(90 days)
Straumann® RidgeFit Implants Ø2.4 mm are for oral endosteal implantation in the upper and/or lower jaw of fully edentulous patients. 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 for all implants. Straumann® RidgeFit Implants are intended for the stabilization of removable dentures.
- For mandibular restorations, at least 4 Straumann® RidgeFit Implants Ø2.4 mm should be placed.
- For maxillary restorations, at least 6 Straumann® RidgeFit Implants Ø2.4 mm should be placed.
The Straumann® RidgeFit Implants are tapered implants manufactured from Roxolid (TiZr) with a finished SLA surface. The implant neck is machined with an Optiloc® attachment portion resulting in a one-piece implant system acting as a retention feature for dentures, this feature is coated in a Titanium Nitride (TiN) coating. 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 are identical to the Straumann® Mini Implants cleared under K191895 apart from proposed labeling changes. Note for US Markets, Straumann has identified Straumann® Mini Implants as Straumann® RidgeFit Implants to distinguish it from other markets, this change has been documented through Memo to File. The purpose of this traditional 510(k) is to propose labeling changes to the cleared indications and the addition of contraindications to the existing devices cleared under K191895.
The provided text does not include information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically associated with algorithms or diagnostic tools. Instead, it is a 510(k) summary for a medical device (dental implants) and focuses on demonstrating substantial equivalence to a predicate device.
The "performance testing" described in the document primarily relates to:
- Sterilization Validation and Shelf Life: Ensuring the device remains sterile and functional over time.
- Biocompatibility Testing: Confirming the materials are safe for use in the human body.
- Electromagnetic Compatibility: Indicating the device is MR Conditional.
- Bench Testing: Mechanical testing (insertion torque, wear, dynamic fatigue) to ensure structural integrity and function, likely against material and mechanical standards.
- Clinical Performance (Reference): A literature review to support a change in "Indications for Use" regarding the number of implants for mandibular and maxillary restorations.
Therefore, many of the requested fields cannot be filled as they pertain to the evaluation of an algorithm's performance, which is not the subject of this document.
However, I can extract the information that is present and note where information is not applicable or not provided.
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Feature/Test | Acceptance Criteria (Implied/Standard) | Reported Device Performance |
|---|---|---|
| Sterilization | Sterility Assurance Level (SAL) of 10^-6 | Validated in accordance with ISO 11137-1:2006 and ISO 11137-2:2013 (VDmax 25 method) |
| Shelf Life | (Implied: Maintain sterility and integrity for 5 years) | 5 years |
| Biocompatibility | (Implied: Meet ISO standards for medical device biocompatibility) | No new issues raised; no additional testing required as materials/methods unchanged from predicate. |
| Electromagnetic Compatibility | (Implied: Safe for MRI environments) | Considered MR Conditional. |
| Bench Testing (Fatigue) | (Implied: Performance equivalent to predicate device per FDA guidance) | New 4.8 mm gingival height demonstrated equivalent performance to predicate. Other relevant bench testing (insertion torque, wear, dynamic fatigue) performed and provided in K191895 in accordance with FDA guidance. |
Study Details (where applicable for a medical device application):
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Bench Testing: Not explicitly stated in this summary. It refers back to K191895 for the detailed bench testing, and for the new gingival height, it mentions "a fatigue test" without specifying sample size.
- Data Provenance: Not applicable in the context of an algorithm's test set. For physical device testing, it's typically internal lab data or certified external lab data.
3. 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. This information pertains to the evaluation of an algorithm's ability to interpret data, which is not what this document describes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This is for algorithm ground truth establishment.
5. 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. An MRMC study is not mentioned as this is a physical dental implant, not an AI/diagnostic tool. The clinical support cited for the labeling change is a systematic review of existing literature, not a new comparative effectiveness study on the device itself.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For Bench Testing: Ground truth is established through engineering standards, test methods, and comparison to predicate device performance.
- For Clinical Support of Indications for Use: The "ground truth" or supporting evidence for the revised Indications for Use (specifying implant numbers) comes from a systematic review of clinical literature (Lemos et al. 2017), which synthesizes existing outcomes data from various clinical studies on mini implants.
8. The sample size for the training set
- Not Applicable. This device is not an AI algorithm.
9. How the ground truth for the training set was established
- Not Applicable. This device is not an AI algorithm.
§ 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.