(100 days)
Ultra SEP is a self etching primer intended to be used for the preparation of an enamel surface prior to bonding with a light cure orthodontic adhesive.
Ultra SEP is a self etching primer which can etch up to 6 teeth with a single drop. The material is dispensed from a bottle into a light impervious mixing well, and transferred to teeth by a saturated microbrush. Ultra SEP creates an ideal surface for a light cure paste to adhere teeth and brackets for orthodontic treatment.
Ultra SEP is used in combination with a light impervious mixing well (SEPW) and microbrushes (MB).
The provided text describes Reliance Orthodontic Products' Ultra SEP device and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the study information:
Acceptance Criteria and Reported Device Performance
The provided document describes non-clinical data and does not explicitly list numerical acceptance criteria with corresponding performance metrics like a typical clinical accuracy study. Instead, the "acceptance criterion" for the device appears to be demonstrating equivalence to the predicate device in terms of effectiveness and safety, and being found non-toxic.
The relevant section states: "Shear bond strength testing comparisons conducted between the Reliance Orthodontics Ultra SEP, the predicate device 3M Unitek Transbond™ Plus Self Etching Primer, and the reference Reliance Orthodontics S.E.P. demonstrate that the applicant device is equivalent to the legally marketed device in terms of effectiveness." and "Additionally, toxicity testing was conducted using an Oral Toxicity Test method and was found to be non toxic."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent effectiveness to predicate device (3M Unitek Transbond™ Plus Self Etching Primer) via shear bond strength. | Ultra SEP demonstrated equivalent shear bond strength to the predicate and reference devices. |
| Non-toxic via Oral Toxicity Test. | Ultra SEP was found to be non-toxic. |
| Biocompatibility according to ISO 7405 and ISO 10993-5. | Biocompatibility was demonstrated via ISO 7405 and ISO 10993-5 evaluations. |
Study Information
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Sample size used for the test set and the data provenance:
The document mentions "shear bond strength testing comparisons" and "toxicity testing," but does not specify the sample sizes for these tests or the data provenance (e.g., country of origin, retrospective/prospective). -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to the type of preclinical testing described (shear bond strength, toxicity, biocompatibility). These are laboratory tests evaluating material properties, not diagnostic or clinical performance requiring expert ground truth. -
Adjudication method for the test set:
This is not applicable as the tests are objective laboratory measurements, not subjective evaluations requiring adjudication. -
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:
No, an MRMC comparative effectiveness study was not done. This device is a self-etching primer, not an AI-powered diagnostic tool. The study focuses on material properties. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, this is not applicable. The device is a material, not an algorithm. The "standalone" performance here relates to its physical and chemical properties in laboratory settings. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For shear bond strength, the "ground truth" would be the measured bond strength values obtained through standardized laboratory testing methods, typically compared against industry standards or predicate device performance. For toxicity, the ground truth is the absence of toxic effects as determined by the specified oral toxicity test and biocompatibility standards. -
The sample size for the training set:
This concept is not applicable as this is a physical product (primer) undergoing non-clinical testing, not a machine learning algorithm that requires a training set. -
How the ground truth for the training set was established:
This concept is not applicable as there is no training set mentioned or required for this type of device and evaluation.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.