(70 days)
The Baby Pacifier Digital Thermometer is a non-sterile, reusable thermometers. They are intended for the measurement of oral body temperatures of infants and young children.
The Baby Pacifier Digital Thermometer is a clinical thermometer intended for the determination of oral body temperature determination in infants and young children. In terms of physical requirements and operating parameters, the thermometer conforms to ASTM E1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature". The pacifier digital thermometer also meets Safety Standards for Baby Pacifiers.
The provided text describes a 510(k) submission for a Baby Pacifier Digital Thermometer. However, it does not contain a detailed study with acceptance criteria and reported device performance in the format requested.
The document states that:
- "In terms of physical requirements and operating parameters, the thermometer conforms to ASTM E1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature"."
- "The pacifier digital thermometer also meets Safety Standards for Baby Pacifiers."
This indicates that the device's performance is expected to meet the specifications outlined in ASTM E1112 for electronic thermometers and relevant safety standards for pacifiers. However, the specific acceptance criteria and the results of a study demonstrating adherence to these criteria are not explicitly detailed in the provided text.
Therefore, I cannot populate the requested table and provide information about sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment for a specific study from the provided text.
To answer your request, here's what could be inferred from the provided information, but it's important to note the significant limitations due to the lack of a detailed study report:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from ASTM E1112) | Reported Device Performance (Inferred to be compliant with ASTM E1112) |
|---|---|
| Accuracy (e.g., within ±0.1°C or ±0.2°F) | The device conforms to ASTM E1112, which specifies accuracy requirements for electronic thermometers for intermittent determination of patient temperature. |
| Response Time | The device conforms to ASTM E1112, which specifies response time requirements. |
| Repeatability | The device conforms to ASTM E1112, which specifies repeatability requirements. |
| Readout Resolution | The device conforms to ASTM E1112, which specifies readout resolution requirements. |
| Environmental Conditions (e.g., temperature, humidity) | The device conforms to ASTM E1112, which specifies performance under various environmental conditions. |
| Safety Standards for Baby Pacifiers | The device meets Safety Standards for Baby Pacifiers. |
Note: The specific numerical values for accuracy, response time, etc., from ASTM E1112 are not listed in the provided document, nor are the direct results of testing the Baby Pacifier Digital Thermometer against these standards. The statement "thermomenter conforms to ASTM E1112" is a general claim of compliance.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. It's implied that testing was done to ensure compliance with ASTM E1112 and safety standards, likely by the manufacturer, K-Jump Health Co., Ltd., which is based in Taiwan. Whether this involved a specific "test set" of patients or a standardized laboratory testing protocol is not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. The assessment against ASTM E1112 typically involves metrological calibration and performance testing rather than expert-established ground truth in a clinical setting in the way an AI diagnostic device would.
4. Adjudication method for the test set
- Not applicable/Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No. This type of study is not relevant for a simple digital thermometer.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The thermometer's performance is standalone in that it directly measures and displays temperature. Its accuracy is evaluated as a standalone device against metrological standards, not as an algorithm's output requiring human interpretation.
7. The type of ground truth used
- Metrological Standards: The ground truth for temperature measurement would be established by calibrated reference thermometers or other metrological standards as part of the testing to conform to ASTM E1112.
- Safety Standards: Compliance with baby pacifier safety standards would involve physical and material testing against those specific standards.
8. The sample size for the training set
- Not applicable/Not specified. This device does not use a "training set" in the context of machine learning or AI. Its operation is based on established thermodynamic principles and electronic sensor technology, not data-driven training.
9. How the ground truth for the training set was established
- Not applicable. The device does not have a "training set."
In summary, the provided document is a 510(k) summary for a digital thermometer, which mainly states compliance with existing industry standards (ASTM E1112 and Baby Pacifier Safety Standards) rather than presenting a detailed clinical study with specific acceptance criteria and performance data as would be typically found for more complex medical devices or AI-based solutions.
§ 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.