Search Results

BIOMET 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.

OSSEOTITE® 2 Dental Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.

OSSEOTITE® 2 Dental Implants are similar to predicate BIOMET 3i OSSEOTITE Implants, currently being sold worldwide. OSSEOTITE 2® Dental Implants are provided with the proprietary OSSEOTITE dual acid-etched surface which has been in commercial distribution since market clearance in 1995 and are made of Commercially Pure Titanium. Implants have a straight wall design, with an External Hex Connection. OSSEOTITE® 2 Dental Implants are offered in diameters of 3.25, 3.75, 4.0, 5.0, and 6.0 in varying lengths from 3 mm to 15 mm. Size appropriate cover screws are provided with each implant.

The provided document is a 510(k) summary for the OSSEOTITE® 2 Dental Implants. This is a special 510(k) submission, meaning it's for a modification to a previously cleared device. Therefore, the "study" described is primarily focused on demonstrating substantial equivalence to predicate devices through bench testing and referencing existing clinical data rather than conducting a de novo clinical trial for the new device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for this device are based on demonstrating that the OSSEOTITE® 2 Dental Implants are substantially equivalent to legally marketed predicate devices (OSSEOTITE II MODEL XIFOSSXXX (K100724) and OSSEOTITE; OSSEOTITE NT; XP; TG Implant(s) (K063286)). This means they must share the same intended use, indications for use, technological characteristics, and principles of operation, and any differences must not raise new questions of safety or effectiveness.

The document directly compares the proposed device to its predicates across various characteristics. The "reported device performance" in this context refers to showing that these characteristics are either identical or that any modifications (specifically the abutment connection) do not negatively impact performance as demonstrated by bench testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: For the bench testing, the document states "All testing conducted met the acceptance criteria and evaluated the worst case scenario including 30° pre-angled abutments as compared to predicate BIOMET 3i designs." It does not specify the numerical sample size for the fatigue testing according to ISO 14801:2007. For the clinical reports cited, specific sample sizes are also not provided in this summary document.
• Data Provenance:
  • Bench Testing: The geographical origin is not specified, but it was conducted by "BIOMET 3i" implying internal company testing or contracted to a lab.
  • Clinical Data: The summary mentions two clinical reports ("Insertional Torque Force, Osseotite 2 Placement Data, Pressure Necrosis" dated September 21st, 2011, and "BIOMET 3i Insertion Torque Report" dated November 10, 2011). These reports summarize clinical projects and "implant placement experience data". The summary doesn't explicitly state if they are retrospective or prospective, nor does it specify the country of origin. However, given they are reports on existing data, they are likely retrospective analyses of clinical experience.

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)

• For the bench testing (ISO 14801:2007), ground truth is established by the standard itself and objective mechanical measurements. No human experts are involved in establishing ground truth in terms of diagnostic assessment.
• For the clinical reports, the "ground truth" relates to clinical outcomes (insertion torque, success, failure). These would have been established by the dental practitioners involved in the implant placement and follow-up. The document does not specify the number or qualifications of these experts; it only cites the reports.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• There is no mention of an adjudication method for either the bench testing or the clinical data in this 510(k) summary. Bench testing results are objective measurements against a standard. Clinical outcomes would typically be derived from patient records and the assessment of the treating clinicians, not through a separate adjudication panel described in this 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

• No MRMC comparative effectiveness study was done or is relevant for this submission. This device is a dental implant, a physical product, not an AI or imaging device that would involve "human readers" or AI assistance in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a physical dental implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For bench testing, the "ground truth" is defined by the acceptance criteria of the ISO 14801:2007 standard and the objective mechanical properties measured.
• For the clinical data cited, the ground truth is derived from clinical outcomes data (e.g., measured insertion torque values, implant success/failure at follow-up).

8. The sample size for the training set

• This is a special 510(k) for a physical medical device, not a machine learning or AI algorithm. Therefore, the concept of a "training set" in the context of AI is not applicable. The device's design and manufacturing rely on established engineering principles and prior predicate devices.

9. How the ground truth for the training set was established

• As the concept of a "training set" for an AI algorithm is not applicable here, there is no ground truth established for a training set. The device's safety and effectiveness are established through comparison to predicates and bench testing against industry standards.

Ask a specific question about this device