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Straumann® Bone Level Tapered Implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann Bone Level Tapered Implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments).

The subject devices represent a line extension of the previously cleared Bone Level Tapered Implants of the Straumann Dental Implant System (K140878 and K150938). The subject devices have the same diameters (3.3, 4.1 and 4.8 mm), the same implant-to-abutment interfaces (NC, RC), the same material (Ti-13Zr) and the same surface finishes (SLA, SLActive) as the identified primary predicate devices. The subject devices differ in that the lengths are 18 mm versus a maximum length for the primary predicate devices of 16 mm.

This document describes the Straumann® Bone Level Tapered Implants, a line extension of existing dental implants. The new implants are identical to previously cleared devices except for an increased length (18mm vs. previous maximum of 16mm).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the new 18mm implant length in a quantitative format as would typically be seen for AI/ML device performance. Instead, it relies on comparison to predicate devices and performance of specific bench tests. The primary acceptance criteria for the new device appear to be:

• Substantial Equivalence: The subject device is substantially equivalent to the identified predicate devices in terms of indications for use, technological characteristics (except length), and performance.
• Safety and Effectiveness through Bench Studies: The device must satisfactorily address safety and effectiveness through relevant bench studies, particularly dynamic fatigue, biological compatibility, sterilization validation, and shelf life, consistent with FDA guidance and ISO standards.
• No New Failure Modes: The new, longer implants, especially the smallest diameter (3.3mm), must not introduce new failure modes compared to predicate or reference devices when tested under simulated clinical conditions.

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

• Test Set Sample Size: Not explicitly stated as a number of devices or clinical cases. The "test set" here refers to the samples used in the bench studies.
  • For the peak insertion torque study: "all three diameters of the subject device" were tested. It is not specified how many samples per diameter were tested.
  • For the studies incorporated by reference (dynamic fatigue, biological compatibility, sterilization, shelf life), the sample sizes are not provided in this document but would have been part of the K140878 submission.
• Data Provenance: Bench studies. There is no indication of human clinical data or geographical origin for this specific submission, as it focuses on extended length and comparison to predicates through bench testing.

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

Not applicable in the context of this submission. The "ground truth" for these types of mechanical and biological tests is derived from standardized testing methods and material properties, not expert clinical interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are relevant for studies involving human reviewers or subjective interpretations. The studies described are objective bench tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

Not applicable. This device is a physical dental implant, not an AI/ML-driven diagnostic or assistive software. Therefore, no MRMC or AI-related studies were performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable, as this is not an AI/ML device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance claims in this submission is established through:

• Standardized Bench Testing: Adherence to international standards (e.g., ISO 14801, ISO 10993, ISO 11137, ASTM F1980) for mechanical strength, biocompatibility, sterilization, and stability.
• Material Specifications: Properties of the Roxolid® (Ti-13Zr) alloy and other materials.
• Clinical Experience/Predicate Devices: The established safety and effectiveness of the existing Straumann® Bone Level Tapered Implants and reference devices.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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Straumann® dental implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.

The subject devices represent a line extension of the previously cleared Bone Level implants of the Straumann Dental Implant System (K062129, K083550 and K121131). The subject devices have the same diameters (3.3, 4.1 and 4.8 mm), the same implant-to-abutment interfaces (NC, RC) the same lengths (8 to 14 mm), the same materials (CP Ti and Ti-13Zr) and the same surface finishes (SLA, SLActive) as the identified predicate devices. The subject devices differ in that the apical aspect of the implants incorporate a tapering thread form, the apical aspect of the implants incorporate three cutting flutes, an additional length of 16mm and the transfer piece is of a new design.

The provided text is a 510(k) premarket notification for a medical device, specifically dental implants. It focuses on demonstrating substantial equivalence to existing predicate devices rather than providing acceptance criteria and performance data in the traditional sense of a study proving performance against defined metrics.

Therefore, much of the requested information cannot be extracted directly from this document because it describes a different type of regulatory submission. This document aims to establish that the new device is as safe and effective as a legally marketed predicate device, not necessarily to meet specific, quantifiable performance targets with a detailed clinical study.

However, I can extract information related to the device characteristics and the type of evidence provided for substantial equivalence.

Here's what can be extracted and what cannot:

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

• Cannot be fully provided as requested. The document doesn't define explicit "acceptance criteria" against which the device performance is measured in a quantitative manner, like sensitivity, specificity, accuracy, or a specific failure rate.
• Instead, for dental implants, "performance" is demonstrated through technological characteristics and non-clinical bench studies (specifically dynamic fatigue testing) to show "substantial equivalence" to predicate devices.
• The comparison table provided (Page 6) shows technological characteristics of the subject device (Straumann® Bone Level Tapered Implants) versus predicate devices. This implicitly suggests that being similar or equivalent in these characteristics is the "acceptance criteria" for substantial equivalence.

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 provided. The document refers to "bench studies" for dynamic fatigue testing (Page 7). This typically involves mechanical testing rigs, not human or animal subjects, so terms like "test set," "data provenance," "retrospective/prospective" in a clinical sense are not applicable. The sample size for materials testing would be part of the ISO 14801 standard and the specific test protocols, which are not detailed in this summary.

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

• Not applicable. This information is relevant for studies involving human interpretation or pathology, which is not the case for this technical submission based on bench testing.

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

• Not applicable. See point 3.

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 device is a dental implant (a physical medical device), not an AI software.

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

• Not applicable. See point 5.

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

• For the bench testing (dynamic fatigue), the "ground truth" or standard for acceptable performance would be defined by ISO 14801 standards and FDA guidance for dental implants. Success is failure to fracture or deform beyond acceptable limits under specified loading conditions.
• For the overall substantial equivalence determination, the "ground truth" is typically the performance of the legally marketed predicate devices. The new device aims to be as safe and effective as these established devices.

8. The sample size for the training set

• Not applicable. This device is hardware, not an AI algorithm requiring a training set in the computational sense.

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

• Not applicable. See point 8.

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