(31 days)
The Flexible Tip Thermometer is an electronic thermometer to measure patient body temperature orally, rectally or axilliary (under arm).
The Teddy Bear Flexible Tip Thermometer is intended for professional and over-the-counter use. A pediatric model will be available.
The Flexible Tip Thermometer is an electronic thermometer to measure patient temperature. Targeted users include professional and over-the-counter users.
Electronic Thermometer
The provided 510(k) submission for the Flexible Tip Thermometer is a premarket notification and does not contain the detailed study results or acceptance criteria that would typically be found in a clinical trial report or a performance testing document. The submission is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device (GT010706 Digital Thermometer K021052).
Therefore, based only on the provided text, I cannot complete most of the requested sections. The document states "Performance Characteristics: The Flexible Tip Thermometer measures patient body temperature in approx. 60 seconds. The thermometer is programmed to display the current body temperature. The temperature detected is graduated on 0.1ºF intervals, reading a range of 90.0ºF. The ambient temperature environment in which the device is intended for use is 60.8°-104°F (95% Relative Humidity)." However, this describes the device's functional characteristics, not specific acceptance criteria or performance metrics from a validation study.
Here's a breakdown of what can be extracted and what cannot, based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided text. Acceptance criteria for a thermometer would typically involve accuracy (e.g., ±0.2°F), response time, and stability over its operating range. These are not present.
- Reported Device Performance: Only general functional characteristics are mentioned.
| Performance Characteristic | Reported Device Performance (from text) |
|---|---|
| Measurement Time | Approximately 60 seconds |
| Temperature Display | Displays current body temperature |
| Graduation | 0.1ºF intervals |
| Measurement Range | 90.0ºF (This phrasing is a bit ambiguous; typically it would be a range like 90.0-108.0ºF, but only "reading a range of 90.0ºF" is stated.) |
| Ambient Operating Range | 60.8°-104°F (95% Relative Humidity) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified. The document mentions the device is "substantially equivalent" to a predicate device but does not detail any specific test set for the Flexible Tip Thermometer itself to prove performance against specified criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not specified. The provided document does not describe a study involving expert-established ground truth for the device's performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. No such study or adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a medical device (thermometer), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not specified. This refers to an algorithm's performance, which is not relevant for a thermometer in this context. The document implies performance testing was done to ensure the device functions as intended and is equivalent to the predicate, but specific "standalone" algorithmic performance data is not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified. For a thermometer, ground truth would typically be established by a highly accurate reference thermometer (e.g., a calibrated mercury thermometer or a high-precision electrical thermometer) in a controlled environment. The document does not describe how any "ground truth" was established for testing within this submission. Its primary argument is substantial equivalence.
8. The sample size for the training set
- Not applicable/Not specified. This device is a thermometer, not an AI-based system that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable/Not specified. Not an AI-based system.
§ 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.