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VisioFocus SMART and VisioFocus Mini are infrared thermometers intermittent measurement of human body temperature in people of all ages. This thermometer is for a measurement site of forehead.

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This document is a 510(k) premarket notification from the FDA for a clinical electronic thermometer (VisioFocus SMART and VisioFocus Mini). It primarily focuses on the device's substantial equivalence to a predicate device and its indications for use.

Therefore, this document does not contain the information requested regarding the acceptance criteria and the study that proves the device meets those criteria. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Details on sample sizes and data provenance for test sets.
• Information on ground truth establishment, including the number and qualifications of experts and the adjudication method.
• Any mention of Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance studies.
• Information about the training set's size or ground truth establishment.

The document is a regulatory approval letter, not a scientific study report.

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VisioFocus 06400, 06450, 06480 and 06490 series are infrared thermometers intended for intermittent measurement of human body temperature in people of all ages.

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This document is a 510(k) clearance letter for a medical device, the VisioFocus infrared thermometer. It primarily focuses on regulatory approval rather than providing detailed study results that would typically include comprehensive acceptance criteria and performance data.

Therefore, the requested information, particularly detailed acceptance criteria and a study proving the device meets them with specific metrics (like sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC effectiveness), is not present in the provided text.

The document states that the FDA reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This equivalence is based on the provided indications for use and other unspecified information in the 510(k) submission.

Without the actual 510(k) submission document, which would contain the detailed performance testing, it's impossible to completely fill out the requested table and answer all questions definitively.

Here's what can be inferred or stated based on the provided text, and what is missing:

The core information requested for a detailed study report is absent. The document is an FDA clearance letter, which confirms regulatory approval based on submitted data, but does not detail that data.

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