Search Results

The source of illumination for curing photo-activated dental restorative materials and adhesives.

VALO® Grand Corded is a mains-powered, visible light activator for polymerization of dental resins of all photo-initiated dental materials. The VALO® Grand Corded version functions the same as the predicate, VALO® (K083647), as a professional hand-held, LED-based, visible light curing device. The modified device, VALO® Grand Corded, is manufactured from the same materials (anodized aluminum, rubber buttons, LED light source, printed circuit board, silicone adhesive, plastic), is used for the same indications, and has the same intended use as the predicate devices have three power output modes ranging from 800 - 2300 mW/cm2. Both the new device and predicate cure dental composite materials in the 395 -480 nm range using an LED light source. Differences from the predicate include an increased light head diameter to provide a larger curing area over a tooth, an additional LED activation ('power') button, and the middle power mode setting has been increased to make it more central between the Standard and Xtra Power modes. Additionally, VALO Grand Corded will include one pair of Blue Light Blocking Glasses, which will replace the Light Shield.

The provided text describes VALO® Grand Corded, a dental curing light, and its substantial equivalence to a predicate device, VALO®. However, it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the way typically required for AI/ML medical devices.

Instead, the document focuses on demonstrating substantial equivalence to an existing predicate device based on similar technological characteristics, indications for use, and performance, as is common for medical devices without an AI/ML component.

Therefore, many of the requested categories for acceptance criteria and study details cannot be filled from the provided text. I will explain what information is present and what is missing.

Acceptance Criteria and Device Performance (Not applicable in the AI/ML sense)

The document claims substantial equivalence based on comparable technological characteristics rather than specific acceptance criteria for performance metrics. The performance aspects mentioned are for the device's operational characteristics, not accuracy, sensitivity, or specificity as would be expected for an AI/ML device.

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria (e.g., minimum sensitivity, specificity) common for AI/ML devices are provided. The "performance" described is in terms of power output modes and light wavelength, which are design specifications, not performance against a clinical ground truth.

Regarding the study proving the device meets acceptance criteria:

The document describes "Device design validation and verification activities" performed according to FDA Guidance Document Dental Curing Lights – Premarket Notification [510(k)] and recognized standards (including ADA), and via internal testing protocols. These activities "confirm that VALO® Grand Corded performs equivalently to the predicate VALO® with the modifications that have been made."

The nature of these validation and verification activities is not detailed in the provided text beyond this general statement. It does not describe a clinical study or performance study in the way one would for an AI/ML device. The focus is on demonstrating that the physical and functional changes (e.g., larger head size, additional button, slight power mode adjustment) do not negatively impact safety and effectiveness and that the new device functions similarly to the predicate.

Missing Information (Not applicable or not provided for an AI/ML device in this document):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not applicable as this is not an AI/ML device or a clinical performance study. The "test set" would refer to internal validation tests for mechanical/electrical performance, which are not detailed here.

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 applicable. There is no mention of expert-established ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable. No adjudication method described.

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 applicable. This is not an AI-assisted device.

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

   • Not applicable. This is a standalone dental curing light, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Not applicable for an AI/ML device. The "ground truth" for this device would relate to its ability to cure dental restorative materials, which would be assessed through physical/chemical properties testing (not detailed).

8. The sample size for the training set

   • Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established

   • Not applicable. This is not an AI/ML device.

In summary:

This 510(k) submission establishes substantial equivalence for a physical dental device (a curing light) by comparing its design and functional characteristics to a previously cleared predicate device. It does not involve AI/ML technology, and therefore, the structure of the requested information (which is tailored for AI/ML device performance studies) does not align with the content of this document. The "study" mentioned refers to internal design validation and verification activities ensuring the modified device performs equivalently to the predicate, rather than a clinical performance study with specific acceptance criteria as you might see for an AI/ML diagnostic or prognostic tool.

Ask a specific question about this device