(10 days)
3 i dental implants are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment.
The 3i TG OSSEOTITE® Wide Implants are trans-gingival implants designed with an internal morse-taper. The wider dimension of the seating surface provides a realistic size proportion of a natural tooth of the posterior area.
The provided document is a 510(k) summary for a medical device, the 3i TG OSSEOTITE® Wide Implants. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets them. It explicitly states under "Performance": "Performance standards have not been established by the FDA under Section 514 of the Federal Food, Drug and Cosmetic Act."
The purpose of a 510(k) is to show that a new device is "substantially equivalent" to an already legally marketed device – meaning it has the same intended use and the same technological characteristics, or if it has different technological characteristics, that these do not raise new questions of safety and effectiveness. It does not typically involve the presentation of acceptance criteria or a dedicated study to prove performance against those criteria in the same way a PMA (Pre-Market Approval) or a clinical trial for a novel device would.
Based on the document, here's what can be extracted, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not available. The document states "Performance standards have not been established by the FDA under Section 514 of the Federal Food, Drug and Cosmetic Act." The submission is based on substantial equivalence to predicate devices, not on meeting specific performance criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not available. No clinical study or test set data is presented to demonstrate performance against acceptance criteria. The submission relies on demonstrating substantial equivalence to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. No test set or ground truth establishment based on expert consensus for performance evaluation is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring adjudication in the context of performance evaluation is described.
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 an endosseous dental implant, not an AI-powered diagnostic tool, so an MRMC study is not relevant to its regulatory submission type.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
- Not applicable. This device is an endosseous dental implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The submission relies on substantial equivalence, not on establishing ground truth for performance evaluation.
8. The sample size for the training set
- Not applicable. No machine learning algorithm or training set is involved in the submission for this type of device.
9. How the ground truth for the training set was established
- Not applicable. No machine learning algorithm or training set is involved.
Summary of the Document's Content:
The document is a 510(k) premarket notification for the "3i TG OSSEOTITE® Wide Implants." Its primary conclusion is that the device is substantially equivalent to legally marketed predicate devices (TG OSSEOTITE® Dental Implants K972444 and OSSEOTITE® IOL Implants K031632). It describes the device as trans-gingival implants designed with an internal morse-taper and a wider seating surface, intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment. The technological characteristics are stated to be similar to the currently available TG OSSEOTITE® Implants. The FDA's letter confirms this substantial equivalence determination, allowing the device to be marketed.
§ 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.