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510(k) Data Aggregation
(353 days)
Parkell Self-Adhesive Cement is intended for the cementation of indirect restoratives including ceramic, zirconia, composite, and metal-based inlays, onlays, crowns, bridges, and posts.
Parkell Self-Adhesive Cement is a two-component, dual-cured, self-adhesive resin cement. It is designed for luting of indirect restorations (inlays, onlays, crowns, bridges, and endodontic posts) made of metal alloys, composite resins, porcelain, lithium disilicate or zirconia. The material also exhibits high bond strength and is radiopaque to allow visibility of excess in sub-gingival areas. Parkell Self-Adhesive Cement will cure in 10 seconds with a dental curing light emitting blue light at 430 - 480 nm and a minimum intensity of 600 mW/cm². The product will self-cure in 3-4 minutes at mouth temperature. Parkell Self-Adhesive Cement will be provided in 5 mL auto-mix syringes. The device comprises catalyst and base components, which are combined just prior to use via a static (1:1) mixing tip which is affixed to the dual chamber syringe.
The provided document is a 510(k) summary for a dental cement (Parkell Self-Adhesive Cement). It aims to demonstrate substantial equivalence to a predicate device. This type of submission relies heavily on bench testing and biocompatibility studies, rather than clinical performance (human trials) for its primary evidence.
Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context pertains to the non-clinical performance and physical properties of the dental cement, as well as its biocompatibility, when compared to the established standards and the predicate device.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance & 6. Standalone Performance:
The document implicitly defines acceptance criteria by comparing the subject device's performance to the predicate device's performance, or to generally accepted values for dental cements (e.g., "Pass/Fail Criteria"). The performance listed is for the standalone (algorithm only without human-in-the-loop performance) of the material itself.
| Property | Predicate Device Performance / Acceptance Criteria (Pass/Fail Criteria) | Parkell Self-Adhesive Cement Performance |
|---|---|---|
| Physical Properties | ||
| Film Thickness (Microns) | ≤ 50 microns | ≤ 50 microns |
| Working time (seconds) @ 35 C | ≤ 60 seconds | ≤ 60 seconds |
| Setting time (minutes) @ 35 C | ≤ 10 minutes | ≤ 10 minutes |
| Flexural strength LC (MPa) | ≥ 50 MPa | ≥ 50 MPa |
| Flexural Strength SC (MPa) | ≥ 50 MPa | ≥ 50 MPa |
| Compressive Strength LC (MPa) | ≥ 200 MPa | ≥ 200 MPa |
| Water Sorption (ug/mm³) | ≤ 40 ug/mm³ | ≤ 40 ug/mm³ |
| Water Solubility (ug/mm³) | ≤ 7.5 u/mm³ | ≤ 7.5 u/mm³ |
| Radiopacity (% Al) | ≥ 100 %Al | ≥ 100 %Al |
| Depth of Cure (mm) | ≥ 1mm | ≥ 1mm |
| Diametral Tensile Strength (MPa) | ≥ 30 MPa | ≥ 30 MPa |
| Barcol Hardness after 20 minutes @35c (MPa) | > 50 MPa | > 50 MPa |
| Barcol Hardness after 20 secs Light Cure each surface (MPa) | > 60 MPa | > 60 MPa |
| Bond Strength (MPa) to Substrates (LC = Light Cure, SC = Self-Cure, Treatment indicated where applicable) | ||
| Dentin LC (None) | ≥ 6 MPa | ≥ 6 MPa |
| Dentin LC (PBA) | ≥ 10 MPa | ≥ 10 MPa |
| Dentin SC (None) | ≥ 3 MPa | ≥ 3 MPa |
| Enamel LC (None) | ≥ 10 MPa | ≥ 10 MPa |
| Enamel LC (H3PO4) | ≥ 10 MPa | ≥ 10 MPa |
| Enamel SC (None) | ≥ 3 MPa | ≥ 3 MPa |
| Lithium Disilicate LC (Silane) | ≥ 5 MPa | ≥ 5 MPa |
| Lithium Disilicate LC (HF) | N/A (Predicate did not have this indication) | ≥ 10 MPa |
| Zirconia LC (SB) | ≥ 10 MPa | ≥ 10 MPa |
| Zirconia LC (PBA) | N/A (Predicate did not have this indication) | ≥ 10 MPa |
| Zirconia LC (HF) | N/A (Predicate did not have this indication) | ≥ 10 MPa |
| Zirconia SC (SB) | ≥ 5 MPa | ≥ 5 MPa |
| Porcelain LC (SB) | ≥ 10 MPa | ≥ 10 MPa |
| Porcelain LC (Silane) | N/A (Predicate did not have this indication) | ≥ 10 MPa |
| Porcelain LC (HF) | N/A (Predicate did not have this indication) | ≥ 10 MPa |
| Porcelain SC (HF) | N/A (Predicate did not have this indication) | ≥ 5 MPa |
| Palladium LC (SB) | ≥ 10 MPa | ≥ 10 MPa |
| Titanium LC (SB) | ≥ 10 MPa | ≥ 10 MPa |
| Titanium SC (SB) | ≥ 5 MPa | ≥ 5 MPa |
| Cobalt LC (SB) | ≥ 10 MPa | ≥ 10 MPa |
| Cobalt SC (SB) | ≥ 5 MPa | ≥ 5 MPa |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the numerical sample size (e.g., number of specimens tested for each property). It only indicates that "Performance and Physical Properties" tests were performed.
- Data Provenance: The data is generated from non-clinical (bench) testing. The country of origin of the data is not specified, but the submission is to the U.S. FDA by a company based in New York. The testing would be considered prospective in the sense that it was conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: This is not applicable to this type of submission. The "ground truth" for the performance and physical properties of the dental cement is established through standardized laboratory test methods (e.g., ISO standards like ISO 4049, ISO 11405, etc.) and direct object measurement, not expert consensus or interpretation.
- Qualifications of Experts: Not applicable, as expert interpretation is not the primary means of establishing "ground truth" for material properties.
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based diagnostic studies involving human readers/interpreters to resolve discrepancies. For bench testing of material properties, the results are quantitative measurements against defined criteria.
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 a submission for a medical device (dental cement), not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, human readers, or AI assistance is involved.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- Quantitative measurements against established international standards and defined criteria. For physical properties, the ground truth is derived from the reproducible results of standardized laboratory tests. For biocompatibility, the ground truth is assessed against the requirements of ISO 10993 series of standards.
8. The Sample Size for the Training Set:
- Not applicable. This is a medical device submission based on bench testing of material properties, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no training set for this type of device.
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(109 days)
Cementation of ceramic and composite inlays, onlays and laminate veneers with less than 2mm thickness
PANAVIA Veneer LC is a light-cure adhesive resin cement system. It consists of the light-cure cement paste (PANAVIA Veneer LC paste), CLEARFIL CERAMIC PRIMER PLUS, K-ETCHANT Syringe, and PANAVIA V5 Try-in Paste. CLEARFIL Universal Bond Quick or PANAVIA V5 Tooth Primer can be chosen for tooth treatment.
The cement paste is a light-cure, resin based material which provides color stability and has radiopacity equal to or greater than 1mm aluminum. It is indicated for inlays, onlays and laminate veneer restorations made of ceramic and composite resin. It is supplied in Kuraray's ergonomic syringe and dispensed via an angled applicator tip (16G) into an inlay cavity or onto an onlay or a laminate veneer. It is available in 4 shades; Universal (A2), Clear, Brown (A4) and White. It is classified as a Type 2 and Class 2 (Group 1) material by ISO 4049. Shade adaptation is available to check by PANAVIA V5 Try-in Paste before cementation. This is the new registration application for the subject device and there have not been any prior submissions regarding the subject device.
We are seeking clearance for PANAVIA Veneer LC paste in this submission.
Concerning Try-in Paste which is included as components of the PANAVIA V5, CLEARFIL Universal Bond Quick, CLEARFIL CERAMIC PRIMER PLUS and K-ETCHANT Syringe, the specification of those 4 components were omitted for the reasons set forth below.
We already have had 510(k) clearance of Try-in Paste of PANAVIA V5(510(k) Number: 150704), CLEARFIL Universal Bond Quick (510(k) Number: 161042), CLEARFIL CERAMIC PRIMER PLUS (510(k) Number: 150703) and K-ETCHANT Syringe (510(k) Number: 133078).
This document describes the marketing authorization for the PANAVIA Veneer LC dental cement. Here's a breakdown of the acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Section | Requirement | PANAVIA Veneer LC (Subject device) | PANAVIA V5 (Primary predicate device) | CLEARFIL MAJESTY ES Flow (Predicate device) |
|---|---|---|---|---|
| 5.2.2 Film thickness, luting materials |
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(108 days)
OsteoDetect analyzes wrist radiographs using machine learning techniques to identify and highlight distal radius fractures during the review of posterior-anterior (PA) and lateral (LAT) radiographs of adult wrists.
OsteoDetect is a software device designed to assist clinicians in detecting distal radius fractures during the review of posterior-anterior (PA) and lateral (LAT) radiographs of adult wrists. The software uses deep learning techniques to analyze wrist radiographs (PA and LAT views) for distal radius fracture in adult patients.
1. Table of Acceptance Criteria and Reported Device Performance
Standalone Performance
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Estimate) | 95% Confidence Interval |
|---|---|---|---|
| AUC of ROC | High | 0.965 | (0.953, 0.976) |
| Sensitivity | High | 0.921 | (0.886, 0.946) |
| Specificity | High | 0.902 | (0.877, 0.922) |
| PPV | High | 0.813 | (0.769, 0.850) |
| NPV | High | 0.961 | (0.943, 0.973) |
| Localization Accuracy (average pixel distance) | Small | 33.52 pixels | Not provided for average distance itself, but standard deviation of 30.03 pixels. |
| Generalizability (AUC for all subgroups) | High | ≥ 0.926 (lowest subgroup - post-surgical radiographs) | Not explicitly provided for all, but individual subgroup CIs available in text. |
MRMC (Reader Study) Performance - Aided vs. Unaided Reads
| Performance Metric | Acceptance Criteria (Implicit: Superiority of Aided) | Reported Device Performance (OD-Aided) | Reported Device Performance (OD-Unaided) | 95% Confidence Interval (OD-Aided) | 95% Confidence Interval (OD-Unaided) | p-value for difference |
|---|---|---|---|---|---|---|
| AUC of ROC | AUC_aided - AUC_unaided > 0 | 0.889 | 0.840 | Not explicitly given for AUCs themselves, but difference CI: (0.019, 0.080) | Not explicitly given for AUCs themselves, but difference CI: (0.019, 0.080) | 0.0056 |
| Sensitivity | Superior Aided | 0.803 | 0.747 | (0.785, 0.819) | (0.728, 0.765) | Not explicitly given for individual metrics, but non-overlapping CIs imply significance. |
| Specificity | Superior Aided | 0.914 | 0.889 | (0.903, 0.924) | (0.876, 0.900) | Not explicitly given for individual metrics, but non-overlapping CIs imply significance. |
| PPV | Superior Aided | 0.883 | 0.844 | (0.868, 0.896) | (0.826, 0.859) | Not explicitly given for individual metrics, but non-overlapping CIs imply significance. |
| NPV | Superior Aided | 0.853 | 0.814 | (0.839, 0.865) | (0.800, 0.828) | Not explicitly given for individual metrics, but non-overlapping CIs imply significance. |
2. Sample Size and Data Provenance for Test Set
Standalone Performance Test Set:
- Sample Size: 1000 images (500 PA, 500 LAT)
- Data Provenance: Retrospective. Randomly sampled from an existing validation database of consecutively collected images from patients receiving wrist radiographs at the (b) (4) from November 1, 2016 to April 30, 2017. The study population included images from the US.
MRMC (Reader Study) Test Set:
- Sample Size: 200 cases.
- Data Provenance: Retrospective. Randomly sampled from the same validation database used for the standalone performance study. The data includes cases from the US.
3. Number of Experts and Qualifications for Ground Truth
Standalone Performance Test Set and MRMC (Reader Study) Test Set:
- Number of Experts: Three.
- Qualifications: U.S. board-certified orthopedic hand surgeons.
4. Adjudication Method for Test Set
Standalone Performance Test Set:
- Adjudication Method (Binary Fracture Presence/Absence): Majority opinion of at least 2 of the 3 clinicians.
- Adjudication Method (Localization - Bounding Box): The union of the bounding box of each clinician identifying the fracture.
MRMC (Reader Study) Test Set:
- Adjudication Method: Majority opinion of three U.S. board-certified orthopedic hand surgeons. (Note: this was defined on a per-case basis, considering PA, LAT, and oblique images if available).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? Yes.
- Effect Size (Improvement of Human Readers with AI vs. without AI assistance):
- The least squares mean difference between the AUC for OsteoDetect-aided and OsteoDetect-unaided reads is 0.049 (95% CI, (0.019, 0.080)). This indicates a statistically significant improvement in diagnostic accuracy (AUC) of 4.9 percentage points when readers were aided by OsteoDetect.
- Sensitivity: Improved from 0.747 (unaided) to 0.803 (aided), an improvement of 0.056.
- Specificity: Improved from 0.889 (unaided) to 0.914 (aided), an improvement of 0.025.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? Yes.
7. Type of Ground Truth Used
Standalone Performance Test Set:
- Type of Ground Truth: Expert consensus (majority opinion of three U.S. board-certified orthopedic hand surgeons).
MRMC (Reader Study) Test Set:
- Type of Ground Truth: Expert consensus (majority opinion of three U.S. board-certified orthopedic hand surgeons).
8. Sample Size for Training Set
The document does not explicitly state the sample size for the training set. It mentions "randomly withheld subset of the model's training data" for setting the operating point, implying a training set existed, but its size is not provided.
9. How Ground Truth for Training Set Was Established
The document does not explicitly state how the ground truth for the training set was established. It only refers to a "randomly withheld subset of the model's training data" during the operating point setting.
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