(48 days)
The Immediate Stabilizing Implant (ISI) is a one-piece threaded dental implant with the abutment incorporated into the design for a single stage surgical procedure. The implant is intended to be surgically placed in the bone of the upper or lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function. Immediate loading can be obtained if implants are rigidly splinted.
Self-tapping one-piece CP Titanium threaded dental implant, with a roughened surface treatment. Available in 3.25mm, 4.0mm, and 5.0mm diameter, and in lengths of 8mm 10mm, 12mm, 14mm & 16mm.
The provided document is a 510(k) Pre-Market Notification for a dental implant (Immediate Stabilizing Implant - ISI). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and performance metrics.
Therefore, the document does not contain the requested information regarding acceptance criteria and a study proving the device meets those criteria, as it's not a clinical study report. The information about sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth, and training sets is typically found in documentation for devices that require extensive performance validation, often through clinical or non-clinical testing that directly measures performance against pre-defined criteria.
Instead, the document focuses on comparing the ISI device's design, function, labeling, material composition, and intended use to existing predicate devices to assert substantial equivalence.
Here's a breakdown of why the requested information is absent:
- Acceptance Criteria and Reported Device Performance: These are usually established for new devices undergoing rigorous testing for safety and efficacy. For a 510(k), the "performance" is primarily assessed against the predicate device's characteristics and historical safety/effectiveness.
- Sample Sizes and Data Provenance: This relates to clinical or analytical studies. The 510(k) summary provided does not describe such a study.
- Number of Experts, Qualifications, Adjudication Method: These are elements of studies involving expert review, common for diagnostic or imaging devices. This is a physical implant, not a diagnostic tool.
- MRMC Comparative Effectiveness Study: This is specific to diagnostic aids that influence human reader performance.
- Standalone Performance: While aspects of a device's physical/mechanical performance might be tested, a "standalone" performance in the context of an algorithm's output (as typically asked) is not relevant here.
- Type of Ground Truth: Ground truth (e.g., pathology, outcomes data) is used to validate the accuracy or effectiveness of a diagnostic or predictive device. For a dental implant, the "effectiveness" is determined by successful integration and function, which is typically demonstrated over time in clinical use, not usually by a single ground truth in a 510(k) submission.
- Training Set Sample Size and Ground Truth for Training Set: These are concepts related to machine learning and AI, which are not applicable to the ISI dental implant.
In summary, the provided document demonstrates substantial equivalence based on a comparison to predicate devices, not through a study with defined acceptance criteria and performance metrics in the way a diagnostic or AI-powered device would.
§ 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.