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

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.

Ask a specific question about this device