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DESS® dental implants are indicated for surgical placement in the upper or lower jaw in edentulous or partially edentulous patients for anchoring tooth replacements to restore patient esthetics and chewing function. They are designed to support single or multi-unit restorations in splinted applications, as well as to support overdenture attachment systems. DESS® dental implants may be used for immediate or early implantation following extraction or loss of natural teeth, and may be used for immediate or delayed loading techniques. Implants may be loaded immediately when good primary stability is achieved and occlusal loading is appropriate. Implants of diameter 3.0 mm, 3.3 mm and 3.5 mm are indicated for use in reduced interdental spaces, where there is not enough alveolar bone for a larger diameter implant. The use of 3.0 mm, 3.3 mm and 3.5 mm diameter implants is intended only for rehabilitation of the anterior region of the mouth.

The purpose of this submission is to obtain marketing clearance for two designs of DESS Dental Implants. The implants are compatible with DESS Dental Smart Solutions abutments manufactured by the sponsor of this submission, Terrats Medical SL and cleared under K170588, K173908 and K191986. The new dental implants are parallel-walled root-form threaded endosseous dental implants made from unalloyed titanium, ranging in diameter from 3.0 mm to 5.5 mm and in length from 7 mm to 18 mm, as described more fully below.

This submission includes two designs of DESS Dental Implants, designated Active and Bone Level. The external portion of each design is threaded, with a uniform major diameter and a slightly decreasing minor diameter along the length of the apical portion of each is tapered and includes cutting flutes to facilitate the insertion of the implant into the alveolar bone. Both designs have an internal connection, an internal anti-rotation feature (used for engaging abutment designs) that also serves to facilitate insertion into bone, and an internal screw channel to secure an abutment. Differences between the designs include the type of antirotational feature which, in the Active implant is an internal hex and in the Bone Level implant is an internal 4-lobed design. The external thread of the Active implant ends below the crest of the implant and a machined collar with shallow grooves is located between the end of the external thread and the crest of the implant. The external thread of the Bone Level implant ends below the crest of the implant, and the collar is included in the surface treatment. The endosseous surface of each implant is treated with a grit blasting and acid etching process to provide a rough surface for attachment of bone.

The provided document describes the 510(k) premarket notification for the DESS Dental Implants. This is a regulatory submission for a medical device seeking substantial equivalence to already legally marketed devices, not a study proving the device meets acceptance criteria derived from a clinical trial or algorithm performance.

Therefore, the information typically requested in your prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not directly applicable to this type of regulatory submission. The document focuses on demonstrating substantial equivalence to predicate devices through design, materials, and non-clinical performance data, rather than establishing efficacy or accuracy through human reader studies or similar clinical investigations.

However, I can extract the relevant information from the document as it pertains to the device's characteristics and the non-clinical performance data provided to support its safety and effectiveness relative to predicate devices.

Here's a breakdown of what can be extracted based on your request, with an explanation of why some fields are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for substantial equivalence based on non-clinical data, there are no specific "acceptance criteria" in the sense of performance metrics from a diagnostic study, nor is there "reported device performance" in terms of clinical accuracy or reader improvement. Instead, the device's characteristics are compared to predicate devices, and testing ensures it meets established engineering and safety standards.

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

This information is not provided in the document as it refers to non-clinical bench testing, not a clinical test set from human data. The tests performed (sterilization, endotoxin, cytotoxicity, shelf-life, surface characterization, mechanical testing) would have involved a specific number of manufactured devices or material samples. The provenance is internal to the manufacturer's testing or contract labs.

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

Not applicable. There is no "test set" in the context of human data requiring expert ground truth in this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of human data requiring adjudication in this 510(k) submission.

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 medical device for surgical placement (dental implant), not an AI-powered diagnostic tool. No MRMC studies were performed or are relevant to this submission.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical performance data, the "ground truth" would be established by:

• Standards Compliance: Meeting the specifications of international standards (ISO 11137, ANSI/AAMI ST72, ISO 10993, ASTM F1980, ISO 25178, ISO 14801).
• Material Specifications: Conforming to recognized material standards (ISO 5832-2).
• Engineering Specifications: The design and functional requirements of the implant itself (e.g., thread form, dimensions, anti-rotational features).

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable.

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