(175 days)
This clinical electronic thermometer is used over the counter to measure the human body temperature orally, auxiliary, and through the rectum.
The clinical electronic thermometer is used over the counter to measure the human body temperature orally, auxiliary, and through the rectum. The device has the following skin contact parts: stainless steel tip, ABS plastic housing, and Ethylene/Butylene-Styrene Block thermoplastic housing. The method used to measure the temperature of a human follows the standard ASTM E1112(Standard Specifications for Electronic Thermometer for Intermittent Determination of Patient Temperature).
The provided text describes the Cotronic Clinical Electronic Thermometer Models TM12 and TM21. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a table format with corresponding reported device performance for specific clinical metrics like accuracy against a reference standard. Instead, it indicates compliance with recognized standards.
| Criterion Type | Standard/Requirement | Reported Device Performance |
|---|---|---|
| Temperature Measurement | ASTM E1112 (Standard Specifications for Electronic Thermometer for Intermittent Determination of Patient Temperature) | The device follows this standard. |
| Electrical Safety | IEC60601-1 | The device follows this standard. |
| Electromagnetic Comp. | IEC60601-1-2 | The device follows this standard. |
| Biocompatibility | ISO 10993-5:2009(E) (Cytotoxicity) | The device meets this standard. |
| Biocompatibility | EPA Nitro-amines - USA 21 CFR Part 58 | The device meets this standard (presumably for testing of materials). |
| Biocompatibility | ISO 10993-10:2002/Amd.1:2006, idt EN10993-10:2009 (Irritation and Skin Sensitization) | The device meets this standard. |
| Biocompatibility | ISO 10993-12:2007 (Sample preparation and reference materials) | The device meets this standard. |
Study Proving Device Meets Acceptance Criteria:
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study proving performance against novel acceptance criteria.
The study that proves the device meets the acceptance criteria is a comparison to the following standards: ASTM E1112, IEC60601-1, IEC60601-1-2, ISO 10993-5:2009(E), EPA Nitro-amines - USA 21 CFR Part 58, ISO 10993-10:2002/Amd.1:2006, idt EN10993-10:2009, and ISO 10993-12:2007 Bioevaluation.
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail specific sample sizes for clinical test sets as it relies on compliance with existing standards and comparison to a predicate device rather than a new clinical performance study. The data provenance is not specified beyond the device being manufactured by Cotronic Manufacturing in Shenzhen, Guang Dong, P.R. China. There is no information provided to indicate whether data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. The 510(k) summary relies on compliance with recognized performance standards for thermometers, not on a human expert-adjudicated ground truth for a test set.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. There wasn't a "test set" in the context of human adjudication mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with imaging devices or diagnostic algorithms where human readers' performance is evaluated with and without AI assistance. This document pertains to an electronic clinical thermometer.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device operates "standalone" in that it directly measures temperature, the term "algorithm only without human-in-the-loop performance" is typically used for AI/software devices. For a simple electronic thermometer, the performance is inherent to the device's design and function in accordance with set standards. No specific "standalone algorithm performance study" beyond meeting the mentioned ASTM and IEC standards is described here.
7. The Type of Ground Truth Used
The "ground truth" for the performance of the thermometer is defined by the standards themselves, specifically ASTM E1112 for temperature measurement accuracy. For biocompatibility, the ground truth is adherence to the specified ISO and EPA biocompatibility standards. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense for a diagnostic device.
8. The Sample Size for the Training Set
This information is not applicable and not provided. Electronic thermometers do not typically use "training sets" in the context of machine learning algorithms. Their performance is based on their physical design and calibration against established measurement practices according to standards.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. There is no "training set" for this device.
§ 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.