(158 days)
The Bi-Directional Spiral & Epoxy Root Canal Cement System is indicated for permanent sealing of root canals following established endodontic procedures.
The subiect device is an obturation system for filling straight and minimally curved canals. The bi-directional spiral and epoxy root canal cement, combined with a single point technique, creates a seal equivalent to lateral condensation and thermoplastic gutta percha. Contained in the kit are the following:
4 - Color Coded to ISO Size 25 Bi-Directional Spirals (1-21 mm length and 3-25 mm length) 7.5 gm - Epoxy Root Canal Cement Gel 8.0 gm - Powder (Epoxy Root Canal Cement) 1 Measuring Scoop
Here's an analysis of the provided text regarding acceptance criteria and the supporting study:
The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance criteria through extensive clinical trials. Therefore, the device's "acceptance criteria" are primarily based on meeting existing industry standards for physical properties and biocompatibility, as compared to its predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|
| Physical Properties (ADA Spec No. 57 / ISO 6876): | |
| - Flow | Meets/Exceeds ADA Spec No. 57 / ISO 6876 |
| - Film Thickness | Meets/Exceeds ADA Spec No. 57 / ISO 6876 |
| - Dimensional Stability | Meets/Exceeds ADA Spec No. 57 / ISO 6876 |
| - Solubility | Meets/Exceeds ADA Spec No. 57 / ISO 6876 |
| - Disintegration | Meets/Exceeds ADA Spec No. 57 / ISO 6876 |
| Biocompatibility: | Evidence does not raise new safety/biocompatibility concerns compared to predicate devices. |
| Radiopacity: | Uses silver as the primary radiopaquing agent (similar to predicate AH-26®). |
| Setting Time: | Compatible with predicate devices (AH® PLUS® and AH-26® Root Canal Sealers). |
| Shrinkage: | Compatible with predicate devices (AH® PLUS® and AH-26® Root Canal Sealers). |
| Microleakage: | Compatible with predicate devices (AH® PLUS® and AH-26® Root Canal Sealers). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of a clinical trial with a defined sample size for human subjects. The evaluation relies primarily on bench testing for physical properties and literature review for biocompatibility.
- Bench Testing: The sample sizes for each specific physical property test (flow, film thickness, etc.) are not explicitly stated. These are typically performed in a laboratory setting.
- Data Provenance: The bench testing would be conducted within a laboratory environment, likely within the submitter's (MDS) facilities or a contracted testing lab. The literature review for biocompatibility is retrospective, drawing upon existing published data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in the context of a clinical test set for this submission. Ground truth for the bench tests would be the established methods and results defined by ADA Specification No. 57 and ISO 6876.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring expert adjudication.
5. 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. This device is a root canal cement system, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness analysis was performed or is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used
- For physical properties: Ground truth is established by the specified standards (ADA Specification No. 57 and ISO 6876 for Dental Root Canal Filling Material). Compliance with these standards serves as the "ground truth" for acceptable physical performance.
- For biocompatibility: Ground truth is established through existing scientific literature and Material Safety Data Sheets (MSDS) for the components, demonstrating a lack of new safety concerns compared to predicate devices.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the machine learning sense. The formulation and design are based on established dental material science and the characteristics of the predicate device (AH-26®).
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no concept of "ground truth for a training set" for this type of device submission. The design and performance targets are derived from well-understood material properties and the successful history of similar predicate devices.
§ 872.3820 Root canal filling resin.
(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.