(43 days)
FREEALGIN is a conventional two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient`s teeth and gums.
FREEALGIN is a conventional two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material
Here's an analysis of the provided text regarding acceptance criteria and a study for the Zhermack SpA Freealgin device:
Important Note: The provided document is a 510(k) clearance letter from the FDA for a dental impression material. It does not contain details about a study proving device performance against acceptance criteria in the way one would describe for, say, an AI/ML medical device. Instead, it states that the device is "substantially equivalent" to a legally marketed predicate device. This implies that its performance is expected to be similar to that predicate device and that it meets the general requirements for its classification (Class II).
Therefore, I will interpret your request in the context of what can be inferred or is typically expected for a device like this, rather than a direct presentation of study results as you might find for a software algorithm. The document primarily focuses on regulatory approval based on substantial equivalence.
Analysis of Acceptance Criteria and Study (Based on 510(k) context)
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for a dental impression material, the "acceptance criteria" are likely to be related to physical and mechanical properties that demonstrate its suitability for its intended use and similarity to predicate devices. The document does not explicitly state a table of acceptance criteria or performance results from a specific study.
However, based on the nature of a dental impression material, typical performance metrics and their implied "acceptance" would be:
| Performance Characteristic (Implied from Dental Impression Material) | Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Not explicitly stated in document, but implied by 510(k) clearance) |
|---|---|---|
| Material Properties: | ||
| - Setting Time | Within clinically acceptable range; comparable to predicate | Within clinically acceptable range for polyvinylsiloxane (VPS) impression materials. |
| - Working Time | Within clinically acceptable range; comparable to predicate | Sufficient for proper placement and manipulation. |
| - Elastic Recovery | High (e.g., >95%); comparable to predicate | High elastic recovery to ensure accurate impression detail after removal. |
| - Shore A Hardness/Resilience | Appropriate for impression material; comparable to predicate | Sufficiently rigid to prevent distortion, yet flexible enough for removal. |
| - Tear Strength | High enough to prevent tearing during removal | Sufficiently high to allow for intact removal of impression from the mouth. |
| - Dimensional Stability (Accuracy) | High (low linear change); comparable to predicate | Accurately reproduces oral structures over time without significant distortion for model pouring. |
| - Hydrophilicity/Wettability | Adequate for detail reproduction in moist environments | Sufficient to capture fine details in the presence of saliva. |
| - Color/Contrast | Adequate for visual inspection and detail differentiation | Visible contrast for clinical use; free from significant color instability. |
| Biocompatibility: | ||
| - Cytotoxicity | Non-toxic | Presumed non-toxic based on material composition and established safety of similar materials. |
| - Sensitization | Non-sensitizing | Presumed non-sensitizing. |
| - Irritation | Non-irritating | Presumed non-irritating. |
| Ease of Use: | ||
| - Mixability | Easy to mix homogeneous paste | Easy to achieve a homogeneous mixture of base and catalyst. |
| - Flow/Viscosity | Appropriate for application method | Viscosity suitable for tray application and capturing fine details without voids. |
| Shelf Life/Stability: | Maintain properties over labelled shelf life | Stable over the specified shelf life, retaining all critical material properties. |
Note: The FDA's substantial equivalence finding indicates that Freealgin is as safe and effective as a predicate device. This implies that any studies conducted by the manufacturer, while not detailed in this public document, would have demonstrated that Freealgin meets the expected performance characteristics of a conventional VPS dental impression material to a degree comparable to existing, legally marketed devices.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) clearance letter. For a dental impression material, testing would typically involve laboratory physical and mechanical property evaluations (e.g., measuring setting time, tear strength, dimensional stability, elastic recovery) and potentially ex-vivo or in-vitro models. The provenance of such data would be internal lab testing, likely conducted in an industrial setting, possibly at the manufacturer's R&D facilities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable or provided in the context of this 510(k) clearance. "Ground truth" established by experts is typically for diagnostic devices or AI/ML algorithms where expert interpretation is key. For a dental impression material, "ground truth" would relate to objective physical and mechanical measurements, rather than expert consensus on interpretation.
4. Adjudication Method for the Test Set
This is not applicable or provided. Adjudication methods like 2+1 or 3+1 are used for expert consensus in diagnostic studies, which is not the nature of the evaluation for a dental impression material.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or mentioned. MRMC studies are generally performed for diagnostic imaging devices or software where human readers interpret medical images. This device is a physical dental impression material.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, this is not applicable. This device is a physical material, not an algorithm. Therefore, "standalone algorithm performance" is not a relevant concept here.
7. The Type of Ground Truth Used
For a dental impression material, the "ground truth" would be established by:
- Objective Laboratory Measurements: Using standardized test methods (e.g., ISO standards for dental impression materials) to measure properties like setting time, tear strength, dimensional accuracy, elastic recovery, Shore A hardness, etc.
- Biocompatibility Testing: In vitro assays for cytotoxicity, sensitization, and irritation.
8. The Sample Size for the Training Set
This information is not provided and is generally not applicable in the typical sense of AI/ML "training sets" for a physical medical device like an impression material. If "training set" refers to internal R&D iterations or optimization of the material formulation, that data would be proprietary and not included in a 510(k) clearance letter.
9. How the Ground Truth for the Training Set Was Established
Again, in the context of a physical impression material, a "training set" with an associated "ground truth" doesn't fit the AI/ML paradigm. If interpreted as internal development and validation, the ground truth would be established through:
- Iterative Material Characterization: Scientists and engineers would formulate, test, and refine the material, comparing its physical and mechanical properties against desired specifications and existing predicate materials using the objective laboratory measurements described in point 7. This iterative process allows them to "train" their formulation to meet performance targets.
- Quality Control Standards: Establishing and adhering to strict quality control standards during manufacturing to ensure consistency of the product.
§ 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).