(54 days)
The Demetron A.2 is a L.E.D. visible light curing unit intended for polymerization of light cure materials by dental professionals.
The Demetron A.2 is a Light Emitting Diode (LED) visible light curing unit used for the polymerization of light-cure materials. The Demetron A.2 consists of an LED curing handpiece and wall plug-in transformer. 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 two (2) different curing modes. Each mode specifies LED curing output, fan, and audible beep timing. A pushbutton "trigger" switch will be used to select the curing mode and activate the LED curing output.
The provided document is a 510(k) summary for the Demetron A.2 L.E.D. Curing Light. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not include detailed scientific study data, acceptance criteria, or performance metrics in the way a typical clinical or AI device study report would.
Therefore, I cannot populate the requested table and sections with specific numbers and methodologies as they are not present in the provided text.
Here is what I can infer and state based on the document's content:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed performance results from a study. The basis for clearance is "substantial equivalence" to a predicate device. This typically means the new device performs as intended and is as safe and effective as the predicate, but specific performance metrics are not always presented as a direct comparison in the 510(k) summary itself.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes a new medical device aiming for 510(k) clearance by demonstrating substantial equivalence, not reporting results from a clinical or performance study with a test set of data.
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. This is not a study involving expert annotation or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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. This device is an LED curing light, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
Summary of what the document does provide:
- Device Name: Demetron A.2 L.E.D. Curing Light
- Intended Use: For the polymerization of visible light-cure materials by dental professionals.
- Predicate Device: Demetron I.D.S. (Kerr Corporation)
- Substantial Equivalence: The device is claimed to be substantially equivalent to the predicate device, functioning in a similar manner and intended for the same use. This is the primary "proof" for 510(k) clearance in this context.
To truly answer the questions about acceptance criteria and study results, one would need to refer to the full 510(k) submission, which often includes engineering specifications, manufacturing controls, and potentially some basic performance testing results (e.g., light intensity, wavelength stability, temperature rise) against internal specifications or industry standards. These are not present in this "510(k) Summary of Safety and Effectiveness."
§ 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.