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DIAPEX PLUS is a calcium hydroxide paste with iodoform, used as a temporary root canal filling material. Application : Root canal filling material / Apexification and hard tissue formation/ Apexogensis

The subject device is packaged with the following:

• 0 Syringe
• Disposable Tip .
• Silicon Cap .

The provided text is a 510(k) summary for a dental device called "DIAPEX PLUS," a root canal filling material. It outlines the device's characteristics and compares it to predicate devices to establish substantial equivalence for regulatory clearance. Since this document is a regulatory submission for a medical device that needs to demonstrate substantial equivalence to a predicate device, it contains extensive information about the characteristics of the new device and the predicate device, and how they are similar. This is not a study that presents a test set, acceptance criteria and results against it.

However, based on the information provided, here's an attempt to structure a response using the requested categories, noting where information is not present in the document.

Acceptance Criteria and Study for DIAPEX PLUS

The document provided does not present a typical "acceptance criteria" table with reported performance against specific quantitative thresholds for the device itself. Instead, it demonstrates conformance to recognized international standards and compares the device's technological characteristics to legally marketed predicate devices. The "study" implicitly refers to the non-clinical performance data and the comparison presented to support substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Instead of explicit acceptance criteria with numerical thresholds, the document states conformance to various ISO standards. The "reported device performance" is essentially that the device conforms to these standards and is substantially equivalent to the predicate devices.

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

• Sample size for test set: Not explicitly stated in the document. The non-clinical performance data likely involved various samples tested according to the referenced ISO standards.
• Data provenance: Not explicitly stated. These would typically be laboratory tests conducted by the manufacturer or a contract research organization.

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

• This information is not provided because this is a regulatory submission demonstrating substantial equivalence through conformance to standards and comparison of technical characteristics, not a clinical study with expert-established ground truth. The "ground truth" here is adherence to specified standard test methods and established benchmarks within those standards.

4. Adjudication method for the test set:

• Not applicable as this is not a study requiring adjudication of expert interpretations (e.g., medical imaging classification). The results would be objectively measured parameters defined by the ISO standards.

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 root canal filling material, not an AI-assisted diagnostic tool. No MRMC study was conducted or would be relevant.

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

• Not applicable. This is not an algorithmic or AI device. The device's performance is standalone in the sense that its physical and chemical properties and biocompatibility are tested independently.

7. The type of ground truth used:

• The "ground truth" for this submission is established through conformance to international standards (e.g., ISO 6876, ISO 10993 series) and through demonstration of substantial equivalence of technological characteristics to legally marketed predicate devices. The tests are bench tests measuring physical, chemical, and biological properties according to standardized methods.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. As this is not an AI device, there is no training set or associated ground truth.

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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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