(30 days)
Impressions for inlay, onlay, crown, and bridge restorations
Functional impressions
Fixation impressions
Implant impressions
PECD-01 and PECD Quick-01 are polyether tray impression materials of medium-bodied consistency. They are designed to be used in 3M ESPE's mixing, dosing and dispensing device, Garant™.
The provided text is a 510(k) summary for a dental impression material (PECD-01 and PECD Quick-01). As such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results in the manner typically found for a diagnostic device.
Therefore, many of the requested details about acceptance criteria, study methodologies, and performance metrics (especially those related to clinical accuracy, human reader performance, or ground truth derivation from pathology/outcomes data) are not present in this document. The safety and effectiveness are primarily established through biocompatibility testing and by demonstrating that the new device has the same fundamental scientific technology and intended use as the predicates, and that performance data are comparable.
Here's a breakdown of the information that can be extracted or inferred based on the provided text, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present specific numerical acceptance criteria or detailed performance metrics. The primary "acceptance criteria" presented is substantial equivalence to the predicate devices based on chemistry, performance data, and indications for use.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) | Notes from provided text |
|---|---|---|---|
| Safety | Biocompatibility | "The results show that PECD-01 and PECD Quick-01 are safe devices." | This is a qualitative statement of safety based on biocompatibility testing. No specific numerical thresholds are provided. |
| Effectiveness/Performance | Comparable to predicate devices (Impregum™ Penta™ M Monosoft, Poly Q Penta M, Ramitec Penta) | "The comparison for chemistry, performance data and indications for use shows that PECD-01 and PECD Quick-01 are substantially equivalent to the predicate devices." | The core claim is substantial equivalence. The document states "performance data" was compared but does not specify what this data was (e.g., tear strength, dimensional stability, working time, etc.) nor does it provide quantitative results or acceptance thresholds for these. |
| Chemical Composition | Modified but fundamental character unchanged from predicate (Impregum™ Penta™ M Monosoft) | "The modification is in chemical composition but, however, the fundamental character of the chemistry of Impregum Penta M Monosoft was not changed." | This emphasizes that despite chemical modification, the core nature remains the same, contributing to the claim of substantial equivalence. |
| Intended Use | Same as predicate devices | "PECD-01 and PECD Quick-01 have the same fundamental scientific technology and the same intended use as Impregum Penta M Monosoft." | The device is intended for "Impressions for inlay, onlay, crown, and bridge restorations, Functional impressions, Fixation impressions, Implant impressions." This matches the predicate's intended use. |
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 for Test Set: Not specified. The document refers to "biocompatibility testing" and "performance data" without detailing the number of samples or tests conducted.
- Data Provenance: Not explicitly stated. The submitting company is 3M ESPE AG, based in Germany. It is reasonable to infer the testing was likely conducted in Germany or a location affiliated with the manufacturer, but this is not explicitly mentioned. No information on retrospective or prospective studies.
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)
- Not applicable / Not specified. This type of study (e.g., involving expert consensus for ground truth) is typically associated with diagnostic devices, not material science evaluations of dental impression materials for 510(k) submission where "substantial equivalence" is the primary goal.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not specified. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which are not detailed for this material science submission.
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 is not a diagnostic device or an AI-assisted tool. Therefore, an MRMC comparative effectiveness study is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For biocompatibility testing, the "ground truth" would be established by standardized toxicological and biological tests according to relevant ISO standards (e.g., ISO 10993 series), comparing results against established safety limits or predicate device performance. For "performance data" (e.g., physical properties), the ground truth would be established by standard test methods (e.g., ISO 4823 for dental elastomeric impression materials) measuring specific properties and comparing them to predicate devices or industry standards. The document does not specify these standards or the exact "ground truth" used beyond stating "biocompatibility testing" and "performance data" were conducted.
8. The sample size for the training set
- Not applicable / Not specified. This is not a machine learning or AI device that requires training data.
9. How the ground truth for the training set was established
- Not applicable / Not specified. This is not a machine learning or AI device.
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).