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For light curing polymerization of small areas of dental materials capable of curing in the 385 – 425 nm wavelength range.

Fibercure is a handheld dental curing light intended for light curing polymerization of small areas of dental materials capable of curing in the 385 – 425 nm wavelength range. Fibercure functions by delivering light energy to photocurable dental materials, which utilize the light energy to induce a photopolymerization reaction.

Fibercure consists of a pen-shaped handpiece, that is powered with a detachable, rechargeable battery. The handpiece features a user interface containing two push buttons and three status LEDs. The hand-piece is equipped with a solid-state laser diode to generate light energy at a wavelength of 405 ± 5mm and a power of 40 mW. The laser diode is coupled to single-use cure tips containing an optical fiber of 200 µm diameter. The cure tip emits light with an irradiance of 1800 - 2200 mW/cm2 and allows the light to be precisely targeted on the area to be photocured. Fibercure has 2 operation modes to provide either 10 or 20 second irradiation. Fibercure is delivered with a charging stand that is connected to the mains power using a USB power supply. It provides two charging stations and a photometer to confirm the intensity of the emitted light.

Fibercure's handpiece is manufactured from anodized aluminum and houses the electronic assembly. The cure tip consists of a silica-ETFE optical fiber, a stainless-steel fiber guide, a plastic housing and a ceramic ferrule. The detachable battery, charging base and power supply are manufactured from injection-molded plastic.

This is a 510(k) summary for the device Fibercure, an ultraviolet activator for polymerization used in dentistry. The document focuses on establishing substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a study with statistical measures.

The information provided is primarily a comparison between the subject device (Fibercure) and predicate devices, detailing various technical specifications and indicating that non-clinical tests were performed. However, it does not include the typical acceptance criteria format (e.g., sensitivity, specificity, AUC with thresholds) or a detailed study description to demonstrate that the device "meets" those criteria in the way one would expect for a diagnostic or AI-driven device.

Here's an attempt to answer your questions based on the provided text, while acknowledging the limitations of this type of regulatory submission in addressing your specific points:

Since the document provided is a 510(k) summary for a dental curing light, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the manner of a diagnostic or AI-driven device. Therefore, many of your questions, particularly those related to sample size, expert ground truth, MRMC studies, and training sets, are not applicable or cannot be answered from this type of document.

However, I can extract the "performance parameters" and the general conclusion that these parameters meet requirements as a proxy for "acceptance criteria."

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

The document doesn't explicitly state "acceptance criteria" with specific numerical thresholds for aspects like irradiance or depth of cure as pass/fail conditions. Instead, it presents the device's performance parameters and compares them to predicate devices and general standards. The "acceptance criteria" here are implied to be "meeting the requirements of recognized standards and guidance" and being "comparable" to predicate devices.

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

This information is not provided in the 510(k) summary. The document describes non-clinical performance testing but does not detail the methodology, sample sizes, or provenance of the data in the way you would expect for a clinical study or AI algorithm validation. The testing appears to be laboratory-based physical measurements rather than human-data-driven.

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)

This information is not applicable/provided. The device is a dental curing light, not an AI or diagnostic device that requires expert ground truth for evaluating performance on a test set of cases. The "ground truth" for its performance relates to physical measurements and adherence to technical standards.

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

This information is not applicable/provided. Adjudication methods are relevant for consensus among experts, typically in diagnostic or AI performance studies on clinical data. For this device, performance is evaluated against technical standards and physical measurements.

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

This information is not applicable/provided. This type of study is specifically for AI-assisted diagnostic devices involving human readers. The Fibercure device is a dental curing light, a tool used by dental professionals, not an AI-driven diagnostic system.

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

This information is not applicable/provided. This question is relevant for AI algorithms. The Fibercure device is a physical instrument for light curing, not an algorithm.

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

The "ground truth" for this device's performance would be derived from physical measurements and adherence to recognized industry and regulatory standards. For example, irradiance is measured with a photometer, wavelength with a spectrometer, and depth of cure according to ISO 4049. It is not based on expert consensus, pathology, or outcomes data in the context of clinical disease.

8. The sample size for the training set

This information is not applicable/provided. The Fibercure device is a physical product (a dental curing light), not a software or AI algorithm that requires a "training set."

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

This information is not applicable/provided. As above, there is no "training set" for this device.

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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.

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