Search Results
Found 1 results
510(k) Data Aggregation
(80 days)
A two bottle, self-etching primer for use with light-curing and self-curing direct bonding orthodontic adhesives.
A two bottle, self-etching primer for use with light-curing and self-curing direct bonding orthodontic adhesives.
Here's an analysis of the provided text regarding the acceptance criteria and study for the "First Step BRACKET ADHESIVE RESIN AND TOOTH CONDITIONER" device:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state acceptance criteria in the form of a numerical threshold (e.g., "shear bond strength must be >= X MPa"). Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device. The performance criterion used is shear bond strength.
| Acceptance Criteria (Implicit from Substantial Equivalence Determination) | Reported Device Performance (First Step) | Predicate Device Performance (Transbond™ Plus) |
|---|---|---|
| Shear bond strength is equivalent to or better than the legally marketed predicate device. | Shear bond strength results were reviewed and found to be equivalent to the predicate device. | Demonstrated "Outstanding bond strengths" (as stated in descriptive text) and used as the benchmark for equivalence. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document states that "Shear bond strength testing results were reviewed," but it does not specify the sample size used for this testing.
- Data Provenance: The document does not provide information on the country of origin of the data or whether it was retrospective or prospective. It implies the testing was conducted for the purpose of this submission (prospective), but no explicit details are given.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable (N/A) in this context. The "First Step" device is an adhesive resin and tooth conditioner, not an AI/imaging device where expert ground truth is typically established through image interpretation or clinical diagnosis. The performance evaluation relies on objective mechanical testing (shear bond strength).
4. Adjudication Method for the Test Set:
This information is not applicable (N/A) for the same reason as point 3. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies among multiple human readers in diagnostic studies.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No. This type of study is specifically designed for evaluating diagnostic devices, particularly those involving human readers and interpretations (e.g., radiology). The "First Step" device is a material, and its performance is assessed through laboratory-based mechanical testing, not human reader interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
No. This concept applies to AI algorithms and diagnostic devices. The "First Step" device is a dental material, and its performance is evaluated in a laboratory setting.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance evaluation is established through objective laboratory measurements of shear bond strength. There is no "expert consensus," "pathology," or "outcomes data" in the typical sense of diagnostic studies. The "truth" is the measured mechanical property.
8. The Sample Size for the Training Set:
Not applicable (N/A). The "First Step" device is a chemical composition for an adhesive, not a machine learning model or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable (N/A). As mentioned above, there is no training set for this type of device.
Ask a specific question about this device
Page 1 of 1