in home environment.

Device Description

Not Found

AI/ML Overview

I apologize, but the provided text from the FDA 510(k) summary for the NPaC Multi-Use Ear Thermometers (K030126) does not contain the detailed information required to answer your request about acceptance criteria and a study proving the device meets those criteria.

This document is a letter from the FDA confirming the substantial equivalence of the device to a legally marketed predicate and allowing it to be marketed. It discusses regulatory classifications, general controls, and compliance requirements, but it does not include the technical study details, performance data, or an explicit table of acceptance criteria that you've asked for.

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

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts and their qualifications for ground truth
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness study details
6. Standalone (algorithm only) performance details
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

To obtain this information for an FDA-cleared device like this, you would typically need to consult the original 510(k) submission document itself, which contains the detailed technical and clinical performance data, or potentially the user manual/labeling for the device. The provided text is solely the FDA's regulatory clearance letter.

Regulation Number and Section

§ 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.