(133 days)
The Bio-Screen is intended to be used by a dentist or health care provider as an adjunct to traditional oral examination by incandescent light to enhance the visualization of oral mucosal abnormalities and aid in defining lesion borders
This device uses an array of short wave blue LED's in the technique of biofluorescence to demonstrate abnormal oral tissue It employs a built in optical filter to improve contrast between healthy and abnormal tissue and improve visualization
This 510(k) submission (K082668) for the Bio-Screen device provides very limited information regarding detailed performance studies and acceptance criteria. This summary will extract all available information, but it is important to note that many of the requested data points are not present in the provided text.
Based on the provided text, the Bio-Screen device is compared to predicate devices like Velscope, Microlux/DL, and Microlux/Blu, relying on the principle of biofluorescence for visualizing oral mucosal abnormalities. The submission primarily focuses on establishing substantial equivalence to these existing devices rather than presenting a standalone study with defined acceptance criteria and detailed performance metrics unique to the Bio-Screen.
1. Table of Acceptance Criteria and Reported Device Performance
No explicit table of acceptance criteria or quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for the Bio-Screen device is provided in the document. The submission states that the Bio-Screen uses a built-in optical filter "to improve contrast between healthy and abnormal tissue and improve visualization." This qualitative statement about improved visualization is the closest the document comes to defining a performance characteristic.
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visualization | Not explicitly stated (implied: "improved visualization to enhance oral mucosal abnormality detection") | "improve contrast between healthy and abnormal tissue and improve visualization" |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not mention any specific test set, its sample size, or the provenance of any data used for evaluating the Bio-Screen. The submission relies on a comparison to predicate devices, implying that their performance characteristics are adopted or assumed through equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no specific test set or study is described, there is no information provided regarding the number of experts used or their qualifications to establish ground truth.
4. Adjudication Method for the Test Set
As no specific test set or study is described, there is no information provided regarding an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done for the Bio-Screen device. The submission focuses on substantial equivalence to predicate devices, not on quantifying human reader improvement with or without AI assistance (which is not relevant as this is a medical device, not an AI).
6. Standalone Performance Study
The provided text does not describe a standalone performance study (algorithm only, without human-in-the-loop performance) for the Bio-Screen. The device is intended to be used "by a dentist or health care provider as an adjunct to traditional oral examination," indicating a human-in-the-loop design.
7. Type of Ground Truth Used
Since no specific study is detailed, the type of ground truth used is not mentioned. For devices like this intended to visualize abnormalities, ground truth would typically come from biopsy and pathology results, or expert clinical consensus.
8. Sample Size for the Training Set
The provided text does not mention any training set or its sample size. This is understandable given the nature of the device (an optical examination light) and the focus on substantial equivalence rather than a machine learning algorithm.
9. How Ground Truth for the Training Set Was Established
As no training set is mentioned, no information is provided on how its ground truth was established.
Conclusion:
The K082668 submission for the Bio-Screen is a 510(k) premarket notification primarily focused on establishing substantial equivalence to already-marketed predicate devices (Vizilite, Microlux/DL, Microlux/Blu, Velscope). The document does not describe a detailed, standalone clinical study with explicit acceptance criteria, performance metrics, and detailed information about test sets, ground truth establishment, or expert involvement. The core argument for market clearance appears to be that the Bio-Screen shares similar technology and intended use with existing, legally marketed devices.
§ 872.6350 Ultraviolet detector.
(a)
Identification. An ultraviolet detector is a device intended to provide a source of ultraviolet light which is used to identify otherwise invisible material, such as dental plaque, present in or on teeth.(b)
Classification. Class II.