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The Thommen SPI® Dental Implant System, TST Surface, is intended to be surgically placed, either immediately or delayed, 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 used for crowns, bridges or overdentures on at least four implants in the mandibular arch or six implants in the maxillary arch.

Contraindications for the use of SPI® CONTACT implant ø 3.5 mm and SPI® ELEMENT implant ø 3.5 mm:
These implants are not suitable for applications in areas where pronounced rotation and/or bending movements are expected to subject the implant to large bending movements.

• Restoration of posterior teeth in the upper or lower jaw -
• Single-tooth restoration of canines and central incisors in the upper jaw -
• Any application involving retentive anchors -

The Thommen SPI® Dental Implant System with TST Surface (the modified design) is a self tapping, root form, endosseous dental implant made of commercially pure grade titanium. The implant surface is smooth machined on the transgingival portion and treated with the TST implant surface process, in the area intended to contact bone. The modified TST Surface is available on all implants in the SPI® Dental Implant System. The system is constructed of materials that have a long clinical history of proven acceptance and performance.

This 510(k) summary describes a device modification to an existing dental implant system. The core of the submission focuses on demonstrating substantial equivalence to a predicate device, particularly concerning a new surface treatment (TST Surface). As such, a traditional "study" proving acceptance criteria with performance metrics, ground truth, and statistical analysis as one might find for an AI/ML diagnostic device is not applicable here.

Instead, the submission relies on the established safety and effectiveness of the predicate device and demonstrates that the modified device's characteristics (intended use, operating principle, basic design, materials, packaging, sterilization) are substantially equivalent.

Therefore, many of the requested categories (2-9) do not have direct answers in this document because they pertain to a different type of device evaluation.

However, I can extract the closest equivalent information for the acceptance criteria and implied "performance."

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" here are inferred from the requirements for demonstrating substantial equivalence for a device modification.

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

Not applicable. This is not a study assessing device performance on a clinical or imaging dataset. The "test" is the demonstration of substantial equivalence through comparison of device characteristics and compliance with standards.

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. No ground truth was established by experts in this context.

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

Not applicable. No adjudication of a test set occurred.

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 not an AI/ML device, and no MRMC study was conducted.

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

Not applicable. This is not an AI/ML algorithm.

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

Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate device, against which the modified device's characteristics are compared for substantial equivalence.

8. The sample size for the training set

Not applicable. This device does not involve a training set.

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

Not applicable. This device does not involve a training set.

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Thommen SPI® EASY Dental Implant Abutments are intended to be used in conjunction with SP1® System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures.

Thommen SPI® EASY Dental Implant Abutments are endosseous dental implant abutments made of commercially pure grade titanium and intended for cemented restorations. They may be used for cemented single crowns or bridges. The existing abutments are offered in four diameterswith lengths from 6.0 mm to 9.0 mm. Straight abutments and abutments with angulation correction of 20° are available. The preangled abutments are also available in the four diameters, with lengths from 6.5 mm to 9.0 mm

The SPI® EASY abutments added by means of this Special 510(k) all are straight abutments and include lengths of 4.3 mm and 7.0 mm in each of the existing diameters. The shorter abutments are intended to reduce or eliminate the need for the clinician to prepare the abutment for restoration.

All SPI® EASY abutments may be used with allSPI® ELEMENT implants (those covered in the HA-Ti predicate device submissions referred to above), as well as withSPI® ONETIME implants, covered by Thommen Medical AG Special 510(k) K022038.

This document is a 510(k) premarket notification for a dental implant abutment, not a study evaluating a device's performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth cannot be extracted from this text.

The document primarily focuses on establishing "substantial equivalence" of the new SPI® EASY Dental Implant Abutment to previously cleared predicate devices. Substantial equivalence is a regulatory pathway for Class II and III medical devices (not requiring PMA) that demonstrates a new device is as safe and effective as a legally marketed device. This does not typically involve detailed performance studies with acceptance criteria in the manner requested for AI/software-as-a-medical-device (SaMD) evaluations.

Here's a breakdown of what can and cannot be extracted based on the provided text:

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

• Cannot be extracted. The document does not describe specific performance acceptance criteria or report device performance data. It focuses on demonstrating equivalence to predicate devices based on design, materials, and intended use. The closest "conformance" mentioned is that the materials (CP titanium Grade 4) meet ASTM F67 and ISO 5832-2, which are material specifications, not device performance criteria.

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

• Cannot be extracted. No test set or data provenance is mentioned. This is not a clinical study report.

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)

• Cannot be extracted. No ground truth establishment is described.

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

• Cannot be extracted. No adjudication method 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

• Cannot be extracted. No MRMC study or AI assistance is mentioned. This device is a physical dental implant abutment, not an AI/software device.

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

• Cannot be extracted. This is not an algorithm.

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

• Cannot be extracted. No ground truth is mentioned.

8. The sample size for the training set

• Cannot be extracted. No training set is mentioned.

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

• Cannot be extracted. No ground truth for a training set is mentioned.

Summary of Relevant Information from the Document:

• Device Type: SPI® EASY Dental Implant Abutment (physical medical device, not AI/SaMD).
• Regulatory Pathway: 510(k) Premarket Notification (special 510(k) for device modification).
• Goal of Submission: Demonstrate substantial equivalence to previously cleared predicate devices.
• Key Arguments for Equivalence:
  • Same intended use.
  • Same operating principle.
  • Same basic design (modified lengths added).
  • Same materials (commercially pure grade titanium).
  • Same packaging and sterilization processes.
• Material Conformance: CP titanium Grade 4 meets ASTM F67 and ISO 5832-2.
• Intended Use: "Thommen SPI® EASY Dental Implant Abutments are intended to be used in conjunction with SP1® System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures."

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