(146 days)
The I-FIX System are intended to load immediately in partially or fully edentulous manidibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.
The I-FIX System is mini implant system, which serves temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants. The I-FIX System is comprised in diameter of 2.0 - 3.0mm and range from 10 - 16 mm and is made of CP Titanium grade 4. The surface treatment of I-Fix System is of R.B.M (Resorbable Blasting Media).
This is a 510(k) premarket notification for a dental implant system, not a device that uses AI or goes through an acceptance criteria study as understood in modern AI/ML medical devices. The document focuses on demonstrating substantial equivalence to a predicate device through material and mechanical performance testing, rather than clinical performance or AI algorithm validation.
Therefore, most of the requested information regarding acceptance criteria, AI performance, ground truth, and training/test sets is not applicable to this submission.
Here's a breakdown of what can be extracted and why other points are not applicable:
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A table of acceptance criteria and the reported device performance
Acceptance Criteria Reported Device Performance Mechanical strength equivalent to predicate devices, consistent with FDA guidance (Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004) "mechanical testing of the implants demonstrated that the I-Fix System possess mechanical strength at least equivalent to the predicate devices." -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The "test set" here refers to the device itself undergoing mechanical testing, not a dataset for an AI model.
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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, in the context of this submission, relates to establishing the substantial equivalence of material and mechanical properties, not clinical or diagnostic accuracy requiring expert consensus.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This refers to adjudication of labels or outcomes in a clinical study, which is not described here.
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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 traditional medical device submission, not an AI-powered device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This device does not involve an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the mechanical testing, the "ground truth" would be established by standardized mechanical testing methodologies and comparison data from the predicate device based on the FDA guidance document.
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The sample size for the training set
- Not applicable. There is no AI model requiring a training set.
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How the ground truth for the training set was established
- Not applicable. There is no AI model requiring a 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.