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CalApex is a calcium hydroxide, polymeric resin, root canal filling material that is used in conjunction with gutta percha or silver endodontic points.

Calplus is a temporary or permanent root canal filling material for use following pulpectomy, or for apexogenesis or apexification.

Cerafill RCS is a MTA (mineral trioxide aggregate) based root canal sealer that provides complete and permanent sealing of root canals. It can be used with or without root canal obturation materials.

Endoseal is used for permanent obturation of the root canal space with the aid of obturating points in accordance with ISO 6876 for Dental Root Canal Sealing materials.

Nanoseal S is indicated in patients for permanent obturations of root canal after vital extirpation or after treatment of pulpal gangrene and temporary filling.

Zical Ultra Paste is used for permanent obturation of the root canal space with the aid of obturating points.

Zical Ultra Powder/Liquid is used for permanent obturation of the root canal space with the aid of obturating points.

CalApex is a non-eugenol, radiopaque, calcium hydroxide polymeric resin root canal filling material. It is a two part, base/catalyst – paste/paste system that is mixed in equal portions. The mixture is then carried to the root canal with endodontic obturation points or directly dispensed in the root canal depending on delivery method, e.g. tube or dual-barrel syringe.

Calplus can be used as a temporary or permanent root canal filling material.

Cerafill RCS is an endodontic sealer based on MTA, providing a biocompatible and effective root canal filling. It is premixed and pre-loaded in a syringe, which allows a complete filling of the entire root canal including accessory and lateral canals. The product is eugenol-free and will not impede adhesion inside the root canal.

Endoseal is a Zinc Oxide/Eugenol root canal sealant. The product is made up of two separate components, a powder base and a liquid catalyst, to form the final device.

Nanoseal S is a permanent root canal filling material which is silicone based (polydimethylsiloxane). It is cold flowable and is in a dual barrel cartridge.

Zical Ultra Paste is a two-part, base/accelerator, paste/paste system that is mixed in equal portions. The mixture is carried to the root canal with endodontic obturation points. The product comes in a dual barrel cartridge.

Zical Ultra Powder/Liquid is a two-part, powder/liquid system for permanent filling of root canals. The mixture is carried to the root canal with endodontic obturation points.

The document describes the acceptance criteria and performance of several root canal sealers developed by Prevest Denpro Limited. The study involved a series of bench tests conducted according to ISO standards to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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• 1. Sealing the root canal of permanent teeth;
• 2. Internal reabsorption treatment.

BIO-C SEALER is a ready-to-use injectable endodontic bioceramic sealer, suitable for obturation of root canals.

The provided text describes a 510(k) premarket notification for a dental device called BIO-C SEALER. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing clinical efficacy studies with specific acceptance criteria as might be found for a novel device or drug.

Therefore, the supplied text does not contain the information requested regarding:

• A table of acceptance criteria and reported device performance in a clinical context. The performance data is for physical-chemical properties to show equivalence to the predicate.
• Sample size used for a test set (clinical data).
• Data provenance for a test set (clinical data).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone performance (algorithm only without human-in-the-loop performance).
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for clinical efficacy.
• Sample size for a training set (clinical data).
• How ground truth for the training set was established (clinical data).

Instead, the document highlights non-clinical (bench) testing to support substantial equivalence.

Here's what can be extracted from the document regarding "performance criteria" in the context of a 510(k) and the "study" (bench tests) that proves them:

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

The document states: "BIO-C SEALER has undergone extensive bench testing to provide evidence that its physical-chemical properties are substantially equivalent to iRoot SP. Bench tests performed are: flow, setting time, film thickness, solubility and radiopacity. Both devices have comparable flowability, setting time, film thickness, solubility and radiopacity."

This implies that the acceptance criteria for BIO-C SEALER's physical-chemical properties were to demonstrate comparability or substantial equivalence to the predicate device (iRoot SP) for these specific metrics. The reported performance is that they are comparable.

2. Sample sized used for the test set and the data provenance

• Sample size: Not specified. The document only mentions "extensive bench testing." The sample size would refer to the number of samples of the material tested for each physical-chemical property.
• Data provenance: Bench test results; conducted by Angelus Indústria de Produtos Odontológicos S/A. It's non-clinical, so country of origin for patients/data is not relevant.

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

Not applicable. This was bench testing of physical properties, not a clinical study requiring expert ground truth.

4. Adjudication method for the test set

Not applicable. This was bench testing.

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 a dental material, not an AI diagnostic device.

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

Not applicable. This is a dental material, not an AI algorithm.

7. The type of ground truth used

For physical-chemical properties, the "ground truth" is measured by standard laboratory methods according to relevant ISO or ASTM standards, against which the test device's performance is compared to the predicate device's established performance or regulatory requirements. For biocompatibility, the ground truth would be established by validated tests for mutagenicity, allergenicity, and general tolerance.

8. The sample size for the training set

Not applicable. This device does not use machine learning or require a training set.

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

Not applicable. This device does not use machine learning or require a training set.

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