(255 days)
The I Macro 6.0mm X 6.0mm Implant system is intended for implantation in the maxillary or mandibular molar region where bone exists. This 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 6.0mm X 6.0mm implants are self-tapping: commercially pure, CP Titanium or 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 K 110337. The I Macro 6.0mm X 6.0mm Implant is available in a 6.0mm diameter and a 6.0mm length.
The provided document is a 510(k) summary for a dental implant (I Macro 6.0mm X 6.0mm) and focuses on establishing substantial equivalence to previously marketed devices. It does not contain information about acceptance criteria, device performance metrics, or details of a specific study to prove the device meets such criteria in the way typically expected for an AI/ML medical device.
The study referenced in the document is a non-clinical testing data used to demonstrate substantial equivalence to predicate devices, rather than proving a novel device meets specific performance acceptance criteria for diagnostic or clinical tasks.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results or effect size with AI assistance.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document describes a regulatory submission for a physical medical device (dental implant), not an AI/ML software device, and thus the type of information requested (e.g., test sets, ground truth, expert adjudication, AI performance metrics) is not applicable or present.
The document states:
"Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: engineering analysis, dimensional analysis, pull-out testing, and static and dynamic compression-bending testing according to ISO 14801."
This indicates that the "study" conducted was a series of engineering and biomechanical tests to ensure the physical properties of the new implant were comparable to existing ones, which is standard for substantial equivalence for physical devices. It does not involve "performance" in the context of diagnostic accuracy, sensitivity, specificity, etc., which would require a clinical dataset and ground truth.
§ 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.