(111 days)
The Swiss Master Light® is a dental curing light that is designed for use in the photopolymerization of dental resins, activation of tooth whitening agents in bleaching procedures.
The Swiss Master Light® consists of a control unit with a handpiece connected to the Main Unit by a detachable handpiece cord. The handpiece contains the halogen light source and a light guide that directs light to the treatment area on the patient. The control unit provides power and cooling water to the handpiece and controls handpiece function.
Here's a breakdown of the acceptance criteria and study information for the Swiss Master Light® as derived from the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Ability to cure resin within specified timeframe without causing thermal damage to tissue. | Performance testing confirmed that the halogen light technology used for the Swiss Master Light® is able to cure resin within the specified timeframe without causing thermal damage to the tissue. |
| Ability to activate tooth bleaching agents within specified timeframe without causing thermal damage to tissue. | Performance testing confirmed that the halogen light technology used for the Swiss Master Light® is able to activate tooth bleaching agents within the specified timeframe without causing thermal damage to the tissue. |
| Substantial equivalence in intended use, technical specifications, and functional performance to predicate devices (Optilux 501 and Elipar® TriLight). | Concluded to be substantially equivalent based on similarities in intended use, technical specifications, and functional performance, with the primary difference being increased light intensity for faster procedures. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for the test set.
The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin mentioned for the specific performance testing. However, given that the sponsor is in Switzerland and the filing is with the US FDA, it's possible testing occurred in either region.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide any information regarding the number of experts used or their qualifications for establishing ground truth in the performance testing.
4. Adjudication Method for the Test Set
The document does not provide any information on the adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as described in the provided summary. This document focuses on the device's technical performance rather than reader interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is an electromechanical device, a dental curing light, not an AI algorithm. Therefore, a standalone (algorithm only) performance study is not applicable and was not conducted. The "performance testing" described refers to the physical output and effect of the light itself.
7. Type of Ground Truth Used
The ground truth for the performance testing appears to be based on objective measurements of material polymerization and thermal effects. For example, the ability to "cure resin" would be assessed by laboratory tests measuring the degree of polymerization (e.g., hardness, depth of cure) and "without causing thermal damage to tissue" would involve temperature measurements or biological assays.
8. Sample Size for the Training Set
This is an electromechanical device, not an AI algorithm, and therefore does not have a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI algorithm, the concept of a training set and its associated ground truth is 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.