(289 days)
SCANWAVE PEN is a source of illumination for the polymerization of light-curing dental materials curing in the wavelength range of 390 nm - 505 nm.
SCANWAVE PEN is a Dental Curing Light. More precisely, SCANWAVE PEN is a source of illumination used for the polymerization of light-curing dental materials curing in the wavelength range of 390 nm - 505 nm. SCANWAVE PEN is equipped with a LED (Light Emitting Diode) which permit to polymerize a large range of dental materials present on the market. SCANWAVE PEN is an Electro-medical Device. SCANWAVE PEN is compatible with only ADEC Dental units. The Handpiece contains the electronic command board, the power board and the light source. The rigid protection shield to the Handpiece reduces the light propagation outside the initial site. This accessory is used to protect the eyes of the patient and the user during the Curing Light polymerization act. The O.E.M. Module is a power supply module intended to deliver the electrical source needed for the Handpiece functioning. The O.E.M. Module is integrated in an ADEC Dental Unit. The User Manual contains all needed information for a correct using (description, safety aspects, problems, cleaning, disinfecting and sterilization procedures).
This document describes the SCANWAVE PEN, an Ultraviolet Activator for Polymerization used for dental applications. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or conducting a study to prove meeting those criteria in the traditional sense of a clinical trial for diagnostic performance.
However, based on the provided text, we can extract details about the performance evaluation conducted.
1. Table of "Acceptance Criteria" (implicit) and Reported Device Performance:
Since this is a substantial equivalence submission for a dental curing light, "acceptance criteria" are implicitly tied to the performance of the predicate devices and compliance with relevant standards. The key performance aspect mentioned is "Depth of Cure."
| Acceptance Criteria (Implicit, based on predicates & standards) | Reported Device Performance (SCANWAVE PEN) |
|---|---|
| Capable of polymerization of light-curing dental materials curing in the wavelength range of 390 nm - 505 nm. | Meets this wavelength range. |
| Depth of Cure substantially equivalent to predicate devices (0.5 to 4.5 mm for Predicate Device n°1, 0.5 to 4 mm for Predicate Device n°2). | "The obtained results show that the Depths of Cure between SCANWAVE PEN are substantially equivalent and coherent with the claimed Intended Use." |
| Compliance with specific standards for Dental Curing Lights (e.g., ANSI / ADA Standard No. 48). | "SCANWAVE PEN has been tested according to a specific standard (Specification No 48). Also, SCANWAVE PEN has been certified according to a particular test bench configuration. The results demonstrate that SCANWAVE PEN is compliant to the applicable standard for Dental Curing Lights." |
| Typical Irradiance at 2 mm (mW/cm²) around 1500-2200 (based on predicates). | Not explicitly stated for SCANWAVE PEN, but implied to be sufficient for substantial equivalence in performance, specifically depth of cure. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a numerical sample size for "non-clinical tests (on test bench)." It refers to "the comparison of the obtained values of SCANWAVE PEN and the bellowed values of Depth of Cure shows that the depths of polymerization of SCANWAVE PEN are substantially equivalent to the valuation of the Predicate Devices." This indicates a comparative test but without specific numbers of samples (e.g., how many measurements for depth of cure, how many dental materials tested).
- Data Provenance: The tests are described as "non-clinical tests (on test bench)." The country of origin of the data is not explicitly stated, but the manufacturer (SATELEC) is based in France. The data appears to be prospective as it involves evaluations of the new device intended to support its market clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable to the provided document. The "ground truth" for a dental curing light's performance in this context is based on objective measurements like "Depth of Cure" using standardized methods, not on expert consensus or clinical interpretation of images. The tests were performed on a test bench.
4. Adjudication Method for the Test Set:
Not applicable. The performance evaluation was based on objective, non-clinical bench tests of polymerization depth and compliance with technical standards, rather than subjective interpretation requiring adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data. The SCANWAVE PEN is a dental curing light, and its performance is evaluated through objective physical measurements, not human interpretation.
6. Standalone Performance:
Yes, a standalone performance evaluation was done through the "non-clinical tests (on test bench)" which demonstrated the "Depth of Cure performance" of the SCANWAVE PEN itself and its compliance with applicable standards. However, its effectiveness is framed in direct comparison to predicate devices, rather than an absolute measure independent of any benchmark.
7. Type of Ground Truth Used:
The ground truth used was objective measurements based on standardized test methods (specifically for "Depth of Cure" and compliance with standards like ANSI / ADA Standard No. 48 for Dental Curing Lights). This is a form of scientific/engineering validation rather than clinical ground truth like pathology or outcomes data.
8. Sample Size for the Training Set:
Not applicable. The SCANWAVE PEN is a physical medical device (a dental curing light) and not an algorithmic or AI-based device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of 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.