(90 days)
Correct Plus 1 is a vinyl polysiloxane impression material which is to be used for taking impression of inlays, crowns & bridges, orthodontic appliances, precision attachments and veneers.
Correct Plus 1 impression material (Fast Set) are versatile impression materials designed to accommodate impressions of inlays, crowns and bridges, orthodontic appliances, precision attachments and veneers. The hydrophilic nature of these materials provides outstanding detail in the presence of fluids and exceptional tear strength ensures your detailed impression will remain intact upon removal. Correct Plus 1 impression material provides multiple packaging options and various set times to accommodate all of your impression needs. For optimal patient acceptance, Correct Plus 1 impression material is available in unflavored and Berry.
Here's a breakdown of the acceptance criteria and the study information for the "Correct Plus 1" device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list "acceptance criteria" for each performance characteristic with numerical targets. Instead, the study aims to demonstrate substantial equivalence to a predicate device ("Correct Plus" K001218) by comparing performance characteristics. Therefore, the "acceptance criteria" can be inferred as "performance comparable to the predicate device."
| Performance Characteristic | Acceptance Criteria (inferred) | Reported Device Performance (Correct Plus 1) | Predicate Device Performance (Correct Plus) |
|---|---|---|---|
| Material Properties | |||
| Work Time | Comparable to predicate device | Tested and compared | Baseline for comparison |
| Oral Set Time | Comparable to predicate device | Tested and compared | Baseline for comparison |
| Catalyst Viscosity | Comparable to predicate device | Tested and compared | Baseline for comparison |
| Base Viscosity | Comparable to predicate device | Tested and compared | Baseline for comparison |
| Out Gassing | Comparable to predicate device | Tested and compared | Baseline for comparison |
| Hardness | Comparable to predicate device | Tested and compared | Baseline for comparison |
| Mixed Consistency | Comparable to predicate device | Tested and compared | Baseline for comparison |
| Dimensional Change | Comparable to predicate device | Tested and compared | Baseline for comparison |
| Detail Reproduction | Comparable to predicate device | Tested and compared | Baseline for comparison |
| Compatibility with Gypsum | Comparable to predicate device | Tested and compared | Baseline for comparison |
| Elastic Recovery | Comparable to predicate device | Tested and compared | Baseline for comparison |
| Strain in Compression | Comparable to predicate device | Tested and compared | Baseline for comparison |
| Tensile Strength | Comparable to predicate device | Tested and compared | Baseline for comparison |
| Tensile Elongation | Comparable to predicate device | Tested and compared | Baseline for comparison |
| Tear Strength | Comparable to predicate device | Tested and compared | Baseline for comparison |
| Contact Angle | Comparable to predicate device | Tested and compared | Baseline for comparison |
| Biocompatibility | |||
| Cytotoxicity | Safe for intended use (ISO L929 MEM) | Passed | Implied safe (marketed predicate) |
| Sensitization | Safe for intended use (ISO Kligman Max) | Passed | Implied safe (marketed predicate) |
| Irritation | Safe for intended use (ISO Oral Irrit.) | Passed | Implied safe (marketed predicate) |
2. Sample Size Used for the Test Set and the Data Provenance
The document only states that "bench testing" was conducted to evaluate performance characteristics without specifying the sample size for each test. The data provenance is not explicitly stated as foreign or domestic, but it is retrospective in the sense that the new device's performance is being compared to an already marketed predicate device, and the testing was conducted to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This study focuses on physical and chemical properties of a dental impression material, not diagnostic accuracy or expert interpretation of medical images. The "ground truth" for these tests would be established by validated measurement techniques and adherence to ISO standards, not expert consensus in a clinical context.
4. Adjudication Method for the Test Set
Not applicable. As described above, this study is not evaluating expert-dependent outcomes.
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
Not applicable. This device is an impression material, not an AI-powered diagnostic tool. No MRMC studies were conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or an AI device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for most of the performance characteristics (e.g., Work Time, Hardness, Tear Strength, Dimensional Change, etc.) would be objective measurements obtained through standardized laboratory testing following established protocols (often ISO standards or similar industry-accepted methods). For biocompatibility, the ground truth is established by passing the specified ISO tests (L929 MEM Elution Test, Kligman Maximization Test, Oral Irritation Test), indicating the absence of adverse biological effects according to the test criteria.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this type of device.
Summary of the Study Proving Device Meets Acceptance Criteria:
The study proving the device meets acceptance criteria is a non-clinical performance study focusing on physical, chemical, and biological properties.
- Study Type: Bench testing and biocompatibility testing.
- Objective: To demonstrate substantial equivalence of Correct Plus 1 to the predicate device, Correct Plus (K001218).
- Methods:
- Biocompatibility: Correct Plus 1 was subjected to ISO L929 MEM Elution Test (cytotoxicity), ISO Kligman Maximization Test (sensitization), and ISO Oral Irritation Test. The device "passed" these tests, demonstrating it is safe for its intended use.
- Bench Testing (Physical/Chemical Properties): Correct Plus 1 was tested for various performance characteristics including Work Time, Oral Set Time, Catalyst Viscosity, Base Viscosity, Out Gassing, Hardness, Mixed Consistency, Dimensional Change, Detail Reproduction, Compatibility with Gypsum, Elastic Recovery, Strain in Compression, Tensile Strength, Tensile Elongation, Tear Strength, and Contact Angle. The results of these tests were compared "as compare to the predicate device, Correct Plus."
- Results & Conclusion: Based on the successful biocompatibility tests and the comparison of bench testing data showing similar performance characteristics to the predicate device, the manufacturer concluded that the "clinical performance of Correct Plus 1 is substantially equivalent to the predicate device."
- Clinical Testing: No clinical testing was conducted on this 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).