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The Stage-1™ Regular Diameter Single Stage TPS Dental Implant System is indicated for use in support of crowns, bridges, or overdentures in completely and partially edentulous maxillary and mandibular arches in areas with sufficient alveolar bone width and height to surround the submerged portion of the implant with at least 1mm of bone, both buccally and lingually.

Device Description

The Stage-1™ Dental Implant System consists of the single-stage, root-form dental implants and associated abutment systems. which provide the clinician with cementretained, screw-retained and overdenture-type restorative options. The system also includes surgical and restorative instrumentation: drills, surgical taps, surgical depth probe, depth gauges, abutment drivers, latch-type drivers, open end wrench and handpiece adapters. The implants, prosthetics, and surgical tools are each packaged separately to allow the clinician to choose only those components required for each clinical situation. The single-stage implant is titanium plasma spray coated on the portion of the implant that is submerged into bone. The non-submerged portion is machined smooth to allow for the attachment of epithelial tissue. This surgical procedure eliminates the need for the second (uncovery) surgery that is required in twostage implant systems.

AI/ML Overview

The provided text describes a 510(k) submission for a dental implant system and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing device performance through clinical studies with acceptance criteria in the way a new medical device aiming for de novo clearance might. Therefore, many of the requested criteria fields related to clinical study design and performance metrics are not directly applicable or extractable from this document.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Nonclinical Performance
Dimensional Inspections	Routinely performed; within acceptable limits.	"Dimensional inspections are routinely performed... All have been found to be within acceptable limits."
Abrasion Testing	TPS coating strength acceptable.	"Abrasion testing to ensure TPS coating strength... All have been found to be within acceptable limits."
Electrochemical Corrosion Eval.	Corrosion properties when exposed to artificial saliva acceptable; galvanic corrosion properties of Precious Alloy/CP titanium and Precious Alloy/Ti-6Al-4V couples acceptable.	"Electrochemical Corrosion Evaluation of Uncoupled and Coupled Implant and Restorative Alloys has been performed to determine corrosion properties when exposed to artificial saliva and to determine the galvanic corrosion properties of the Precious Alloy/CP titanium and Precious Alloy/Ti-6Al-4V galvanic couples... All have been found to be within acceptable limits."
Mechanical Properties of Coating	Acceptable.	"the Mechanical Properties of the Plasma Spray Coating have been analyzed. All have been found to be within acceptable limits."
Compatibility
Dimensional Testing	Ensure interchangeability and compatibility with predicate ITI Straumann 4.1mm and 4.8mm Solid Screw Implant System. Components must seat fully and have no rotational play.	"The data demonstrates that the Stage-1™ Dental Implant and Prosthetics are compatible and therefore interchangeable with the ITI Straumann 4.1mm and 4.8mm Solid Screw Implants and Prosthetics."
Mating Part Verification	Components connect properly, fully seated, no rotational play. Critical implant to abutment and implant to cover screw connections verified.	"Mated components were examined visually to ensure components were fully seated and there was no rotational play between components. The critical implant to abutment connections and implant to cover screw connections were also examined using the video measuring machine and SEM."
Instrumentation Compatibility	Lifecore instrumentation can be used with ITI Straumann system; ITI instrumentation can be used with Stage-1™ system.	"Additionally, the associated Lifecore instrumentation can be used with the ITI Straumann 4.1mm and 4.8mm Solid Screw Implant System, and the associated ITI instrumentation can be used with the Stage-1™ Dental Implant System."

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated as a numerical sample size of implants or test cycles for non-clinical testing. The document refers to "routinely performed" dimensional inspections. For compatibility testing, various precision instruments were used on components. It's implied that sufficient components were tested to make a blanket statement about compatibility.
Data Provenance: The tests mentioned are non-clinical, likely conducted in a laboratory setting by the manufacturer (Lifecore Biomedical, Inc.). No country of origin for specific test data is provided, but the manufacturer is based in Chaska, MN, USA. The studies are not clinical studies; they are engineering and material science tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the document describes non-clinical engineering and materials testing, not a study involving human experts establishing ground truth for a diagnostic AI device.

4. Adjudication method for the test set:

This information is not applicable as the document describes non-clinical engineering and materials testing, not a study involving human expert adjudication.

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:

This information is not applicable. The document is for a dental implant system, not a diagnostic AI device requiring MRMC studies.

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

This information is not applicable. The device is a physical dental implant system, not an AI algorithm.

7. The type of ground truth used:

For the non-clinical tests (dimensional, abrasion, corrosion, mechanical properties), "ground truth" would be established by:

Engineering specifications and design tolerances.
Standard material testing methodologies (e.g., ASTM or ISO standards for material properties, corrosion, and wear).
Visual and instrumental verification of component fit and function.

For compatibility testing, the "ground truth" was the physical and functional fit and interchangeability with the predicate device components, measured dimensionally and visually.

8. The sample size for the training set:

This information is not applicable. The document describes a physical medical device, not a machine learning model that requires a training set.

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

This information is not applicable. As in point 8, this is not an AI/ML device.

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