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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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The ViziLite Blue Oral Exam Product consists of the Vizilite and ViziLite Blue Oral Lesion Identification and Marking System.

The Vizilite (OralLite) is a chemiluminescent light source system indicated for use as an adjunct to conventional oral mucosal screening by trained health care providers for the identification, evaluation, and monitoring of oral mucosal abnormalities in a population at increased risk for oral cancer.

The ViziLite Blue Oral Lesion Identification and Marking-System, is a threecomponent swab system which is indicated as an adjunct to the ViziLite Test for oral mucosa lesions, for further evaluation and monitoring of lesions already differentially identified with Vizil ite in a population at increased risk for oral cancer

The ViziLite Blue Oral Lesion Identification and Marking System is not being proposed for use in the initial oral mucosal examination without initial lesion identification with ViziLite. Furthermore, this ViziLite Blue Oral Lesion Identification and Marking System is not intended to be used as an indicator of lesions warranting further study, including biopsy. Whether a lesion is marked with the dye or not should not alter the clinician's clinical behavior as dictated by the results of the ViziLite examination. The marking dye, when positive, acts as a lesion marker that allows for the removal of the ViziLite device while preserving the anatomic character of the lesion.

ViziLite Blue Oral Exam Kit includes the ViziLite used as an adjunct to visual examination of the oral mucosa with incandescent light for identification of oral mucosal abnormalities and ViziLite Blue Oral Lesion Identification and Marking System to further assist with the evaluation and monitoring of ViziLiteldentified oral white mucosal abnormalities in patients at increased risk for oral cancer.

The ViziLite-Blue™ Oral Exam Kit is a visualization system that is intended as an adjunct to conventional visual examination with incandescent light of oral mucosa and employs the same components and mechanism of action as the previously cleared ViziLite Test Kit (a.k.a. ViziLite Comprehensive Exam Tray K012070 and the OralLite Test Kit, K03995 and Acetic Acid Rinse) and is indicated for the same patient population and intended use. The ViziLite examination light source and accessories, including the 1% Acetic Acid Rinse, have not been changed nor significantly modified for production of the ViziLite-Blue Oral Exam Kit.

The ViziLite Blue Oral Lesion Identification and Marking System, consists of three swab components, two swabs of 1% Acetic Acid Rinse, including a postdye decolorizer, and one swab with a metachromatic vital tissue dye, Tolonium chloride, also called Toluidine Blue. The application of the dye to ViziLite-Identified oral white mucosal lesions in a population at increased risk for oral cancer, during clinical trials was able to assist with evaluation, monitoring, and tissue sampling and helped physically mark and stain 51% of the ViziLite-Identified white lesions to allow the health care provider to visualize lesions with incandescent light.

The document describes the ViziLite Blue Oral Exam Product (K033033), which includes the ViziLite and the ViziLite Blue Oral Lesion Identification and Marking System. The ViziLite is a chemiluminescent light source, and the ViziLite Blue system uses a metachromatic vital tissue dye (Tolonium chloride/Toluidine Blue) for marking lesions.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner as typically seen for AI/ML device performance. Instead, it describes the expected performance and utility of the device based on previous clearances and a clinical study.

• "Thus, it appears that the ViziLite is a useful adjunct to help direct the examiner to lesions that would be difficult or poorly seen with incandescent light alone." |
  | ViziLite Blue Oral Lesion Identification and Marking System Performance: | |
  | Ability to assist with evaluation, monitoring, and tissue sampling of ViziLite-Identified oral white mucosal abnormalities. | - The system "was able to assist with evaluation, monitoring, and tissue sampling and helped physically mark and stain 51% of the ViziLite-Identified white lesions to allow the health care provider to visualize lesions with incandescent light."
• "When the Tolonium Chloride dye marked the acetowhite lesions, the health care provider was able to remove the ViziLite device from the patient's mouth and see the lesion with incandescent illumination."
• "This allows the examiner to measure the lesion size, observe the lesions borders, and obtain an appropriate tissue sample (biopsy) when clinically indicated." |
  | Indication for use as an adjunct to ViziLite test, not as an initial screening tool. | The system is "not for "initial identification" of abnormalities" and "not intended to be used as an initial screening examination." Its use is "as an adjunct or an accessory to the ViziLite examination." |
  | Clinical behavior should not be altered by marking dye results in terms of warranting further study/biopsy. | "Whether a lesion is marked with the dye or not should not alter the clinician's clinical behavior as dictated by the results of the ViziLite examination." |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Clinical Trials): 86 adult patients and 92 biopsied lesions.
• Data Provenance: The clinical trials were "conducted at three University Hospital sites." The country is not explicitly stated, but given FDA submission, it is typically in the U.S. or international studies following U.S. regulatory standards. The study appears to be prospective clinical trials.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts or their qualifications for establishing ground truth from the clinical trials. It mentions "examiners" and "health care provider," but details on their roles in determining ground truth (e.g., biopsy results interpretation) are not provided.

4. Adjudication Method for the Test Set

The document does not describe the adjudication method used for the clinical trial results or ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• None. This device (ViziLite Blue Oral Exam Product) is a physical device (light source and dye system), not an AI/ML algorithm. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not applicable and was not performed. The "improvement" described relates to the device's ability to aid human clinicians directly.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• None. As noted above, this is a physical diagnostic aid, not an algorithm. Its performance is always "human-in-the-loop" as it is an adjunct to a clinical examination.

7. The Type of Ground Truth Used

For the ViziLite performance:

• "Biopsy proven squamous cell dysplasia and malignancy in squamous epithelium" is mentioned in the context of the predicate device's mechanism of action, implying that pathology (biopsy) is the ultimate ground truth for identifying significant lesions.
  For the ViziLite Blue Marking System:
• Its role is to "assist with evaluation, monitoring, and tissue sampling," and its ability to help "physically mark" lesions that are "ViziLite-Identified white lesions" is highlighted. The ultimate "ground truth" for the significance of these marked lesions would still be pathology (biopsy), though the dye helps visualize them for that purpose. The document states its marking capability "should not alter the clinician's clinical behavior as dictated by the results of the ViziLite examination," implying the ViziLite examination (which could lead to biopsy) is a primary consideration for decision-making.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here as the device is not an AI/ML algorithm that requires training. The clinical studies described are for validation/demonstration of effectiveness.

9. How the Ground Truth for the Training Set was Established

Not applicable, as this is not an AI/ML device.

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