(99 days)
The SprintRay NightGuard Flex is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners.
The NightGuard Flex is intended to be used for the manufacture of orthodontic and dental appliances in a clinical setting by trained dental professionals.
The NightGuard Flex is indicated for use in the fabrication of orthodontic and dental appliances such as mouthquards, nightquards, splints and repositioners.
The NightGuard Flex consists of a curable dental acrylate resin that is manufactured in a dental office based on a 3D scanned image of a patient's teeth. The acrylate resin material is designed to be used in conjunction with a scanned 3D image, and 3D printer assembly, to locally manufacture out a dental appliance based on the clinician's judgment of patient need.
NightGuard Flex is designed to meet appropriate ISO standards for flexibility, sorption and tensile strength to withstand prolonged use in the oral cavity. It is delivered non-sterile and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed and verified to fit in the dental office before the patient leaves.
This is a 510(k) summary for the SprintRay NightGuard Flex, a dental acrylate resin used for 3D printing orthodontic and dental appliances. The summary focuses on demonstrating substantial equivalence to a predicate device (KeySprint's KeySplint Soft, K183598).
Based on the provided text, here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a direct table with specific numerical acceptance criteria and corresponding reported performance values for each test. Instead, it states that the NightGuard Flex "meet predefined acceptance criteria" without specifying those criteria.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material Properties: | |
| Tensile Strength | "functioned as intended" and "outcomes were as expected" |
| Flex Strength | "functioned as intended" and "outcomes were as expected" |
| Impact | "functioned as intended" and "outcomes were as expected" |
| Hardness | "functioned as intended" and "outcomes were as expected" |
| Water Sorption | "functioned as intended" and "outcomes were as expected" |
| Solubility | "functioned as intended" and "outcomes were as expected" |
| Biocompatibility: | |
| Biocompatibility | "functioned as intended" and "outcomes were as expected" |
| Residual Monomers: | |
| Residual Methyl-Methacrylate Monomers | "functioned as intended" and "outcomes were as expected" |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the bench testing or the provenance of any data (e.g., country of origin, retrospective/prospective). It only mentions "samples of the NightGuard Flex" and "dental appliance fabricated from NightGuard Flex."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the study described is bench testing of physical material properties, not a clinical study involving expert interpretation or ground truth establishment in a diagnostic context.
4. Adjudication Method for the Test Set
This information is not applicable as the study described is bench testing of physical material properties. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpretation disagreements among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes bench testing of material properties, not a study involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. This device is a dental material, not an algorithm or AI software.
7. The Type of Ground Truth Used
The ground truth for the bench testing was based on predefined acceptance criteria derived from "appropriate ISO standards for flexibility, sorption and tensile strength." These standards set the benchmarks for the physical and chemical properties of the material.
8. The Sample Size for the Training Set
This information is not applicable. The device is a dental material, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device.
N/A