(74 days)
The Starlight Pro and Silverlight devices are dental curing light units intended for use in the oral cavity for the polymerization of photo-hardening dental materials that are activated in the 440 - 480 nm wavelength range.
The Starlight Pro and Silverlight are dental curing light units intended for the polymerization of photo-hardening dental materials in the oral cavity. A light emitting diode (LED) with a wavelength between 440 nm is used in both devices as the light source. The spectrum of the light emitted by the LED corresponds to the absorption spectrum of camphorquinone photo-initiator, which is the most common and widely used visible light photo-initiator in among available photohardening dental materials. Camphorquinone photo-initiator has an light absorption curve ranging approx. from 400 - 500 nm, with a peak absorption at approx. 468 nm. This range falls within the emission spectrum of the LED used in the subject devices, making the units effective for the polymerization of camphorquinone-based dental materials. The subject devices consist of a cordless handpiece, powered by a rechargeable battery, and incorporating a LED as light source, a battery charger unit and a fiber optic that directs the light onto the material being polymerized. The devices allow the user to activate two curing modes ('Fast' and 'Slow Rise') by pressing the relevant push-button on the handpiece. These two curing modes differ in the light exposure and in the mode with which the light is emitted. In particular: The fast curing mode has an exposure time of 10 sec. at the maximum light intensity. The slow rise exposure mode has an exposure time of 20 sec. with a gradual increase of light during the first 3 seconds up to the maximum intensity. Acoustic signal timings are emitted by the handpiece during program execution. The charger unit allows recharging of the battery and it has an integrated light meter to check the light output. On the charger unit are three signaling LED lamps, indicating the on/off unit state, the battery charge state, and the functionality of the battery.
Here's a summary of the acceptance criteria and study information for the Mectron Starlight Pro and Silverlight dental curing light units, based on the provided 510(k) summary:
Overview of Device and Study Type:
The Mectron Starlight Pro and Silverlight are dental curing light units used for polymerizing photo-hardening dental materials. This 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device (Translux Power Blue (K042199) - Heraeus Kulzer GmbH) rather than establishing novel clinical performance. Therefore, the "acceptance criteria" and "study" are geared towards proving this equivalence through non-clinical functional and performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" in a typical pass/fail format with specific thresholds. Instead, it describes general compliance and functional equivalence. The reported performance is an affirmation of compliance and functional similarity to the predicate.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Intended Use: Polymerization of photo-hardening dental materials in the oral cavity, activated in 440-480 nm wavelength range. | The Starlight Pro and Silverlight devices are dental curing light units intended for use in the oral cavity for the polymerization of photo-hardening dental materials that are activated in the 440 - 480 nm wavelength range. This matches the predicate and the class of device. |
| Technological Characteristics: Similar to predicate (light source, operating principles, curing modes, built-in light meter). | - Light Source: Both devices use an LED with a wavelength between 440 nm (stated as 440-480nm for the system, with peak absorption at ~468nm for camphorquinone photo-initiator). This falls within the emission spectrum of the LED used in the subject devices, making them effective for camphorquinone-based materials, consistent with the predicate. |
- Operational Principles: Identical to the predicate, including a cordless handpiece, rechargeable battery, LED light source, removable fiber optic.
- Curing Modes: Both devices (and the predicate) offer two curing modes: 'Fast' (10 sec at max intensity) and 'Slow Rise' (20 sec with gradual increase to max intensity over 3 sec).
- Built-in Light Meter: Both subject devices and the predicate have a built-in light meter to check light output/intensity. |
| Safety and Effectiveness (Non-clinical testing): Functional and performance evaluation. | The following non-clinical tests were conducted: - Measurements of spectrum and irradiance: Confirmed the devices' light emission characteristics.
- Depth of cure (mm) on resin samples: Assessed the effectiveness of polymerization.
- Software validation: Ensured proper functioning of device software.
- Electromagnetic compatibility: Compliance with EN IEC 60601-1 and EN IEC 60601-1-2 standards was demonstrated.
Results from these tests confirm that the proposed devices are safe and effective for the polymerization of photo-hardening dental materials in the oral cavity and support substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a numerical sample size for the "test set" in terms of how many devices were tested or how many resin samples were used for the depth of cure measurement. It generically states "resin samples."
- Data Provenance: The data is from non-clinical testing conducted by the manufacturer, Mectron S.p.A. The country of origin for the data (testing location) would be Italy, where Mectron S.p.A. is based. The data is prospective in the sense that it was generated specifically for this submission to demonstrate device performance and safety.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" here is objective physical measurements and compliance with standards, not expert interpretation of clinical images or outcomes.
4. Adjudication Method for the Test Set
This is not applicable. The non-clinical tests involved objective measurements (e.g., spectrum, irradiance, depth of cure, EMC compliance) rather than subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. This submission relies on non-clinical testing and comparison to a predicate device for substantial equivalence, not a clinical trial evaluating human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable in the context of an "algorithm" as this is a physical dental curing light, not an AI or software algorithm in the conventional medical device sense. The device's "standalone performance" was evaluated through the non-clinical tests (spectrum, irradiance, depth of cure, software validation, EMC).
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical testing was based on:
- Physical measurements: Objective measurements of light spectrum, irradiance, and depth of cure in resin samples.
- Established standards: Compliance with electromagnetic compatibility standards (EN IEC 60601 -1 and EN IEC 60601-1-2).
- Performance specifications: Validation of the device's software functionality.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm 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 an AI/ML algorithm.
§ 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.