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Permanent root canal filling in combination with gutta-percha points in case of inflamed or necrotic pulp. Permanent root canal filling in combination with gutta-percha points following a retreatment procedure.

BioRoot™ Flow 0.5g, BioRoot™ Flow 2g is hydrophilic mineral root canal sealer presented as a ready-to-use paste in a syringe. BioRoot™ Flow 0.5g, BioRoot™ Flow 2g is based on a tricalcium silicate reaction with in situ water to seal the root canal. The sealer ensures a good adaptation to the root canal, tight interface with gutta-percha point and an adequate radiopacity. It is an implantable medical device intended to be used in dentistry. It is part of endodontic cements used as permanent root canal sealer. BioRoot™ Flow 0.5g. BioRoot™ Flow 2g is used in combination with gutta-percha points to fill the root canal.

This document, K212283, is a 510(k) summary for a medical device called "BioRoot™ Flow 0.5g, BioRoot™ Flow 2g" manufactured by Septodont. It describes a root canal filling resin. The document establishes substantial equivalence to predicate devices based on non-clinical and clinical testing, primarily focusing on physical-chemical properties and functional characteristics.

Here's an analysis based on the provided text, addressing your questions:

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

The document does not explicitly state "acceptance criteria" in a quantitative format for specific performance metrics that were tested for the new device. Instead, it presents a side-by-side comparison of the subject device (BioRoot™ Flow) with its predicate devices (BioRoot™ RCS and iRoot SP) and claims "substantial equivalence" based on various characteristics. The performance reported is essentially the successful demonstration of this equivalence through bench testing and by leveraging clinical data from the predicate.

Here's a table based on the provided "Side-by-Side Comparison" section, highlighting where performance is discussed implicitly:

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

The document primarily relies on non-clinical bench testing for the new device and equivalence to a predicate that likely had clinical data.

• Test Set Sample Size: The document does not specify the sample sizes for the bench tests conducted on BioRoot™ Flow. It states "extensive bench testing" and that results demonstrated "substantial equivalence" for physical-chemical properties, setting time, sealing, and adhesion.
• Data Provenance: The document does not specify the country of origin of the data nor whether the studies were retrospective or prospective. Given it's a 510(k), regulatory submissions typically rely on a mix of existing data and new testing. The reference to "existing data" for biocompatibility suggests some retrospective component, but the bench testing would be prospective for the new device.

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)

The document does not mention using experts to establish ground truth for a test set. This device is a dental material, and its equivalence is based on physical, chemical, and biological properties, not interpretative tasks (like image reading) that would require expert consensus for ground truth.

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

Not Applicable. Since there is no mention of expert review or interpretation of data in a way that would require adjudication (e.g., in an image-based diagnostic study), no adjudication method is specified.

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 MRMC study was done. This is a root canal filling material, not an AI-assisted diagnostic device. The "clinical testing" mentioned (Section 8) refers to demonstrating clinical equivalence to the primary predicate based on the predicate's existing clinical data, rather than performing new clinical trials for the subject device. It states, "Clinical evaluation data obtained using the equivalent device, BioRoot™ RCS, was used to support clinical evidence of BioRoot™ Flow 0.5g, BioRoot™ Flow 2g and can be extended to BioRoot™ Flow 0.5g, BioRoot™ Flow 2g in terms of clinical performance and clinical safety."

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

Not Applicable. This is a physical medical device (root canal sealer), not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm does not apply.

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

For the non-clinical bench testing of the subject device (BioRoot™ Flow), the "ground truth" would be established by standardized laboratory testing procedures and predefined specifications for material properties (e.g., setting time measurement according to ISO standards, or specific measurements for sealing and adhesion). For biocompatibility, it's based on chemical characterization and toxicological risk assessment, and biological data (likely in vitro and/or in vivo animal studies as per ISO 10993).

For the claim of clinical equivalence, the "ground truth" for the predicate device's clinical performance would have been established through its own clinical studies and outcomes data, which are then leveraged for the new device by demonstrating substantial equivalence in technology and intended use.

8. The sample size for the training set

Not Applicable. This document describes a traditional medical device (dental material), not an AI/ML product that would have a "training set."

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

Not Applicable. As there is no AI/ML component, there is no training set or associated ground truth establishment process for that purpose.

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