(104 days)
The Faichney Medical Company and Becton-digital thermometers are intended for measuring body temperature using oral, rectal, or axillary sites.
The Faichney Medical Company and Becton-digital thermometers are intended for measuring body temperature using oral, rectal, or axillary sites. There are no technological differences between these thermometers.
This 510(k) summary for the Faichney Medical Clinical Electronic Thermometer provides some, but not all, of the requested information. Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device references compliance with ASTM standards instead of setting specific acceptance criteria within the 510(k) itself. The reported performance is in comparison to a mercury-in-glass thermometer.
| Acceptance Criteria (ASTM E1112-86 or comparison to mercury-in-glass) | Reported Device Performance (Faichney Digital Thermometer) |
|---|---|
| Accuracy: (Implicitly, to be comparable or better than mercury-in-glass) | Better than mercury-in-glass thermometer's accuracy across temperature range (Mean & Standard Deviation). |
| Within 0.10°F of mercury-in-glass accuracy (with 89% confidence interval) at every range except 96.40°F to 98.00°F. | |
| Response Time: (Implicitly, to be comparable enough for clinical use) | Average 26 seconds to register peak temperature (without probe covers). |
| Average 28 seconds to register peak temperature (with probe covers). | |
| (Not explicitly compared to mercury-in-glass for this metric, but noted as a "slight increase"). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the test set used in the "Summary of Bench Data." It refers to "the product" and "the same units" without specifying numbers.
- Sample Size (Test Set): Not explicitly stated.
- Data Provenance: The tests were conducted by an "independent testing house." The country of origin is not specified, but it's likely within the US given the FDA submission. The study was prospective bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not relevant or provided for a clinical electronic thermometer's bench testing. Accuracy is determined against a known standard or a reference thermometer (mercury-in-glass), not by expert interpretation.
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
Not applicable for a device that measures a physical property against a reference. The "investigator" made conclusions, but this is not an adjudication method in the context of clinical interpretation or diagnostic agreement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is typically for diagnostic imaging or interpretation where multiple human readers assess cases. For a thermometer, the measurement is objective.
6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done
Yes, the "Summary of Bench Data" describes standalone performance testing of the electronic thermometer. Its accuracy and response time were measured directly.
7. The Type of Ground Truth Used
The ground truth for accuracy was based on comparison to a "mercury-in-glass thermometer" which served as a reference standard. While not explicitly stated as the absolute ground truth, it was the comparator for assessing the electronic thermometer's performance. Response time was measured objectively.
- Ground Truth Type: Comparison to a reference standard (mercury-in-glass thermometer).
8. The Sample Size for the Training Set
This device does not use machine learning or AI, so there is no "training set."
- Sample Size (Training Set): Not applicable.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 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.