(135 days)
The VALO® Grand is a source of illumination for curing photo-activated dental restorative materials and adhesives.
VALO® Grand is a battery operated, visible light activator for polymerization of dental resins of all photo-initiated dental materials. The VALO® Grand version functions the same as the predicate, VALO® Cordless, K110582, as a professional hand-held, LED-based, visible light curing device. The modified device, VALO® Grand, 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 device. Both 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 for better ergonomics, and the middle power mode setting has been changed from 1400 to 1600 mW/cm², which makes it more central between the Standard and Xtra Power modes.
The provided text describes a Special 510(k) Summary for the VALO® Grand dental curing light. While it outlines the device's characteristics and its substantial equivalence to a predicate device, it does not contain detailed acceptance criteria and the comprehensive study data typically requested for proving a device meets specific performance criteria.
Here's an analysis based on the information provided and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions "Verification activities included curing hardness, depth of cure per ADA Specification No. 48, maximum light intensity measurements at 2 mm for all power modes, spectral irradiance plots of all power modes, and representative user testing."
However, it does not provide a table specifying the acceptance criteria (e.g., minimum curing hardness, minimum depth of cure) for these parameters, nor does it present the actual reported device performance values against such criteria. It only states that "Based on the results of verification testing, the differences in technological characteristics did not raise different questions of safety or performance..." without showing the data.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "representative user testing" but does not specify the sample size for any of the verification activities (curing hardness, depth of cure, light intensity, spectral irradiance, or user testing).
The data provenance is also not explicitly stated (e.g., country of origin, retrospective or prospective). It simply refers to "verification testing."
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The studies mentioned are primarily technical performance tests of the device itself (curing properties, light output), not expert-driven assessments requiring ground truth establishment in the typical sense for diagnostic or prognostic devices. "Representative user testing" is mentioned, but details about the users (experts or not, qualifications) and their role in establishing "ground truth" are absent.
4. Adjudication Method
This information is not applicable/provided. The verification activities described are objective measurements of the device's physical and curing properties, not subjective assessments requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed or mentioned. The device is a dental curing light, and the studies described focus on its physical performance in curing dental materials, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance
A standalone performance study was not performed or mentioned. The device is a physical light-emitting product, not an algorithm.
7. Type of Ground Truth Used
For the performance tests mentioned (curing hardness, depth of cure, light intensity, spectral irradiance), the "ground truth" would be established by objective laboratory measurements against predefined physical and chemical standards (e.g., ADA Specification No. 48 for depth of cure, calibrated light power meters for intensity, spectrophotometers for spectral irradiance). The document implies these standard methods were used ("per ADA Specification No. 48"), but doesn't explicitly detail the "ground truth" creation process beyond that.
8. Sample Size for the Training Set
This information is not applicable. The device is not an AI/ML algorithm that requires a training set. The descriptions are of physical device verification.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As there is no training set for an algorithm, there is no ground truth to establish for it.
In summary:
The provided document is a 510(k) summary for a dental curing light, demonstrating substantial equivalence to a predicate device through engineering and performance verification. It focuses on physical and curing properties of the device. Consequently, many of the requested details, particularly those related to expert-driven ground truth, MRMC studies, or AI/ML algorithms, are not relevant or present in this type of submission. While it states that verification activities were performed, it lacks the specific quantitative results and acceptance criteria tables that would fully answer the request for "acceptance criteria and the study that proves the device meets the acceptance criteria."
§ 872.6070 Ultraviolet activator for polymerization.
(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.