(11 days)
The Timex AccuCurve ™ Talking 30 Second Thermometer is an electronic thermometer to measure patient body temperature orally. Timex AccuCurve ™ Talking 30 Second Thermometer is intended for professional and over-the-counter use.
Electronic Thermometer
The provided text is a 510(k) summary for the Timex AccuCurve™ Talking 30 Second Thermometer. It describes the device, its intended use, and states its substantial equivalence to a predicate device. However, it does not contain detailed information about specific acceptance criteria or the study data that would demonstrate the device explicitly meets those criteria.
Based on the provided text, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Temperature range | 90.0°F to 108.0°F |
| Measurement accuracy | ±0.2°F |
| Display graduation | 0.1°F intervals |
| Measurement time | Approx. 30 seconds |
| Ambient temperature environment | 60°-94°F (95% Relative Humidity) |
| Voice announcement | Yes |
| Nightlight display | Yes (Indiglo™) |
| Curved probe | Yes |
Missing Information: The document states these are "Performance Characteristics" but does not explicitly label them as "acceptance criteria" nor does it provide a study report detailing how the device's performance was measured against these characteristics. It only lists what the device is designed to do.
2. Sample size used for the test set and the data provenance
- Sample size: Not mentioned.
- Data provenance: Not mentioned. The document only references substantial equivalence to another device and lists performance characteristics, not actual test data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not provided. The device is a thermometer, and its accuracy would typically be verified against known temperature standards or highly accurate reference thermometers, not expert opinions.
4. Adjudication method for the test set
- Not applicable and not provided, as ground truth is not established by expert consensus for this type of device.
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 device is an electronic thermometer, not an AI-assisted diagnostic tool that requires human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not explicitly stated, but the "Performance Characteristics" section describes the device's inherent capabilities, which implies standalone performance. However, there is no detailed study report provided.
7. The type of ground truth used
- The document implies that the ground truth for evaluating temperature accuracy would be a known temperature standard or a highly accurate reference thermometer. This is inferred from the nature of the device (a thermometer) and the specified accuracy (±0.2°F). However, the document does not explicitly state the methodology for establishing ground truth during testing.
8. The sample size for the training set
- Not applicable. This device is a traditional electronic thermometer, not a machine learning or AI-based device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of device.
Overall Conclusion based on the provided text:
The 510(k) summary provided describes the device's intended performance characteristics and asserts its substantial equivalence to a predicate device. However, it does not include the detailed study reports or data that would explicitly demonstrate how these characteristics were tested and met in a formal study. The FDA's letter simply acknowledges the 510(k) submission and determines substantial equivalence based on the information provided by the applicant, but it does not reproduce the full study details within this summary document. For a complete understanding of how these performance criteria were met, one would typically need to review the full 510(k) submission, which contains the detailed testing information.
§ 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.