(295 days)
For measuring, and recording basal body temperature(BBT) as an aid in ovulation prediction to aid in conception (not to be used for contraception).
This device is the clinical thermometer with memory the following functions.
(1) Alarm clock function for measuring temperature at constant time.
(2) Measuring accuracy within +/-0.05°C(between 35.00°C and 38.00°C) +/-0.1°C(between 34.00°C and 35.00°C, 38.00°C and 40.00°C)
(3) Displaying the measured temperature precisely, generating the measurement completion signal(buzz) and warning of a measuring error by buzzer, in case happened.
(4) Memory capacity of data for 6 menstrual cycles or 210 days.
(5) Displaying the measured temperature value in graph.
(6) Transferring the stored data to an external instrument.
The provided text is a 510(k) summary for the "Petit Sophia, Computerized Basal Body Thermometer, Model No. BT-14E". It focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria through clinical trials. Therefore, much of the requested information regarding acceptance criteria and a study proving performance cannot be directly extracted as it's not present in this type of submission.
However, I can extract the specific performance characteristics mentioned and the basis for substantial equivalence.
Here's the information based on the provided text, with N/A indicating information not found in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Measuring Accuracy | Should be equivalent to the predicate device, L-Sophia, BT-01 (K 901512), which itself must have met established accuracy standards for clinical thermometers. | +/-0.05°C (between 35.00°C and 38.00°C) |
| +/-0.1°C (between 34.00°C and 35.00°C, 38.00°C and 40.00°C) | ||
| Memory Capacity | Should be equivalent or improved compared to the predicate device. | 6 menstrual cycles or 210 days |
| Display | Clear display of measured temperature, graphical display of temperature value. | Displaying the measured temperature precisely, generating the measurement completion signal (buzz) and warning of a measuring error by buzzer, in case happened. Displaying the measured temperature value in graph. |
| Data Transfer | Ability to transfer stored data. | Transferring the stored data to an external instrument. |
| Alarm Function | Alarm for consistent measurement time. | Alarm clock function for measuring temperature at constant time. |
Note: The acceptance criteria for the "Petit Sophia" are primarily based on its substantial equivalence to the predicate device, "L-Sophia, BT-01," described as having "the same general design and performance characteristics." The explicitly stated performance characteristics are a description of the device's features, implicitly suggesting they meet the requirements for a basal body thermometer.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): N/A (The document does not detail a specific test set or clinical study for the Petit Sophia beyond confirming its performance characteristics through comparison to a predicate device.)
- Data Provenance: N/A
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)
- N/A (No information on ground truth establishment for a test set is provided as the submission relies on substantial equivalence.)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A
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
- N/A (This device is a basal body thermometer, not an AI-assisted diagnostic tool for which an MRMC study would be relevant.)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A (This device is a physical thermometer with memory and display functions; "standalone" algorithm performance is not applicable in this context.)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- N/A (The document indicates the device's performance is based on its technological characteristics and intended use being similar to the predicate device, rather than a new ground-truth validation study.)
8. The sample size for the training set
- N/A (No training set is mentioned for this type of device.)
9. How the ground truth for the training set was established
- N/A
Summary of Device Acceptance and Study Type:
The acceptance of the "Petit Sophia, Computerized Basal Body Thermometer" (K021978) by the FDA is based on a 510(k) Premarket Notification demonstrating substantial equivalence to a legally marketed predicate device, "Nishitomo, L-Sophia, BT-01 (K 901512)".
The document explicitly states: "The Petit Sophia Basal Body Thermometer has the same general design and performance characteristics as the predicate device 'L-Sophia', which is manufactured by the same company Nishitomo Co., Ltd. The main difference is the physical size, shape, weight and temperature display. The Petit Sophia Basal Body Thermometer has the same intended use, general design and incorporates similar materials and components, hence should therefore raise no new questions of safety and effectiveness."
Therefore, the "study" proving the device meets acceptance criteria (which are primarily alignment with the predicate device's characteristics and regulatory standards for clinical thermometers) is not a new clinical trial or performance study. Instead, it is a comparison and justification that the new device's specifications (e.g., accuracy, memory, display) are equivalent to those of the predicate device, which was previously cleared by the FDA. The submission asserts that because of this substantial equivalence, the "Petit Sophia" raises no new questions of safety and effectiveness.
N/A