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The Thommen SPI® ELEMENT Dental Implant is intended to be surgically placed, either immediately after extraction or following healing, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. SPI® Dental Implants can be loaded immediately if they are splinted with a bar on four implants in the mandibular arch or six implants in the maxillary arch.

The Thommen SPI® ELEMENT Platform Ø 4.0 mm is a root form endosseous dental implant made of commercially pure grade 4 titanium. The implant surface is smooth machined on the transgingival portion and sandblasted and acid-etched in the area designed to contact bone.

This K070007 510(k) submission for the Thommen SPI® ELEMENT Platform Ø 4.0 mm dental implant does not contain specific acceptance criteria, a detailed study report proving the device meets those criteria, or information on AI/ML-based performance.

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device for device modification (addition of a new platform diameter). It primarily addresses administrative information, device description, intended use, conformance to standards (material properties only), packaging, and equivalence to a marketed product.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, AI/ML performance, study design, and ground truth establishment as they are not present in the provided text.

Here's an explanation of why the requested information is not available in the given document:

• Acceptance Criteria & Device Performance: This document does not present quantitative performance metrics or acceptance criteria for the device itself (e.g., success rates, torque values, osseointegration rates). The "conformance with performance standards" section only mentions compliance with material standards (ASTM F 67 and ISO 5832-2) for the pure titanium, not a clinical or mechanical performance study.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication): No study is described that would provide this information. The submission relies on demonstrating similarity to a predicate device rather than presenting new clinical or in-vitro study data with defined endpoints.
• MRMC, Standalone Performance, AI/ML: The device is a physical dental implant. There is no mention or implication of any AI/ML components, software, or human interpretation studies in this 510(k) summary.
• Ground Truth Type: Since no performance study is detailed, there's no mention of how ground truth would be established.
• Training Set Sample Size & Ground Truth: These concepts are relevant to AI/ML models, which are not part of this device submission.

In summary, the provided document is a regulatory submission focused on substantial equivalence for a physical dental implant modification, not a performance study report for an AI/ML-enabled device.

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