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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:

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.

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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

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.

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VELscope is to be used by qualified health-care providers to enhance the identification and visualization of oral mucosal abnormalities by exciting the tissue with blue light and allowing the direct visualization of the resulting natural tissue fluorescence. VELscope is complimentary to and is intended to be used in combination with a traditional oral mucosal examination with white light.

VELscope is intended to be used by a dentist or heatth-care provider as an adjunct to traditional oral examination by incandescent light to enhance the visualization of oral mucosal abnormalities.

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.

It appears that the provided text is a 510(k) summary for the VELscope device, which focuses on demonstrating substantial equivalence to a predicate device (Vizilite) rather than a direct study proving specific acceptance criteria for the new device. As such, many of the requested data points for a clinical or performance study proving acceptance criteria are not present in this document.

However, I can extract the information that is available and highlight what is not provided based on the context of a 510(k) summary.

Analysis of the Provided Text for Acceptance Criteria and Study Details:

The 510(k) summary for VELscope (K060920) explicitly states that the device is "substantially equivalent to Vizilite" and details the similarities and minor differences. It does not provide a standalone study with defined acceptance criteria for the VELscope itself. Instead, it relies on the predicate device's existing market clearance.

The document mentions: "NIH funded scientific studies provide evidence to support that VELscope is effective in enhancing the visualization of oral mucosal abnormalities." However, it does not provide details about these studies, their design, or their specific findings in the context of acceptance criteria for the VELscope device.

Therefore, for many of your specific requests (acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details for training/test sets), the information is not available in this 510(k) summary. These details would typically be found in a separate clinical study report or a more detailed performance evaluation document that a 510(k) summary often references but doesn't fully reproduce.

Based on the available text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information from the Provided Text:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. The document mentions "NIH funded scientific studies" but doesn't detail their methodology, sample size, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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: Not provided. This device is an adjunctive light system, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. VELscope is a direct visualization system intended to be used by a human practitioner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device with a distinct "training set" in that sense. The efficacy relies on bio-fluorescence properties of tissue.
9. How the ground truth for the training set was established: Not applicable.

Summary of Study (as per the 510(k) document):

The 510(k) for VELscope relies on establishing substantial equivalence to the predicate device, Vizilite, and general statements about "NIH funded scientific studies" supporting its effectiveness. It does not present a detailed, standalone clinical study with specific acceptance criteria, performance metrics, sample sizes, or ground truth methodologies for the VELscope device itself within this document. The FDA's letter confirms substantial equivalence based on the provided information, allowing it to market the device.

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