(80 days)
Light source for the activation of light cured resin polymers and glass ionomer materials used in dentistry as pit and fissure sealants, restorative materials, and bonding materials.
SAVEDENT The BLUE is a LED based curing light intended to polymerise and therefore cure, harden or set resin or glass ionomer based dental materials used for restorative, sealing or cementing procedures. It is a lightweight handheld unit delivering up to 1000mW/cm2 for set times between 10 and 40 seconds.
The provided text describes a 510(k) submission for a dental light-curing unit called SAVEDENT BLUE. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria in the typical sense of a clinical trial for diagnostic performance.
Here's an analysis based on the provided text, addressing the requested points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The text does not explicitly state formal "acceptance criteria" in a quantitative, pre-defined manner often seen for diagnostic devices (e.g., sensitivity, specificity thresholds). Instead, the demonstration of equivalence is based on meeting or exceeding the performance of the predicate device for "cure depth."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Same or better performance in terms of cure depth for a given exposure time compared to the predicate device | "Comparative tests have demonstrated that SAVEDENTTM BLUE provides the same or better performance in terms of cure depth for a given exposure time as the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The text does not specify the sample size used for the comparative tests or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Comparative tests."
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not applicable or available from the provided text. The device is a light-curing unit, and its performance is measured by objective physical properties (cure depth) rather than a diagnostic interpretation requiring expert judgment.
4. Adjudication Method for the Test Set
This information is not applicable or available from the provided text, as the "ground truth" (cure depth) is based on physical measurement, not expert interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The SAVEDENT BLUE is a therapeutic device (light-curing unit).
6. If a Standalone Performance (Algorithm Only) Study Was Done
No, a standalone performance study in the context of an algorithm or AI is not applicable. The SAVEDENT BLUE is a hardware device (light-curing unit), not an algorithm. The "standalone performance" mentioned implicitly refers to its physical output parameters and ability to cure materials as designed.
7. The Type of Ground Truth Used
The ground truth used is the measured "cure depth" of the dental materials. This is an objective, quantitative physical property, not based on expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
This information is not applicable for this device. As a hardware light-curing unit, there is no "training set" in the context of machine learning or AI algorithms. The development involves engineering and testing, not algorithmic training.
9. How the Ground Truth for the Training Set Was Established
This information is 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.