(193 days)
Straumann® RidgeFit Implants ∅ 2.4 mm are indicated for oral endosteal implantation in the fully edentulous mandible and/or maxilla for the stabilization of removable dentures. The implants can be placed with immediate function when primary stability is achieved for all implants or with conventional loading if primary stability is not achieved on all implants.
- Mandibular restorations require at least 4 Straumann® RidgeFit Implants ∅ 2.4 mm.
- Maxillary restorations require at least 6 Straumann® RidgeFit Implants ∅ 2.4 mm.
The Straumann® RidgeFit Implants are tapered implants manufactured from Roxolid® (Titanium-Zirconium alloy, TiZ) with a finished SLA surface. The implant neck is machined with an Optiloc® attachment portion, which is coated in Titanium Nitride (TiN) coating, resulting in a one-piece implant system acting as a retention feature for dentures. The Straumann® RidgeFit Implants have an external diameter of 2.4 mm and are available in implant lengths 10 mm, 12 mm and 14 mm with a gingival height of 2.8 mm and implant lengths 10 mm and 12 mm for gingival heights 3.8 mm and 4.8 mm. The Straumann® RidgeFit Implants ∅ 2.4 mm are suitable for oral endosteal implantation in the upper and lower jaw of fully edentulous patients. Conventional loading is recommended if primary stability cannot be achieved immediately on all implants.
The provided FDA 510(k) clearance letter and summary for the Straumann® RidgeFit Implants contains information regarding the device's technical specifications and non-clinical testing. However, it does not include any information about acceptance criteria or a study that uses a test set with ground truth established by experts to prove the device meets these criteria.
The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical engineering tests (fatigue, insertion torque, biocompatibility, sterilization, packaging stability, MRI compatibility). These are performance tests on the device itself, not evaluations based on human-in-the-loop or standalone AI performance using a study with a test set and expert-established ground truth.
Therefore, I cannot provide the requested information for the following points as they are not present in the given text:
- A table of acceptance criteria and the reported device performance: The document implicitly states that passing the non-clinical tests demonstrates "substantial equivalence," but does not define explicit acceptance criteria or performance metrics directly from a comparative study with a test set and ground truth.
- Sample sized used for the test set and the data provenance: No such test set or study is described within the provided text.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such test set or expert ground truth establishment is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned. The clearance is for an endosseous dental implant, which is a physical device, not an AI software intended for interpretation or diagnostic assistance that would typically undergo such studies.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
What the document does provide regarding testing:
The device's performance is proven through a summary of non-clinical testing, which includes:
- Dynamic fatigue testing: Conducted according to FDA guidance (Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments) and ISO 14801 ("Dentistry — Implants — Dynamic loading test for endosseous dental implants"). This testing demonstrated the subject devices are equivalent to primary predicate and reference devices.
- Insertion torque and Torque-to-failure test: Conducted and demonstrated substantial equivalence to the primary predicate device.
- Biocompatibility evaluation: Referenced K211052 and K191895 for evaluation in accordance with ISO-10993-1:2018 and FDA guidance.
- Sterilization validation: Referenced K211052 and K191895 for validation in accordance with ISO 11137-1:2006 (VDmax25 method).
- Packaging stability and shelf-life study: Referenced K211052 and K191895 for studies in accordance with ISO 11607-1:2019, ASTM F1886, ASTM F1929, and ASTM F88.
- MRI simulations: Conducted to demonstrate that the devices are MR Conditional.
These tests are primarily physical and chemical performance assessments of the implant materials and design, aimed at establishing safety and effectiveness, and equivalence to existing cleared devices, not at evaluating an AI's diagnostic performance against human experts.
§ 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.