(112 days)
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.
| Performance Parameter | Acceptance Criteria (Implied / Standard) | Reported Subject Device Performance (Fibercure) |
|---|---|---|
| Intended Use | Photocuring of dental materials | Photocuring of dental materials |
| Indications for Use | For light curing polymerization of dental materials capable of curing in the 385 - 425 nm wavelength range (similar to predicate, within specified wavelength) | For light curing polymerization of small areas of dental materials capable of curing in the 385 - 425 nm wavelength range |
| Irradiance | Comparable to predicate/reference devices | 1800 - 2200 mW/cm^2 |
| Peak Wavelength | Consistent with compatible dental materials | 405 ± 5 nm |
| Depth of Cure | ≥ 1 mm (per ISO 4049:2019, clause 5.2.8) | 1.4 ± 0.1 mm |
| Operational Modes | Functional and comparable to predicate | 10 seconds, 20 seconds |
| Electrical Safety | Meets IEC 60601-1 Class II, Type B requirements | Class II, Type B Applied Part |
| Laser Safety | Meets IEC 60825-1 requirements | Class 3R (Laser diode) |
| Overall Performance | Meets requirements of ISO 10650:2018 and FDA guidance "Dental Curing Lights..." | Meets requirements; comparable to predicate device |
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.
§ 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.