(107 days)
The Accu-Dent XD impression materials are recommended for used to create highly detailed impressions of the hard and soft tissues of the oral cavity includin the following list of indications:
- Complete and partial denture impressions ●
- Opposing models for fixed and removable prosthesis ●
- o Study Model
- Temporary crown & Bridge impressions
- Whitening Trays ●
- Mouth Guards ●
- Orthodontic Impressions o
Accu-Dent XD is a two-part Alginate impression system 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 impressions models for study and for production of restorative prosthetic devices, such as full and partial dentures.
This document describes the premarket notification (510(k)) for the Accu-Dent® XD impression material. It is a Class II medical device used to create detailed impressions of the oral cavity. The submission aims to demonstrate substantial equivalence to predicate devices, Tropicalgin (K043131) and Neocolloid (K981091) by Zhermack sPA.
Below is a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details physical properties for the Accu-Dent® XD and its predicate devices, aligning them with relevant ISO standards.
| Characteristic | Predicate Device (Tropicalgin) | Predicate Device (Neocolloid) | Acceptance Criteria (Standard) | Accu-Dent® XD (Tray) | Accu-Dent® XD (Syringe) | Accu-Dent® XD Performance (Tray) | Accu-Dent® XD Performance (Syringe) |
|---|---|---|---|---|---|---|---|
| Mixing Time | 45" | 45" | - | 45" | 45" | Meets | Meets |
| Working Time | 1'35" | 2'00" | - | 1'15" | 2'00" | Comparable | Comparable |
| Setting Time | 2'35" | 3'30" | - | 2'30" | 3'30" | Comparable | Comparable |
| Time in Mouth | 1'00" | 1'30" | - | 30" | 45" | Shorter | Shorter |
| Ratio Powder/Water | 18gm/36ml | 18gm/36ml | - | 24gm/44ml | 9gm/21ml | Different | Different |
| Compressive Strength | 1.362 N/mm (ISO 1563:1990) | 1.336 N/mm (ISO 1563:1990) | ISO 21563:2013 (no direct AC) | .943 N/mm | N/A | Result provided | Not applicable (Syringe material) |
| Tear Strength | 0.647 N/mm (ISO 21563:2013) | 0.597 N/mm (ISO 21563:2013) | ISO 21563:2013: 0.38 N/mm(min) | 0.778 N/mm | 0.504 N/mm | Meets (above min) | Meets (above min) |
| Strain in Compression | 11.5% (ISO 1563:1990: 5.0-20.0%) | 10.3% (ISO 1563:1990: 5.0-20.0%) | ISO 21563:2013: 5.0% - 20.0% | 10.0% | 14.62% | Meets | Meets |
| Recovery from Deformation | 99% (ISO 1563:1990: Min. 95.0%) | 99% (ISO 1563:1990: Min. 95.0%) | ISO 21563:2013: Min 95.0% | 95.56% | 97.63% | Meets (within criteria) | Meets (within criteria) |
| Gypsum Compatibility | complies (ISO 1563:1990: 50 um) | complies (ISO 1563:1990: 50 um) | ISO 21563:2013: Line reprod 50 µm | Complies | Complies | Meets | Meets |
Note: The discussion section notes that the "primary change from the predicate is the powder/water ratio for the mixed alginate. This change impacts the physical properties, but not in a significant manner. The most notable change is the difference in the Recovery from deformation results. Although lower, the result remains within the acceptance criteria of the ISO 21563 and ISO 1563 of minimum 95%." The conclusion states that "The above data and analysis demonstrates that Accu-Dent XD is substantially equivalent to the predicate device."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes for each physical property test. However, it indicates these tests were conducted to demonstrate compliance with ISO standards (ISO 21563:2013 and ISO 1563:1990) and FDA Guidance.
The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective, but it is implied to be laboratory testing conducted to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The ground truth for these types of dental impression materials is typically established through adherence to standardized laboratory test methods and compliance with ISO standards, not through expert consensus in the clinical sense.
4. Adjudication Method for the Test Set
Adjudication methods like 2+1 or 3+1 are typically relevant for studies involving human interpretation or clinical endpoints. This document focuses on the physical and technological characteristics of a material tested against laboratory standards. Therefore, an adjudication method is not applicable in this context.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document does not mention any MRMC comparative effectiveness study. The comparison is based on physical properties tested against ISO standards and existing predicate devices.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is an impression material, not a software algorithm or an AI-based system. Its performance is evaluated through material science and physical property testing.
7. The Type of Ground Truth Used
The ground truth used for evaluating the Accu-Dent® XD is based on standardized laboratory testing and compliance with recognized international standards (ISO 21563:2013 and ISO 1563:1990) for dental impression materials. These standards define the acceptable range for various physical properties such as tear strength, strain in compression, recovery from deformation, and gypsum compatibility.
8. The Sample Size for the Training Set
Not applicable. This device is a material, not an AI or algorithm that requires a "training set" in the machine learning sense. The development of the material would involve various formulations and iterative testing, but this is not referred to as a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device. The development process for the Accu-Dent® XD impression material would involve R&D and quality control testing, ensuring the material meets desired performance characteristics, but not by establishing ground truth for a training set.
§ 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).