(253 days)
Partial Flex® is indicated for the fabrication of partial or full removable dentures, as well oclusional splints or night guards.
Partial Flex® dental resin is a polymer base material used for the fabrication of partial removable dentures and prosthesis. Partial Flex is made from a resin of polypropylene that is designed and manufactured for injection molding. Partial Flex® is available in two shades as a granular material (so-called pellets) contained in an aluminum tube with 27 g or in a plastic bag of 250 g. In addition to high biocompatibility, Partial Flex® material features hypoallergenic properties, no risk of discoloration and the dental prosthesis made are unbreakable, which differentiates the from acrylic materials. The resin material is pigmented in one color and without pigment presentation: Light pink and Natural color (without pigment).
The provided FDA 510(k) Clearance Letter for the device "Partial Flex" does not describe acceptance criteria, the study that proves the device meets acceptance criteria, or any details about AI/human reader studies.
The document primarily focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device. It confirms that the device is a "Denture Relining, Repairing, Or Rebasing Resin" and lists some non-clinical performance tests conducted to show compliance with ISO standards (ISO 20795 and ISO 10993 for biocompatibility), but it does not provide specific acceptance values or the actual results of these tests beyond "passed the acceptance criteria" or "complies with the requirements."
Therefore, it's impossible to fill in the requested information based solely on the provided text. The prompt asks for details that are typically found in a clinical study report or a more detailed section of a 510(k) submission, neither of which is present in the provided clearance letter.
However, I can illustrate what a hypothetical response would look like if the information were available, using the structure of your request.
Hypothetical Response (Illustrative, as the provided document lacks the necessary data):
This document, an FDA 510(k) Clearance Letter, primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. It details non-clinical performance testing but does not contain the specific acceptance criteria, detailed study results, or information pertaining to AI performance, human reader studies, or ground truth establishment that would be required to fully answer the prompt. The information below is hypothetical and structured as if the data were present in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Hypothetical) | Reported Device Performance (Hypothetical) |
|---|---|
| Material Properties (per ISO 20795) | (Stated in document as "The material complies with the requirements" or "passed the acceptance criteria") |
| Ultimate Flexural Strength: > X MPa | Y MPa (Meets requirements) |
| Flexural Modulus: > A GPa | B GPa (Meets requirements) |
| Sorption: 65 MPa" and then a result like "72 MPa".)* |
2. Sample Sizes and Data Provenance
The provided document describes non-clinical bench testing and biocompatibility testing. It does not specify sample sizes for these tests, nor does it refer to patient data (e.g., medical images, clinical outcomes) that would typically have provenance data.
- Test Set Sample Size: Not applicable/Not specified in the provided document for human data or AI model evaluation. For bench tests, typical sample sizes are per ISO standards but not detailed here.
- Data Provenance: Not applicable for the type of testing described (bench and biocompatibility). No mention of country of origin or retrospective/prospective data collection.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The provided document describes material testing and biocompatibility. It does not involve human readers, clinical data interpretation, or AI ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. No expert review or clinical test set adjudication is described in the provided document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a material science device (dental resin), not a diagnostic imaging or AI-assisted interpretation device. No MRMC study was performed or is relevant to this device's 510(k) submission as described.
6. Standalone Algorithm Performance
Not applicable. This device is a physical dental resin, not an algorithm or software.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical tests described in the document (material properties and biocompatibility) would be based on:
- Established ISO Standards (e.g., ISO 20795 for dental base polymers, ISO 10993 for biocompatibility): These standards define the test methodologies and acceptable performance limits.
- Laboratory Measurements and Biological Assays: Objective, quantitative measurements performed in a laboratory setting (e.g., measuring flexural strength, assessing cell viability, observing tissue reactions in animal models).
There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of this 510(k) submission.
8. Sample Size for the Training Set
Not applicable. This device is a manufactured resin, not an AI model requiring a training set.
9. How Ground Truth for the Training Set Was Established
Not applicable. This device is a manufactured resin, not an AI model.
§ 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.