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The Inclusive Zirconia Abutment Blank is intended to be used in conjunction with endosseous implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdenture prostheses. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

Inclusive Zirconia Abutment Blanks for Zimmer Implants are compatible with Zimmer Screw Vent and Tapered Screw Vent internal hex implants. Inclusive Zirconia Abutment Blanks for 3i Implant are compatible with 3i Certain internal hex implants. Inclusive Zirconia Abutment Blanks for Nobel Biocare Implant are compatible with Nobel Biocare Replace straight and tapered internal-connection implants.

Abutments with angulations greater than 20 degrees are contraindicated.

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The provided text is a 510(k) summary for a medical device (K083480) and a subsequent FDA letter acknowledging its clearance. It establishes substantial equivalence to predicate devices but does not contain information about specific acceptance criteria or a study proving device performance against those criteria.

The document explicitly states: "The effectiveness and suitability to the intended purpose of the device is assured through wide, general use of similar other predicate devices, and demonstrates the safe use of the device to construct dental restorations." This indicates that the regulatory clearance was based on substantial equivalence rather than new performance studies with specific acceptance criteria.

Therefore, most of the requested information cannot be extracted from this document, as it describes a device cleared based on equivalence, not on a new performance study with defined criteria.

Here's a breakdown of the requested information, indicating why it's not available in the provided text:

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

• Not available. The document does not define specific acceptance criteria for performance for this device, nor does it report detailed performance metrics from a study. Clearance was based on substantial equivalence to predicate devices.

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

• Not applicable/Not available. No new test set data is described as the basis for clearance.

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)

• Not applicable/Not available. No new test set requiring expert ground truth establishment is described.

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

• Not applicable/Not available. No new test set requiring adjudication is described.

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/Not available. This device is an abutment blank, not an AI diagnostic tool. No MRMC study was conducted or described.

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

• Not applicable/Not available. This device is a physical dental component, not an algorithm.

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

• Not applicable/Not available. No new ground truth for performance evaluation of this device is described. The basis for safety and efficacy is "wide, general use of similar other predicate devices."

8. The sample size for the training set

• Not applicable/Not available. No training set for an algorithm is described.

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

• Not applicable/Not available. No training set for an algorithm is described.

In summary: The provided document is a 510(k) premarket notification and subsequent FDA clearance letter based on "substantial equivalence" to existing, legally marketed predicate devices. This regulatory pathway typically relies on demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as a predicate device, rather than requiring new, extensive performance studies with specific acceptance criteria like those outlined in the questions.

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The Inclusive Titanium Abutment Blank is intended to be used in conjunction with endosseous implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdenture prostheses. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

Inclusive Titanium Abutment Blanks for Nobel Biocare are compatible with NobelActive Internal NP and RP implants. Inclusive Titanium Abutment Blanks for Institut Straumann are compatible with Straumann Bone Level implants in the NC and RC platform sizes. Inclusive Titanium Abutment Blanks for the Nobel Biocare Branemark System are compatible with the Branemark RP size implant.

Abutments with angulations greater than 20 degrees on implants less than 4mm in diameter are not indicated for the posterior region because of strength limitations of the implant.

The device is comprised of titanium alloys. The device is designed to be screw-retained for use with Endosseous dental implants as an aid in prosthetic rehabilitation.

The provided text is for a 510(k) summary for a dental device, "Inclusive Titanium Abutment Blanks." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria and performance metrics.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details is not available in the provided document.

The 510(k) summary states:

• Substantial Equivalence: The device is substantially equivalent to other legally marketed devices, specifically Nobel Biocare's Branemark (K042658) and NobelActive Internal (K071370) implants, and Institut Straumann's (K062129) implants.
• Safety and Efficacy: "The device functions in a similar manner to other comparative devices and the intended use is the same. The differences between comparative devices are minor and do not raise new safety concerns. The effectiveness and suitability to the intended purpose of the device is assured through wide, general use of similar other predicate devices, and demonstrates the safe use of the device to construct dental restorations."

This indicates that the FDA cleared this device based on its similarity to already approved devices, meaning extensive de novo clinical trials or performance studies with predefined acceptance criteria were likely not required. The focus was on demonstrating that the new device does not introduce new questions of safety or effectiveness compared to its predicates.

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The Inclusive Abutment is intended to be used in conjunction with endosseous implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdenture prostheses. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

The Inclusive Abutment for Zimmer Implant is compatible with Zimmer Screw Vent and Tapered Screw Vent internal hex implants. The Inclusive Abutment for 3i Implant is compatible with 3i Certain internal hex implants. The Inclusive Abutment for Nobel Biocare Implant is compatible with Nobel Biocare Replace straight and tapered internalconnection implants.

Please note: This device may be used in an early load situation, dependent on the specific implant system and protocol used by the dental professional; and, highly angled abutments (i.e. 20 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

The device is comprised of titanium alloys. The device is designed to be screw-retained for use with Endosseous dental implants as an aid in prosthetic rehabilitation.

The provided 510(k) summary does not contain information about acceptance criteria or a study proving the device meets said criteria in the way typically associated with AI/ML-driven medical devices.

This documentation describes a dental implant abutment (Inclusive™ Implant Abutment), which is a physical device, not a software algorithm or an AI-based system. Therefore, the standard elements of an AI/ML device study (like test sets, ground truth, expert adjudication, MRMC studies, standalone performance, training sets, etc.) are not relevant and are not present in this submission.

Instead, the submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. This is a common pathway for physical medical devices where the innovation is incremental.

Here's a breakdown of why the requested information is not applicable and what the document does provide:

• 1. A table of acceptance criteria and the reported device performance: Not applicable. There are no specific performance metrics like sensitivity, specificity, AUC, or F1-score for this type of physical device. The "performance" is implicitly deemed acceptable if it functions similarly to predicate devices.
• 2. Sample sized used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI/ML study.
• 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 ground truth establishment for a physical dental abutment.
• 4. Adjudication method: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used: Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

What the submission focuses on instead:

• Description: The device is made of titanium alloys and is screw-retained for use with endosseous dental implants.
• Intended Use: To be used by dental technicians in the construction of custom-made dental restorations supported by implants.
• Substantial Equivalence: The primary proof of safety and efficacy relies on its similarity to other legally marketed devices (3i, Nobel Biocare, Zimmer abutments). The submission states, "The device functions in a similar manner to other comparative devices and the intended use is the same. The differences between comparative devices are minor and do not raise new safety concerns."
• Indications for Use: The abutment supports crowns, bridges, or overdenture prostheses, and is compatible with specific Zimmer, 3i, and Nobel Biocare internal hex and internal connection implants. It also includes specific warnings regarding early load situations and highly angled abutments.

In summary, this 510(k) pertains to a traditional medical device, not an AI/ML device. Therefore, the questions about acceptance criteria and studies are not relevant in the context of this document.

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