Search Results

The PS System is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures.

The PS System presents a clinically effective way to irrigate the entire canal space during root canal treatments. The PS System is a closed system negative pressure irrigation apparatus that draws fluid through the individually placed cannula toward the coronal chamber by way of evacuation that is controlled independently through the dental chair vacuum system, eliminating the risk of apical irrigant extrusion during root canal procedures. The PS System creates a closed system by establishing an air tight seal between the tooth and stage via a lightcurable barrier. The PS System is designed to accommodate the full range of tooth and root canal anatomy and is offered in three specific procedural kits based on the type of tooth to be treated: anterior, premolar, and molar.

The provided document is a 510(k) summary for the PS System, a dental device used for endodontic irrigation. It describes the device's function, comparison to a predicate device, and non-clinical and clinical performance data.

Based on the document, here's an analysis of the acceptance criteria and study information, addressing your points:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria with corresponding performance metrics. Instead, it lists the types of performance tests conducted and then concludes based on the results. The key "acceptance criteria" appear to be:

• Ability to deliver and evacuate endodontic irrigation solutions.
• Performance akin to the predicate device (EndoVac System K140685).
• Reduction of apical extrusion risk compared to conventional positive pressure syringe irrigation.
• Safety and effectiveness equivalent to the predicate.

Reported Device Performance (based on the "Non-Clinical Performance Testing and Compliance" section):

The document states that the following performance tests were conducted as part of design verification:

• Suction Flow Rate Performance
• Critical Dimensions for Clinical Performance Analysis
• Corrosion Testing
• Simulated Canal Performance Testing
• Shelf Life Verification
• Biocompatibility Analysis
• Transit Testing
• Additive Manufacturing Summary Document

The conclusion states that based on "extensive comparative analysis and testing," the PS System is substantially equivalent to the predicate, and that differences "do not raise any new questions of safety and effectiveness." This implies the tests successfully demonstrated comparable performance and met the underlying safety and effectiveness expectations for such a device. However, specific quantitative performance metrics or pass/fail thresholds for these tests are NOT provided in this summary document.

2. Sample sizes used for the test set and the data provenance

The document is a 510(k) summary, which typically provides an overview rather than detailed study protocols. As such, the sample sizes for the non-clinical tests are not specified.

Data Provenance: The studies are described as "Non-Clinical Performance Testing." The document is submitted by Inter-Med, Inc. from Racine, WI, USA, suggesting the testing was likely conducted in the US or by a US-affiliated entity. The document doesn't specify if the data is retrospective or prospective, but as it's for design verification, it would inherently be prospective testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The tests performed are primarily engineering and material performance tests (e.g., suction flow rate, corrosion, biocompatibility, dimensions). These types of tests typically rely on established standards and laboratory measurements rather than expert human interpretation for "ground truth." Therefore, experts in establishing "ground truth" would not be relevant in the same way they would be for, say, an AI-based diagnostic device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Adjudication methods (like 2+1, 3+1 for consensus readings) are typically used in clinical studies or studies involving human readers/interpreters, especially for AI or diagnostic devices where subjective interpretation is involved. Since this document focuses on non-clinical performance testing of a physical medical device, adjudication methods are not applicable and thus not mentioned.

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. The PS System is a dental handpiece/irrigation system, not an AI or diagnostic imaging device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is not an algorithm or AI device. It is a physical medical device for irrigation. Therefore, a standalone algorithm performance study is not applicable and was not performed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance tests mentioned (Suction Flow Rate, Critical Dimensions, Corrosion, Simulated Canal Performance, Shelf Life, Biocompatibility, Transit), the "ground truth" would be established by:

• Reference standards and measurements: For dimensions, flow rates, and physical properties.
• Standardized testing protocols: For corrosion, shelf life stability, and transit resilience.
• ISO standards and established biological assays: For biocompatibility (e.g., ISO 7405, ISO 10993-1).

There is no mention of expert consensus, pathology, or outcomes data being used for ground truth in this context, as they are not relevant to the types of tests described.

8. The sample size for the training set

The device is a physical medical device, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established

As there is no "training set" (see point 8), this question is not applicable.

Ask a specific question about this device

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.

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.

Ask a specific question about this device

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.

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.

Ask a specific question about this device

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

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.

Ask a specific question about this device

The RinsEndo is used for root canal irrigation/ disinfection.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device called "RinsEndo". This document confirms that the device is substantially equivalent to a legally marketed predicate device for its indicated use (root canal irrigation/disinfection) and allows it to be marketed.

However, the document does NOT contain any information regarding:

• Acceptance criteria for the device's performance.
• The specifics of any study performed to prove the device meets acceptance criteria.
• Device performance results.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness study details or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for training was established.

This 510(k) letter is an administrative document about market clearance, not a technical report detailing the performance evaluation studies. Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device