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510(k) Data Aggregation
(178 days)
For light curing polymerization of dental composites, luting materials, cements and other light cured materials.
LED Curing Light is used to restore teeth on dental patient. The device can only be used by the dentist who is qualified and well trained. This product is used on dental patient in the place of hospital or professional medical site.
LED Curing Light adopts the principle of ray radiation to solidify the light sensitive resin by shooting at it in a short time. It is composed of high-power LED, main unit, curing light shield, charger and charge station. The main unit contains the ON/OFF button, display screen, mode button and time button.
LED Curing Light provides TURBO mode and NORMAL mode with different preset exposure time. The high-power LED can produce visible blue light in the 430nm to 490nm waveband of spectrum with a power density of 1000m W/cm² to 1800m W/cm². Using different modes gives dental professionals the flexibility to polymerize virtually almost all types of composites, boding agents and sealants available in the market.
The enclosure of main unit was composed of ABS material and Aluminum, and the light guide base (patient contact part) was made from ABS material.
Here's a breakdown of the acceptance criteria and study information for the LED Curing Light, Model CV-215, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a Class II medical device, the "acceptance criteria" are primarily based on established performance standards and comparability to a predicate device, rather than specific numerical thresholds for diagnostic accuracy. The reported device performance is demonstrated through its compliance with these standards.
| Acceptance Criteria (Standard / Test) | Reported Device Performance (Compliance / Result) |
|---|---|
| Light Output Performance (ANSI ADA 48: 2004) | Evaluated and Complied (FDA recognition number 4-139) |
| Basic Safety and Essential Performance (IEC 80601-2-60: 2012) | Evaluated and Complied (FDA recognition number 4-229) |
| Electrical Safety (ANSI/AAMI 60601-1: 2005+A1:2012) | Tested and Complied (FDA recognition number 19-4) |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2: 2014) | Tested and Complied (FDA recognition number 19-8) |
| Biocompatibility - In vitro cytotoxicity (ISO 10993-5:2009) | Evaluated and Complied (FDA recognition number 2-245); Patient contact material (ABS plastic) complies |
| Biocompatibility - Irritation and skin sensitization (ISO 10993-10:2010) | Evaluated and Complied (FDA recognition number 2-174); Patient contact material (ABS plastic) complies |
| Software Verification & Validation (FDA Guidance for Industry and Staff) | Conducted; Software determined to be of "moderate" level of concern; Documentation provided as recommended by FDA guidance. |
| Light intensity | $1000mW/cm^2-1800mW/cm^2 \pm 10%$ (within the effective power range of the predicate device, also complied with IEC 60601-1 and IEC 80601-2-60) |
| Light wavelength | 430nm-490nm (Same as predicate device) |
| Peak wavelength | 455 nm (Similar to predicate device's 460nm) |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical study with a "test set" in the traditional sense of patient data. The evaluations were primarily conducted through lab bench testing by the manufacturer against recognized industry standards. Therefore, there is no information on sample size for a test set or data provenance from patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The evaluations were based on compliance with engineering and biocompatibility standards, not expert-adjudicated ground truth from patient data.
4. Adjudication method for the test set
Not applicable, as there was no test set requiring ground truth adjudication.
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
No MRMC comparative effectiveness study was conducted. This device is an LED Curing Light, not an AI-powered diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical dental device, not an algorithm, so standalone performance in that context is not relevant.
7. The type of ground truth used
The "ground truth" for the device's acceptable performance is defined by its compliance with international and national standards for safety (electrical, EMC, biocompatibility) and performance (light output for dental curing). These standards outline measurable parameters and testing methodologies.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable, as there was no training set.
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