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510(k) Data Aggregation
(167 days)
The VDT985US Vicks® SmartTemp™ Thermometer is indicated for the intermittent measurement and monitoring of human body temperature orally, rectally or under the arm. It can be used on people of all ages except preterm babies or very small (for gestational age). This thermometer is intended to be used with Apple and Android mobile devices. It is intended for household use only.
The VDT985US Vicks® SmartTemp™ Thermometer is a general purpose thermometer. The thermometer is intended for oral, axillary temperature measurements of the human body. The main user interface for the thermometer is a smartphone or other Bluetooth smart device on which the Kaz SmartTemp app is installed. The thermometer communicates with the user's device through a Bluetooth smart connection.
Here's a breakdown of the acceptance criteria and study information for the VDT985US Vicks® SmartTemp™ Thermometer, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance (VDT985US Vicks® SmartTemp™ Thermometer) |
|---|---|
| Accuracy | ±0.2° F (±0.1 ° C) within measurement range 95.9-107.6° F and ±0.4° F outside this range |
| Operating environment | Complies with ASTM E1112:2006 Standard |
| Clinical Accuracy (clinical bias with uncertainty and repeatability) | Per ASTM E 1965-09 Clinical Requirements |
| Limit of agreement (clinical) | Per ASTM E 1965-09 Clinical Requirements |
| Clinical Repeatability | Statistically and clinically acceptable (less than 0.3 °C or 0.58°F) |
| Biocompatibility | Complies with ISO 10993-5 (cytotoxicity), 10993-10 (irritation/sensitization), and FDA memo G95-1 |
Study Details
2. Sample Size and Data Provenance
The document states that a comparison study and clinical repeatability testing were performed on four age groups: 0-12 months, 12 months- <5 years, 5 years- <18 years, and 18 years and older. However, the exact sample size for the test set is not explicitly provided in the furnished text.
The data provenance is implied to be prospective clinical data since it refers to a "clinical comparison study" and "clinical repeatability testing" performed in accordance with ASTM E1112-00(2006) and ASTM E1965. The country of origin of the data is not specified.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish ground truth.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of an MRMC comparative effectiveness study in the provided text. The study described is a comparison study between the test device, a predicate device, and a gold standard reference thermometer.
6. Standalone Performance Study
Yes, a standalone performance study was done in the sense that the VDT985US Vicks® SmartTemp™ Thermometer (test thermometer) was compared directly to a "gold standard" device (Welch Allyn SureTemp® Plus in monitoring mode) and a predicate device (Vicks V966 Thermometer) to assess its clinical accuracy and repeatability. The results reported are for the device's performance itself.
7. Type of Ground Truth Used
The ground truth used was established by a reference device: the Welch Allyn SureTemp® Plus in the monitoring mode (K030580), which is referred to as the "gold standard."
8. Sample Size for the Training Set
The document does not provide information about a training set or its sample size. The study described appears to be a validation/testing study rather than a development study involving specific training data.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, this information is not available in the provided text.
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