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Metapex 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

This product is a calcium hydroxide paste material that is temporarily filled into the root canal. It is pre-mixed in a syringe for convenient delivery in the root canal. When applied to root canal, it is alkaline by calcium hydroxide. The state of the treatment can be confirmed by the radiopacity of iodoform contained. Metapex Plus is used for patients of all ages requiring root canal treatment.

The provided text describes the 510(k) premarket notification for "Metapex Plus," a root canal filling material. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on AI performance or diagnostic accuracy.

Therefore, the provided input does not contain the information requested to describe acceptance criteria and a study proving a device meets them in the context of an AI/human reader performance study.

The information in the document pertains to:

• Device Type: A medical device (root canal filling material), not an AI-powered diagnostic tool.
• Approval Type: 510(k) clearance, which focuses on substantial equivalence to a legally marketed predicate device, primarily through comparing technological characteristics and performance standards (like ISO 6876 for dental materials), rather than clinical efficacy trials or AI performance evaluations.
• Testing: Non-clinical testing for performance (e.g., flowability, radiopacity) and biocompatibility, as well as shelf-life testing, all against established ISO standards for dental materials. There is no mention of a test set, training set, ground truth established by experts, or human reader performance studies.

To answer your request, if this were an AI-powered diagnostic device, the following information would be expected but is NOT present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance: This would define metrics like sensitivity, specificity, AUC, or F-score and specify threshold values for acceptance.
2. Sample Size and Data Provenance: For an AI study, this would detail the number of images/cases in the test set, their origin (e.g., country, hospital), and whether the data was collected retrospectively or prospectively.
3. Number and Qualifications of Experts for Ground Truth: This would specify how many radiologists (or other medical specialists) with what level of experience established the ground truth.
4. Adjudication Method: How discrepancies between experts were resolved (e.g., 2+1 agreement, majority vote).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Whether human readers were tested with and without AI assistance, and the effect size of the AI's improvement on human performance.
6. Standalone Performance: The AI algorithm's performance without human interaction.
7. Type of Ground Truth: How the definitive diagnosis was established (e.g., pathology, long-term outcomes, expert consensus).
8. Training Set Sample Size: The number of cases used to train the AI model.
9. Training Set Ground Truth Establishment: How the labels for the training data were determined.

In summary, the provided FDA 510(k) clearance letter and summary discuss a dental material's substantial equivalence based on material properties and non-clinical testing against ISO standards, not a study evaluating the performance of an AI-powered diagnostic device or human-in-the-loop performance.

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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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