(35 days)
This device is intended for use:
- As a source of illumination for curing dental restorative materials,
- Assisting in the whitening process in a dental office.
The RapiCure 2000 is a high pressure mercury light source filtered and transmitted through an optical fiber for the curing of composite resins, as an aid in the whitening of teeth, and for other dental purposes. The device emits filtered light in the range from 400 to 500 nm. It accepts voltages from 100-230 VAC.
The provided text is a 510(k) summary for the Mediphotonix RapiCure 2000™ Curing and Whitening Light. This document focuses on establishing substantial equivalence to existing devices rather than presenting a performance study with detailed acceptance criteria and results as would be found for a novel, high-risk device.
Therefore, the document does not contain the information needed to fill out all requested sections regarding acceptance criteria and a study proving device performance in the way a typical AI/software device submission would.
However, I can extract the available information and explain why other sections cannot be completed based on this specific document.
Missing Information:
The document is a 510(k) submission summary for a physical medical device (a light source). It focuses on demonstrating substantial equivalence to predicate devices already on the market, rather than proving performance against specific quantitative acceptance criteria through a clinical study. As such, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of an AI/software device (e.g., accuracy, sensitivity, specificity thresholds) is not present.
Specifically, the following details are not available in the provided text:
- A table of acceptance criteria and the reported device performance: This type of data is not required or typically included in a 510(k) for a light-curing device where substantial equivalence is the primary pathway to market. There are no specific quantitative metrics (like accuracy, sensitivity, specificity) for a software algorithm's performance.
- Sample size used for the test set and the data provenance: Not applicable.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Available Information (related to "performance" and "equivalence" as presented):
The document states that "Performance standards: None established under section 514." This indicates that the device operates under general controls and does not have specific performance standards set by regulation that it must meet.
The "study" or justification provided is the Substantial Equivalence argument. The device's performance is implicitly proven by demonstrating that it is similar in design, intended use, and technological characteristics to legally marketed predicate devices that have already been deemed safe and effective.
Summary of Substantial Equivalence Information (as a proxy for "study"):
- Device Name: RapiCure 2000™ Curing and Whitening Light
- Indications for Use:
- Source of illumination for curing dental restorative materials.
- Assisting in the whitening process in a dental office.
- Predicate Devices:
- Plasma Arc Curing system (American Dental Technologies, K-952333)
- Apollo 95 curing and whitening system (Dental/Medical Diagnostic Systems, Inc., K-981948)
- Ardent Radiance Curing Light (Air Techniques, Inc., K-982615)
- Spectrum 800 Curing Unit (Dentsply, K-982318)
- CU-100A Light Cure Unit (K-980792)
- O-Luxpro V/Q-Luxpro II Light Unit (K-980793)
- "several other curing lights cleared under code EBF as accessories to composite materials classified as 'tooth-shade resin and described in CFR 872.3690."
- Technological Characteristics (briefly described as justification for equivalence): High pressure mercury light source filtered and transmitted through an optical fiber. Emits filtered light in the range from 400 to 500 nm. Accepts voltages from 100-230 VAC.
- Methodology for establishing equivalence: Followed the "510(k) Substantial Equivalence Decision-making Process (Detailed) from ODE Guidance Memorandum #86-3."
In conclusion, for this specific type of device and 510(k) submission, the concept of "acceptance criteria" and "study results" as typically requested for AI/software-based medical devices is not directly applicable. The device's safety and effectiveness are established through demonstrating substantial equivalence to predicate devices, implying that its performance is comparable to those already on the market.
§ 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.