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Endocyn Root Canal Irrigation Solution is intended to irrigate, cleanse, and debride root canal systems including the removal of foreign material and debris during root canal therapy. It is also intended to provide for lubrication and irrigation during root canal instrumentation.

The Endocyn Root Canal Irrigation Solution is a colorless, slightly chlorinated odor, clear aqueous solution intended to irrigate, cleanse, and debride root canal systems. The solution will be supplied in polyethylene terephthalate (PET) round-bottles with polypropylene (PP) screw-top closure.

The provided document is a 510(k) premarket notification for the "Endocyn Root Canal Irrigation Solution." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies against predefined acceptance criteria. Therefore, the information typically found in such a study (like sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not presented in this document.

Here's an analysis of the available information:

1. Acceptance Criteria and Reported Device Performance

The document does not define explicit "acceptance criteria" in the sense of performance thresholds for efficacy in a clinical study. Instead, the device's performance is demonstrated through a series of tests to show it meets specifications and is comparable to predicate devices.

2. Sample size used for the test set and the data provenance:

This document describes a 510(k) submission, which relies on performance testing and comparison to predicate devices, not a clinical study involving a test set of patient data. Therefore, there is no "sample size used for the test set" or "data provenance" (country of origin, retrospective/prospective) in the context of a clinical performance study. The tests would have been performed on batches of the Endocyn Root Canal Irrigation Solution itself.

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

This information is not applicable as the submission is not a clinical study involving human interpretation of data for ground truth establishment.

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

This information is not applicable for the same reason as point 3.

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:

This is not applicable. The device is an irrigation solution, not an AI-powered diagnostic tool, and therefore no MRMC study would be performed for this product.

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

This is not applicable as the device is not an algorithm or AI system.

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

The "ground truth" for the performance tests (pH, osmolality, etc.) would be established by analytical chemistry and microbiology standards and laboratory testing protocols, not expert consensus or pathology in a clinical sense. For biocompatibility, it relied on established ISO standards (ISO-10993).

8. The sample size for the training set:

This is not applicable as the device is not an AI/machine learning model that requires a training set. The "training" for this device would refer to the development and manufacturing processes to ensure it consistently meets specifications.

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

This is not applicable for the same reason as point 8.

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Endo-CHXTM is intended to irrigate and cleanse root canal systems.
ENDO-CHX™ is intended to irrigate and cleanse root canal systems.

Endo-CHX™ is a root canal cleanser for use in endodontic procedures. After endodontic instrumentation, the product should be used to cleanse the canal space before placement of the endodontic filling. The material should be delivered into the canal using an irrigating neede. A side-vented, closed tip irrigation needle is most preferred.

The provided document is a 510(k) summary for a root canal cleanser called Endo-CHX™. As such, it primarily focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study demonstrating performance against those criteria in the way that might be expected for an AI-powered diagnostic device.

Here's an analysis based on the information provided, while noting the limitations due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not applicable in the traditional sense for this type of device and submission. For a root canal cleanser, "acceptance criteria" would typically relate to its chemical properties, biocompatibility, and efficacy in cleaning the root canal system, often demonstrated through in vitro or ex vivo studies. The 510(k) summary focuses on substantial equivalence to predicate devices rather than setting and meeting specific quantitative performance metrics like sensitivity or specificity.

The "device performance" is implicitly established by demonstrating that it functions similarly to legally marketed predicate devices and is considered safe and effective.

2. Sample Size Used for the Test Set and Data Provenance

There is no test set in the context of an AI/diagnostic device performance study. The 510(k) relates to a chemical solution.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable. Ground truth, expert consensus, or clinical adjudication as would be relevant for an AI/diagnostic device is not part of this submission type.

4. Adjudication Method

This information is not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. This is not an AI-powered diagnostic device.

6. Standalone Performance Study

The submission mentions "Non-Clinical Testing: The performance and biocompatibility documentation provided the submission support the safety and effectiveness of the Endo-CHX root canal cleanser for the indicated uses." This suggests standalone testing was performed, but the details (e.g., specific tests, outcomes, quantitative measures) are not provided in this summary exhibit. It just states that such documentation exists and supports safety and effectiveness.

7. Type of Ground Truth Used

For non-clinical testing of a root canal cleanser, the "ground truth" would likely involve standardized in vitro models or ex vivo tooth specimens. The effectiveness would be measured by properties such as debris removal, antibacterial activity, or smear layer removal, often compared to controls or predicate devices. However, direct "ground truth" establishment in a clinical sense (like pathology for cancer) is not specified or generally applicable here.

8. Sample Size for the Training Set

There is no training set for this device as it is not an AI/machine learning product.

9. How the Ground Truth for the Training Set was Established

There is no training set for this device.

Summary of Relevant Information from the Provided Text:

• Acceptance Criteria & Performance: Not explicitly stated as quantitative metrics. Performance is inferred through "substantial equivalence" to predicate devices and general statements about non-clinical testing supporting safety and effectiveness.
• Study Type: Non-clinical (e.g., in vitro or ex vivo) testing was performed for performance and biocompatibility. No clinical trials were deemed necessary ("Clinical Testing: Not applicable").
• Predicate Devices: The device was compared to K061689 (Aquatine™ EC Endodontic Cleanser) and K053167 (BioPure™ MTAD™ Root Canal Cleanser). The comparison focuses on mechanism of action and composition.
• Conclusion: The device is considered "substantially equivalent to the predicates and raises no issues of safety and effectiveness."

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