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510(k) Data Aggregation
(258 days)
The Demi Ultra is a Light Emitting Diode (LED) visible light curing device used for the polymerization of light-cured materials by dental professionals.
The Demi Ultra is a Light Emitting Diode (LED) visible light curing device used for the polymerization of light-cured materials by dental professionals. The Demi Ultra consists of a handpiece, LED light curing attachment, and charging dock. The aluminum and plastic molded handpiece contains two (2) ultracapacitors (electric double-layer capacitors), printed circuit boards containing the electronics and user interface buttons, receptacle for retaining the LED light curing attachment, and receptacle for interfacing with the charging dock. The LED light curing attachment contains the curing LED, clear lens and two (2) copper head spreaders, all over molded in plastic. The charging dock contains printed circuit boards containing electronics to support charging the handpiece and built-in LED radiometer functionality. For the handpiece, a digital circuit and microprocessor is utilized to control three (3) different curing modes (5, 10 and 20 seconds). Each mode specifies LED curing output and optional audible beep timing. The handpiece uses one button to activate the LED curing output and another to select the curing time mode. For the charging dock, a digital circuit and microprocessor is utilized to monitor the charging of the handpiece ultracapacitors, as well as respond to light at the radiometer input by illuminating lights on a radiometer meter. Demi Ultra is required to be used with an FDA cleared barrier sleeve.
The provided text describes a 510(k) premarket notification for a dental light-curing device called Demi Ultra. The submission asserts substantial equivalence to a previously cleared predicate device, the Demi Ultra (K123468).
Here's an analysis of the acceptance criteria and the study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative format for specific performance metrics that the device needs to meet. Instead, it lists performance tests that were conducted and compares the technological characteristics of the proposed device to a predicate device. The core argument for acceptance is substantial equivalence to the predicate device.
| Element (Performance Test/Characteristic) | Predicate Demi Ultra Performance/Characteristic | Proposed Demi Ultra Performance/Characteristic | Acceptance Criteria (Implicit) |
|---|---|---|---|
| Depth of Cure | Tested per ISO 10650:2015 & ANSI/ADA 48-2:2010 | Tested per ISO 10650:2015 & ANSI/ADA 48-2:2010 | Performance comparable to predicate, meeting standards |
| Irradiance (Intensity & Peak Wavelength) | Tested per ISO 10650:2015 & ANSI/ADA 48-2:2010 | Tested per ISO 10650:2015 & ANSI/ADA 48-2:2010 | Performance comparable to predicate, meeting standards |
| Charge Time | 35 seconds, 60 seconds | 40 seconds, 70 seconds | Functionally equivalent/acceptable to predicate (slight increase in charge time noted) |
| Run Time | 4 minutes | 4 minutes, 10 seconds | Functionally equivalent/acceptable to predicate (slight increase in run time noted) |
| Biocompatibility | Tested per ISO 10993 | Tested per ISO 10993 | Compliant with ISO 10993, comparable to predicate |
| Electromagnetic Compatibility (EMC) | Tested per IEC 60601 | Tested per IEC 60601 | Compliant with IEC 60601 |
| Electrical Safety | Tested per IEC 60601 | Tested per IEC 60601 | Compliant with IEC 60601 |
| Software Validation | Performed | Performed | Software functions as intended |
| Cleaning Validation | Performed on worst case conditions, following FDA guidance | Performed on worst case conditions, following FDA guidance | Cleaning efficacy validated per FDA guidance |
| Peak Wavelength | 450-470 nm | 450-470 nm | Matches predicate |
| Wavelength Range @ 50% | 438-485 nm | 438-485 nm | Matches predicate |
| Typical Output Intensity (8mm turbo light guide) | 1100mW/cm2 pulsed to 1330mW/cm2 | 1100mW/cm2 pulsed to 1330mW/cm2 | Matches predicate |
The document explicitly states: "The nonclinical performance testing demonstrates that the Demi Ultra performs as well as the predicate device Demi Ultra." This implies that the acceptance criteria for these tests were to demonstrate comparable performance to the predicate and compliance with relevant standards.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on specific sample sizes for the performance tests (e.g., number of cure samples for depth of cure, number of units for charge/run time). The data provenance is not explicitly stated beyond the fact that the tests were performed by Sybron Dental Specialties as part of their product lifecycle and design validation. It is implied to be prospective testing for the proposed device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The performance tests (e.g., depth of cure, irradiance) are objective measurements based on standards, not expert interpretation of data points.
4. Adjudication Method for the Test Set
This information is not provided. Given that the tests are objective physical measurements, a traditional adjudication method for subjective assessments would not be applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study typically assesses the impact of a device (often AI-driven) on human reader performance, which is not applicable to a dental light-curing device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. The Demi Ultra is a physical medical device, not an AI/software algorithm, so this type of study is irrelevant.
7. The Type of Ground Truth Used
For the performance tests, the "ground truth" would be the physical measurements obtained from testing the device against established international and national standards (ISO 10650:2015, ANSI/ADA 48-2:2010, ISO 10993, IEC 60601). For instance, the "ground truth" for depth of cure would be the actual measured depth under standardized conditions.
8. The Sample Size for the Training Set
This information is not applicable. The Demi Ultra is a hardware device, not an AI/machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no training set for this type of device.
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