(44 days)
The Pencure is intended to polymerize (set) resinous dental pit and fissure sealants or dental restorative materials by light from head.
The VL-7 is a dental curing light manufactured by J. MORITA MFG. CORP. The VL-7 is to be used at the dental treatment of curing polymer cement by the dentist. The VL-7 delivers an optimum wavelength of between 420 and 480nm by using blue LED. Its powerful light beam is directly irradiated on polymer material. There are three characteristics. 1. The irradiated beam is almost the same as parallel. Therefore, the percentage of reducing light intensity is lower. 2. The cordless handpiece can be easily positioned at molars. 3. The head part of the handpiece is able to be rotated around the axis of handpiece.
The provided text is a 510(k) summary for the J. Morita USA Inc.'s Pencure VL-7, a dental curing light. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed de novo clinical study with explicit acceptance criteria and performance data. Therefore, many of the requested elements regarding specific study design, sample sizes, expert involvement, and ground truth establishment are not typically included in this type of regulatory document.
However, based on the information provided, here's an analysis:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics against those criteria. Instead, it relies on a comparison of characteristics to predicate devices to establish substantial equivalence. The "Performance" characteristic listed in the comparison table is simply marked as "Similar," implying that the device's performance is expected to be comparable to the predicate devices without providing numerical targets or measured results.
| Category | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|---|
| Indication for Use | Same as predicate devices | Similar to predicate devices: "polymerize (set) resinous dental pit and fissure sealants or dental restorative materials by light from head." |
| Target Population | Same as predicate devices | Identical to predicate devices |
| Design | Similar to predicate devices | Similar to predicate devices |
| Materials | Presumed similar to predicate devices | Presumed similar to predicate devices |
| Performance | Comparable to predicate devices | Similar to predicate devices |
| Sterility | Similar to predicate devices | Similar to predicate devices |
| Biocompatibility | Presumed similar to predicate devices | Presumed similar to predicate devices |
| Mechanical safety | Similar to predicate devices | Similar to predicate devices |
| Chemical safety | Similar to predicate devices | Similar to predicate devices |
| Anatomical sites | Same as predicate devices | Identical to predicate devices |
| Human factors | Same as predicate devices | Identical to predicate devices |
| Energy used and/or delivered | Similar to predicate devices | Similar to predicate devices (delivers optimum wavelength between 420 and 480nm) |
| Compatibility with environment and other devices | Similar to predicate devices | Similar to predicate devices |
| Where used | Same as predicate devices | Identical to predicate devices |
| Standards met | Presumed similar to predicate devices | Presumed similar to predicate devices |
| Electrical safety | Similar to predicate devices | Similar to predicate devices |
| Thermal safety | Presumed similar to predicate devices | Presumed similar to predicate devices |
| Radiation safety | Similar to predicate devices | Similar to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of a formal clinical performance study that would involve a specific sample size. The evidence for substantial equivalence is based on comparing the characteristics of the Pencure VL-7 to existing predicate devices (JETLITE5000 and SmartLite™ PS Pen-Style LED Curing Light). No de novo data from a test set is presented.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The submission does not detail a study involving expert-established ground truth for a test set. This is a 510(k) submission, which primarily relies on comparison to known predicate devices for safety and effectiveness.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of an adjudication process for a test set in this 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
Not applicable. The document does not describe an MRMC comparative effectiveness study, nor does it discuss human reader performance or the effect of AI assistance. The device is a dental curing light, not an AI-powered diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
Not applicable. The device is a physical dental curing light, not an algorithm.
7. The Type of Ground Truth Used
Not applicable in the context of a clinical performance study. The "ground truth" for this submission is effectively the established safety and effectiveness of the predicate devices. The new device is deemed "substantially equivalent" if it shares similar technological characteristics and intended uses, without raising new questions of safety or effectiveness.
8. The Sample Size for the Training Set
Not applicable. The device is a physical product and does not involve machine learning or a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an algorithm, there is no ground truth to be established for it.
§ 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.