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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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CLEARFIL AP-X 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 is a 510(k) premarket notification for a dental material (CLEARFIL AP-X), not a medical device that would involve a study with acceptance criteria in the typical sense (performance metrics, ground truth, expert review, etc.).

The submission focuses on a change of manufacturer name and address for an already cleared device (predicate device K943168). Therefore, the provided documentation explicitly states that:

• "The aim of 510(k) submission is to alter the name and address of manufacturer, and not to intend other changes."
• "This device is essentially the same as CLEARFIL AP-X manufactured by Kuraray Co., Ltd. (K943168). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as CLEARFIL AP-X."

This means there's no new study conducted to establish acceptance criteria or demonstrate device performance for this specific 510(k) submission (K012740). The acceptance of this submission is based on the substantial equivalence to the predicate device, which has already met its regulatory requirements.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not applicable to this specific 510(k) submission as it is merely an administrative change.

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