(513 days)
The REVOIS® Implant System is an implant system recommended for: Surgical placement in the edentulous or partially edentulous jaw bone (upper or lower jaw bone) to create support for prosthetic devices such as single artificial teeth, fixed or removable bridges or dentures. The titanium implant can be applied either in a one-stage surgical procedure with immediate loading when good primary stability is achieved and with appropriate occlusal loading, or in a two-stage surgical procedure (after osseointegration of the implant).
The REVOLS® Implant System is a self-contained, modular dental implant system for placement into the jaw bone (upper or lower jaw bone) to support prosthetic devices for dental restoration. The system is designed for one-stage or two-stage surgical procedures. The REVOIS® Implant System is composed of titanium, screw type implant, preassembled with a multifunctional precision abutment and a transfer tool that snaps onto the abutment (Snap-on-tool). The implant is also available with a transfer tool only. A cover screw is contained in the top of the snap-on or transfer tool. The system offers implants in various diameters and lengths (3.8; 4.3; 5.0 mm diameter; 9; 11; 13; 15 mm lengths). The REVOIS® Implant System is provided with a number of corresponding tools and surgical instruments, as well as a variety of prosthetic components which are definitely 510(K)-exempt or still cleared by the submission K063106. For ease of identification the implants and corresponding tools are color coded according to diameter. The main components of the implant system are made of Grade V Titanium. The used materials comply with the ASTM standards ASTM F067, ASTM F0136-2a, and ASTM F2026. The implant surface is blasted with aluminium oxide and then acid-etched for microroughness. Blasting and acid -etching contributes to the implant surface characteristics. Furthermore grooves increase resistance to shear forces in difficult clinical cases. The REVOIS® titanium implant (pre-assembled with the multifunctional precision abutment and snap-on-tool or with the transfer tool only) is supplied in double sterile packages (sterile inner plastic vial in a sterile glass vial, which is sealed in a blister) and is for single use only. Tools and other re-usable instruments must be sterilized prior to use.
This document is a 510(k) summary for the REVOIS® Implant System. It describes a medical device, specifically a dental implant system, and its substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to your request:
1. Acceptance Criteria and Reported Device Performance
The submission for the REVOIS® Implant System is a Special 510(k) Summary, not a de novo submission or a traditional PMA application that typically requires defining and meeting specific performance acceptance criteria for clinical outcomes.
Instead, the primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a predicate device already legally marketed. The submission aims to show that the new REVOIS® Implant System is as safe and effective as its predicate.
The reported device performance is based on demonstrating this substantial equivalence. The document states:
- "The stability of the implant body of the REVOIS® implant system thread was tested in non-clinical performance testing as fatigue testing according to ISO 14801 and Bench testing with Animal Model." This indicates mechanical performance testing was conducted.
- Essential similarity conclusion: The document emphasizes the comparability in "main and most important characteristics" and that "differences between the systems represent minor updates as described and do not affect the device safety or effectiveness."
Therefore, a table of acceptance criteria and reported numeric device performance as typically expected for clinical validation studies (e.g., sensitivity, specificity, accuracy) cannot be directly extracted from this document because the regulatory pathway chosen (Special 510(k)) does not require such criteria in this format. The performance is implicitly "accepted" if substantial equivalence to the predicate is shown through design, materials, and non-clinical testing.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document mentions "fatigue testing according to ISO 14801" and "Bench testing with Animal Model." However, it does not specify the sample size (e.g., number of implants, number of animals) for these tests.
- Data Provenance:
- Country of Origin: The manufacturing company is Riemser Arzneimittel AG, located in Greifswald-Insel Riems, Germany. The tests mentioned (ISO 14801 and animal model) would likely have been conducted in Germany or a location compliant with international standards, but this is not explicitly stated.
- Retrospective or Prospective: The "fatigue testing" and "Bench testing with Animal Model" are by nature prospective non-clinical studies. They are laboratory or controlled animal experiments designed to evaluate specific aspects of the device's physical performance before widespread clinical use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The concept of "ground truth" and expert consensus as applied to diagnostic or AI-driven devices for medical image interpretation is not applicable to this submission.
- This is a submission for a dental implant system, a physical medical device.
- The "testing" referenced (ISO 14801, animal model) relates to the mechanical and biological properties of the implant, not to the interpretation of medical data by experts.
- Therefore, there were no experts establishing "ground truth" concerning diagnostic accuracy in the context you describe.
4. Adjudication method for the test set
Not applicable for the same reasons as #3. Adjudication methods (like 2+1 or 3+1) are used to resolve disagreements among human readers interpreting data, which is not the type of testing described here.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.
- This type of study is relevant for AI-powered diagnostic or assistive devices where human readers (e.g., radiologists) interact with or are assisted by AI.
- The REVOIS® Implant System is a physical dental implant. There is no AI component that would assist human readers in, for instance, interpreting dental images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance assessment was not done.
- This type of assessment is also specific to AI/software as a medical device (SaMD). The REVOIS® Implant System is a physical surgical implant device.
7. The type of ground truth used
The relevant "ground truth" for this device would be established by:
- Defined engineering standards and physical measurements: For fatigue testing (ISO 14801), the "ground truth" is whether the implant can withstand specified forces for a certain number of cycles without failure, as defined by the standard.
- Histopathological or biological outcome measures: For the "Bench testing with Animal Model," the "ground truth" would involve histological examination of bone integration, absence of inflammation, mechanical stability post-implantation, etc., compared to established benchmarks or the predicate device.
- Clinical outcomes (implicitly): While not directly part of the substantial equivalence argument summarized here, the predicate device's existing safety and effectiveness in clinical use forms an implicit "ground truth" that the new device aims to match.
8. The sample size for the training set
Not applicable. This device is a physical medical implant, not an AI/ML algorithm that requires a "training set" of data.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML algorithm, this question is irrelevant to the provided document.
In summary, the provided document is a regulatory submission for a physical medical device (dental implant) seeking clearance via the 510(k) pathway. It focuses on demonstrating substantial equivalence to an existing predicate device through design, materials, and non-clinical performance testing, not on clinical performance metrics or AI algorithm validation using expert ground truth or training/test sets.
§ 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.