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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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Adseal is a biocompatible root canal sealer for permanent 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). Adseal is intended for use by qualified healthcare personnel trained in its use.

Adseal root canal sealer is a two component paste:paste device based upon epoxy-amine resin chemistry. This sealer is easy to mix and adapts closely to the walls of the prepared root canal and provides outstanding long-term dimensional stability with minimal shrinkage upon setting. The device consists of tow components, the epoxy resin paste (Paste A) and the aminecontaining paste (Paste B); portions of which are mixed prior to insertion into the root canal. This two component system reacts via an epoxide-amine chemical reaction to cause setting. It may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points). Paste A and Paste B are contained, separately, with the chambers of a two component plastic syringe, packaged with a disposable applicator.

Here's an analysis of the provided 510(k) summary regarding the Adseal Root Canal Sealer, focusing on acceptance criteria and supporting studies:

This 510(k) summary is for a traditional medical device (a root canal sealer), and as such, the nature of its "acceptance criteria" and "study" is different from what one might expect for an AI/ML powered device. For such devices, "acceptance criteria" are typically based on established performance standards for the material, and the "study" is a series of laboratory tests demonstrating compliance with those standards. There is no AI component involved here, so questions related to AI performance, ground truth, expert adjudication, or MRMC studies are not applicable.

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

The acceptance criteria are derived from the international standard ISO 6876, "Dental root canal sealing materials." The 510(k) implicitly indicates that Adseal meets these criteria by stating "Similar Physical Properties" and then listing those properties under the Adseal column in the substantial equivalence comparison table.

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

This information is not provided in a 510(k) summary for a material-based device. The "test set" would refer to the samples of the material tested in the laboratory. The document doesn't specify the number of samples or batches tested. The provenance is likely Korea, as the manufacturer is Meta Dental Co. 82-06 Grand Avenue Elmhurst, NY 11373 (US presence but likely manufacturing in Korea, common for medical device companies) and the ultimate letter is addressed to "Meta Biomed Company Limited." The testing would have been prospective to demonstrate compliance with the standard for the specific formulation.

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. For a root canal sealer, "ground truth" refers to the objective physical and chemical properties of the material, as measured and evaluated according to the specified international standard (ISO 6876). This does not involve expert readers or diagnostic accuracy assessments.

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

Not applicable. There is no adjudication method in the context of laboratory testing for material properties. The tests are designed to produce objective, measurable results.

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 device is a material, not an AI-powered diagnostic tool. There are no "human readers" in this context, nor an AI component.

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

Not applicable. This device is a material, not an algorithm.

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

The "ground truth" for the performance claims of this device is the objective measurements and observations performed in a laboratory setting according to the methodologies prescribed by ISO 6876 Dental root canal sealing materials. For biocompatibility, it's defined by the outcome of an "Agar diffusion test" per ISO/TR 7405.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. There is no "training set" or associated ground truth establishment for this type of device.

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