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Thermal Imaging is a noninvasive diagnostic technique that allows a practitioner to quantify and visualize skin surface temperature changes. The Spectrum 9000 MB allows the user to graphically map the body temperature and display the image on a monitor. The Spectrum 9000MB will be used as an aid for diagnosis as well as to follow up therapy on such areas as orthopedics, pain management, neurology and diabetic foot care.

The intended use for the Spectrum 9000 MB is similar to what is being used currently on the Dorex DTI-16 thermal imager. Images are captured and stored on a computer that can be used to diagnose problem areas.

Not Found

This FDA 510(k) clearance letter dated November 14, 2002, for the Dorex Spectrum 9000MB Thermography System does not contain the detailed information required to describe acceptance criteria and a study proving the device meets those criteria.

The document is a clearance letter, indicating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It focuses on regulatory compliance and administrative details, not on a detailed performance study.

Therefore, I cannot provide the requested information based solely on the provided text.

Here's why and what's missing:

• No Acceptance Criteria: The letter does not list any specific performance metrics (e.g., sensitivity, specificity, accuracy, temperature measurement precision) that the device must meet.
• No Study Description: There is no mention of a specific study, its design, methodology, results, or statistical analysis. The letter just states equivalence to a predicate device.
• No Sample Sizes: Consequently, there are no details on sample sizes for test or training sets.
• No Information on Experts, Ground Truth, Adjudication, or MRMC Studies: These specific elements related to a performance study are absent.
• No Standalone Performance: While the device itself is standalone, the letter doesn't report its standalone performance metrics.

In summary, the provided document is a regulatory clearance and not a technical report or clinical study summary. To answer your questions, one would need access to the actual 510(k) submission itself or any associated clinical/technical reports that were part of that submission, which are not included in this extract.

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