(88 days)
The bonding base is indicated for use with a standard ITI implant placed in the posterior oral cavity, to serve as a base for orthodontic attachment during orthodontic treatment.
The orthodontic bonding base is screwed onto the ITI Octa system. The bonding base has an interior icositetrahedron (24 facets) which allows a positioning in the desired angulation (15° steps). The bonding surfaces are eccentric to the implant axis such that four different distances are available between implant axis and bonding surface. An orthodontic bracket is cemented to the orthodontic bonding base and it acts as an anchor for the application of orthodontic forces during treatment. After orthodontic use, the bonding base is removed and a standard prosthetic restoration placed on the implant.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Bonding Base Orthodontic Bonding Base:
Based on the provided 510(k) summary, formal acceptance criteria and a structured study demonstrating performance against those criteria are not explicitly detailed in a way that would be typical for a modern medical device submission. This document pre-dates many of the more rigorous requirements for clinical evidence and performance studies that are common today.
The "study" presented here is a demonstration of substantial equivalence to predicate devices, which is the primary pathway for 510(k) clearance. The acceptance criteria are implicitly met by showing that the device is similar in intended use, materials, and design to devices already on the market, and therefore, it is considered as safe and effective as those legally marketed devices.
Here's a breakdown of the requested information based on the provided text, with points that cannot be determined clearly marked:
Acceptance Criteria and Device Performance
The acceptance criteria are implicitly defined by the characteristics of the predicate devices. The "reported device performance" is a comparison to these predicates rather than an independent measure against objective benchmarks.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Intended Use: Serve as a base for orthodontic attachment. | The device's intended use is identical: "Serve as a base for orthodontic attachment." (Matches 3M Unitek Orthodontic Bands). |
| Materials: Biocompatible and suitable for dental use. | The device uses Titanium. (Compared to Stainless Steel for 3M bands, and Titanium/gold alloy for other ITI copings. Titanium is a well-established biocompatible material for dental implants and components). |
| Design: Mechanically sound, allows proper fit and function with ITI Octa system and orthodontic brackets. | Heights: 5.5 mm and 6.5 mm. |
| Width: 6.8 mm. | |
| Internal icositetrahedron (24 facets): For seating on Octabutment. | |
| Axial screw channel: For attachment to abutment. | |
| These design features are comparable in principle to the designs of the predicate ITI copings (e.g., internal icositetrahedron, screw channels) and fulfill the basic mechanical requirements implied by the functional description. (Matches features for attachment to implant system). |
Study Details for Substantial Equivalence
The "study" here is the comparison table for substantial equivalence, not a typical performance study with patients or controlled laboratory tests against predefined success/failure criteria.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of a comparative substantial equivalence study based on design and materials. No test set of patient data or device performance data is described for this comparison.
- Data Provenance: Not applicable. The comparison is against the specifications and known characteristics of legally marketed predicate devices, not empirical data from a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the sense of expert consensus on patient outcomes or interpretations, was not established for this type of submission. The "ground truth" for the comparison is the publicly available information and regulatory clearance status of the predicate devices.
4. Adjudication method for the test set:
- Not applicable. There was no test set requiring multi-expert adjudication.
5. 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:
- Not applicable. This device is not an AI/imaging device, and no MRMC study was performed or required for this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. Not an algorithm or AI device.
7. The type of ground truth used:
- The "ground truth" used for this submission is the regulatory status and descriptive characteristics of legally marketed predicate devices. The argument is that because the new device is sufficiently similar to these cleared devices, it can be considered safe and effective.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device, so there is no training set in that context. The device design and materials were likely developed through engineering design processes, possibly including bench testing, but these are not described as a "training set."
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.