(115 days)
VELscope Vx 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 and premalignant dysplasia.
VELscope Vx 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.
The VELscope Vx system 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 Handpiece, incorporating light source, viewing optics and rechargeable battery. Charging Cradle and external power supply. 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, abnormal tissue typically appears as an irregular, dark area that stands out against the otherwise normal green fluorescence pattern of surrounding health tissue.
The document provided does not contain specific acceptance criteria outlined in a table or a detailed study proving the device meets particular numerical performance targets. Instead, it focuses on demonstrating substantial equivalence to a predicate device (VELscope, K070523).
Here's an analysis of the provided information related to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria:
The core "acceptance criteria" presented in this 510(k) summary are based on demonstrating substantial equivalence to the predicate VELscope device (K070523). The key "criteria" for equivalence are:
- Identical Indications for Use.
- Equivalent essential performance specifications, specifically:
- Excitation band (400-460nm) is the same as the predicate.
- Optical output power in that excitation band is comparable.
- Emission (viewing) optics are identical to the predicate.
- Clinical equivalence demonstrated through comparative imaging of oral mucosal lesions between the new device and the predicate.
Reported Device Performance:
| Acceptance Criteria (for Substantial Equivalence to Predicate) | Reported Device Performance (VELscope Vx vs. VELscope - K070523) |
|---|---|
| Identical Indications for Use | Identical Indications for Use. |
| Equivalent Essential Performance Specifications: | |
| - Excitation band (400-460nm) | Same (400-460nm). |
| - Optical output power in excitation band | Comparable. |
| - Emission (viewing) optics | Identical. |
| Clinical Equivalence (through comparative imaging) | Clinical photographs of a variety of oral mucosal lesions show substantial equivalence between VELscope Vx and predicate VELscope images. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states that "Clinical photographs were taken of a variety of oral mucosal lesions." It does not specify the exact number of lesions or patients included in this "variety."
- Data Provenance: The patients were "referred to oral medicine and oral dysplasia clinics," suggesting a clinical setting. The country of origin is not explicitly stated, but the submitter's address is in Burnaby, BC, Canada. The data appears to be prospective in the sense that images were specifically "acquired" for the comparison, but it's not clear if these were newly diagnosed cases or existing cases.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The study relies on "conventional (white light) as well as fluorescence photographs" and a comparison of these images. There is no mention of independent experts evaluating the images or establishing ground truth.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. It states "A comparison of the predicate VELscope and VELscope Vx images supports the substantial equivalence," implying a qualitative assessment, but the process of this comparison (e.g., blinded, adjudicated, single reviewer) is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. The study's purpose was to demonstrate substantial equivalence between the new VELscope Vx and its predicate (VELscope) through comparative imaging, not to evaluate the improvement of human readers with AI assistance. The VELscope Vx is described as an "adjunct to traditional oral examination" and a "natural tissue fluorescence direct visualization system," not an AI-assisted diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the VELscope Vx is a direct visualization device, not an algorithm. Its operation inherently involves a human observer (dentist or healthcare provider) viewing the fluorescence to identify abnormalities.
7. The Type of Ground Truth Used
The "ground truth" implicitly used is the visual identification of "oral mucosal lesions" and "diseased tissue" by conventional examination and the use of the predicate VELscope. The clinical context is "oral medicine and oral dysplasia clinics," suggesting that these lesions would have a known clinical or pathological status. However, the document does not explicitly state if pathology or outcomes data was used to confirm the nature of the "variety" of lesions imaged. The substantial equivalence is based on the visual comparability of images, not on a definitive ground truth of diagnosis for each lesion.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The VELscope Vx is a medical device, not an AI/machine learning algorithm that requires a "training set." The engineering and design of the device would have been based on established principles of fluorescence and previous knowledge from the predicate device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" in the context of this device.
§ 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.