(22 days)
The Demetron I.D.S. is a L.E.D. visible light curing unit intended for polymerization of light cure materials by dental professionals.
The LED based Demetron I.D.S. Curing Light is a device used for the polymerization of dental materials. It consists of an LED curing handpiece and flexible cord designed to be connected to a dental chair unit. The plastic molded handpiece will contain an LED light "engine", a cooling fan and a printed circuit board. A digital circuit and microprocessor will be utilized to control 2 different curing modes and power to the LED. Each mode specifies LED curing output timing, fan timing and audible beep timing. A pushbutton "trigger" switch will be used to select the curing mode and activate the LED curing output. The dental chair manufacturer's transformer or power supply will provide power for the handpiece.
Here's an analysis of the provided text regarding the Demetron I.D.S. L.E.D. Curing Light, focusing on your requested information:
Unfortunately, the provided document (K042888) is a 510(k) summary for a dental light-curing unit, not an AI/algorithm-based diagnostic or triaging device. Therefore, the questions related to acceptance criteria for algorithmic performance, ground truth, expert adjudication, sample sizes for AI training/testing, or MRMC studies are not applicable to this type of device.
The 510(k) submission process for a device like a curing light focuses on demonstrating substantial equivalence to a predicate device already on the market, primarily based on similar intended use, technology, and safety/performance characteristics. It does not typically involve the rigorous statistical studies of diagnostic accuracy, sensitivity, and specificity that would be required for an AI-powered device.
However, I can extract the relevant information that is present in the document.
Device: Demetron I.D.S. L.E.D. Curing Light
Device Type: Ultraviolet activator for polymerization (L.E.D. Curing Light)
Intended Use: For the polymerization of visible light cured materials by dental professionals.
Predicate Device: Kerr Corporation, L.E. Demetron
Reason for K042888: To demonstrate substantial equivalence to the predicate device.
Here's how I can answer your questions, highlighting where they are not applicable to this specific device:
1. A table of acceptance criteria and the reported device performance
For a dental curing light, acceptance criteria are generally related to its ability to cure dental materials effectively and safely, matching the performance of a predicate device. This would typically involve measuring light output, wavelength, and the ability to cure various dental resins within specified times. The provided 510(k) summary does not contain a specific table of acceptance criteria or detailed performance data in the way you might find for an AI algorithm. Instead, it relies on the assertion that its function is "similar to" and its intended use is "the same as" the predicate device, implying it meets the same general performance standards.
| Acceptance Criteria (Conceptual for Curing Light - Not Explicitly Stated in Document) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Light Output/Irradiance: Sufficient power to polymerize dental resins | "Functions in a manner similar to," and "is intended for the same use as" the L.E. Demetron predicate device. This implies its light output and curing capability are comparable and adequate for its intended purpose, as demonstrated by the predicate's established performance. |
| Wavelength: Appropriate spectrum for visible light-cured materials | As an "L.E.D. visible light curing unit," it is implied to emit light in the necessary spectrum for available dental resins, similar to the predicate. |
| Curing Modes/Timing: Control over curing cycles | "A digital circuit and microprocessor will be utilized to control 2 different curing modes and power to the LED. Each mode specifies LED curing output timing, fan timing and audible beep timing," similar to predicate. |
| Safety: Electrical, thermal, and mechanical safety | Not explicitly detailed in the summary, but implied by adherence to general controls provisions of the Act and manufacturing practices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable. The 510(k) summary does not describe a "test set" in the context of evaluating an AI algorithm's performance. For a medical device like a curing light, physical and electrical testing would be performed, but this is not typically presented as a "test set" in the same statistical sense for regulatory submissions.
3. 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)
Not Applicable. Ground truth, in the context of algorithms relying on expert interpretation, is not relevant for a dental curing light. Its function is physical (light emission for polymerization), not diagnostic or interpretive.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. As there is no "test set" from an algorithmic performance perspective, no adjudication method was used.
5. 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
Not Applicable. An MRMC study is designed for evaluating diagnostic devices that assist human readers (e.g., radiologists, pathologists). A dental curing light does not involve human readers' interpretation or an AI component to assist them.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. There is no algorithm in this device that would have standalone performance. The device is a physical tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not Applicable. As explained above, the concept of "ground truth" for a physical device like a curing light is not relevant. Its performance is evaluated through engineering specifications and the demonstration of equivalent curing capability through laboratory tests (e.g., depth of cure, material hardness), which are not described in detail in this summary but are implied by substantial equivalence.
8. The sample size for the training set
Not Applicable. This device does not use machine learning or AI, and therefore has no "training set."
9. How the ground truth for the training set was established
Not Applicable. As there is no AI component or training set, there is no ground truth to establish for such a set.
§ 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.