(231 days)
Oral Applications: A source of illumination for curing photo-activated dental restorative materials, adhesives, pit and fissure sealants and activating tooth whitening materials via a light emitting diode (LED).
The Palmlight is a corded or cordless (battery operated) hand-held device. No filters are required to block out unnecessary rays. The light created by these diodes are specifically optimum for curing (430 to 500 nm). The Palmlight LED System is an instrument for use in the application of restorative compounds. sealants, and whitening compounds. The light is produced by a high intensity light emitting diode. With an adjustable light output of up to 500 Milliwatts. Therefore the applied for indications of use are warranted. Delivery devices (replacement tips) for the hand held probe are part of the package that allows the user to use the device with or without using direct current as rechargeable batteries are part of the handle.
The provided document describes the Palmlight dental curing light, a device intended to polymerize dental materials. It largely focuses on establishing substantial equivalence to existing predicate devices rather than presenting detailed performance studies with acceptance criteria in the typical sense for a novel device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this submission is primarily about demonstrating substantial equivalence to predicate devices, the "acceptance criteria" are framed more in terms of matching the characteristics and performance of those predicates, especially concerning safety and fundamental functional parameters.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Implied) Light Spectrum: Optimized for curing. | "The light created by these diodes are specifically optimum for curing (430 to 500 nm)." |
| (Implied) Beam Integrity: Similar to predicate devices. | "share similar ... beam integrity." |
| (Implied) Delivery Power and Energy Type: Similar to predicate devices. | "Functional features such as delivery power and energy type are also similar to the aforementioned devices." |
| (Implied) Adjustable Light Output: Capability to vary output. | "With an adjustable light output of up to 500 Milliwatts." (Explicitly stated for the Palmlight) "The variable light output... is the same as the submitted device." (Comparing to Ultradent Palmlight predicate) |
| (Implied) Corded/Cordless Operation: Ability to operate with or without a power cord (rechargeable batteries). | "The Palmlight is a corded or cordless (battery operated) hand-held device." "The ability to use the device with or without power cord (rechargeable batteries) is the same as the submitted device." (Comparing to Ultradent Palmlight predicate) |
| (Implied) Safety Systems: Inclusion of control systems like interlocks. | "Control systems such as interlock devices, (safety systems) are constantly monitored for user intervention." |
| Regulatory Compliance: Adherence to specific FDA regulations. | "The Palmlight complies with the requirements of 21 CFR Sub Chapter J, as required by 21 CFR 1010.2" and "The Palmlight is designed to meet the electrical safety requirements of IEC 601-1." |
2. Sample Size Used for the Test Set and Data Provenance
- None provided. The submission explicitly states: "Clinical Performance Data: None included with this submission." This indicates that no specific test set or clinical study was conducted to demonstrate device performance in terms of clinical outcomes or direct comparison. The reliance is on established equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable (N/A). As no clinical performance data was included, there was no test set requiring expert-established ground truth.
4. Adjudication Method for the Test Set
- Not applicable (N/A). No test set, no adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. The document does not mention any MRMC study. The focus is on the device's characteristics and its equivalence to predicates, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable (N/A). This is a hardware device (a curing light), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
- Since no original clinical performance data was provided, there was no ground truth explicitly established for this device's efficacy. The ground truth for its safety and effectiveness is implicitly tied to the established safety and effectiveness of the legally marketed predicate devices to which it claims substantial equivalence.
8. The Sample Size for the Training Set
- Not applicable (N/A). This is a hardware device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable (N/A). As there is no training set for a machine learning model, this question is not relevant.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" presented is a demonstration of substantial equivalence rather than an independent clinical or laboratory performance study with novel acceptance criteria. The Palmlight is shown to meet its "acceptance criteria" by demonstrating that its design, technological characteristics, and intended uses are similar or identical to legally marketed predicate devices.
Key points of this "study" (i.e., the substantial equivalence argument):
- Comparison to Predicates: The Palmlight is compared feature-by-feature to the Ultradent Palmlight and Jetlite 4000.
- Similar Indications for Use: All devices are for polymerizing dental materials using light.
- Similar Design Features: Light spectrum (430-500 nm), beam integrity, delivery power, energy type.
- Similar Control Systems: Safety systems like interlock devices.
- Identical Performance Characteristics: The Ultradent Palmlight is stated to be "identical in features and light output" to the submitted device, including variable light output and corded/cordless capability. The Jetlite 4000 also uses "similar transmission of light technology with similar light output."
- Regulatory Compliance: The device complies with 21 CFR Sub Chapter J and IEC 601-1 for electrical safety.
The conclusion is that because the Palmlight is substantially equivalent to existing, legally marketed devices and raises no new safety or effectiveness issues, it is deemed to have met its requirements. No new clinical performance data was provided or deemed necessary for this 510(k) submission.
§ 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.