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The ORABLU Oral Lesion Marking System is a three component swab system intended to be used by a dentist as an adjunct to traditional oral examination by incandescent light, combined with further examination with one of three oral examination lights manufactured by AdDent, Inc. The Microlux DL (K041614), Microlux BLU (K072309), and Bio/Screen (K082668). The ORABLU Oral Lesion Marking System is used as an aid to enhance the visualization of oral mucosal irregularities by physically marking areas of oral mucosa that may warrant further investigation.

The ORABLU Oral Lesion Marking System is a three component swab system.

This document is a 510(k) premarket notification decision letter from the FDA for the ORABLU Oral Lesion Marking System. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter confirms substantial equivalence to a predicate device and states that the device can be marketed.

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

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This device is used as an aid to improve the visualization of oral lesions. It is designed to be used by a dentist or health care provider, in combination with a traditional examination by incandescent light.

The Microlux/DL is used to enhance dental examination of lesions of the oral mucosa. The device consists of a battery powered light source that uses a blue-white LED, a rigid diffused fiber optic light guide. It is used in conjunction with a non-toxic dilute (1%) acetic acid rinse for the viewing of oral lesions. The fiber optic illuminator itself is non-tissue contacting, and is classified as a 510(k) Exempt FDA Device.

This submission for the Microlux/DL device (K041614) does not include a study with acceptance criteria and device performance results. The document is a 510(k) summary for a premarket notification for a dental device, establishing substantial equivalence to a predicate device rather than presenting a detailed performance study against specific acceptance criteria.

The submission primarily focuses on comparing the Microlux/DL to its predicate device, the Speculite/OraLite (also sold as Visilite), based on its description and intended use.

Here's a breakdown of why the requested information cannot be provided from the given text:

• No specific acceptance criteria or tabulated performance data are present. The document states that "The Microlux DL compares favorably and is substantially equivalent to another legally marketed device." This is a general statement of equivalence, not a report of performance against predefined metrics.
• No study details are provided. The submission does not describe a clinical or performance study that would involve sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established for training or testing sets. The general statement of equivalence implies that the device is expected to perform similarly to the predicate, but no empirical data is presented to demonstrate this.

In summary, the provided text is a 510(k) premarket notification for substantial equivalence, which does not typically include the detailed performance study data requested. The FDA's letter concurs with the substantial equivalence claim, allowing the device to be marketed based on its similarity to existing cleared devices, rather than requiring a detailed performance study with specified acceptance criteria in this specific submission.

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