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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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For use to stimulate the healing process due to the mixture of calcium hydroxide and iodoform and the induction effect of these two ingredients. Used to promote healing effects and to help prevent bacterial contamination of the canal, as the two ingredients improve the induction effect for hard tissue induction and deposition. To be used as a medicament for the treatment of infected root canals, and as a permanent, low volume additive to the filling process of a treated root canal to assist in the induction and deposition of hard tissue to make the healing process more rapid and complete. For use in the treatment of infected root canals, or following pulpectomy, or for the apexegenesis or apexification, and/or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha. These indications include application in: Intracanal Medicament, Apexification, Periapical Lesions, Root Resorption, Temporary Root Filling, Perforations, Underdeveloped pulpless teeth.

DIAPEX is a yellow radiopaque calcium hydroxide paste with iodoform, used as a root canal filling material. It is packaged as a 2 gm syringe. Intraoral application uses enclosed disposable intracanal tips.

This document is a 510(k) summary for the medical device "DIAPEX," a calcium/iodoform root canal treatment paste. The purpose of this summary is to demonstrate that DIAPEX is substantially equivalent to a legally marketed predicate device, Vitapex Pre-loaded dental syringe (K973667).

The document does not contain information regarding a study with specific acceptance criteria and detailed device performance metrics in the format requested. Instead, it relies on demonstrating substantial equivalence to a predicate device through a comparison of intended use, chemical composition, and mechanical/physical properties.

Therefore, many of the requested sections below cannot be populated from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The submission focuses on substantial equivalence rather than performance against pre-defined acceptance criteria from a specific study. The "reported device performance" is implied to be equivalent to the predicate device's performance.

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

Not applicable. No specific test set or study with performance data is presented. The substantial equivalence argument relies on direct comparison of characteristics.

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

Not applicable. Ground truth for a test set is not established as no performance study is described.

4. Adjudication method for the test set

Not applicable. No test set adjudication method is described.

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 treatment paste, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a treatment paste, not an algorithm.

7. The type of ground truth used

Not applicable. No performance study requiring a specific type of ground truth is described. The "ground truth" for substantial equivalence is the characteristics and intended use of the predicate device.

8. The sample size for the training set

Not applicable. No training set is relevant for a medical paste device submission based on substantial equivalence.

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

Not applicable. No training set is relevant for a medical paste device submission.

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