(15 days)
The Pre-Cemented Orthodontic Bracket System Extension is indicated for use in bonding orthodontic appliances for orthodontic treatment.
The Pre-Cemented Orthodontic Bracket System Extension is comprised of pre-cemented ceramic and metal orthodontic brackets, transfer tray, and the adhesives described in K061252. Components of this system are used exactly as described in K061252 (Pre-cemented Orthodontic Bracket System) with the same fundamental technology and for the same intended use. This modification adds a second ceramic orthodontic bracket to the Pre-cemented Orthodontic Bracket System (K060837).
This 510(k) submission (K081291) describes a modification to an existing device, adding a second ceramic orthodontic bracket to an already cleared Pre-Cemented Orthodontic Bracket System (K061252), which itself includes components from K060837. This submission does not contain information about a study based on acceptance criteria in the traditional sense of a clinical performance study with defined endpoints like sensitivity, specificity, or inter-reader agreement.
The device, a Pre-Cemented Orthodontic Bracket System Extension, is a dental device intended for use in bonding orthodontic appliances. The core of this submission focuses on demonstrating that the new component maintains the same safety and effectiveness characteristics as the predicate devices.
Here's an breakdown of the information available in relation to your questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Evaluated and passed biocompatibility testing for devices classified as surface-contacting devices with permanent contact. No additional testing required as there are no changes in formulation from predicate devices (K060837 and K061252). |
| Equivalence to Predicate Devices (Safety and Effectiveness) | Components of the Pre-Cemented Orthodontic Bracket System Extension have been used in legally marketed devices and/or were found safe for dental use. The prior use of components, previous biocompatibility data, and "performance date" (likely meant "performance data") support safety and effectiveness. The device maintains the same fundamental technology and intended use as the predicate device K061252. |
| Compliance with Regulatory Requirements | The device is deemed substantially equivalent to legally marketed predicate devices, allowing it to be marketed under general controls provisions of the Act. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. There is no explicit "test set" in the context of a clinical performance study to evaluate diagnostic performance or similar metrics. The evaluation relies on established safety and performance data from predicate devices and component materials rather than a new clinical trial.
- Data Provenance: Not applicable. The submission refers to "previous biocompatibility data" and "performance date (data)" from the predicate devices (K060837 and K061252) and the prior use of components in legally marketed devices. This would be considered retrospective in the sense of leveraging existing data, but it's not a prospective study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. There is no "test set" in the context of a clinical performance study requiring expert ground truth establishment.
4. Adjudication Method for the Test Set
- Not applicable. There is no "test set" requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This device is not an AI-based diagnostic tool, but rather a physical orthodontic bracket system. Therefore, the concept of human readers improving with or without AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This is not an AI algorithm.
7. The Type of Ground Truth Used
- The ground truth, in an indirect sense, is established by regulatory clearance and historical safety/effectiveness of the predicate devices and the individual components used. The biocompatibility data also serves as a ground truth for a specific safety aspect. It's not based on expert consensus for diagnostic accuracy, pathology, or outcomes data from a new study.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI-based device that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. No training set for an AI algorithm is involved.
Summary of the Study (or Lack Thereof) to Prove Acceptance Criteria:
The "study" in this context is a benchmarking and equivalency assessment against predicate devices and known material safety. The manufacturer did not conduct a new clinical study to establish acceptance criteria for performance; instead, they demonstrated that:
- The device components are already used in legally marketed devices.
- The device's materials have established biocompatibility, and since the formulation hasn't changed, no new biocompatibility testing was deemed necessary.
- The device maintains the same fundamental technology and intended use as its predicate.
The FDA's review concluded that the device is "substantially equivalent" to the predicate devices, thereby meeting the necessary regulatory acceptance for marketing. This type of submission relies heavily on a comparison to existing, cleared devices rather than new performance data generation for defined acceptance criteria.
§ 872.3750 Bracket adhesive resin and tooth conditioner.
(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.