(169 days)
The Microlife Digital Basal Thermometer is a device intended for measuring, and aiding in the monitoring and tracking of basal body temperature (BBT) as an aid in ovulation prediction to aid in conception (not to be used for contraception).
The Microlife Digital Basal Thermometer, which uses the Basal Temperature method can be used for helping in family planning in healthy adults by understanding their menstrual cycle and ovulation and interpreting basal temperature changes. This Thermometer provides easy, quick and highly accurate readings over the body temperature range. The body temperature is measured by the thermistor (inside the probe tip) and displayed as numbers on the LCD (liquid crystal diplay) through microprocessor of IC. The basic principle of this thermometer is that change of thermistor resistance, caused by changes of temperature, are converted to changes of frequency of R-C oscillator circuit. Therefore, temperature can be given by measuring the frequency of oscillator. For a given time period by applying to R-C oscillator circuit, changes of temperature will correspond to changes of pulse number.
The provided text describes the Microlife Digital Basal Thermometer and its 510(k) submission, confirming its substantial equivalence to a predicate device. However, it does not contain the detailed acceptance criteria or the specifics of a study that proves the device meets those criteria in the way requested by the prompt.
The document states:
- "Controlled human clinical studies were conducted using the Microlife Digital Basal Thermometer MT1921 for measurement and accuracy."
- "Compliance to applicable voluntary standards includes ASTM E1112, as well as IEC60601-1 and IEC60601-1-2 requirements."
- "Guidance documents included the "FDA Guidance on the Content of Premarket Notification 510(K) Submissions for Clinical Electronic Thermometers."
While these statements indicate that testing was performed and standards were met, the actual acceptance criteria values and the results of those tests are not provided in the summary. Therefore, directly filling out most of the requested fields is not possible from the given input.
Based on the provided text, here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Generalized statements) |
|---|---|
| Specific temperature accuracy limits (e.g., ±0.1°C) | Met ASTM E1112, IEC60601-1, IEC60601-1-2 |
| Specific measurement time limits | Easy, quick, and highly accurate readings |
| Reproducibility/Precision metrics | Substantiated by controlled human clinical studies |
| Safety standards | Compliant with IEC60601-1 and IEC60601-1-2 |
| Effectiveness for BBT monitoring | Aiding in monitoring and tracking of BBT |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: "Controlled human clinical studies were conducted," but country of origin and retrospective/prospective nature are not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not describe the establishment of a ground truth by experts for the clinical studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
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/Not done. This device is a thermometer, not an AI-assisted diagnostic tool that would involve "human readers" or "AI improvement." The study focused on the accuracy of the device itself.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device is a standalone electronic thermometer. The "controlled human clinical studies" would have assessed the device's performance in human subjects, implying a standalone assessment of the device's ability to measure temperature.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Given it's a thermometer, the ground truth for accuracy would typically be a reference thermometer or a calibrated temperature standard against which the device's readings are compared. This is implied by "measurement and accuracy" testing and compliance with ASTM E1112 (Standard Specification for Electronic Thermometers for Intermittent Determination of Patient Temperature).
8. The sample size for the training set:
- Not applicable/Not specified. This device is a hardware-based electronic thermometer, not an AI/ML algorithm that requires a separate training set. The "human clinical studies" are for validation/testing, not training.
9. How the ground truth for the training set was established:
- Not applicable. (See #8)
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