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510(k) Data Aggregation
(102 days)
The Up-Grade is an over-the-counter, non-sterile, reusable clinical thermometer intended for the determination of oral, rectal and axillary body temperature determination in humans.
The Up-Grade is a compact predictive clinical thermometer designed to measure human body temperature by detecting heat from three different body sites: axilla, rectum and mouth, by using the heat conduction principle and prediction. The device is designed to calculate the maximum temperature of probe tip in contact with the body site, without waiting for thermal equilibrium to occur, by heat transfer data and mathematical algorithm. The temperature reading range is from 35.5℃ to 42.0℃ (95.5℃ to 107.6℃F) and the time of measurement varies between 4 to 6 seconds.
The provided 510(k) summary for the Medisim Ltd. Up-Grade Electrical Thermometer does not contain specific acceptance criteria, detailed study results, or the other requested information regarding sample sizes, expert qualifications, and ground truth establishment in the level of detail typically associated with medical device studies.
However, based on the limited information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) states that the device conforms to "acceptable voluntary standards" and that "safety and efficacy performance of the device has been non-clinically and clinically established through comparative testing with market-cleared devices." It also explicitly mentions compliance with ASTM E1112 and IEC 601-1. These voluntary standards would contain the specific acceptance criteria for accuracy and performance of an electronic thermometer.
Without the actual standards document or a detailed study report, the precise numerical acceptance criteria are not available in this 510(k) submission. However, assuming compliance with these standards, the reported device performance implicitly meets those criteria.
| Acceptance Criteria (Inferred from Standards) | Reported Device Performance |
|---|---|
| Accuracy / Measurement Range: | |
| (Defined by ASTM E1112 for clinical electronic thermometers) | Temperature reading range: 35.5℃ to 42.0℃ (95.5℉ to 107.6℉) |
| Measurement Time: | |
| (Defined by ASTM E1112 for predictive thermometers) | Measurement time: 4 to 6 seconds |
| Safety and Electrical Standards: | |
| (Defined by IEC 601-1) | Conforms to IEC 601-1 |
| Clinical Performance: | |
| (Performance comparable to predicate devices for oral, rectal, and axillary use) | "safety and efficacy performance... established through comparative testing with market-cleared devices." |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not specified in the provided text.
- Data Provenance: Not specified. It's unclear if the data was collected in Israel (where the applicant is located) or elsewhere, nor if it was prospective or retrospective.
3. Number of Experts and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method
- Adjudication Method: Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: Not applicable for this device. A clinical thermometer measures a direct physiological parameter and does not involve human readers interpreting complex images or data in a diagnostic context that would typically necessitate an MRMC study. Its performance is evaluated against reference standards or predicate devices.
6. Standalone Performance Study
- Standalone Performance Study: Yes, implicitly. The statement "The Up-Grade Electrical Thermometer conforms with the following voluntary standards: ASTM E1112 and IEC 601-1" and "safety and efficacy performance of the device has been non-clinically and clinically established through comparative testing with market-cleared devices" indicates that the device's performance was evaluated on its own merits against established standards and other similar devices. The comparison "with market-cleared devices" serves as the clinical data point for substantial equivalence.
7. Type of Ground Truth Used
- Ground Truth: For a clinical thermometer, the "ground truth" would typically be established by highly accurate reference thermometers (e.g., traceable to national standards) or by the performance of the predicate devices themselves in comparative studies. The focus would be on accuracy, precision, and response time.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a predictive clinical thermometer, using a "mathematical algorithm" to predict temperature. The development of such an algorithm would involve data for calibration and optimization, which could be considered an internal "training set." However, the 510(k) does not provide details on the size or nature of this data. The submission focuses on the validation against standards and predicate devices.
9. How Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not specified. For a predictive thermometer, the "ground truth" for developing its algorithm would be actual body temperatures measured with a highly accurate, often slower, reference thermometer over a wide range of conditions and body sites, against which the predictive model is trained to correlate its rapid measurements.
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