(84 days)
The implant system is intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, freestanding bridges and to retain over dentures by means of o-ring abutments or bar-attachments
Almitech is an Endosteal Root-form (Cylindrical) Implant. The implant system consists of multiple components that are precision-machined and are manufactured from grade-4 pure titanium or a medical grade titanium alloy.
Implants: Almitech implant (See attachment 5, 6, 7) is intended for cither single-stage or two-stage surgical placement. Implant consist of fine pitch threads with 60° profiles, spherical tips and have two cutting grooves that give the implant its self-tapping feature. The outside surface is sandblasted with calcium phosphate abrasive to create surface roughness about Ra= 70μIN. (See Blasted surface information Attachment 1, 2, 3, 4). The inside of the implant consists of 8° Morse taper with three cutouts to drive it in place and provide positioning to abutment and threaded hole to deliver abutment in to place.
Cover screw / healing caps: The cover screws and healing caps (See attachment 8, 9) are manufactured from grade 4 titanium and are placed in the implant using a Hex Tool. Using the 1.25mmD Hex Tool, by carrying the cover screw/healing cap to the surgical site thread it into the implant. Suture the soft tissue over the implant or around the cover screw (healing cap) or transmucosal neck. The cover screw/ healing cap keeps free from ingrowth of bone and soft tissue as well accumulating debris by occluding the internal surface of the implant. The parts are found freely floating inside a sterile individual Tyvek pouches.
Abutment systems and superstructures: The abutment (See attachment 10, 11) selection process occurs at the start of the prosthetic procedure and is dependent on the measurement of gingival thickness. After adequate osseo-integration the implants should be uncovered if necessary and the cover screw should be removed. The internal part of the implant irrigated. freed from debris and dried. The appropriate abutment should be placed, by using an inserting driver (1.25mmD Hex Tool) and a torque wrench applying 30 Ncm of torque. Once the abutment is fit on the implant, it delivers maximum stability with the use of the torque wrench.
Solid Abutments do not have to be modified but can be, and if it is necessary to modify the abutments, carbide or a diamond bur can be used with copious irrigation.
Abutments are not to be over-prepared, taking into consideration retention of restoration and strength of the abutment. It is not recommended to modify the abutment at the junction with implant.
Surgical Instruments: The range of instruments made available as part of the Almitech Inc. Dental Implant System include: drills, adapters, implant inserts, screw drivers, torque ranges, ratchets and metal cassettes for sterilization.
The provided text (K052733) describes a 510(k) submission for the "Almitech Inc. Dental Implant System." This submission aims to demonstrate substantial equivalence to previously cleared predicate devices, rather than establishing specific acceptance criteria and proving performance through a new clinical study.
Therefore, many of the requested sections about acceptance criteria, study details, expert involvement, and ground truth establishment are not applicable.
Here's an analysis based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
This section is not applicable in the context of this 510(k) summary. The submission primarily focuses on demonstrating substantial equivalence to predicate devices, meaning it argues that the new device is as safe and effective as existing legally marketed devices, rather than establishing and meeting novel performance acceptance criteria through a dedicated study.
The comparison in the 510(k) is based on device features and intended use, not quantitative performance metrics against pre-defined acceptance criteria. The "performance characteristics" mentioned are in the context of similarity to predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable. No specific test set or clinical study data (in terms of patient samples) is referenced for the Almitech Inc. Dental Implant System to prove its performance against specific criteria. The submission relies on comparative analysis with predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable. Ground truth establishment by experts for a test set is relevant for analytical or clinical performance studies, which are not detailed in this 510(k) summary.
4. Adjudication Method for the Test Set
This is not applicable for the same reasons as points 2 and 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This is not applicable. This is a dental implant system, not an AI-powered diagnostic device involving human readers or interpretation of medical images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. This describes a physical dental implant system, not a software algorithm.
7. The Type of Ground Truth Used
This is not applicable. No specific ground truth (like pathology or outcomes data) was used to prove the Almitech system's performance in a standalone study within this 510(k) framework. The "ground truth" for substantial equivalence is the established safety and effectiveness of the predicate devices.
8. The Sample Size for the Training Set
This is not applicable. A training set is relevant for machine learning algorithms. This document describes a physical medical device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as point 8.
Summary of the 510(k) Submission's Approach:
The K052733 submission for the Almitech Inc. Dental Implant System demonstrates "substantial equivalence" to predicate devices by:
- Comparing specifications: The document provides a detailed table (Section 2.5) comparing features like material, one-stage capability, coating, dimensions, external screw threads, anti-rotational features, sterilization method, types of abutments, instruments, and intended use.
- Stating similar technological characteristics: The submission claims, "All other technological characteristics are similar, and all four devices show equivalent performance characteristics." This is a qualitative claim based on the design and intended use being similar to already-cleared devices, rather than presenting new quantitative performance data.
- Not raising new questions of safety or effectiveness: The conclusion (Section 2.6) states that "The evaluation of Almitech Inc. Dental Implant System does not raise any new questions of safety or effectiveness and may therefore be considered substantially equivalent to the predicate devices."
In essence, this 510(k) relies on the established safety and effectiveness of the predicate devices (ITI Solid screw implant, Blue Sky Bio Dental Implant System, and Paragon Screw-Vent System) to assert that the Almitech system, being sufficiently similar, is also safe and effective. It does not present new, independent performance studies with associated acceptance criteria.
§ 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.