(104 days)
The Implant-One™ system is indicated for surgical placement in partially or completely edentulous upper or lower jaws to provide a means for prosthetic attachment to restore a patient's chewing function. The Implant-One™ system is indicated for immediate loading only when primary stability is achieved and with the appropriate occlusal loading.
The Implant-One™ Dental Implants include endosseous dental implants, cover screws, healing caps, dental implant abutments and abutment screws in a variety of sizes to accommodate differing patient anatomy. Endosseous implants are self-tapping, root-form and threaded. They range from 3.25mm to 5.5mm in diameter with lengths ranging from 8mm to 14mm and have an internal, threaded abutment connection having a Morse style taper. Cover screws and healing caps provide protection to the threads of the abutment connection during endosseous and gingival healing. Cover screws are pre-packaged with each implant. Healing caps are provided as an alternative to the cover screw and are packaged separately. Abutment options include Standard and Restorative in various heights. These are fastened to the implant using an abutment screw.
The provided text describes the 510(k) summary for Custom Dental Implants Inc.'s Implant-One™ Dental Implants. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing rather than through clinical studies involving human patients or complex AI algorithms. Therefore, many of the requested elements for describing a study proving device acceptance (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific ground truth types for AI models) are not applicable to this submission.
The acceptance criteria are implicitly defined by the demonstration of equivalent performance to predicate devices through mechanical testing.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The acceptance criteria for this device are not explicitly stated as quantitative thresholds in the document. Instead, the acceptance is based on demonstrating that the "worst case Implant-One™ system construct performed as well as or better than the predicate devices" in non-clinical dynamic testing according to ISO 14801.
| Acceptance Criteria (Implicit) | Reported Device Performance (Non-Clinical Dynamic Testing according to ISO 14801) |
|---|---|
| Mechanical performance for worst-case construct is equivalent to or better than predicate devices. | The Implant-One™ system performed as well as or better than the predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for non-clinical testing, however it refers to "worst case Implant-One™ system construct" which usually implies a limited number of samples designed to represent the most challenging scenario.
- Data Provenance: Not applicable as it's a non-clinical mechanical test. The test was performed by Custom Dental Implants Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as no human experts were involved in establishing ground truth for mechanical testing. The "ground truth" here is the objective measurement of mechanical properties.
4. Adjudication method for the test set
- Not applicable as no adjudication was needed for objective mechanical testing.
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 is a medical device (dental implant) 510(k) submission, not an AI/software as a medical device (SaMD) submission, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (dental implant) 510(k) submission, not an AI/SaMD submission.
7. The type of ground truth used
- Ground Truth Type: Objective mechanical measurements (e.g., fatigue life, fracture strength) as defined by the ISO 14801 standard for dynamic testing of endosseous dental implants. This is a physical, measurable "ground truth" for the device's performance under simulated physiological loading conditions.
8. The sample size for the training set
- Not applicable. There was no training set as no machine learning or AI algorithm was developed or evaluated.
9. How the ground truth for the training set was established
- Not applicable. There was no training set.
§ 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.