(406 days)
The I Macro Implant system is intended for implantation in the mandibular molar region where bone exists and the surgeon has determined that placement of a narrower diameter implant would increase the chance of failure due to poor primary stability, or increased surgical procedures leading to complications. This I Macro implant provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or complete arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with proper occlusal loading, to restore the chewing function.
The I Macro implants are self-tapping; commercially pure; Titanium Alloy threaded screws, with light grit blasting or roughened surface treatment. These materials and procedures are exactly the same as cleared in the OCO Biomedical submission K090174. The I Macro Implant is available in a 6.0, 7.0, 8.0 & 9.0mm diameter and is available in 8, 10, and 12mm lengths.
The provided text describes a medical device submission (K110337) for the "I Macro Implant System," a dental implant. The submission primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through comparisons of materials, design, processing, packaging, sterilization methods, and indications for use.
Based on the provided information, the device is a dental implant, and the "study" mentioned refers to various testing standards used to demonstrate the device's properties. These are not clinical studies in the typical sense of evaluating AI performance or diagnostic accuracy. Instead, they are engineering and biological evaluations.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| Fatigue Testing (ISO 14801:2007) | Testing conducted according to ISO 14801. (No specific numerical results provided) |
| Biocompatibility Testing (ISO 10993-5, ISO 10993-1) | Testing conducted according to ISO 10993-5 and ISO 10993-1. |
| Surface Analysis (SEM) | SEM analysis of the implant surface after RBM blasting and acid etching performed. (No specific results provided) |
| Risk Management (ISO 14971:2007) | Claims compliance with ISO 14971:2007. |
| Biological Evaluation (ISO 10993-1, -5, -10, -11, ISO 7405) | Claims compliance with these ISO standards. |
| Packaging (ISO 11607-1, ISO 11607-2, EN 868-5, ASTM F 1980) | Claims compliance with these standards. |
| Sterilization (ISO 11137-1, ISO 11137-2, ISO 11137-3, ISO 17665-1) | Claims compliance with these standards. |
| Labeling (ISO 1041, ISO 980, ISO 15223) | Claims compliance with these standards. |
| Clinical Investigation (ISO 14155-1:2003) | Claims compliance with ISO 14155-1:2003. |
Note: The document states that the fundamental scientific technology, including materials, processing, packaging, and sterilization methods, is "identical or very similar to referenced predicate devices." The acceptance criteria are largely met by demonstrating compliance with established international standards for medical device manufacturing and testing, rather than explicit numerical performance targets from a clinical trial.
2. Sample Size Used for the Test Set and the Data Provenance
This information is not applicable and not provided in the document. The document describes engineering and biological testing of the device itself (fatigue, biocompatibility, surface analysis), not a "test set" of patient data for evaluating an AI algorithm's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable and not provided. This document does not describe the evaluation of an AI algorithm requiring a ground truth established by experts.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. This document does not describe an AI evaluation requiring an adjudication method.
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
There is no mention of an MRMC comparative effectiveness study, or any AI component, in this document.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
There is no mention of a standalone algorithm performance study or any AI component in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable and not provided. The "ground truth" in this context would likely refer to the physical and chemical properties of the implant meeting the specifications outlined in the standards (e.g., fatigue strength exceeding a certain threshold, materials matching composition specifications).
8. The sample size for the training set
This information is not applicable and not provided. This document describes a medical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided. This document describes a medical device, not an AI algorithm.
§ 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.