(52 days)
3i dental implants are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function.
The provided 510(k) summary for the OSSEOTITE® Dental Implants does not describe an AI/ML powered device, therefore, many of the requested details about acceptance criteria, study methods, and ground truth are not applicable. This document is a summary for a traditional medical device (dental implants) and focuses on substantial equivalence to predicate devices rather than performance metrics typically associated with AI.
However, I can extract the relevant information presented in the document pertaining to the closest equivalent of "acceptance criteria" and the study that supports it.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Study Type |
|---|---|---|
| No significant difference in long-term cumulative survival of OSSEOTITE® implants in smokers and non-smokers (compared to previous labeling which might have included smoking as a warning/precaution). | A meta-analysis of clinical data indicated no significant difference in the long-term cumulative survival of OSSEOTITE® in smokers and non-smokers. | Meta-analysis of clinical data |
| Long-term survival of OSSEOTITE® implants in smokers to be greater than that of 3i machined implants in smokers. | A second analysis demonstrated that the long-term survival of OSSEOTITE® implants in smokers is greater than that of 3i machined implants in smokers. | Meta-analysis/Clinical data analysis |
| Substantial equivalence of OSSEOTITE® implants with revised Instructions for Use labeling to predicate OSSEOTITE® implants. | The presented data supports the conclusion that the OSSEOTITE® implants with revised Instructions for Use labeling are substantially equivalent to the predicate OSSEOTITE® implants. | Comparison to predicate devices |
Detailed Study Information (where applicable and extractable)
-
Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated. The document refers to a "meta-analysis of clinical data" and "a second analysis" but does not provide the number of patients or implants included in these analyses.
- Data provenance: Not explicitly stated. It is inferred that the data is clinical, but the country of origin, whether retrospective or prospective, is not mentioned.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. The "ground truth" here is implied to be clinical outcomes (implant survival), which would be derived from patient data, not expert consensus on an image or diagnostic output.
-
Adjudication method for the test set:
- Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used for expert review of images or diagnostic assessments. This study relies on clinical outcomes data.
-
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 is not an AI/ML device, and no MRMC study was performed or is relevant to this submission.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI/ML device.
-
The type of ground truth used:
- Clinical outcomes data (specifically, long-term cumulative survival of dental implants).
-
The sample size for the training set:
- Not applicable/Not provided. Dental implants do not typically have "training sets" in the context of AI/ML. The "meta-analysis of clinical data" would represent the overall dataset analyzed for the study.
-
How the ground truth for the training set was established:
- Not applicable. The "ground truth" (clinical survival) would have been established through follow-up observations of patients who received the implants in clinical studies. The details of how this was measured (e.g., specific criteria for survival, follow-up period) are not provided in this summary.
§ 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.