(107 days)
The Mistral one stage screw-type dental implant is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
The Mistral is a one stage, screw-type, internal octagon dental implant and is provided in the following range of dimensions:
- Diameters: 3.75. 4.10 and 4.80 mm
- Length: 8, 10, 11.50, 13 and 16 mm
All implants are manufactured from medical grade 5 pure titanium, which meets requirements of standard ASTM F136.
The required surface roughness and microgeometry of the implants is achieved by blasting sand particles and acid etching. Blasted surfaces archive more bone contact with the implant surface.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria for the "Mistral one stage screw-type dental implant."
The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria.
The key points from the provided text are:
- Predicate Device: One stage implant from MIS Dental Implant System (K040807).
- Description of Device: Mistral is a one-stage, screw-type, internal octagon dental implant made from medical grade 5 pure titanium with a sand-blasted and acid-etched surface.
- Indications for Use: Placement in the upper or lower jaw to support prosthetic devices for restoring chewing function.
- Substantial Equivalence: The device is considered substantially equivalent to the predicate device because it has the same intended use and equivalent performance characteristics.
- Conclusion: No additional concerns regarding safety and effectiveness were identified, leading to substantial equivalence.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth was established for the training set.
This information is typically found in design validation reports or detailed performance studies, which are not part of this 510(k) summary document.
§ 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.