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The Enaden Flow is intended for use in :

1. Restoration of class I~V cavities
2. Blocking out of undercuts
3. Sealing hypersensitive areas

Enaden Flow is a polymer-based restorative material. Enaden Flow is visible light-cured, radiopaque flowable composite and it is easy to handle, ready to be applied to restorations directly. The Enaden Flowl is available in 5 shades: A1, A2, A3, A3.5, and B2 (according to VITAPAN® classic shade guide). The device is used for the restorations of both anterior and posterior teeth. The device is contained in a plastic syringe and the system includes a plunger, disposable needle, protective cap, and a holder for direction control of the needle.

Here's a breakdown of the acceptance criteria and study information for the Enaden Flow device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance for Enaden Flow (K140976)

1. Table of Acceptance Criteria and Reported Device Performance

The application states that the device was tested based on referenced standards and that "All the test results support substantial equivalence to the predicate devices." This implies that the acceptance criteria for each tested property were to meet or exceed the performance of the predicate devices or to conform to the specified ISO standards. The direct acceptance criteria values are not explicitly specified in numerical terms in this summary, but rather implied by adherence to standards and substantial equivalence.

Note: The summary states that "The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices." This means that the device was evaluated against the performance of the existing predicate devices (Tetric Evocream, G-aenial Universal Flo, Denfil Flow) for these properties, and found to be comparable or better.

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

The 510(k) summary provides details on non-clinical performance data (bench testing) but does not specify sample sizes for these tests.
The data provenance is from bench testing and not human clinical data. Therefore, notions of country of origin or retrospective/prospective do not apply in the typical sense for clinical studies. The tests were performed by the manufacturer, KM Corporation, based in the Republic of Korea.

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

Not applicable. This submission relies on non-clinical (bench) testing. There were no human readers or experts establishing ground truth for a test set in the context of diagnostic performance.

4. Adjudication Method for the Test Set

Not applicable. As this is non-clinical bench testing, there is no test set in the context of human data requiring an adjudication method.

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 conducted. This is a submission for a dental restorative material, which does not involve human readers interpreting images, and therefore does not assess the effect of AI on human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical dental restorative material, not a software algorithm. Therefore, "standalone performance" in the context of algorithm-only performance is not relevant. The performance data provided relates to the physical and biocompatible properties of the material itself.

7. The Type of Ground Truth Used

The ground truth for the performance claims is based on established international standards (ISO 4049, ISO 9917, ISO 10993) and comparison to legally marketed predicate devices. The "ground truth" is the established performance benchmarks set by these standards and the observed performance of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. As this is a physical medical device (restorative material) and not an AI/ML algorithm, there is no "training set" in the context of machine learning. The device itself is manufactured to specifications, and its properties are tested to demonstrate compliance and substantial equivalence.

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

Not applicable. There is no training set for this type of device. The quality and performance of the device are ensured through manufacturing controls and adherence to material specifications and testing against established standards.

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TRC-Paste is a biocompatible temporary root canal sealer for use in the treatment of root canals, or following pulpectomy, or for apexegenesis or apexification, and for the tip filling of prepared, treated root canals at the time of final filling with gutta- percha.

TRC-Paste is an immediately available pre-mixed root canal filling material based on Calcium hydroxide and Polypropylene Glycol 2000. This pre-mixed temporary filling material maintains a constant flow, which makes it easy to inject into the canal. Depending on apicoectomy or infected root canal therapies, it can be used as a temporary root canal filling material. The device is contained in a plastic syringe and the system includes a plunger, disposable tips, a rubber, a protective cap, an indo stop and a holder for direction control of the tip.

The provided text describes a 510(k) summary for the device TRC-Paste, a temporary root canal filling material. It outlines non-clinical performance data and states that the device is substantially equivalent to a predicate device. However, the document does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria in the way typically associated with AI/ML-driven medical devices.

Instead, the performance data presented is for a traditional medical device (a paste) and focuses on compliance with established ISO and ASTM standards for material properties and biocompatibility.

Here's an analysis of the provided information, framed to address your request, with a clear indication of what is missing based on the typical requirements for AI/ML device studies:

1. Table of acceptance criteria and the reported device performance

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of non-clinical bench tests performed by KM Corporation. The 510(k) summary states, "All the test results met the preset test criteria." This implies that for each listed standard (ISO 6876, ISO 10993-5, ISO 10993-6, ISO 10993-11, ASTM F1980-07) and other bench tests, the TRC-Paste exhibited properties within the acceptable limits defined by those standards.

Regarding the AI/ML specific information requested, the provided document does NOT contain this information because the device is a material, not an AI/ML algorithm. Therefore, the following points are largely not applicable or missing from this specific submission:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable / Missing: This information is not relevant for a physical material product. The "test set" here refers to samples of the TRC-Paste material, implicitly tested in a lab setting. No specific sample sizes for these bench tests are provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable / Missing: This is not relevant. Ground truth for material properties is established by objective measurements against recognized standards, not by expert consensus in the diagnostic sense.

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

• Not Applicable / Missing: This refers to expert adjudication for clinical or imaging data, which is not part of this device's evaluation.

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

• Not Applicable / Missing: This is for AI/ML diagnostic aids, not a root canal filling material.

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

• Not Applicable / Missing: This is for AI/ML algorithms.

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

• Type of Ground Truth (for a material): The "ground truth" for this device's performance is objective measurement against the limits and specifications defined by the referenced international standards (ISO, ASTM) for properties like radiopacity, flowability, cytotoxicity, implantation response, systemic toxicity, and shelf life.

8. The sample size for the training set

• Not Applicable / Missing: This is for AI/ML models.

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

• Not Applicable / Missing: This is for AI/ML models.

In summary, the provided document details the non-clinical performance data for a temporary root canal filling material, showing its compliance with various ISO and ASTM standards to demonstrate substantial equivalence. It does not involve AI/ML technology, so many of the requested data points (related to algorithms, readers, ground truth establishment for diagnostic tasks, etc.) are not present in this type of submission.

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TRC-Pex: The TRC-Pex is a temporary root canal sealer for use in the treatment of root canals, following a pulpectomy or for apexegenesis or apexification.
Radic-Sealer: The Radic-Sealer is a root canal sealing of root canals following established endodontic procedures and may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points). The Radic-Sealer is intended for use by qualified healthcare personnel trained in its use.

TRC-Pex: TRC-Pex is an immediately available pre-mixed root canal filling material based on Calcium Hydroxide and lodoform. This pre-mixed temporary filling material maintains a constant flow, which makes it easy to inject into the canal. Depending on apicoectomy or root canal therapies, it can be used as a temporary root canal filling material. The device is contained in a plastic syringe and the system includes a plunger, disposable tips, a rubber, a protective cap, an indo stop and a holder for direction control of the tip.
Radic-Sealer: Radic-Sealer is a root canal sealing & filling material based on epoxy-amine resin. Radic-Sealer is contained in a dual syringe which makes it easy to mix and inject. It makes permanent obturation of root canals using adhesion properties between root canal walls and the root canal filling materials. The base and catalyst are contained separately in the chambers of two separate plastic syringes. The product consists of a mixing tip with a mixing joint, a protective cap, a mixing pad, and a plunger.

Here's an analysis of the provided text regarding the acceptance criteria and study for the TRC-Pex and Radic-Sealer devices:

This document is a 510(k) summary for medical devices, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device's safety and effectiveness from scratch through extensive clinical trials. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of showing equivalence to existing, legally marketed devices.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the standards and properties of the predicate devices. The study aims to show that the new devices meet the established performance parameters defined by these standards.

Study Proving Acceptance Criteria:

The study conducted was a series of non-clinical performance tests and biocompatibility tests. The document states:

• "Performance testing that confirmed to the protocols and recommended values described in ISO 6876 was performed."
• "Biocompatibility data were provided to demonstrate substantial equivalence to the predicate devices."
• "Side-by-Side cytotoxicity testing was performed that compared the TRC-Pex and a predicate device, and the test results showed that they have similar biocompatibility properties."
• "The bench and biocompatibility tests provided evidence that the chemical and physical properties of TRC-Pex and Radic-Sealer are substantially equivalent to the predicate devices."

Additional Information Not Present in the Document:

The provided text describes a 510(k) submission for dental materials (root canal filling and sealing materials). For this type of device, the performance evaluation primarily relies on bench testing and biocompatibility studies as per ISO standards, which is what the document reports. It does not involve studies typically associated with AI/software devices or diagnostic image analysis. Therefore, many of the requested points below are not applicable or cannot be answered from the provided text.

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

• Test Set Sample Size: Not explicitly stated for each test, but standard protocols for material testing (e.g., ISO 6876, ISO 10993 series) involve a specified number of samples for each property being evaluated (e.g., usually 3-5 samples per test condition for material science, but this is not detailed here).
• Data Provenance: The tests were conducted by KM Corporation, likely in a laboratory setting. No country of origin for "data" in the sense of patient data is applicable. These are material properties tests.
• Retrospective or Prospective: Not applicable. These are laboratory-based material characterization tests.

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

• Not applicable. For material properties and biocompatibility, "ground truth" is established by adherence to standardized testing methods (e.g., ISO standards) and instrument measurements, not expert consensus in the human interpretation sense.

4. Adjudication method for the test set:

• Not applicable. Material property tests are objective measurements, not subject to human adjudication or interpretation disputes.

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:

• Not applicable. This is not an AI/imaging device.

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

• Not applicable. This is not an AI/software device.

7. The type of ground truth used:

• Bench Test Ground Truth: Measured physical and chemical properties according to ISO standards.
• Biocompatibility Ground Truth: Cellular responses (e.g., cytotoxicity) and tissue reactions according to ISO 10993 standards and comparison to established predicate device performance.

8. The sample size for the training set:

• Not applicable. These materials are not "trained" in the machine learning sense. The "training" might refer to the development and refinement process of the material formulations, which is not detailed here.

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

• Not applicable for this type of device submission.

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