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510(k) Data Aggregation
(82 days)
K950514 GC/3M Tri-Cure Glass Ionomer Orthodontic Band Cement, Unitek™Multi-Cure Glass Ionomer Band Cement
Opal® Band™ Cement uses chemical, light polymerization and glass ionomer to cement all types of orthodontic bands to the teeth.
Opal® Band™ Cement is a triple cure, band cement which is light blue, two-part, resin based, fluoride releasing, glass ionomer orthodontic cement.
Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in precise numerical terms for all tests, nor does it provide the exact performance values for the predicate device to allow for a direct comparison table as requested. Instead, it describes objectives for the Opal® Band™ Cement in relation to the predicate device (e.g., "higher number than our competitors is good," "as close to our predicate as possible," "similar number to our predicate").
However, I can extract the general goals that implicitly serve as acceptance criteria and note the reported performance in relation to these goals:
| Test Name | Acceptance Criteria (Stated Goal) | Reported Device Performance (Opal® Band™ Cement) |
|---|---|---|
| Flexural Strength | Higher than competitors/predicate. | Shows more "give" (elasticity) due to less glass ionomer compared to stiffer predicate. |
| Hardness | ± 6.0 HK of predicate (with water), ±14.0 HK (without water) | This shows the elastic properties of our cement (implicitly met, as it's stated as "acceptable"). |
| Setting Time | As close to predicate as possible. | No specific performance value provided, but likely considered to be "as close as possible" for substantial equivalence. |
| Ambient Light Sensitivity | Higher times (for working and curing). | No specific performance value provided, but aiming for higher times. |
| Sorption | Low readings. | Shows hydrophilic properties, indicative of base materials (implicitly met the low reading expectation relative to its material type). |
| Film Thickness | (Implied: adequate bond strength at defined thickness) | Tested for bond strength, no specific goal/value provided. |
| Radiopacity | Clear visibility during X-ray. | No specific performance value provided, but tested for verifying clarity. |
| Solubility | Pass in this section (not degrade in solutions/saliva). | No specific result provided, but expected to "pass." |
| Working Time | (Implied: adequate time to work with product) | No specific performance value provided, but tested. |
| Compressive Strength | Higher number. | Tested, no specific performance value provided, but goal is higher. |
| Compressive Modulus | Similar number to predicate. | No specific performance value provided, but aiming for similarity. |
| Metal Shear | Similar number to predicate. | Tested, no specific performance value provided, but aiming for similarity. |
| Dimension Change | (Implied: acceptable water absorption) | Tested, two sets of measurements recorded to validate numbers. |
| Fluoride Release | (Implied: measurable fluoride release) | Tested over 28 days and for fluoride burst on the first day. |
| Fluoride Burst | (Implied: measurable initial fluoride release) | Tested on the first day. |
| Biocompatibility | Meet ISO 10993-1:2009 standards. | Tested for Cytotoxicity, Sensitization, Irritation, and Genotoxicity according to ISO 10993-1:2009, with an abstract and signed reports included. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the sample sizes used for each of the bench tests. It mentions that "bench tests were conducted during the R & D phase on Opal® Band™ Cement and compared to K950514 GC/3M Tri-Cure Glass Ionomer Orthodontic Band Cement."
- Data Provenance: The bench testing was conducted "in-house" (Opal Orthodontics by Ultradent Products, Inc.) and involved "side-by-side comparisons to predicate devices." It is not specified if the data is retrospective or prospective, but bench tests are typically conducted prospectively in a lab setting. There is no mention of country of origin of the data beyond the company's location in South Jordan, UT, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish "ground truth" for the bench tests. The tests are laboratory-based and rely on instrumental measurements and standardized protocols rather than expert interpretation of results.
4. Adjudication Method for the Test Set
Not applicable. As described in point 3, the "bench tests" performed are objective measurements. There is no mention of any human interpretation or adjudication process for the test results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes only "bench tests" and a "literature study" to show safety and effectiveness. There is no mention of human readers or AI assistance in the context of this device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone (algorithm only) performance study was not done. This device is a cement for orthodontic bands; it does not involve any algorithms or AI for diagnostic or interpretive purposes.
7. The Type of Ground Truth Used
For the bench tests, the "ground truth" can be understood as the quantifiable and objective measurements obtained through standardized laboratory procedures (e.g., measurements of flexural strength, hardness, setting time, etc.). For the biocompatibility tests, the ground truth was adherence to the ISO 10993-1:2009 standards, which are specific scientific criteria.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product (orthodontic cement) and does not involve AI or machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device.
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