(738 days)
An endosseous dental implant is indicated for surgical placement in the upper or lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on 4 interforaminal placed implants, and not indicated for single, unsplinted implants. Patient must be subject for dental treatment with endosseous implants
Ankylos dental implants consist of uncoated pure titanium (grade 2 per ISO 5832/II). The threaded area features a rough structure, the cervical margin is polished. The implants come packaged in a sterile double glass container for contact-free handling. The cover screw has already been mounted in the implant and is only removed prior to placing the abutment.
This document, K012681, is a 510(k) summary for a dental implant system. The purpose of a 510(k) is to demonstrate that a device is "substantially equivalent" to predicate devices already on the market. Therefore, the information provided focuses on this equivalence rather than a detailed study proving performance against defined acceptance criteria.
Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical trial or performance study for a novel device would. The document is a premarket notification to the FDA, stating the device's substantial equivalence to existing products. It does not contain details of a de novo study with acceptance criteria, sample sizes, or ground truth establishment.
Here's a breakdown of why the requested information cannot be fully provided from the given document, and what can be inferred:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated. For a 510(k) submission, the "acceptance criteria" for going to market is often demonstrating substantial equivalence to a predicate device. This is achieved by showing comparable technological characteristics and intended use, along with safety and effectiveness that are equivalent to the predicate.
- Reported Device Performance: Not explicitly reported in a quantitative manner against specific performance metrics. The document describes the device (uncoated pure titanium, rough threaded area, polished cervical margin, sterile packaging) and its intended use, implying its performance is similar to the identified predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable/not provided. This document is a 510(k) premarket notification, not a report of a new clinical or performance study where a test set would be used to evaluate novel performance. The FDA's substantial equivalence review is based on comparing the new device's characteristics and indications for use to legally marketed predicate devices.
- Data Provenance: Not applicable. The document refers to predicate devices (Straumann ITI Implant, Branemark System) but does not detail new data generation for the Ankylos system in the context of a "test set."
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. Ground truth for a test set is not mentioned because no new performance study with such a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or expert adjudication is described in this 510(k) summary.
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 a dental implant, not an AI-powered diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device (dental implant), not an algorithm or software. Standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No new "ground truth" was established in the context of demonstrating performance as described in a clinical study. The "truth" for a 510(k) centers around the established safety and effectiveness of the predicate devices and demonstrating that the new device is substantially equivalent.
8. The sample size for the training set
- Not applicable. This relates to machine learning models, which is not relevant for a dental implant 510(k) submission.
9. How the ground truth for the training set was established
- Not applicable. As above, this pertains to machine learning and not to this type of medical device submission.
Summary of what is provided:
- Device Name: Ankylos Implant System
- Intended Use: Surgical placement in upper/lower jaw arches to provide root-form means for prosthetic appliance attachment, restoring chewing function. Can be placed via 2-stage or single-stage (immediate loading, restricted to anterior mandible based on 4 interforaminal placed implants, not single unsplinted implants).
- Predicate Devices:
- Straumann ITI Implant (510k - 984104)
- Branemark System (510k - 992937)
- Device Description: Uncoated pure titanium (grade 2 per ISO 5832/II), threaded area with rough structure, polished cervical margin, sterile packaged.
- Substantial Equivalence: The FDA's letter (K012681) confirms that they reviewed the 510(k) and "determined the device is substantially equivalent...to legally marketed predicate devices." This is the "acceptance" in the context of a 510(k) for market clearance.
In essence, the document serves as evidence of the FDA's decision regarding market clearance based on substantial equivalence, not as a detailed report of a performance study with specific acceptance criteria and ground truth methodologies.
§ 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.