(41 days)
VELscope 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 that may not be apparent or visible to the naked eye, such as oral cancer or premalignant dysplasia.
VELscope is further intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion and thus aid in determining the appropriate margin for surgical excision.
VELscope is a natural tissue fluorescence direct visualization system to be used as an adjunctive tool for oral mucosal examination.
The main components of VELscope are the Light Source Unit (LSU) and the viewing Handpiece. The VELscope Handpiece emits a safe, visible, blue light into the oral cavity, which excites the oral tissue and causes it to fluoresce. The oral cavity can then be examined in real time and suspicious tissue that may require further investigation can be quickly identified. When viewed through the VELscope Handpiece, healthy tissue typically shows up as a brighter green color while suspicious tissue can cause a loss of fluorescence, which thus appears dark.
Here's an analysis of the provided text regarding the VELscope device, focusing on the acceptance criteria and the study details:
The provided text does not explicitly state acceptance criteria in a table format nor does it describe a specific study (with detailed methodology, sample sizes, expert qualifications, etc.) that directly proves the device meets pre-defined quantitative acceptance criteria.
Instead, the submission refers to "peer-reviewed and published scientific studies" as evidence to support the expanded indications for use. This suggests that the regulatory body (FDA) is relying on external, previously conducted research rather than a de novo clinical study described within the 510(k) submission itself.
Here's a breakdown of the requested information based on the provided text, with notes on what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance (as claimed by Submitter) |
|---|---|
| NONE EXPLICITLY STATED. The submission implies acceptance based on the effectiveness in detecting and visualizing abnormalities and aiding surgical margins. | - Effective in helping detect occult cancerous and dysplastic lesions. |
| - Can help an oral surgeon assess the extent of occult diseased tissue around a clinically apparent precancerous or cancerous lesion and thus aid in determining the appropriate margin for surgical excision. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified.
- Data Provenance (country of origin, retrospective/prospective): Not specified. The submission refers generally to "peer-reviewed and published scientific studies," which would contain this information, but it's not present in the 510(k) summary itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not specified.
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
- MRMC Study: Not specified. The VELscope is a direct visualization system, not an AI software. The concept of "human readers improve with AI" does not directly apply here. It's an adjunctive tool for a human healthcare provider.
- Effect Size: Not applicable/not specified.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. VELscope is a direct visualization tool used by a human healthcare provider; it's not an algorithm that provides an output independently.
7. The type of ground truth used
- Type of Ground Truth: Not explicitly stated within the provided text. However, given the nature of the device (detecting cancerous/dysplastic lesions and aiding surgical margins), the ground truth in the underlying studies would most likely be pathology results (histopathologic diagnosis) obtained from biopsies. Outcomes data (e.g., long-term patient follow-up) could also contribute.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/not specified. The VELscope is not an AI/machine learning device that requires a training set in the conventional sense. Its function relies on the physical properties of tissue fluorescence.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable, as detailed above.
Summary of what the K070523 submission does say about evidence:
The FDA 510(k) summary for VELscope (K070523) states that its expanded indications for use are "based on recently published clinical data in peer-reviewed publications." It further asserts that these publications provide evidence that:
- "VELscope is effective in helping detect occult cancerous and dysplastic lesions."
- "VELscope can help an oral surgeon assess the extent of occult diseased tissue... and thus aid in determining the appropriate margin for surgical excision."
This implies that the burden of proof for effectiveness, and thus meeting an implicit acceptance criteria of being "effective" and "helpful," was satisfied by referencing existing scientific literature rather than by conducting and detailing a new, specific clinical trial within this 510(k) submission. The exact quantitative acceptance criteria and detailed study methodologies would need to be found within those referenced "peer-reviewed and published scientific studies" themselves, which are not included in this document.
§ 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.