(13 days)
The Identium® Impression Materials are intended to: be placed on an impression tray (or injected directly into the mouth, depending on the technique and device) and used to reproduce the structure of a patient's teeth and gums; provide models for study and for production of restorative prosthetic devices.
Identium Heavy is to be used as a heavy-bodied impression material in one-step technique (double mix) for: Impressions for crowns/bridges, inlays/onlays and veneer preparations. Functional impressions. Impressions for full or partial dentures. Implant impressions.
Identium Medium is to be used as a medium-bodied tray or syringeable impression material in one-step technique (monophase or double mix) for: Impressions for crowns/bridges, inlays/onlays and veneer preparations. Implant impressions. Fixation impressions. Functional impressions.
Identium Medium soft is to be used as a medium-bodied tray or syringeable impression material in one-step technique (monophase or double mix) for: Impressions for crowns/bridges, inlays/onlays and veneer preparations Functional impressions Reline impressions
Identium Light is to be used as a light-bodied, syringeable impression material in one-step technique (double mix) for: Impressions for crowns/ bridges, inlays/ onlays and veneer preparations. Reline impressions. Impressions for full or partial dentures.
Identium® Impression Materials are addition-curing, elastomeric materials. Identium® Impression Materials have excellent flow and hydrophilic properties, high tear strength, dimensional accuracy, and resistance to permanent deformation. The Identium® Impression Materials family consists of three different viscosities (heavy-bodied, medium-bodied, light-bodied). They are available in two delivery systems, for use in most automatic dispensing and mixing systems: standard 1:1 (50 ml automix cartridges) and 5:1 (362 ml foil bags). The Identium® Impression Materials are available in regular-set and fastset versions.
Here's an analysis of the provided 510(k) summary for Identium® Impression Materials, outlining the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Properties (Implicit, based on ISO 4823) | |
| Excellent flow properties | Demonstrated |
| Hydrophilic properties | Demonstrated |
| High tear strength | Demonstrated |
| Dimensional accuracy | Demonstrated |
| Resistance to permanent deformation | Demonstrated |
| Intended Use Equivalence (relative to predicate devices) | Suitable for use as dental impression materials, designed and manufactured to perform in a manner substantially equivalent to predicate devices. |
| Safety and Effectiveness | Demonstrated by evaluation against applicable criteria and performance testing. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective). It simply states that "Identium® Impression Materials have been evaluated in accordance with the applicable criteria established in Guidance for Industry and FDA Staff: Dental Impression Materials – Premarket Notification (Doc#2203, 8/17/1998) and ISO 4823 (Dentistry – Elastomeric impression materials):2000/Cor 1:2004/Amd 1:2007."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth. The evaluation appears to be based on adherence to ISO standards and FDA guidance for material performance, rather than clinical expert assessment of impressions.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. The evaluation seems to be primarily laboratory-based testing against established material standards.
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 section is not applicable. The device is an impression material, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is an impression material, not an algorithm. Performance testing would be material-specific, not algorithm-specific.
7. The Type of Ground Truth Used
The ground truth for the performance evaluation appears to be based on objective measurements and criteria defined in recognized international standards (ISO 4823) and FDA guidance documents for dental impression materials. This typically involves laboratory testing for physical and mechanical properties.
8. The Sample Size for the Training Set
The document does not specify a training set size. This type of submission (510(k) for a physical material) does not typically involve a "training set" in the context of machine learning or AI. Performance is evaluated against established material specifications.
9. How the Ground Truth for the Training Set was Established
This section is not applicable. As mentioned above, there isn't a "training set" in the context of this device. The evaluation is based on meeting the defined physical and chemical properties outlined in the relevant standards and guidance.
§ 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).