(106 days)
The EndoVac® system is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures.
The EndoVac® System is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures. EndoVac® Apical Negative Pressure Irrigation System is used in root canal therapy and is comprised of four main components. The Multi-Port Adapter is used to connect the Master Delivery Tip to the dental office Hi-Vac system. The Master Delivery Tip provides a constant flow of irrigant that lowers the risk of overflow due to continuous suction. Additional tips include the MacroCannula which is used to remove coarse debris after instrumentation, and the MicroCannula which features microscopic evacuation holes allowing the irrigant to flow to the apical termination.
This document pertains to a 510(k) premarket notification for the EndoVac® Apical Negative Pressure Irrigation System. The purpose of the 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, not to prove that the device meets specific acceptance criteria through a standalone study with defined performance metrics.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be fully provided from this document as it does not contain the specific type of performance study typically conducted for AI/ML device evaluations.
Here's a breakdown of why and what information can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as performance metrics in this 510(k) summary. The "acceptance criteria" for a 510(k) are typically demonstrating substantial equivalence to a predicate device, which is a regulatory standard rather than a set of quantitative performance targets.
- Reported Device Performance: This document focuses on technological characteristics and a comparison to a predicate device, rather than quantitative performance data like sensitivity, specificity, or accuracy. The performance is assessed through compliance with various ISO and AAMI standards for aspects like biocompatibility and sterilization.
| Criterion | Reported Performance of EndoVac® System |
|---|---|
| Intended Use Equivalence: | The EndoVac® system is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures. (This is equivalent to the predicate RinsEndo for root canal irrigation/disinfection). |
| Biocompatibility: | Complies with ISO 10993 standards (ISO 10993-1, -5, -10). |
| Sterilization: | Autoclavable Master Delivery Tip, Multi-Port Adapter, Handpiece and Finger-Piece. Verified using AAMI TIR 12, ANSI/AAMI ST:79, AAMI TIR 39, ISO 17665-1, and an internal method for autoclave life testing. |
| Method of Aspiration: | Suction through tubing attached to dental office Hi-Vac (This differs technologically from the predicate's air-driven piston but achieves the same intended purpose of irrigation/disinfection). |
| Safety - General: | The document asserts that "The similarities in design, function, safety and intended use of EndoVac® Apical Negative Pressure Irrigation System with the legally marketed device RinsEndo dental handpiece (K052271) provide evidence that these devices are substantially equivalent." Compliance with several biological and sterilization standards also supports safety. |
| Electrical Safety/EMC (Implied): | Not explicitly mentioned but often part of general controls for medical devices. The document focuses on the mechanical and material aspects of the device's safety. |
| Single-use disposable cannula (tips): | Yes |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided: This document describes compliance with recognized standards (e.g., ISO, AAMI) and a literature review, not a specific performance study with a "test set" in the context of AI/ML or a new, novel performance claim. The biocompatibility and sterilization tests would have involved specific sample sizes as per the standards referenced, but these are not disclosed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided: There was no "test set" and no "ground truth" to establish in the context of an AI/ML device. The "ground truth" for the predicate device's safety and effectiveness was established through its prior 510(k) clearance and market history.
4. Adjudication method for the test set:
- Not applicable / Not provided: No test set or adjudication process described.
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:
- No: This is not an AI-powered device. Therefore, no MRMC study or AI assistance effect size is relevant or provided.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable / No: This is not an algorithm, it is a physical medical device.
7. The type of ground truth used:
- Regulatory Substantial Equivalence and Compliance with Recognized Standards: The "ground truth" is effectively the established safety and effectiveness of the predicate device (RinsEndo, K052271) and the compliance with consensus standards for material safety (biocompatibility) and functional attributes (sterilization). For the non-clinical performance data, the "ground truth" is that the device complies with the specified ISO and AAMI standards.
8. The sample size for the training set:
- Not applicable / Not provided: This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable / Not provided: No training set.
In summary: This document is a 510(k) premarket notification for a traditional medical device, not an AI/ML device. The "study" described is a demonstration of substantial equivalence to a predicate device and compliance with relevant non-clinical (biocompatibility, sterilization) performance standards. It does not involve performance metrics, expert adjudication, or AI-specific evaluation methodologies.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.