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Lady-Comp® USA is intended for measuring and recording basal body temperature (BBT) as an aid in ovulation prediction to facilitate conception (not to be used for contraception).

Lady-Comp® USA is a computerized basal body temperature thermometer with the following functions:

1. Alarm clock function for measuring temperature at a consistent time.
2. Measuring accuracy within +/- 0.05°C (0.09°F).
3. Displaying the measured temperature.
4. Generating the measurement completion signal.
5. Memory Capacity of data for 180 days.
6. Transferring the stored data to an external instrument.

I am sorry, but the provided text does not contain detailed information about the acceptance criteria and the study that proves the device meets the acceptance criteria. It primarily focuses on the 510(k) summary for the Lady-Comp® USA device, including its description, intended use, and substantial equivalence to a predicate device.

The document states:

• Measuring accuracy within +/- 0.05°C (0.09°F). This is the only explicit performance characteristic mentioned that could be considered an acceptance criterion for the temperature measurement function. However, no study details are provided to demonstrate how this criterion was met.

There is no information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or study design for testing.
• Number of experts, qualifications, or adjudication methods for establishing ground truth.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set or how ground truth for the training set was established.

The core of the document is a regulatory submission demonstrating substantial equivalence to a predicate device, not a detailed performance study report.

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