(35 days)
The DVI Curing Light is a dental curing light that is intended for the photopolymerization of dental resins.
The DVI Curing Light consists of three major components; a handpiece, curved fiber optic end tip, and cradle. The handpiece contains the LED light source and a fiber optic light guide that directs light to the treatment area on the patient. The handpiece is placed in a cradle, which is connected via a plug-in transformer to an AC outlet for charging. A Protective light-shield and Fiber-optic end-tips are accessories provided with the DVI Curing Light, which support the operation and maintenance of the device.
The DVI curing light initiates curing (polymerization) of materials that are activated by photo initiators with an absorption in the wavelength range of between 405 to 470 nm. It is recommended that materials manufacturer's directions be followed for curing times. It is recommended that curing times be extended when curing through the tooth structure or when the distance from the curing light end tip to the material exceeds 3 mm.
The provided text describes a 510(k) summary for the Designs for Vision Inc. Curing Light (DVI Curing Light). However, it does not contain specific acceptance criteria or detailed results of a study proving the device meets acceptance criteria.
The document indicates that performance testing was conducted, but only generally lists the types of tests without providing the criteria or outcomes. Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred or explicitly stated from the text, with limitations noted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Performance & Safety | The test results confirm that the proposed DVI Curing Light is safe and effective for use as a curing light. |
| Software and Hardware Verification and Validation | Testing was conducted, but specific criteria or detailed results are not provided. |
| Electrical Safety and Electromagnetic Compatibility | Testing was conducted, but specific criteria or detailed results are not provided. |
| Resin Polymerization Times | Testing was conducted, but specific criteria (e.g., target polymerization times for certain resins) or detailed results are not provided. The document states: "It is recommended that materials manufacturer's directions be followed for curing times." |
| Wavelength Range | The device initiates curing of materials activated by photo initiators with an absorption in the wavelength range of 405 to 470 nm. (This is a characteristic, not an acceptance criterion, but it implies the device must operate within this range). |
| Distance for Curing | It is recommended that curing times be extended when curing through tooth structure or when distance from tip to material exceeds 3 mm. (This is a recommendation, not an acceptance criterion for the device itself). |
Limitations: The document states what kinds of tests were performed (software/hardware V&V, electrical safety/EMC, resin polymerization times), but does not provide the specific acceptance criteria for these tests or the detailed numerical results that demonstrate these criteria were met. It only provides a general statement that "The test results confirm that the proposed DVI Curing Light is safe and effective for use as a curing light."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used and Their Qualifications for Ground Truth
- This type of device (dental curing light) typically undergoes engineering and performance testing as described in Section 7, rather than ground truth established by experts.
- Therefore, the number and qualifications of experts for ground truth are not applicable in the context described in this document.
4. Adjudication Method for the Test Set
- Not applicable, as expert-based ground truth and adjudication methods are not relevant for the type of device performance testing described.
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 diagnostic devices where human readers interpret images or data, often comparing human performance with and without AI assistance. The DVI Curing Light is a functional medical device, not a diagnostic one.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone (algorithm only) performance study was not done. This concept is primarily relevant for AI/ML-based software devices. The DVI Curing Light is a hardware device with an LED light source; while it has "software and hardware verification and validation," this refers to its internal operational software, not a diagnostic algorithm.
7. Type of Ground Truth Used
- For the performance tests described (e.g., resin polymerization times, electrical safety, software/hardware V&V), the "ground truth" would be established by engineering specifications, regulatory standards, and established scientific principles of material science (for resin curing) and electrical/EMC safety. It is not based on expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or predictive devices.
8. Sample Size for the Training Set
- This concept is not applicable. The DVI Curing Light is a functional device, not an AI/ML device that requires a "training set" for an algorithm.
9. How Ground Truth for the Training Set Was Established
- Not applicable (see point 8).
§ 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.