(112 days)
The EndoVac™ Pure System is intended for the delivery and evacuation of endodontic irrigation solutions and removing debris of injured or necrotic pulp tissue during root canal procedures.
The EndoVac Pure™ system builds on the EndoVac System and presents a unique way to irrigate during root canal treatments. The system is an apical negative pressure system that draws fluid apically by way of evacuation, reducing the risk of apical irrigant extrusion during root canal procedures. The vacuum is routed through the system and controlled independently through the dental chair vacuum system. The fluid delivery is controlled by peristaltic pumps. The pumps are driven by Printed Circuit Board Assemblies (PCBA) and controlled by Field Programmable Gate Array (FPGA) configuration files.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the EndoVac Pure device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with direct performance metrics alongside the reported performance of the EndoVac Pure. Instead, it details various "performance tests were conducted as part of design verification" and then provides a comparison table (Table 7.1) outlining technological characteristics between the proposed EndoVac Pure and its predicate device. This comparison implicitly serves as evidence of meeting performance requirements by demonstrating similarity to a legally marketed device.
Therefore, the table below is constructed by interpreting the "Technological Characteristics Non-Clinical Performance Data" section and the "Predicate and Proposed Device Comparison Table" (Table 7.1) as the reported performance, and the fact that these tests were conducted as "design verification" implies they met established internal acceptance criteria for substantial equivalence to the predicate.
| Acceptance Criteria (Implied by Design Verification & Predicate Equivalence) | Reported Device Performance (EndoVac Pure) |
|---|---|
| Functional Performance: | |
| Flow Rate Delivery and Selection | Performed, met design requirements |
| Suction Flow Rate Performance (MicroCannula) | 5ml/min ± 15% |
| Suction Flow Rate Performance (MacroCannula) | 40ml/min ± 20% |
| Unclogging Mechanism | Built-in, allows clearing without disconnecting from vacuum line |
| System Purge (Emptying reservoirs) | Double press purge button to empty each reservoir |
| MicroCannula Working Length Adjustment | Uses rigid hood and ratcheting slider to set working length (prevents inadvertent adjustment) |
| MacroCannula Working Length Adjustment | Can be adjusted by clinician if needed |
| Alarm System | Multiple alarms incorporated (Low fluid: audible alarm/yellow flashing light; System malfunction: red flashing light) |
| Sterility/Biocompatibility: | |
| Cleaning and Disinfection Validation | Meets Requirements |
| Biocompatibility | Meets requirements |
| Sterilization Validation | Meets requirements |
| Shelf Life Validation | Performed, met design requirements |
| Cross contamination | Patient contacting portion is single use and sterile. Handheld controller cleaned/disinfected and covered with cleared dental barrier |
| Adverse Tissue Reaction and Biocompatibility | Meets requirements |
| Electrical/Software: | |
| Electromagnetic Compatibility (EMC) Testing | Meets requirements |
| Electrostatic Discharge (ESD) Suppression | Performed, met design requirements |
| Software Validation | Meets requirements |
| Mechanical/Physical: | |
| MicroCannula Suction Performance | Performed, met design requirements |
| Suction Adapter OD (HVE adapter) | 11.0 ±0.1 mm (0.434 in) |
| MacroCannula OD (on Apex Cartridge) | 0.595 ±0.012 mm (0.023 inch) |
| MicroCannula OD (on Apex Cartridge) | 0.0125 to 0.0118 in |
Study Proving Device Meets Acceptance Criteria
The study primarily relies on non-clinical performance testing and a comparison to a legally marketed predicate device (EndoVac® Apical Negative Pressure Irrigation System K140685) to demonstrate substantial equivalence. The document explicitly states: "The EndoVac Pure™ and the predicate EndoVac System (K140685) perform the same function, which is a method to deliver irrigant, rinse and evacuate during root canal procedures. The following performance tests were conducted as part of design verification:" followed by a list of tests.
The conclusion further reinforces this: "The proposed EndoVac Pure™ is substantially equivalent to the predicate Endo Vac System (K140685) based on design, performance, biocompatibility testing, and the intended use."
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state specific sample sizes for each non-clinical performance test. It lists the types of tests conducted (e.g., Flow Rate Delivery, Suction Flow Rate, Biocompatibility, Sterilization, etc.) but not the number of units or datasets used for each.
The data provenance is from non-clinical performance testing, presumably conducted internally by Sybron Dental Specialties. There is no information provided about country of origin of data (apart from the manufacturer being in Orange, CA). The studies are inherently prospective with respect to the device's design verification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the evaluation is based on non-clinical performance testing against engineering specifications and comparison to a predicate device. There is no mention of human experts establishing "ground truth" for the performance tests in the context of diagnostic accuracy or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable for non-clinical performance testing. Adjudication methods (like N+1 consensus) are typically used in clinical studies where expert reviewers evaluate cases and make subjective judgments, which is not the nature of the tests performed here.
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 explicitly states: "Clinical performance testing has not been performed for EndoVac Pure™" in section 8.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical dental system, not an algorithm or AI software. There is no "standalone" algorithm performance to evaluate. The device's performance is inherently tied to its use by a human operator within a clinical procedure.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance tests was established by engineering specifications, accepted industry standards (e.g., ISO, IEC), and the performance characteristics of the legally marketed predicate device. For instance, flow rates were expected to fall within a specified range, and biocompatibility tests were conducted according to ISO standards.
8. The Sample Size for the Training Set
This information is not applicable. The EndoVac Pure is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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.