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510(k) Data Aggregation
(258 days)
Demi Ultra
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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(131 days)
DEMI ULTRA
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 Ultro 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Demi Ultra device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided submission does not explicitly list "acceptance criteria" in a quantitative, measurable format for the Demi Ultra. Instead, it relies on demonstrating substantial equivalence to a predicate device (Demi, K071251) through comparisons of technological characteristics and performance data. The implicit acceptance criterion is that the Demi Ultra performs comparably to the predicate device.
| Characteristic / Performance Metric | Predicate Device (Demi - K071251) | Demi Ultra (Reported Performance) | Comparison / Implied Acceptance |
|---|---|---|---|
| Indications for Use | Polymerization of light-cured materials by dental professionals | Polymerization of light-cured materials by dental professionals | Equivalent |
| Light Source | LED | LED | Equivalent |
| Peak Wavelength | 450-470nm | 450-470nm | Equivalent |
| Wavelength range @ 50% (spectrum) | 438-485nm | 438-485nm | Equivalent |
| Typical Output Intensity (400-500nm, 8mm turbo light guide) | 1100mW/cm² pulsed to 1330mW/cm² | 1100mW/cm² pulsed to 1330mW/cm² | Equivalent |
| Biocompatibility | (Implied to be acceptable) | Passed (material manufacturer statements) | Accepted |
| Depth of Cure | (Implied to be acceptable) | Test data compared to predicate | Deemed comparable |
| Irradiance Data | (Implied to be acceptable) | Demonstrates light intensity and peak wavelength | Deemed acceptable |
| Software Validation | (Implied to be acceptable) | Successfully validated | Accepted |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated. The submission mentions "depth of cure test data" and "irradiance data" for comparing the Demi Ultra to the predicate device, but does not provide details on the number of samples or trials used for these tests.
- Data Provenance: The data appears to be from internal testing conducted by the manufacturer, Sybron Dental Specialties, Inc./Kerr Corporation. The country of origin is not specified but implicitly assumed to be where the company operates, likely the USA based on the submission to the FDA. The tests are retrospective in the sense that they were conducted by the manufacturer as part of the submission process, but the testing itself would be prospective for the evaluated device properties.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This device is an LED curing light, not an AI/ML diagnostic or prognostic device that requires expert adjudication of images or data to establish ground truth. The "ground truth" here is the physical performance characteristics of the device (light output, depth of cure, etc.) measured using scientific instruments and established protocols.
4. Adjudication Method for the Test Set
Not applicable, as this is not a study assessing human reader performance or requiring subjective interpretation. The performance characteristics are measured objectively.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic or prognostic tools where human interpretation plays a significant role. The Demi Ultra is a medical device for polymerization of materials, not a diagnostic tool requiring interpretation by human readers.
6. Standalone Performance Study (Algorithm Only)
Not applicable directly in the AI/ML sense. However, the "Non-Clinical Test Data" section describes standalone performance evaluations of the Demi Ultra in terms of:
- Biocompatibility: Materials designed to be in contact with a patient were tested and passed.
- Depth of Cure: Data was collected to evaluate the Demi Ultra's performance.
- Irradiance: Data was collected to demonstrate light intensity and peak wavelength.
- Software Validation: The software was successfully validated to confirm device performance.
These can be considered standalone performance evaluations of the physical device and its embedded software. The performance was then compared to the predicate device.
7. Type of Ground Truth Used
The "ground truth" in this context refers to objectively measured physical and chemical properties:
- Biocompatibility: Established through standard biocompatibility tests (e.g., ISO 10993 series) performed by material manufacturers.
- Depth of Cure: Likely measured in a laboratory setting using standardized dental materials and techniques to assess the extent of polymerization.
- Irradiance: Measured using radiometers or spectroradiometers to quantify light intensity and spectral distribution.
- Software Functionality: Verified through validation testing against defined software requirements.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that learns from a training set of data. It is a hardware device with embedded software where performance is determined by its design and manufacturing.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
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