(151 days)
The ANKYLOS® C/X Dental Implant System is for single-stage or two-stage surgical procedures and cemented or screw retained restorations. The ANKYLOS® C/X Dental Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted with a bar.
The new ANK YLOS® C/X Dental Implant System introduces a new configuration of the current ANKYLOS® plus dental implant line. The new line extension includes the: ANKYLOS® C/X Implant, ANK YLOS C/ Regular Abutments, ANKYLOS /X Regular Abutments, ANKYLOS® Regular C/X Gingiva Former, and the ANK YLOS® Titanium Alloy Screws (Membrane Screw and Fixation Screw). The ANKYLOS® C/X Dental Implant was modified to integrate an indexation into the taper connection to provide a precise position of the abutment. With the new index, the relocation of the abutment is possible without using a transfer-kev for the impressions taking.
The provided text describes a 510(k) summary for the ANKYLOS® C/X Dental Implant System, focusing on its substantial equivalence to predicate devices. However, the document does not contain the detailed study information typically associated with acceptance criteria, sample sizes, ground truth establishment, or expert evaluations as requested in the prompt.
The document states:
- "The results regarding the fatigue tests of the ANKYLOS® C/X Implant and the predicate devices were comparable. Therefore, it concluded that the ANKYLOS® C/X Implant performs as intended."
This is the only mention of performance data. It refers to a "fatigue test" and a "comparable" result. This does not provide specific acceptance criteria, numerical performance metrics, or details about the study design beyond stating "fatigue tests."
Therefore, I cannot populate the table or answer most of the requested questions based on the provided text.
Here's a breakdown of what can and cannot be answered from the provided text:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "comparable" to predicate devices in "fatigue tests" (specific metrics not provided) |
2. Sample size used for the test set and data provenance:
- Cannot be determined from the provided text. The text only mentions "fatigue tests" without any details on the number of devices tested or the origin of the data.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Cannot be determined from the provided text. This type of information is not present. The evaluation focuses on non-clinical performance (fatigue tests), not expert interpretation.
4. Adjudication method for the test set:
- Cannot be determined from the provided text. This is not relevant for the type of non-clinical testing described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
- No. An MRMC study was not done. The document describes a non-clinical performance evaluation (fatigue tests) of a dental implant system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This question is typically relevant for AI/software devices. The device is a physical dental implant system, so "standalone" performance in this context would refer to its physical function, which was assessed via "fatigue tests."
7. The type of ground truth used:
- For the "fatigue tests," the "ground truth" would be the engineering standards for fatigue life or fracture resistance of dental implants. However, the specific standards or methods for establishing this "ground truth" are not detailed beyond the mention of "fatigue tests."
8. The sample size for the training set:
- N/A. This question is typically relevant for AI/machine learning models. The device is a physical dental implant system and would not have a "training set" in this context.
9. How the ground truth for the training set was established:
- N/A. (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.