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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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