(39 days)
The Sirius Max Diode Curing Light is intended for use as a source of illumination for photo initiated curing and/or activation/ polymerization of dental restorative materials and adhesives.
The Sirius Max Diode Curing Light is shipped as a system consisting of the charging station ("charger"), the handpiece, 50 SiriusMax Barrier Sleeves, an orange protective eye shield, and screwdriver for removal of the battery. The charger allows for placement of the handpiece in a holder with electrical connection for battery charging and interface with the 5vdc power source. The handpiece is constructed of aluminum with plastic control surface and glass output lens and is non-sterile utilizing the barrier sleeves for infection control. The handpiece houses the control circuitry with microprocessor and user interface for selection of mode and curing light output providing visual indications of power settings and of the unit's status. This interface also features the unit's power ON/OFF switch as well as the button to activate the white light intraoral illumination light to aid in the visualization of dental anatomy. The unit is battery operated and contains an internal battery pack with Li batteries. The battery pack is service removable with the use of the screwdriver provide. An instruction for use is also included inside the packaging. The Instructions For Use detail the function of the device and describe the 6 different curing modes. They are Normal mode 1200mw/cm2, Softstart mode 1400mw/cm2, Pulse mode 1400mw/cm2, High Power mode 1300 mw/cm2, Xtra Power mode, 3000mw/cm2, and Orthodontics mode 1400mw/cm2. The curing LED module provides high intensity light in the range of 430-490nm. The white light transillumination LED module (400-700nm) is provided as an aid for illuminating anatomy in the oral cavity.
This document is a 510(k) premarket notification for a dental curing light, describing its substantial equivalence to a predicate device. It addresses the device's technical specifications and compliance with standards, but does not contain a study comparing its performance against specific acceptance criteria in a clinical or reader study context for an AI/ML device.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, cannot be extracted from this document.
However, I can provide the available information about the device's performance in relation to international standards.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance (Sirius Max Diode Curing Light) | Predicate Device Performance (VALO CORDLESS K110582) |
|---|---|---|
| IEC 60601-2-22 Standard: Curing Light output should vary from the device's setting by less than ± 20% of the setting. | The device's output measurements (ranging from 0.1 to 5.0W in all modes) varied by an average of only 1.4% from the unit's settings. | Satisfies this standard. (Explicit deviation not stated but implied by substantial equivalence) |
| Peak Wavelength: Primary peak at 460nm. | Single Peak wavelength at 460nm. | Primary peak at 460nm, small peak at 410nm. (Deemed substantially equivalent due to low energy and lower penetration depth of 410nm). |
| Compliance with Standards: (Implied acceptance criteria for safety and performance) | Complies with IEC 60601-1, IEC 60601-2-2, IEC 60601-2-22, ANSI/ADA 48-2. Bench tests performed: depth of cure, conformance to ANSI/ADA Specification No. 48-2, Temperature Control Validation, cleaning and disinfection validation, software verification and Validation and IEC 60601-1 Electrical Safety. | Complies with relevant international safety standards. |
Below is a breakdown of the requested information, with clarification that much of it is not applicable or not present in this type of 510(k) submission for a non-AI/ML device.
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A table of acceptance criteria and the reported device performance
- See table above. The primary acceptance criterion explicitly mentioned is regarding the accuracy of light output. Other criteria are implied by compliance with international safety and performance standards.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This document describes a physical medical device (dental curing light) and its performance through bench testing against established standards and comparison with a predicate device. It does not involve a "test set" in the context of an algorithm or AI/ML model, nor does it refer to patient data provenance.
- The "measurements of the subject devices output" were used for testing, but a specific "sample size" of devices or measurements isn't provided beyond stating "all modes".
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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)
- N/A. There is no "ground truth" established by experts in the context of clinical interpretation for an AI/ML device. The ground truth for this device's performance is based on physical measurements and compliance with engineering and safety standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. This is not relevant for the type of device and testing described.
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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
- N/A. This document is for a standalone physical curing light, not an AI/ML diagnostic tool that assists human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device itself is standalone in its function as a curing light, but it is a physical device, not an algorithm. Bench tests were performed on the device's physical outputs (e.g., light intensity, depth of cure).
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" here is based on physical measurements (e.g., actual light output) and compliance with established international and national standards (e.g., IEC 60601 series, ANSI/ADA 48-2).
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The sample size for the training set
- N/A. This document describes a manufactured medical device, not an AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established
- N/A. This is not relevant for the 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.