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The Quantec-E Irrigation System 2 is an AC-powered, self-contained, fluid delivery unit consisting of a pump unit console, irrigation reservoirs and tubing intended to be used in dentistry to provide irrigation while using the dental handpieces attached to the Quantec-E Endo System.

The device is an AC-powered, self-contained, fluid delivery unit consisting of a pump console, two irrigation reservoirs and tubing intended to be used in dentistry to provide irrigation while using the dental handpieces attached to the Quantec-E Endo System. The unit attaches to the Quantec-E Endo System via the accessory port located on the rear panel of the unit. The unit has a positive displacement peristaltic design to prevent fluid retraction which could result in patient cross-contamination. To operate the Quantec-E Endo System 2 without irrigation, the Power Switch on the Quantec-E Irrigation System 2 console is turned to the "O" position. When irrigation is desired, the switch is turned to "I". The irrigation tip assemblies supplied with the Quantec-E Irrigation System 2 is autoclavable.

This document is a 510(k) summary for the Quantec-E Irrigation System 2, a fluid delivery unit for dental irrigation. It focuses on establishing substantial equivalence to existing devices and describes the device's technical specifications and intended use.

No acceptance criteria or study details proving device performance against acceptance criteria are provided in the document.

The document discusses the device's features, intended use, and its substantial equivalence to other legally marketed devices, but it does not include any information on:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or their data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone (algorithm only) performance studies.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training sets was established.

This type of information is typically found in design verification and validation reports or clinical study summaries, which are not part of this 510(k) summary. The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through detailed studies as might be seen for novel or higher-risk devices.

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The Quantec-E Irrigation System is a self-contained, fluid delivery unit consisting of a pump unit console, irrigation reservoirs and tubing intended to be used in dentistry to provide irrigation while using the dental handpieces attached to the Quantec-E Endo System.

The device is a self-contained, fluid delivery unit consisting of a pump console, two irrigation reservoirs and tubing intended to be used in dentistry to provide irrigation while using the dental handpieces attached to the Quantec-E Endo System. The unit attaches to the Quantec-E Endo System via the accessory port located on the rear panel of the unit. The Quantec-E Irrigation System cannot operate as a stand alone device. The unit has a positive displacement peristaltic design to prevent fluid retraction which could result in patient cross-contamination. To operate the Quantec-E Endo System without irrigation, the Power Switch on the Quantec-E Irrigation System console is turned to the "O" position. When irrigation is desired, the switch is turned to "I". The irrigation tip assemblies supplied with the Quantec-E Irrigation System is autoclavable.

The provided 510(k) summary for the Quantec-E Irrigation System (K991035) does not contain information regarding detailed acceptance criteria or a study proving the device meets specific performance criteria.

Instead, this submission is a premarket notification (510(k)) which aims to demonstrate substantial equivalence to a predicate device already legally marketed in the United States. The focus of the 510(k) process is not to establish new performance metrics through clinical trials or detailed validation studies, but rather to show that the new device is as safe and effective as a legally marketed predicate device.

Therefore, the requested information about acceptance criteria, detailed performance results, sample sizes, expert qualifications, ground truth establishment, and MRMC studies is not available in the provided document because the nature of a 510(k) submission for this type of device does not typically require such extensive performance testing to be detailed in the summary.

The document primarily focuses on:

• Device Description: What the device is and how it functions.
• Intended Use: The purpose for which the device is designed.
• Substantial Equivalence Claim: Identifying a predicate device (Micro Motors, Inc., Micro SWP Sterile Water Pump) and arguing that the new device is sufficiently similar in function and intended use.

In summary, the provided text does not contain the information requested in your prompt regarding acceptance criteria and performance study details.

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