(128 days)
DD base P HI are pre-colored dental milling blanks made of impact-resistant PMMA for the manufacture of denture bases for removable dentures. DD base P HI is suitable for long-term use in the oral cavity up to 10 years.
DD Bio Splint P HI are transparent dental milling blanks out of PMMA for the manufacture of splints, therapeutic splints and bite requlators for long-term application in the oral cavity up to 12 months.
DD medical polymers (PMMA), made from PMMA, are industrially polymerized, pre-colored or clear dental milling blanks designed for milled fabrication of bite splints (clear variant) or denture bases (gingiva-colored variants) on dental CAD/CAM systems.
The provided text is a 510(k) Summary for a medical device (DD medical polymers (PMMA)). This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria and performance data in the format of a clinical or analytical study.
Therefore, the requested information cannot be fully extracted because the document is a regulatory submission for substantial equivalence based on in vitro testing and comparison to existing standards, not a standalone clinical or performance study with detailed acceptance criteria and expert reviews in the typical sense of a diagnostic device.
However, I can extract the relevant information regarding the tests performed to demonstrate substantial equivalence and what serves as the "acceptance criteria" in this context (meeting relevant standards).
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present acceptance criteria and device performance in a direct "acceptance criteria vs. reported performance" table format. Instead, it indicates that the device's physical properties "meet the requirements of the relevant standards ISO 20795-1 and ISO 20795-2 as well as the values of the Predicate Device / Reference Device." The table on pages 8-9 provides a comparison of physical characteristics between the new device, primary predicate device, and reference device. The "acceptance criteria" here are implicitly defined by the requirements of the standards and the performance of the predicate/reference devices.
Interpretation based on the provided table (pages 8-9) and text:
| Feature | Acceptance Criteria (based on standards/predicate) | Reported Device Performance (New Device) | Comment/Justification |
|---|---|---|---|
| Flexural strength | ≥ 75 MPa (Predicate) / 90 MPa (Reference) | ≥ 64 MPa | Comparable (meets standards ISO 20795-1 / ISO 20795-2, see discussion on page 11) |
| Flexural modulus | 2800 (± 200) MPa (Predicate) | ≤ 2030 MPa | Comparable (meets standards ISO 20795-1 / ISO 20795-2, see discussion on page 11) |
| Water absorption | ≤ 23 µg/mm³ (Predicate) / 2200 J/m² (DD base P HI) | See discussion (raw material is same, values comply with relevant standards and FDA Guidance, no increased risk) | |
| Biocompatibility | No cytotoxicity (EN ISO 10993-1, EN ISO 10993-5 standards) | Classified as eminently suitable | Tested by an accredited testing laboratory, results show no cytotoxical potential. |
| Application time | ≤ 12 months (DD Bio Splint P HI) / Not restricted (Reference for DD base P HI) | 12 months (DD Bio Splint P HI) / 10 years (DD base P HI) | Comparable (10 years is less risky than "not restricted" and supported by accelerated aging test, see discussion). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact sample sizes used for each physical test. It only states that "Non-clinical testing was performed in order to validate the product against the company's specified design requirements."
- Data Provenance: The company, Dental Direkt GmbH, is located in Spenge, Germany. The testing was performed by "an accredited testing laboratory." The specifics of whether the data were retrospective or prospective are not mentioned, but in vitro physical and biocompatibility testing is typically prospective for new device submissions.
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 is not applicable. The tests performed are non-clinical (physical and biocompatibility) against established international standards (ISO 20795-1, ISO 20795-2, EN ISO 10993-1, EN ISO 10993-5). Ground truth is established by these standards' methodologies and acceptance criteria, not by expert consensus in clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable, as the document refers to non-clinical physical and biocompatibility testing not requiring adjudication involving expert readers.
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 is not applicable. The device is a dental material (PMMA milling blanks) and not an AI-powered diagnostic device or an imaging product requiring human reader interpretation. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable, as the device is a dental material and not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests is based on:
- Established international standards (ISO 20795-1, ISO 20795-2, EN ISO 10993-1, EN ISO 10993-5).
- The performance values of legally marketed predicate and reference devices.
- The company's specified design requirements validated by testing.
8. The sample size for the training set
This is not applicable, as this is a physical medical device (materials) and does not involve AI or algorithms that require a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this type of device.
§ 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.