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3i Dental Implant Systems are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function.

Implant Innovation's dental implant systems are available in a wide range of diameters and lengths. 3i implants include screw-form (i.e., threaded) or cylinder; are manufactured from titanium; and are coated or non-coated. The OSSEOTITE® brand implants have a special dual acid-etched treatment process to increase surface roughness.

The provided text is a U.S. FDA 510(k) summary for a dental implant system. It outlines the device, its indications for use, and a comparison to predicate devices, ultimately leading to a substantial equivalence determination.

However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for a study proving the device meets acceptance criteria.

The document is a regulatory submission for premarket notification, not a clinical study report. It focuses on demonstrating substantial equivalence to existing devices, which is a different type of evaluation than proving a device meets specific performance criteria through a dedicated study.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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OSSEOTITE NT™ Implant System is indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function.

Implant Innovation's dental implant systems include screw-form (i.e. threaded) titanium implants with a machined, external HEX to assist in placement and to provide antirotation features for the restoration. The OSSEOTTE® Brand implants have a special dual acid-etched treatment process to increase surface roughness.

The OSSEOTITE NTTM Dental Implants are tapered implants designed to mimic the shape and form of a natural tooth. The taper aspect ratio varies depending upon the length and diameter. The NT implants will be available in diameters of 3.25, 4.0, 5.0 and 6.0 mm and lengths of 8.5, 10.0, 11.5, 13.0 and 15.0 mm.

The provided document, K014235 for OSSEOTITE NT™ Implants and Accessories, is a 510(k) premarket notification. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving device effectiveness through clinical trials with specific acceptance criteria, as might be seen with a PMA (Premarket Approval) application.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria, specific study designs (test set sample size, data provenance, expert adjudication, MRMC studies, standalone performance), or ground truth establishment for a training set.

However, I can extract the information that is present concerning performance data and substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• The document mentions "mechanical testing of the implants." This implies in vitro testing.
• Sample Size: Not specified.
• Data Provenance: In vitro testing (laboratory-based), not specified geographical origin. This is not human data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• Not applicable. The performance data is based on mechanical testing, not a human-interpreted ground truth.

4. Adjudication Method for the Test Set:

• Not applicable. The performance data is based on mechanical testing, not a human-interpreted ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC study was not done. This device is not an AI/imaging device where human reader performance would be assessed.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done:

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

7. The Type of Ground Truth Used:

• For the mechanical performance, the "ground truth" would be the measured mechanical properties (e.g., strength, fatigue resistance) of the predicate device, against which the new device was compared. This is a scientific measurement, not an expert-derived ground truth.

8. The Sample Size for the Training Set:

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. This is a physical medical device, not an AI model.

In summary, this 510(k) filing relies on demonstrating substantial equivalence primarily through comparison of physical characteristics and mechanical testing to existing predicate devices, rather than clinical efficacy studies with specific acceptance criteria or expert-based ground truth evaluations.

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