(53 days)
Xantropren Comfort is a silicone based condensation curing impression material used for all inlay, crown and bridge, edentulous and partial impressions. The Xantropren Comfort Activator is the catalyst. This product is packaged in a cartridge delivery system which will dispense equal amounts of base and activator.
Xantopren Comfort is a is silicone based condensation curing impression material used for all inlay, crown and bridge, edentulous and partial impressions. The advantage of Xantopren Comfort Light and Xantopren Comfort Medium is that the product is available in a cartridge delivery system that ensures that the correct amount of base and catalyst is used each time. With the cartridge delivery system a homogenous mix is obtained each time the material is expressed through the mixing tip. The user cannot manipulate the properties of the product because of the delivery system.
The provided text describes a 510(k) summary for the medical device Xantopren Comfort Base and Activator. It focuses on demonstrating substantial equivalence to a predicate device, CutterSil Light [K760756]. The study described is a clinical handling characteristics evaluation and a comparison of physical properties.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" as clear pass/fail thresholds for each property. Instead, it presents a comparison of the Xantopren Comfort's properties against the predicate device, CutterSil Light. The underlying acceptance criterion for substantial equivalence is that the new device's properties are similar to or within the range of the predicate device for relevant characteristics.
| PROPERTIES | Acceptance Criteria (Predicate: CutterSil Light) | Reported Device Performance (Xantopren Comfort Light) | Reported Device Performance (Xantopren Comfort Medium) |
|---|---|---|---|
| Mixing Time (s) | 30 (Light), 45 (Medium) | - (Not reported for Xantopren Comfort) | - (Not reported for Xantopren Comfort) |
| Working Time (min) | 2:00 (Light), 2:00 (Medium) | 2:00 | 2:30 |
| Setting Time (min) | 4:00 (Light), 4:00 (Medium) | 3:00 | 3:30 |
| Shore A Hardness | - (Not reported for CutterSil Light/Medium) | 36 | 38 |
| Max. Deformation Under Pressure (%) | 2-10 (Light and Medium) | 8.0 | 7.5 |
| Recovery From Deformation (%) | 97.5 (Light and Medium) | >98 | >98 |
| Linear Dimensional Change (%) | -1.0 - 0 (Light and Medium) | 1.0 | 1.0 |
Note on "Acceptance Criteria" interpretation: For the "Mixing Time", "Shore A Hardness", and "Linear Dimensional Change" for some predicate devices, explicit values are missing or presented differently, making direct "acceptance criteria" from the predicate challenging to define precisely from this text alone. The overall assessment is one of "similarity."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size:
- For the clinical handling characteristics evaluation (dispensing, viscosity, working time, setting time, color differentiation, quality of impression, ease of disinfection): "A minimum of 20 impressions were taken." This refers to clinical use.
- For the physical property comparison, the sample size for individual tests (e.g., Shore A Hardness, Max. Deformation, Recovery, Dimensional Change) is not specified.
- Data Provenance: Not specified in the document. It does not mention country of origin or if it was retrospective or prospective. It is implied to be prospective data collection given the nature of a 510(k) submission for a new device.
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)
- The document implies evaluation by dentists or dental professionals during the clinical handling characteristics evaluation, stating "The injection tips on the cartridge delivery system can be angled to suit the needs to the dentist." However, the number of experts and their specific qualifications are not explicitly stated.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- None described. The text does not detail any formal adjudication method for the clinical observations or property measurements. The findings presented are reported as observations ("flowed well," "determined to be adequate," "received an excellent rating").
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices or AI algorithms where human interpretation is involved. The device in this submission is an impression material, and the evaluation focuses on its physical and handling properties.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This submission is for an impression material, not an algorithm. The "standalone" evaluation refers to the physical and handling characteristics of the material itself. The physical properties listed in the tables (e.g., Shore A Hardness, Recovery from Deformation) represent standalone performance of the material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For physical properties: The ground truth is established by standard laboratory testing methods for dental impression materials (e.g., ISO standards for measuring working time, setting time, hardness, deformation, dimensional change).
- For clinical handling characteristics: The ground truth is based on practical observations and qualitative assessments by dental professionals ("good," "adequate," "excellent rating"). This could be considered a form of expert consensus on handling characteristics.
8. The sample size for the training set
- Not applicable. This device is an impression material, not a machine learning model, so there is no training set in the AI sense.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, this question is not relevant to this submission.
§ 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).