(4 days)
Polibond is used to fix custom-fit prosthetic teeth in appropriately milled cavities of prosthetic bases.
The Subject device is a single-component self-cure bonding agent intended for use with milled PMMA denture base resins and milled PMMA denture teeth. The Subject device is used by a dental professional (dentist or dental technician) in the fabrication or repair of removable dentures. Dentures fabricated using the Subject device are one-time use, prescription-only devices. Polibond is intended for bonding Zirkonzahn PMMA materials such as Abro® Basic Multistratum® and Denture Gingiva Basic Mono resins in the manufacturing of dental prostheses. Abro® Basic Mono and Abro® Basic Multistratum® are dentin colored and used for milling denture Gingiva Basic Mono is a material used for milling denture bases.
Here's the information about the acceptance criteria and the study that proves the device meets the acceptance criteria, extracted from the provided text:
Device: Polibond (Denture relining, repairing, or rebasing resin)
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Property Testing | ISO 20795-1 (Dentistry — Part 1: Denture base polymers) | Meets the property requirements of the referenced standards as applicable to self-curing bonding agents for denture base polymers. | "Results demonstrated the Subject device meets the property requirements of the referenced standards for the endpoints which could be applied to self-curing bonding agents for denture base polymers such as the Subject device." |
| Comparative Performance | Comparative tensile strength testing vs. Predicate Device (VITA VIONIC Bond®) | Demonstrate similar performance to the predicate device. | "Comparative tensile strength testing was performed with the Subject and Predicate devices and demonstrated similar performance between the Subject and Predicate devices." |
| Shelf-life | Shelf-life testing | Supports the shelf-life stated in device labeling. | "Shelf-life testing was performed to support the shelf-life stated in device labeling." |
| Biocompatibility | ISO 10993-1, ISO 10993-3, ISO 10993-5, ISO 10993-10 | Meets the requirements of these biological testing endpoints. | "Biocompatibility testing was performed on the Subject device according to ISO 10993-1:2018 according to the standards listed in the Technological Characteristics comparison table above." (Implies compliance with the listed standards and endpoints). |
| MRI Safety | FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment)" | Supports MR Safety labeling as required by the FDA guidance. | "An MRI safety assessment was performed on the Subject device to support MR Safety labeling as required by the FDA guidance 'Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment'." |
2. Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes used for the non-clinical performance testing (e.g., number of samples for tensile strength, biocompatibility, or shelf-life tests).
- The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective/prospective, but it is implied to be prospective as these are tests conducted specifically for the device's premarket notification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the document describes non-clinical performance testing of a material, not a diagnostic or AI-driven device that requires expert-established ground truth. The acceptance criteria are based on established ISO standards and direct measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None. This is not relevant for the type of non-clinical material testing described. Results are derived from physical and chemical measurements against predefined 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:
- No. This type of study is not mentioned and is not relevant for the assessment of this particular device (a dental bonding agent).
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Not applicable. This device is a material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by objective measurements against recognized international standards (ISO 20795-1, ISO 10993 series) and comparative testing against a legally marketed predicate device for tensile strength.
8. The sample size for the training set:
- Not applicable. This device is a material, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This device is a material, not an AI/ML algorithm.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.