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DenFil™ is indicated for the following restorative applications;

1. Class: I, II, V restorations of posterior teeth
2. Class III, IV, V restorations of anterior teeth
3. Cervical cavities or defects involving root surfaces

DenFillM is light-cured restorative hybrid composite resin and accessories for use in both Posterior and Anterior restoration

This document is a 510(k) premarket notification for a dental composite material, DenFil™. It establishes substantial equivalence to existing predicate devices. However, it does not contain a study that proves the device meets specific acceptance criteria in the way modern AI/ML device submissions do.

Instead, the submission relies on the concept of substantial equivalence to predicate devices (Clearfil AP-X, Kuraray Medical Inc., K012740; Clearfil AP-X PLT, Kuraray Medical Inc., K023002; Multiple, Dentsply Intl., K863092). This means that the device is deemed safe and effective because it has the "same device characteristics as the predicate device" and its "material, design and use concept is similar."

Therefore, I cannot fill out the requested table and answer the study-specific questions as they do not apply to this type of submission.

Here's a breakdown of why and what information is available:

• Acceptance Criteria & Device Performance: Not applicable in the context of an AI/ML device and specific performance metrics. The implicit "acceptance criteria" is that it performs similarly enough to the predicate devices.
• Study That Proves the Device Meets Acceptance Criteria: No clinical study or performance study with defined acceptance criteria and statistical analysis is provided or required for this type of 510(k) submission. The document states:
  • "DenFil™ has been subjected to extensive safety, performance, and product validations prior to release."
  • "Safety tests have been performed to ensure the devices comply to applicable industry and US regulations."
  • "An extensive review of literature pertaining to the safety and biocompatibility of DenFil™ has been conducted."
    These are general statements about pre-market activities, not a specific study detailing results against acceptance criteria.
• Sample size, data provenance, experts, adjudication, MRMC, standalone, ground truth, training set: These concepts are relevant for AI/ML device submissions, which involve algorithms learning from data and then being tested. This 510(k) is for a physical medical device (dental composite) and therefore these questions do not apply.

In summary, this 510(k) submission for DenFil™ is based on establishing substantial equivalence to legally marketed predicate devices, not on a clinical or performance study that explicitly defines and measures quantifiable acceptance criteria for an AI/ML component.

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CLEARFIL AP-X PLT is indicated for the following applications:

1. Class I, II, V restorations of posterior teeth
2. Class III, IV, V restorations of anterior teeth
3. Cervical cavities or defects involving root surfaces

This product is classified into Tooth shade Resin Material, CFR 29 Section 872.3690, because it is a device composed of materials such as bisphenol A glycidylmethacrylate (Bis-GMA) intended to restore carious or structural defects in teeth.

This 510(k) summary describes a new dental restorative material, CLEARFIL AP-X PLT, which is substantially equivalent to a previously cleared device, CLEARFIL AP-X. Due to this substantial equivalence claim for a dental material, the provided document does not contain information typically found in studies for AI/ML-powered medical devices. Therefore, I cannot provide a detailed response for points 2 through 9 as they are not applicable or the information is not present in the provided text.

Here's what I can extract and infer based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a dental material, "acceptance criteria" and "device performance" are typically related to material properties (e.g., strength, biocompatibility, setting time, wear resistance, color stability) which are evaluated against industry standards or the predicate device's established performance. The submission is based on substantial equivalence, implying that the new device meets or performs similarly to the predicate.

Study Proving Acceptance Criteria:
The document states, "This device is substantially same to CLEARFIL AP-X manufactured by Kuraray Medical Inc. (K012740). Therefore CLEARFIL AP-X and CLEARFIL AP-X PLT are substantially equivalent on the technological characteristics, chemical ingredients and safety."

This statement implies that the "study" proving acceptance criteria is a comparison of the new device (CLEARFIL AP-X PLT) to its predicate device (CLEARFIL AP-X) across these characteristics. However, the details of this comparative study (e.g., specific tests, methodologies, results of material properties) are not included in this 510(k) summary. These details would typically be in the full submission, but not in the summary document.

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 applicable to this type of 510(k) submission for a dental composite material, which does not involve a "test set" in the context of an AI/ML device. The "test" here refers to material testing or equivalence comparisons, not clinical image or diagnostic data.

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)

This information is not applicable. "Ground truth" in the context of expert consensus or clinical diagnosis is not relevant for this material-based device submission.

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

This information is not applicable. Adjudication methods are typically used for establishing ground truth in diagnostic studies, not for material equivalence comparisons.

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

This information is not applicable as this is not an AI/ML device.

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

This information is not applicable as this is not an AI/ML device.

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

This information is not applicable in the typical sense. For a dental material, "ground truth" might refer to established physical, chemical, and biological properties measured by standardized tests, rather than clinical diagnostic ground truth. The basis for declaring equivalence is a comparison of these material properties, not a diagnostic outcome.

8. The sample size for the training set

This information is not applicable as this is not an AI/ML device.

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

This information is not applicable as this is not an AI/ML device.

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CLEARFIL AP-X PLT INTRO KIT is indicated for the following applications:

1. Class I, II, V restorations of posterior teeth

2. Class III, IV, V restorations of anterior teeth

3. Cervical cavities or defects involving root surfaces

This product is classified into Tooth shade Resin Material, CFR 29 Section 872.3690, because it is a device composed of materials such as bisphenol A glycidylmethacrylate (Bis-GMA) intended to restore carious or structural defects in teeth. This device is combination of CLEARFIL AP-X PLT and CLEARFIL SE BOND (K012442). CLEARFIL AP-X PLT is substantially same to CLEARFIL AP-X(K012740) manufactured by Kuraray Medical Inc. on the technological characteristics, chemical ingredients and safety.

The provided text is a 510(k) premarket notification for a dental material (CLEARFIL AP-X PLT INTRO KIT). It focuses on establishing substantial equivalence to predicate devices based on technological characteristics, chemical ingredients, and safety. This type of submission is not a clinical study report for a diagnostic AI device, and therefore, none of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, or human reader performance is available in the provided text.

The document is a regulatory filing stating that the device is "substantially equivalent" to existing, legally marketed dental materials. This means the manufacturer is asserting that the new device is as safe and effective as a predicate device without needing new clinical performance data because its fundamental properties and intended use are similar.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details. The input text does not contain information about:

1. Acceptance Criteria/Reported Device Performance: No performance metrics (e.g., sensitivity, specificity, accuracy, F1 score) are mentioned, nor are any acceptance criteria for such metrics.
2. Sample Size and Data Provenance: No test set or training set data is described.
3. Number of Experts/Qualifications/Adjudication: No human experts were involved in establishing ground truth for performance, as no performance study is described.
4. MRMC Comparative Effectiveness Study: Not applicable, as this is a dental material, not an AI diagnostic device.
5. Standalone Performance: Not applicable.
6. Type of Ground Truth: Not applicable, as there's no performance study to establish ground truth for.
7. Training Set Sample Size: Not applicable.
8. Training Set Ground Truth Establishment: Not applicable.

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