(104 days)
31 dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
In addition, when a minimum of 4 implants, ≥ 10 mm in length, arc placed in the maxilla and/or the mandible and splinted in the anterior region, immediate loading is indicated.
The 3i Nano CaP OSSEOTITE Dental Implants are provided with the proprietary OSSEOTITE acid-etched surface further treated with a deposition of nano-crystals of calcium phosphate. Implants are offered in both tapered and parallel-walled /straight designs, and each design provides offerings for either external hex or internal connections.
This is a 510(k) premarket notification for a modification to a dental implant, the 3i Nano CaP OSSEOTITE® Dental Implants. The provided document does not contain acceptance criteria for device performance in the form of specific quantitative metrics or a study demonstrating that the device meets such criteria.
Instead, the submission focuses on demonstrating substantial equivalence to legally marketed predicate devices based on:
- Similar Design Features and Functions: The device is stated to have similar design features and functions to existing OSSEOTITE, OSSEOTITE NT, OSSEOTITE Certain, OSSEOTITE Certain NT, Prevail Implants, and 3i Innovative Implants and Cover Screws. The specific enhancement, the deposition of nano-crystals of calcium phosphate, is compared to already available Hydroxylapatite (HA) Coated Endosseous Dental Implants.
- Performance Testing: The document briefly states that "Laboratory testing was conducted to determine device functionality and conformance to design input requirements, as well as FDA's Class II Special Controls Root-form Endosseous Dental Document: Guidance Implants and Endosseous Dental Abutments." It also mentions "Risk analysis was conducted in accordance with ISO 14971."
Therefore, many of the requested criteria cannot be extracted from this particular 510(k) summary. This type of 510(k) relies heavily on comparing the new device's characteristics and performance to existing, legally marketed devices, rather than establishing new, specific acceptance criteria for performance in a clinical study.
Here's a breakdown of what can and cannot be answered:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative acceptance criteria. The basis for equivalence is similarity to predicate devices and conformance to design requirements and Class II Special Controls guidance. | "Laboratory testing was conducted to determine device functionality and conformance to design input requirements" |
| "The proposed and currently marketed devices are identical in terms of size, biocompatible materials of construction, performance characteristics, and basic design." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document refers to "Laboratory testing" but does not specify sample sizes or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. This type of information is typically relevant for studies involving subjective assessment (e.g., image interpretation). For a dental implant, performance testing would likely involve mechanical, material, and biocompatibility testing, not expert interpretation of data in the way, for example, a diagnostic AI would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
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:
- No. This is not an AI/software device; it's a physical dental implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/software device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For the "Performance testing" mentioned, the ground truth would typically be established by engineering specifications, material standards, and biocompatibility testing protocols. This would involve objective measurements against predefined limits for mechanical strength, fatigue resistance, surface characteristics, and biological response, rather than expert consensus on a clinical outcome in this context.
8. The sample size for the training set:
- Not applicable/Not provided. There is no "training set" in the context of this device's regulatory submission.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. There is no "training set" in the context of this device's regulatory submission.
In summary: This 510(k) primarily demonstrates substantial equivalence through similarity to predicate devices and general statements about laboratory testing confirming functionality and conformance to design requirements and special controls guidance, rather than presenting specific quantitative acceptance criteria or detailed study results.
§ 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.