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510(k) Data Aggregation
(111 days)
This Device is intended for use as a light cure, orthodontic adhesive.
This device is a light-cure orthodontic adhesive intended for bonding brackets and appliances to a tooth surface. This device will bond to any enamel, porcelain, composite or metal tooth surface that has been properly conditioned. This device will be available in push syringe or tips for preferences in dispensing.
The provided text describes a 510(k) submission for the "Quantum LB" orthodontic adhesive. The study aims to demonstrate substantial equivalence to a predicate device, Transbond XT.
Here's an analysis of the acceptance criteria and the study presented:
Quantum LB Orthodontic Adhesive - Acceptance Criteria and Study Details
1. Acceptance Criteria and Reported Device Performance
The core acceptance criterion for the Quantum LB device, as per the provided summary, is similar performance to the predicate device (Transbond XT) in shear bond strength. No specific numerical thresholds are given for this similarity, but the summary states it was achieved.
| Property | Acceptance Criteria (Implied) | Reported Device Performance (Quantum LB) |
|---|---|---|
| In-vivo Shear Bond Strength | Similar to Transbond XT | "Testing resulted in similar performance between the two adhesives." |
| Biocompatibility (Local/Systemic Effects) | No adverse effects | "determined to not directly or through the release of material constituents produce adverse local or systemic effects." |
| Cytotoxicity (ISO 10993-5 Elution Method) | Grade < 2 (Mild reactivity) | "showed no evidence of causing cell lysis or toxicity and met the requirements of the test with a grade of less than grade 2 (Mild reactivity)." |
2. Sample Size Used for the Test Set and Data Provenance
The document states an "in-vivo performance test method for shear bond strength" was used. However, it does not explicitly state the sample size for this test. The data provenance is also not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable as the study appears to be a laboratory/performance test, not one relying on expert interpretation for ground truth. The "ground truth" here is the measured shear bond strength, which is an objective, quantitative metric.
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The study focuses on direct performance comparison of the device against a predicate, not on the improvement of human readers with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical orthodontic adhesive, not a diagnostic algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth used for the shear bond strength testing is the measured shear bond strength itself, which is an objective, quantitative outcome. For biocompatibility and cytotoxicity, the ground truth is established by the results of standardized biological assays (ISO 10993).
8. The Sample Size for the Training Set
This question is not applicable. The Quantum LB is a physical medical device, not a machine learning algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there is no training set for this type of device.
In summary, the provided document focuses on demonstrating the performance and safety of a new orthodontic adhesive by comparing it to an already legally marketed predicate device through physical and biological testing. It is a traditional medical device submission and does not involve AI or expert-based diagnostic performance studies.
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