(238 days)
The Straumann® PURE Ceramic Implant (Monotype) is indicated for restoration in single tooth gaps and in an edentulous or partially edentulous jaw. The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components.
The Ø3.3 mm reduced diameter implants are recommended for central and lateral incisors only.
The Straumann® PURE Ceramic Implant Protective Cap is intended to protect the Straumann® PURE Ceramic Implant (Monotype) during the healing phase after implant placement for up to 6 months.
Temporary copings are intended to serve as a base for temporary crown or bridge restoration for the Straumann® PURE Ceramic Implant (Monotype) for up to 30 days.
The Straumann® PURE Ceramic Implant (Monotype) is made of 100% yttrium-stabilized zirconia. The endosteal region presents macro- and micro-roughness to support osseointegration (ZLA® surface). The implant has a 1.8 mm high machined neck. The implant features a monotype design where the ceramic abutment for final restoration is already built in. Straumann® PURE Ceramic Implant (Monotype) prosthetic components are identified with RD (Regular Diameter) corresponding to the neck diameter of 4.8 mm, and ND (Narrow Diameter) corresponding to the neck diameter of 3.5 mm.
The Protective Caps are manufactured from polyetheretherketone (PEEK Classix).
The temporary copings are manufactured from polymethylmethacrylate (PMMA).
This document is a 510(k) premarket notification from the FDA, approving the Straumann® PURE Ceramic Implants. It details the device, its intended use, and substantial equivalence to predicate devices, but it does not describe a study that validates the device against acceptance criteria in the way a clinical trial or performance study for an AI/diagnostic device would.
The "acceptance criteria" mentioned in the document refers to the success rate of the implant in a clinical study, which is a different type of acceptance criteria than what would be presented for an AI device.
Let's break down what information is available based on your request and what is not available for a device like this.
1. A table of acceptance criteria and the reported device performance
For an AI/diagnostic device, acceptance criteria would typically involve metrics like sensitivity, specificity, AUC, etc., compared against predefined thresholds. For this dental implant, the primary "acceptance criterion" mentioned is the clinical success rate.
| Acceptance Criteria (Clinical Success) | Reported Device Performance (Clinical Study) |
|---|---|
| Exceeded 85% survival rate in the protocol | 97.6% survival rate at two years (among 41 ITT patients with complete follow-up) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set (Clinical Study): 41 ITT (Intent-To-Treat) patients with complete follow-up through two years.
- Data Provenance: Not explicitly stated in terms of country of origin. The study appears to be a prospective clinical follow-up as it refers to patients' survival to at least two years.
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)
This section is not applicable to this type of device and study. For an implant, "ground truth" would be the patient's clinical outcome (survival, successful integration, etc.), not an expert's interpretation of an image or a condition.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods like 2+1 (two readers agree, third adjudicates disagreement) are used for diagnostic interpretations, not for direct clinical outcomes of an implant. The outcomes (survival) are directly observed.
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
This section is not applicable. This is not an AI or diagnostic device, so there is no concept of human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Outcomes data (specifically, implant survival/success at two years).
8. The sample size for the training set
This section is not applicable. This is not a machine learning or AI device that requires a training set. The clinical study investigated the implant's performance directly.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as 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.