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510(k) Data Aggregation
(86 days)
VATEA ENDONTIC IRRIGATION SYSTEM
The VATEA system is intended to be attached to dental handpieces to deliver irrigation during endodontic procedures.
The VATEA device is a self contained, digitally-controlled fluid delivery unit consisting of a pump unit console, irrigation reservoir and tubing intended to be connected to an endodontic file. The device consists of a positive pressure peristaltic pump console with control panel, LCD display, irrigation reservoir, disposable silicone tubing, and a footswitch control to provide irrigation during endodontic rocedures. One end of the silicone tubing connects to the VATEA and the other end connects to the dental handpiece using a silicone ring. The silicone ring is elastic, and may be stretched to the domar handpiece as my of dental handpieces used in endodontic procedures. The irrigation reservoir is filled as needed with sodium hypochlorite solution for irrigation during endodontic rocedures. The irrigation fluid is pumped from the reservoir and then out of the silicone tubing, proodation: the internet of the tooth. The silicone tubing for the delivery of the iring the lumand the silicone ring connecting the pump to the dental handpiece are disposable and replaced after each treatment.
The irrigation fluid flow may be switched on and off with a footswitch that is connected to the VATEA. The fingulon had now his his of the device are displayed on the LCD screen on the control r no how rate and operation is 0, and the user must increase the flow rate using the - / + buttons on panel. The using for face of the irrigation fluid. The irrigation fluid flow rate may be adjusted the control parter in increments of 1 ml/min using the - /+ push-button control on the control panel.
The VATEA is an electronically operated device, powered by a rechargeable battery.
Here's a summary of the acceptance criteria and the study details for the VATEA Endodontic Irrigation System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Verification of flow rate | Actual irrigant flow rate matched the displayed flow rate. |
| Battery indication and life time | With batteries fully charged, the system can operate without the charger for 4 continuous hours at maximum output. |
| Compliance with IEC 60601-1 Medical Electrical Equipment Part 1, General Requirements for Safety | The company performed testing to evaluate the safety and performance, implying compliance with this standard. |
| Compliance with IEC 60601-1-2 Medical Electrical Equipment, General Requirements for Safety. Collateral Standard: Electromagnetic Compatibility- requirements and tests. | The company performed testing to evaluate the safety and performance, implying compliance with this standard. |
| Comparable performance and safety to predicate device | Performance data establishes that the VATEA has comparable performance and safety as compared to its claimed predicate device (Quantec-E Irrigation System). The minor technological differences raise no new issues of safety or effectiveness. Preclinical performance data demonstrates it is as safe and effective. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a sample size for a test set in the traditional sense of a clinical trial involving human subjects or a large collection of case data. The "test set" here refers to the number of units or conditions tested during the performance validation.
- Sample Size for performance validation: Not explicitly stated as a number of devices, but implies testing of the device's flow rate mechanism and battery under specified conditions.
- Data Provenance: The studies were performed by the company (ReDent Nova Ltd.) as "performance validation." The location is Israel, as this is the sponsor's country of origin. The studies are prospective in the sense that they are specifically designed to test the VATEA device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The performance validation involved objective measurements of flow rate and battery life, not interpretation by experts.
4. Adjudication Method for the Test Set
Not applicable. The data appears to be quantitative measurements, not subjective evaluations requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance validation represents a standalone study of the device's functionality. The device (VATEA) itself was tested for its performance characteristics (flow rate, battery life). There is no "algorithm" in the sense of AI being evaluated here; rather, it is electro-mechanical performance.
7. The Type of Ground Truth Used
The ground truth used was based on:
- Objective measurement: For flow rate, the "actual irrigant flow rate" was measured against the "displayed flow rate." For battery life, it was based on continuous operation at maximum output.
- Engineering and safety standards: Compliance with IEC 60601-1 and IEC 60601-1-2 implies that the device was tested against established international safety and performance benchmarks.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is not a machine learning or AI-driven device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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