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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.

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.

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:

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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The Regular Diameter Single Stage TPS Dental Implant System is indicated for use in support of crowns, bridges, or overdentures in completely and partially edentulous in support of orewnlo; and good es in areas with sufficient alveolar bone width and maxilliary and manufacturersed portion of the implant with at least 1mm of bone, both buccally and lingually.

The Regular Diameter Single Stage (RDS) TPS Dental Implant System consists of the The Regular Diameter Single Stage (RDB) 11 Sociated abutment systems, which single-stage, foot-form dental implants and associatined and overdentive instrument provide the clinician with certiently and restorative instrumentation: restorative options. The system also includes surgical and restorative instrumentation: restorative options. The system aloo included beath gauges, abutment drivers, and drivers, surgical taps, surgical depth problem and the implants, prosthetics, and drivers, open eno wrench and hallphouse dubtore. The clinitian to choose only those only those surgical tools are each packaged separately to . The cinning to singly m surgical tools are each packaged soparation. The single-stage implant is titanium. components required for each clinical situation. The single-stage The components required for each olimour of the implant that is submerged into bone. The problemant of enithelial plasma spray coated on the portion of the attachment of epithelial non-submerged portion is machined cimestin to allett for the second (uncovery) surgery that is required in two-stage implant systems.

This document describes the Lifecore Regular Diameter Single Stage (RDS) TPS Dental Implant System.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly established through a substantial equivalence comparison to predicate devices, rather than explicit numerical thresholds for performance metrics. The study aims to demonstrate that the subject device performs as safely and effectively as the predicate devices.

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

This submission does not describe a clinical study with a traditional "test set" of patients or data. Instead, it relies on non-clinical bench testing to demonstrate substantial equivalence.

• Sample Size: Not applicable in the context of a patient-based test set. The reported tests (dimensional, bending strength, corrosion, abrasion, mechanical properties of coating) would have involved specific numbers of device samples or material specimens, but these quantities are not specified in the document.
• Data Provenance: The tests are explicitly described as "Nonclinical Tests" performed on the device itself. Therefore, the data originates from laboratory and bench testing. The country of origin is not explicitly stated for the testing facilities, but the submitter is Lifecore Biomedical, Inc. located in Chaska, Minnesota, USA. The data is retrospective in the sense that these tests were conducted on the manufactured device models to support the 510(k) submission.

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

Not applicable. There is no human "ground truth" establishment for this type of non-clinical, bench testing. The "ground truth" for these tests would be the established engineering and materials science principles and the specifications of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as there is no human "test set" or diagnostic assessment requiring adjudication. The assessment of test results would be against pre-defined engineering specifications and comparison to predicate device characteristics.

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 document pertains to a dental implant, a physical medical device, not a diagnostic AI system. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used

The "ground truth" in this context is the established performance and characteristics of the legally marketed predicate devices, coupled with engineering specifications and scientific principles for material safety and mechanical integrity. The goal is to show the subject device is "substantially equivalent" to these established devices.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable. There is no training set for this type of device submission.

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