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Inclusive® Tapered Implant System is indicated for use in maxillary and mandibular partially or fully edentulous cases, to support single, multiple-unit, and overdenture restorations. The implants are to be used for immediate loading only in the presence of primary stability and appropriate occlusal loading.

The proposed device, Inclusive® Tapered Implant System, is manufactured from biocompatible Titanium alloy. The implant is designed with an internal hex connection with a diameter of implant with a 6-point flower (drawings are provided in the table below). Equipped with a tapered body and used to replace one or more missing teeth. The surface is blasted with Hydroxyl Apatite and acid etched. The dental implant (proposed device) will be provided sterile using gamma sterilization. The Inclusive Tapered Implant System, includes abutments in the form of healing abutments, engaging and non-engaging temporary abutments, straight and angled titanium abutments, titanium abutment fixation screws and straight multi-unit abutments.

The provided text is a 510(k) summary for the Inclusive® Tapered Implant System. It describes the device, its indications for use, and a comparison to predicate devices to establish substantial equivalence.

Based on the document, here's an analysis of the acceptance criteria and study information:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or AUC, as would be typical for an AI/algorithm-driven medical device. This is because the device in question is an endosseous dental implant, a physical medical device, not a diagnostic algorithm.

Instead, the "acceptance criteria" are implied by adherence to recognized standards and successful completion of non-clinical performance tests for mechanical integrity and biocompatibility. The "reported device performance" is the conclusion that the device meets these standards and functions equivalently to predicate devices.

Here's a table summarizing the performance evaluation strategy:

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

This information is not applicable in the context of this 510(k) submission for a physical dental implant. The "test set" here refers to the physical samples of the device and its components used for non-clinical (laboratory) testing, not a dataset for an algorithm.

• Sample Size: The document does not specify the exact number of implants or abutments tested in the fatigue and static load failure tests. It refers to "finished assembled implant/abutment systems" being tested.
• Data Provenance: The data is generated from laboratory testing of the manufactured devices, not from patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" studies do not apply in this context.

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)

This is not applicable. "Ground truth" in the context of this device refers to the physical properties and performance characteristics of the implant, which are established through standardized engineering and material science tests, not through expert human interpretation or consensus. The tests themselves (e.g., fatigue testing, material composition analysis) provide objective data.

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

This is not applicable. Adjudication methods like "2+1" or "3+1" are used in studies where human interpretations of data (e.g., medical images) need to be reconciled to establish a ground truth. For mechanical and material testing of a physical device, the results are derived from standardized test procedures and measurements, not human consensus on interpretation.

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 is not applicable. The device is a physical dental implant, not an AI or algorithm. Therefore, an MRMC study related to AI assistance for human readers is irrelevant.

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

This is not applicable, as the device is a physical dental implant, not an algorithm.

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

For this physical device, the "ground truth" for demonstrating performance and safety is established through:

• Adherence to recognized standards: E.g., ISO 10993-1 (biocompatibility), ASTM F136 (material properties), ISO 14801 (dynamic fatigue).
• Non-clinical (laboratory) performance testing: Mechanical strength (fatigue and static load failure testing).
• Material verification: Titanium Grade 23 (Ti-6AL-4V ELI) meeting ASTM F-136.
• Sterilization validation: Conformance to ISO and AAMI standards.

These are objective, measurable criteria verified through specific test protocols, rather than subjective expert consensus or clinical outcomes data.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This is not applicable, as there is no "training set."

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Inclusive® Tapered Implants are indicated for use in maxillary and mandibular partially or fully edentulous cases, to support single, multiple-unit, and overdenture restorations. The implants are to be used for immediate loading only in the presence of primary stability and appropriate occlusal loading.

The Inclusive® Tapered Implants are manufactured from biocompatible Titanium alloy. The implant is designed with an internal hex connection and a tapered body to replace one or more missing teeth. The surface is blasted with Hydroxyl Apatite and acid etched to facilitate osseointegration. The Implants are available in the following diameters: 3.7mm. 4.7mm. and 5.2mm, and each diameter is available in the following lengths: 8mm, 10mm, 11.5mm, 13mm, and 16mm. The dental implants are provided sterile (gamma).

The provided document describes the PRISMATIK DENTALCRAFT, INC. Inclusive® Tapered Implant System, a medical device. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting the results of a standalone study against specific acceptance criteria in the format requested. However, it does reference performance data and biocompatibility tests conducted to meet acceptance criteria.

Based on the information provided, here's a breakdown of the requested elements:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the sample sizes used for the mechanical performance testing (fatigue tests) or the biocompatibility tests (irritation, cytotoxicity, sensitization). It only states that worst-case scenarios were evaluated. There is no information regarding data provenance (e.g., country of origin, retrospective/prospective).

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

Not applicable. The tests described are laboratory-based mechanical and biological evaluations, not studies requiring human interpretation or expert ground truth for a test set in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set:

Not applicable for the types of tests described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The document describes a 510(k) submission for substantial equivalence based on mechanical and biological performance, not a study involving human readers or AI assistance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

No. This device is a physical dental implant, not an algorithm or AI system. The performance data relates to the physical properties and biocompatibility of the implant itself.

7. Type of Ground Truth Used:

For the mechanical performance, the "ground truth" or standard was established by the specified FDA guidance and ISO 14801: 2007 standard for dynamic fatigue testing. For biocompatibility, the "ground truth" was established by the relevant ISO 10993 standards. These are internationally recognized standards and guidance documents for medical device testing.

8. Sample Size for the Training Set:

Not applicable. This device is a physical implant and does not involve AI or machine learning algorithms that would require a training set.

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

Not applicable, as there is no training set for this type of device.

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