Search Results

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:

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.

Ask a specific question about this device