(109 days)
Fixture MicroThread™ OsseoSpeed™ is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla where immediate implant stability may be obtained.. The device may be used equally well in a single-stage ) or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded after implantation where immediate implant stability may be obtained.
The fluoride-modified surface, though having a fluoride ion level far below that needed for caries prevention in teeth, provides a favorable substrate for bone attachment and osseointegration. Fixture MicroThread OsseoSpeed is especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective. Because initial stability may be difficult to obtain in Type IV bone, immediate loading of single tooth restorations may not be appropriate in such situations.
Fixture MicroThread OsseoSpeed is a threaded, root-formed dental implant intended for supporting prosthetic devices in edentulous or partially dentate patients to restore their esthetics and chewing function. Fixture MicroThread OsseoSpeed is made from titanium with a micro-roughened and fluoride-modified surface, designated OsseoSpeed.
The implant is available with a straight or tapered contour at the implant neck and comes in different diameters and lengths. The abutments are screw-retained.
This 510(k) summary describes a dental implant and does not include an AI/ML device or a study with acceptance criteria and device performance as typically understood for such devices (e.g., sensitivity, specificity, AUC).
Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device, which is the primary regulatory pathway for many medical devices. The core argument for acceptance is that the device, "Fixture MicroThread™ OsseoSpeed™," is similar enough to existing, legally marketed devices that it doesn't raise new questions of safety and effectiveness.
Here's an analysis based on the provided text, using the structure of your request but acknowledging that some sections will be non-applicable due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present acceptance criteria or reported device performance in the form of quantitative metrics (e.g., sensitivity, specificity, accuracy) typically associated with AI/ML or diagnostic device studies.
Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device. The "performance" is described qualitatively as:
| Acceptance Criterion (implicitly met by substantial equivalence) | Reported Device "Performance" (compared to predicate or general claims) |
|---|---|
| Intended Use Equivalence: To replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla, with immediate implant stability. | Substantially equivalent to "currently marketed Fixture OsseoSpeed" and "TiUnite implant" in intended use, material, design, and surface characteristics. May be used in single or two-stage procedures, immediate implantation, immediate loading (where stability allows). |
| Material Equivalence: Made from titanium. | Substantially equivalent to existing devices in material. |
| Design Equivalence: Threaded, root-formed dental implant, various diameters/lengths, straight/tapered neck contour, screw-retained abutments. | Substantially equivalent to existing devices in design. |
| Surface Characteristics Equivalence: Micro-roughened and fluoride-modified surface (OsseoSpeed). | Substantially equivalent to existing devices in surface characteristics. The fluoride-modified surface promotes increased and more rapid bone formation and increased bone-to-implant strength early in healing, maintained over time. Allows safe and efficacious use in soft bone and with immediate loading. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This submission does not describe a "test set" in the context of an AI/ML algorithm or diagnostic study. The "data" mentioned refers to pre-clinical and clinical data supporting the biological performance of the implant surface.
- Data Provenance: The document states "previously submitted data and additional pre-clinical and clinical data with Fixture MicroThread OsseoSpeed." Specifics about country of origin or whether it was retrospective/prospective are not provided in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. There is no mention of a "test set" requiring ground truth established by experts in the context of evaluating an AI/ML device's performance. The review and approval process involved FDA scientific review, not expert consensus on image interpretation.
4. Adjudication Method for the Test Set
- Not applicable. There is no test set or adjudication method described for performance evaluation in this 510(k) summary.
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
- Not applicable. This is not an AI-assisted device. The submission pertains to a physical dental implant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or software device.
7. The Type of Ground Truth Used
- The "ground truth" here is biological and clinical evidence of bone attachment, osseointegration, and implant stability. This is inferred from pre-clinical (e.g., animal studies, in-vitro) and clinical data (human studies) demonstrating the properties of the implant's surface and overall function. It is not an "expert consensus" or "pathology" in the diagnostic sense, but rather a demonstration of medical efficacy through biological response and clinical outcomes.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" for an AI/ML model described in this submission. The "previously submitted data and additional pre-clinical and clinical data" would be analogous to the evidence base considered for justifying substantial equivalence.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI/ML training set, this question is not relevant to the provided text. The "ground truth" for the device's claims (e.g., "fluoride-modified surface promotes increased and more rapid bone formation") would be established through scientific methods in pre-clinical studies (e.g., histological analysis, biomechanical testing) and clinical trials (e.g., radiographic assessment, implant stability measurements, clinical follow-up), typically evaluated by dental and medical professionals specializing in implantology.
§ 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.