(138 days)
The Monet Curing Laser is a source of illumination for curing photo-active materials and adhesives.
The Monet Curing Laser is a device for delivering light energy to dental restorative materials and adhesives, which utilize the light energy to affect a photopolymerization reaction. This energy is generated by a solid-state laser diode, which provides a consistent and reliable generation of laser energy at 450 ± 5nm for a maximum of 2.0 watts (2400 mW/cm²) of energy output. The laser energy is delivered to the dental material by means of an optical focusing lens that collimates the laser energy to a nearly parallel beam size that remains highly consistent regardless of distance to the target material. The device also includes a low-intensity aiming beam feature that allows the operator to see the delivery site of the energy without risk of premature polymerization of the material. The device features a metal construction with glass output window that contains all device electronics. The device features a simple on/off switch and set 3-second activation time. The device incorporates a detachable rechargeable battery which is recharged on an accompanying charging stand. The charging stand incorporates a basic radiometer to allow the user to confirm the output intensity of the emitted light.
The provided text describes the regulatory clearance for the "Monet Curing Laser" and offers information about its performance testing. However, it does not contain specific acceptance criteria tables or detailed study results in the manner requested for AI/software-based devices. The document is an FDA 510(k) clearance letter and summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical trial outcomes with statistical acceptance criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions related to sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details as these are not present in the provided document.
Information that CAN be extracted from the document:
1. Device Name: Monet Curing Laser
2. Regulation Number: 21 CFR 872.6070
3. Regulation Name: Ultraviolet activator for polymerization
4. Product Code: QNF, GEX
5. Regulatory Class: Class II
6. Indications for Use: The Monet Curing Laser is a source of illumination for curing photo-active materials and adhesives. For dental applications, this is specified as curing photo-activated dental restorative materials and adhesives.
7. Description of Submitted Device:
- Delivers light energy to dental restorative materials and adhesives to affect photopolymerization.
- Energy generated by a solid-state laser diode.
- Wavelength: 450 ± 5nm.
- Maximum energy output: 2.0 watts (2400 mW/cm²).
- Optical focusing lens collimates the laser energy to a nearly parallel beam.
- Includes a low-intensity aiming beam feature.
- Metal construction with glass output window.
- Simple on/off switch and set 3-second activation time.
- Detachable rechargeable battery.
- Accompanying charging stand with a basic radiometer to confirm output intensity.
8. Legally Marketed Predicate Device: Valo Grand, manufactured by Ultradent Products, Inc. (K160551)
9. Performance Data (as reported in the 510(k) Summary):
- ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY:
- Complies with 21 CFR 1040.10 and 1040.11 (with permissible deviations relative to Laser Notice 50, dated June 24, 2007).
- Complies with IEC 60601-2-22 Edition 3 and IEC 60825-1 Edition 2.
- Complies with IEC 60601-1: Edition 3.1, IEC 60601-1-2 Edition 4, and IEC 60601-1-6 Edition 3.1.
- PERFORMANCE BENCH TESTING (Depth of Cure):
- "Depth of cure testing was performed with the Monet and with the VALO curing light, assessing different popular brands of dental composite and lighter and darker shades of composite from each of these brands."
- "Both light sources were activated for a single exposure of the same amount of time."
- Reported performance: "The Monet is capable of achieving polymerization of the tested composites at a level that is generally equal to or better than the VALO while doing so with a lower light intensity."
- BIOCOMPATIBILITY:
- Features the same nature of incidental patient contact as the predicate device.
- Composed of similar materials to the predicate device.
- END-USER STERILIZATION:
- Not intended to be sterilized by the end-user.
- Includes single-use barrier sleeves for infection control (not sterile, not intended for end-user sterilization).
Summary of missing information based on your request:
- A table of acceptance criteria and the reported device performance: Specific quantitative acceptance criteria (e.g., "Depth of cure must be X mm with less than Y% variability") are not provided. The performance is qualitatively compared to the predicate ("equal to or better than").
- Sample sized used for the test set and the data provenance: No numerical sample sizes for depth of cure testing are mentioned. No information on data provenance (country, retrospective/prospective).
- Number of experts used to establish the ground truth... and qualifications: Not applicable. This is a physical device, not an AI/software device requiring expert ground truth for classification.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI/software device that assists human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For depth of cure, the "ground truth" would be the measured physical polymerization depth, but the method details are not provided.
- The sample size for the training set: Not applicable (not an AI/ML device).
- How the ground truth for the training set was established: Not applicable.
§ 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.