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510(k) Data Aggregation
(344 days)
Accusil Dental Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.
Accusil Dental Impression Materials are designed for dental applications to define and reproduce the structure of a patient's teeth and gums for producing crowns, bridges, occlusal models and dental implant restorative devices. Base and catalyst components are mixed in an equal ratio 1:1, placed into an impression tray and inserted into the patient's mouth. The material will conform to the patient's dentition and when set will produce a reproduction of the patient's teeth and occlusion.
The document describes the acceptance criteria and performance of Accusil Dental Impression Materials as part of a 510(k) premarket notification for FDA clearance.
Here's an analysis of the provided information, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document indicates that Accusil Dental Impression Materials were tested against specific ISO standards (ISO 4823 and ISO 48-4) and internal protocols. The "Acceptance Criteria" are implicitly derived from the requirements of these standards. The "Reported Device Performance" for Accusil is provided in the comparative table with predicate and reference devices.
| Performance Characteristic | Accusil Dental Impression Materials (Reported Performance) | Acceptance Criteria (Implicit from ISO standards and comparison with predicate/references) |
|---|---|---|
| Working/Processing Time | 40-150 sec | Similar to predicate (90 sec) and reference devices (35-120 sec). |
| Setting time/Time in the mouth | 60-300 sec | Similar to predicate (90 sec) and reference devices (120-330 sec). |
| Hardness | 63-70 Shore A | Similar to predicate (46-70 Shore A) and reference devices (42-75 Shore A). |
| Working Humidity | 50% | Matches predicate (50%). |
| Dimensional Accuracy | 99.9%-99.2% | Similar to predicate (99.9%-99.2%) and reference devices (98%-99.9%). |
| Stability (Linear Dimensional Change) | <0.8% typical | Similar to predicate (<0.2% typical) and reference devices (<0.1% to <0.50% typical). |
| Consistency | Type 0-type 3 ISO 4823 | Matches predicate (Type 0-type 3 ISO 4823) and similar to reference (Type 1-type 3 ISO 4823). |
| Compatibility with Gypsum | All tests results met the criteria in standards. | Criteria specified in ISO 4823 for impression materials. |
| Elastic Recovery | All tests results met the criteria in standards. | Criteria specified in ISO 4823 for impression materials. |
| Strain in Compression | All tests results met the criteria in standards. | Criteria specified in ISO 4823 for impression materials. |
| Shelf Life | 3 years | Established through relevant protocols, meeting specified criteria. |
| Biocompatibility | No biocompatibility testing was done. | Assumed to meet criteria due to similar ingredients and contact type as predicate/references, introducing no new risks. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in the provided text. The document mentions "Accusil light, heavy, monophase and putty were tested" and "Accusil bite registration was tested," implying samples of these product lines were used. However, the exact number of units or measurements for each test is not provided.
- Data Provenance: The testing was performed by Prevest Denpro Limited, based in India ("Export Promotion Industrial Park Bari Brahmana, Jammu 181133 India"). The nature of the testing (physical property measurements against international standards) suggests these were prospective tests conducted on manufactured samples, rather than retrospective data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable to this type of device and study. The "ground truth" for dental impression materials is established by objective physical and chemical measurements against internationally recognized standards (ISO 4823, ISO 48-4), not by expert consensus or interpretations.
4. Adjudication Method for the Test Set:
This information is not applicable. Since the evaluation involves objective physical property measurements against standardized criteria, there is no need for an adjudication method in the context of expert review. The results are quantitative and compared directly to standard specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is relevant for diagnostic imaging AI devices, not for physical property testing of dental impression materials.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone AI algorithm performance study was not done. This is not an AI-driven device. The testing focused on the physical and chemical properties of the material itself.
7. The Type of Ground Truth Used:
The "ground truth" used for this device is based on objective standards and measurements of physical and chemical properties. Specifically, performance was evaluated against the requirements outlined in:
- ISO 4823 (Dentistry - Elastomeric impression materials)
- ISO 48-4 (Rubber, vulcanized or thermoplastic - Determination of hardness - Part 4: Indentation hardness by means of a durometer)
- Internal protocols for setting time (as ISO 4823 does not specify setting time).
8. The Sample Size for the Training Set:
This information is not applicable. As this is not an AI/machine learning device, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
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