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The Spiraltech Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients esthetics and chewing function. Spiraltech implants are intended for single or multiple unit restorations on splinted or non-splinted applications. The implants ESi Dynamic and Ultimate are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants [along with Premium and One Piece] can also be used for loading after a conventional healing period.

Solo One Piece 3.0 and 3.3 implants, Ultimate (conical) 3.0 implants, and ESi (conical) 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.0 and/or 3.3 implants adjacent to one another.

The SpiralTech implant system is a comprehensive product line that includes implants, corresponding abutments, and closure screws. SpiralTech dental implants are grade 5 titanium (Ti 6Al-4V ELI, conforms to ASTM F136) implants that come in 2 different surface treatments - SLA, and RBM.

SpiralTech dental implants come in five product lines with four based on their thread designs. The ESi has sharp, square, and rounded threads. The Ultimate and Dynamic lines also have sharp threads with the Dynamic having a reverse buttress thread design. The Premium line features square and sharper threads in a more conventional design. The implants have diameters ranging from 3.0 mm, and the lengths from 8mm to 15 mm. ESi, Ultimate, and Dynamic are intended to be used for immediate loading. The fifth implant type is the One Piece which comes with an abutment which cannot be used with low mechanical stability cases.

Abutments are available in various types including straight, shoulder, angulated, ball attachments, multiunit, temporary and healing. All abutments come in both hex and conical connections. Temporary abutments come in PEEK and zirconia. Healing abutments come in titanium alloy and zirconia. Abutments come in titanium alloy and as a titanium base with zirconia abutments and multi-units are titanium alloy. No SpiralTech abutments are intended to be modified.

The SpiralTech Dental Implant System's acceptance criteria and studies are focused on demonstrating substantial equivalence to predicate devices, rather than establishing direct clinical performance metrics against a defined standard. Therefore, the device performance is reported in terms of equivalence to established devices and compliance with relevant standards.

Here's an breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This section is derived from the "Non-Clinical Testing" and "Substantial Equivalence" sections, as well as the comparison tables. The acceptance criteria essentially reflect conformance to established standards and similarity to predicate devices.

2. Sample size used for the test set and the data provenance

The document describes non-clinical laboratory testing, not clinical studies involving patient data. Therefore, there isn't a "test set" in the sense of patient data.

• Sample Size for Testing: The specific sample sizes for fatigue testing, sterilization validation, SEM/EDS analysis, and biocompatibility testing are not explicitly stated in the provided text. They are implied to be sufficient for compliance with the referenced ISO and ASTM standards.
• Data Provenance: The studies are non-clinical, laboratory-based tests conducted following international standards (ISO, ASTM, USP). There is no country of origin for "data" in the context of patient information, nor is it retrospective or prospective. The data originates from the manufacturer's testing or contracted laboratories.

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

Not applicable. This device's approval is based on substantial equivalence through non-clinical testing and comparison to predicate devices, not on interpretation of patient data by a panel of human experts.

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

Not applicable, as there is no "test set" requiring expert adjudication.

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 document pertains to a dental implant system, which is a physical medical device, not an AI-powered diagnostic or decision support system.

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

Not applicable, as this is not an algorithm-based device.

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

The "ground truth" in this context is the established performance and safety requirements outlined in international standards (ISO, ASTM, USP) for dental implants and materials, as well as the documented characteristics of the predicate and reference devices. For example:

• Sterility: Demonstrated by meeting specified sterility assurance levels (SAL) according to ISO standards.
• Mechanical Strength: Demonstrated by meeting fatigue resistance criteria according to ISO 14801.
• Biocompatibility: Demonstrated by passing cytotoxicity tests (MEM elution) and material characterization (SEM, EDS) in accordance with relevant standards.
• Design & Materials: Comparison to the known, established designs and materials of legally marketed predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. There is no "training set."

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