(58 days)
Source of illumination for curing photo-activated dental restorative materials and adhesives.
Valo® Cordless is a visible light activator for polymerization of dental resins. In other words, it is a dental curing light used for polymerization of all photo-initiated dental materials. The VALO Cordless is shipped as a system with the VALO Cordless wand, 4 rechargeable batteries, 2 for initial use and 2 for later use, a battery charger and 50 VALO Cordless Barrier Sleeves. An Instruction for Use is also included inside the packaging. The Instructions for Use details the function of the device and describes the modes for the VALO Cordless. VALO Cordless has three operating modes. They are Standard Power Mode: 1000mW/cm², High Power Mode: 1400mW/cm² and Xtra Power Mode: 3200mW/cm².
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the VALO® Cordless device. It's important to note that this document is a 510(k) premarket summary for a dental curing light, not an AI/ML device. Therefore, several sections of your request related to AI/ML specific criteria (like MRMC studies, training set details, or number of experts for ground truth) will not be applicable.
Acceptance Criteria and Device Performance for VALO® Cordless
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Characteristic | VALO® Cordless Performance (Reported) |
|---|---|
| Wavelength Range | 395nm – 480nm (Effective output Power) |
| Minimal power: 380nm – 395nm and 480nm – 510nm | |
| Complies with ADA 48 specifications for power limitations within specific wavelength bands. | |
| Light Intensity (Power Modes) | Standard Power Mode: ~1000 mW/cm² +/- 10% |
| High Power Mode: ~1400 mW/cm² +/- 10% | |
| Xtra Power Mode: ~3200 mW/cm² +/- 20% (formerly 'Plasma Emulation') | |
| Power Supply | Same as predicate (wall powered, 12VDC, medical grade with adapters for International capability, UL Approved) - Note: The descriptor "Cordless" implies rechargeable batteries are the primary power supply for operation, while the "Power Supply" row likely refers to the charging unit's input. |
| Indications For Use | Source of illumination for curing photo-activated dental restorative materials and adhesives. (Same as predicate) |
| Structure | Ergonomic wand (Same as predicate) |
| Light | Blue and UV wavelengths (Same as predicate) |
| Current Control | Regulates current in the light source (Same as predicate) |
| Buttons | Two buttons that function the light (Same as predicate) |
| Power ON button | Located on handle of wand (Same as predicate) |
| Power cord | 8' length (Same as predicate) - Again, likely refers to the charger. |
| Time | Device indicates time and time selection (Same as predicate) |
| Operation | 110VAC (Same as predicate) - Refers to the charger's input. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for individual tests like depth of cure or software verification. The "Performance Data" section discusses general instrument specifications (wavelength, intensity) and refers to "bench tests."
- Sample Size: Not explicitly stated for specific tests.
- Data Provenance: The tests were "conducted along with bench tests described in the 510(k)." This suggests the data is prospective and generated by Ultradent Products, Inc. (the applicant) as part of their device development and submission process. The country of origin of the data is implicitly the USA, where Ultradent Products, Inc. is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the VALO® Cordless is a physical medical device (dental curing light), not an AI/ML diagnostic or image analysis device that relies on expert interpretation for ground truth. The "ground truth" here refers to the physical and functional performance characteristics of the light itself, measured by instruments.
4. Adjudication Method for the Test Set
This is not applicable for the same reasons as point 3. Adjudication methods are typically used when human interpretation (e.g., of images) is involved in establishing ground truth, which is not the case for this type of device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML devices where human readers' performance with and without AI assistance is being evaluated. The VALO® Cordless is a standalone physical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance data presented (wavelength, light intensity, depth of cure, etc.) represents the standalone performance of the VALO® Cordless device itself, without human-in-the-loop considerations in the measurements of its physical properties. However, it's not "algorithm only" as it's a hardware device. The "software verification and validation" would assess the standalone performance of its internal control software.
7. The Type of Ground Truth Used
The ground truth used for verifying the device's performance is based on instrumental measurements and established physical/electrical safety standards.
- Wavelength and Light Intensity: Measured by instruments like a Demetron® L.E.D. Radiometer and a spectrum analyzer. Compliance with ADA 48 standards (for wavelength bands) is also a form of established ground truth.
- Depth of Cure: This would be measured using standardized laboratory procedures to determine how effectively the light cures dental materials.
- Software Verification and Validation: This process establishes that the software performs as designed according to its specifications, which form the ground truth.
- IEC 60601-1 Electrical Safety: Adherence to this international standard for medical electrical equipment forms a critical part of the safety ground truth.
8. The Sample Size for the Training Set
This is not applicable. The VALO® Cordless is a physical device; it does not utilize a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this device.
§ 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.