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510(k) Data Aggregation
(217 days)
CuringPen Dental Curing Light
The CuringPen Dental Curing Light is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 380~515nm waveband of visible light.
This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel and not used in the oxygen-rich environment.
The CuringPen Dental Curing Light is designed to polymerize all photo-activated dental materials in the wavelength range of 380-515 nm per ISO 10650:2018. It is a cordless pen-style, LED light polymerization device, and must only be used in hospital environments, clinics or dental offices by qualified dental personnel and not used in the oxygen-rich environment.
This document describes the premarket notification for the CuringPen Dental Curing Light. The information provided is for a traditional 510(k) submission, demonstrating substantial equivalence to a predicate device, not an AI/ML software device study. Therefore, many of the requested categories related to AI/ML software performance studies are not applicable.
Here's an attempt to answer the questions based on the provided text, indicating "Not Applicable" or "Not Provided" where relevant for AI/ML specific criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (from predicate/standards) | Reported Device Performance (CuringPen Dental Curing Light) |
|---|---|---|
| Depth of Cure | ≥ 2 mm (Same as Predicate) | ≥ 2 mm |
| Wavelength Range | 385-515 nm (Predicate) | 380-515 nm |
| Peak Wavelength | Dual peak: 405nm, 460nm (Predicate) | Dual peak: 400-410nm, 450-460nm |
| Light output intensity | Sufficient to polymerize materials (Predicate operational modes: 900-2400 mW/cm²) | Offers various modes: 1000, 1500, 2300 mW/cm² (Standard mode), 1000 mW/cm² (RAMP/PULSE), 600 mW/cm² (Detect) |
| Material Polymerization | Effective polymerization of resinous dental materials | Intended to polymerize resinous dental materials |
| Biocompatibility | No cytotoxicity, sensitization, or significant irritation (based on ISO 10993 standards) | No cytotoxicity, sensitization, or significant oral mucosa irritation reactions |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-2 | Complies with IEC 60601-1-2, IEC 80601-2-60, ANSI AAMI ES60601-1 |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2 | Complies with IEC 60601-1-2 |
| Software Verification | Compliance with IEC 62304 and FDA guidance for medical device software | Conducted as recommended, considered "moderate" level of concern |
| Irradiance over Distance | Not explicitly stated, implied to be sufficient for curing | Testing conducted (results not detailed) |
2. Sample Sizes Used for the Test Set and Data Provenance
This is not an AI/ML study involving a test set of data. This is a medical device clearance.
- Test Set Sample Size: Not Applicable for an AI/ML test set. The performance testing was conducted on the device itself.
- Data Provenance: Not Applicable. The testing was conducted internally or by accredited labs on the physical device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This is not an AI/ML study.
- Number of Experts: Not Applicable.
- Qualifications of Experts: Not Applicable. Performance was measured against established physical and electrical properties, and biological safety standards.
4. Adjudication Method for the Test Set
This is not an AI/ML study.
- Adjudication Method: Not Applicable. Performance was measured objectively against engineering and biological standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, a multi-reader, multi-case comparative effectiveness study was not done. This device is a dental curing light, not an AI/ML diagnostic or assistive tool for human readers.
- Effect Size of Human Readers' Improvement with AI: Not Applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- Standalone Study: Not Applicable. This is a physical device, not an algorithm. Performance tests were conducted on the device itself (standalone in terms of being tested independently).
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on established engineering standards, physical measurements, and biological safety standards.
- Engineering Standards: ISO 10650:2018 (dental curing lights), IEC 60601 series (electrical safety and EMC).
- Biocompatibility Standards: ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization, irritation).
- Specific Device Performance: Measured irradiance, wavelength, depth of cure, heat generation.
8. The Sample Size for the Training Set
This is not an AI/ML study.
- Training Set Sample Size: Not Applicable. There is no AI/ML model being trained.
9. How the Ground Truth for the Training Set Was Established
This is not an AI/ML study.
- Ground Truth for Training Set: Not Applicable.
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