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Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in the edentulous or partially edentulous maxilla or mandible to provide support for cement-retained or screw-retained prosthetic restorations.

All digitally designed abutments for use with Inclusive Titanium Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.

Compatible Implant System: Dentsply Implants Astra Tech Implant System® EV

Inclusive® Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV, which are the subject of this submission, are designed and fabricated to be compatible exclusively with Dentsply Implants Astra Tech Implant System EV, and have a prefabricated, precision interface (implant/abutment connection) compatible with the primary predicate device connection. The proposed product line includes stock abutments and abutments intended for fabrication of patient-specific custom abutments using CAD/CAM technology. Each patient-specific abutment is individually prescribed by the clinician and manufactured by an authorized milling center validated by Prismatik Dentalcraft.

The subject devices are manufactured from titanium alloy conforming to ASTM F136, and have a taper followed by a keyway connection feature that prevents rotation of the abutment. The abutments are compatible exclusively with the Astra Tech OsseoSpeed EV implant line (cleared under K120414) in the following diameters: 3.0S, 3.6S, 4.2S, 4.2C, 4.8S, 4.8C, 5.4S mm. The subject device includes the following components: Titanium Abutment Blanks, intended to fabricate all-titanium, patientspecific abutments using CAD/CAM technology; Titanium Abutment 4.5mmH and Titanium Abutment 6mmH, intended to be used for support of CAD/CAM fabricated crowns/bridges or zirconia copings; Titanium Esthetic Abutments, prefabricated abutments intended to be connected directly to an endosseous implant for retention of a prosthesis in straight and 15° angled designs; and Titanium Screws, indicated for the temporary or long-term retention of the abutments to the compatible dental implant fixtures. All subject device components are provided non-sterile.

Titanium Abutment 4.5mmH are two-piece abutments. The crowns/bridges or zirconia copings produced at the validated milling center compose the second part of the two piece abutment.

The provided text describes the 510(k) premarket notification for Inclusive® Titanium Abutments compatible with Dentsply Implants Astra Tech Implant System® EV. This document is a regulatory submission for a dental device, not an AI/ML medical device. Therefore, the information requested in your prompt regarding acceptance criteria and study proving performance for an AI/ML device (e.g., sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable to this document.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through non-clinical performance data.

Here's an analysis based on the information that is available in the document:

Device Type: Dental Implant Abutment (Hardware, not Software/AI)

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

Since this is a hardware device submission, the "acceptance criteria" are related to mechanical, material, and biological compatibility, and "performance" refers to demonstrating equivalence to a predicate device through non-clinical testing.

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

• Test Set Sample Size: Not explicitly stated as "sample size" in the context of statistical testing for AI/ML. For mechanical testing, it would refer to the number of abutments tested, which is not detailed in the summary (e.g., "Worst-case constructs were subjected to static compression and compression fatigue testing.").
• Data Provenance: The studies are non-clinical, likely conducted in a lab environment rather than on human patients. The document does not specify a country of origin for the testing data, beyond the manufacturer being in Irvine, CA, USA.
• Retrospective/Prospective: Not applicable, as this refers to non-clinical lab testing of a hardware device.

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

• Not Applicable. This is a hardware device not requiring human interpretation of medical images or data for "ground truth" establishment in the AI/ML sense. The "ground truth" here is adherence to engineering specifications and performance standards, validated by accredited testing methods.

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

• Not Applicable. No human adjudication process is described or implied for the performance validation of this hardware device.

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 is a hardware device; no human reader or AI assistance is involved in its use or evaluation for regulatory purposes. The document explicitly states: "No clinical data were included in this submission."

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

• Not Applicable. There is no algorithm for standalone performance. This device is a physical component used in dental procedures.

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

• For Hardware Devices: The "ground truth" is defined by established engineering and material standards, validated through laboratory tests:
  • Mechanical Integrity: Conformance to ISO 14801 (static compression and fatigue limits).
  • Biocompatibility: Conformance to ISO 10993 series.
  • Sterilization: Conformance to ISO 17665-1.
  • Dimensional Accuracy: Verified through reverse engineering and dimensional analysis against OEM specifications.

8. The sample size for the training set:

• Not Applicable. This is a hardware device, not an AI/ML algorithm that requires a training set.

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

• Not Applicable. As above, no training set for an AI/ML algorithm is involved.

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