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Rodo Abutment System is intended to be used in conjunction with compatible implant systems in the maxillary or mandibular arch to provide support for crowns, bridges or overdentures.

The Rodo Abutment System includes the Rodo Abutment, Smileloc Sleeve, Silicone Seal, Titanium Coping, Temporary Cap, abutment screws, and Smileloc Activator (or Smileloc Remover). The Smileloc Sleeve is used to lock and unlock the Titanium Coping for final restoration to or from the abutment. This makes the prosthesis removable.

Rodo Abutment is provided in five series designs (100 F. 200 P. 300 S. 400 M. 500 D) with the 200 P and 500 D series having angled abutments (17°, 30°), for a total of nine designs. The 200 P and 500 D series are designed for multi-unit restorations only, the 300 S series is designed for limited occlusal space, and the 400 M series is designed for large interproximal spaces. Abutments are available in sizes ranging from 0 3.0 mm depending on the compatible implant system in use. Designs are available with engaging and non-engaging implant-abutment interfaces.

The provided document is a 510(k) summary for the Rodo Abutment System, a dental device. It outlines the device's indications for use, its classification, and a comparison to predicate devices, but does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in terms of algorithm-based metrics (like sensitivity, specificity, or AUC) as would be typical for an AI/ML device.

The closest information available that might relate to "acceptance criteria" for a medical device (not specifically an AI/ML device) typically involves demonstrating substantial equivalence to a legally marketed predicate device through various tests and comparisons.

Here's an analysis based on the provided document, addressing the requested points:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a physical dental abutment system and not an AI/ML device, there are no specific performance metrics like sensitivity, specificity, or accuracy mentioned as "acceptance criteria" for an algorithm. Instead, the "performance" is demonstrated through various non-clinical and clinical tests to show safety and effectiveness and substantial equivalence to predicate devices.

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

• Sample Size (Clinical Trial): 34 subjects were enrolled, 32 subjects received Rodo Abutments and restorations. Out of these, 3 subjects received 4 abutments each as part of full arch treatment, resulting in a total of 41 Rodo Abutments placed and restored.
• Data Provenance: The document states, "A prospective multi-center clinical trial... was conducted under an Investigational Device Exemption study according to FDA guidelines." This indicates it's prospective data. The document does not explicitly state the country of origin, but given the FDA submission context, it's presumed to be a US-based study or at least data acceptable for US regulatory purposes.

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

This information is not provided in the document. For a physical device like a dental abutment, "ground truth" might refer to clinical outcomes assessed by trained dental professionals, but the study description does not detail the number or qualifications of experts involved in assessing device performance or generating the "ground truth" of safety and effectiveness outcomes beyond the medical staff conducting the trial.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods (like 2+1 or 3+1) are typically relevant for studies where multiple readers interpret data and discrepancies need to be resolved, which is common in imaging studies for AI/ML devices. For a clinical trial of a physical implant, such a method for "test set" adjudication is not typically described in this manner.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is specific to evaluating diagnostic performance, often of AI/ML systems or diagnostic tests, comparing multiple readers' interpretations of cases. The Rodo Abutment System is a physical dental device.

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

No, a standalone algorithm performance study was not done. The Rodo Abutment System is a physical dental device, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the clinical study, the "ground truth" for evaluating the Rodo Abutment System's safety and effectiveness was based on clinical outcomes data from human subjects who received the device. This included:

• Observation of adverse events (e.g., abutment screw loosening, crown separation, non-device related events).
• The overall clinical assessment that the system "provides an appropriate method of attaching prosthetic restorations to dental implant abutments" and "if necessary, it allows repeated removal of the restoration."

For non-clinical tests, the "ground truth" was based on engineering standards and direct measurement/testing results (e.g., SAL for sterility, acceptable ranges for biocompatibility, mechanical strength, corrosion resistance).

8. The Sample Size for the Training Set

This product is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The clinical and non-clinical data collected serve as validation for the device's design and manufacturing rather than training an algorithm.

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

As there is no training set for an AI/ML algorithm, this question is not applicable.

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The Inclusive® Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with Straumann Standard Plus Tissue Level Implants in RN (4.1mm and 4.8 mm) and WN (4.8 mm) sizes.

Inclusive® Titanium Abutments are endosseous implant abutments which are placed into the dental implant to provide support for a prosthetic restoration. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. Abutments and screws are made of titanium alloy (Ti-6AL-4V ELI) and meet ASTM F136 Standard. They are compatible with Straumann Standard Plus Tissue Level Implants in RN (4.1 mm and 4.8 mm) and WN (4.8 mm) sizes. Prismatik Dentalcraft. Inc. provides premanufactured titanium abutments of a stock type with no inherent angulation which require further modification to obtain the desired shape before being used. The modifications are intended to be performed by dental laboratories with laboratory hand tools, as delineated in the device's instructions for use.

This document describes a 510(k) premarket notification for Inclusive® Titanium Abutments compatible with the Straumann synOcta Implant System. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets those criteria in the same way a de novo or PMA submission might.

Therefore, the information you've requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not explicitly present in the provided text. The document employs a different regulatory strategy, relying on demonstrating that the new device is as safe and effective as devices already on the market through comparison and non-clinical testing.

Here's an analysis based on the available information, noting where specific requested details are not provided:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a table of explicit acceptance criteria with numerical targets and reported performance in the way a clinical trial or performance study would. Instead, substantial equivalence is demonstrated through a comparison table of attributes (Indications for Use, Dimensions, Connection, Sterility, Material, Abutment Angle, Abutment Seat, Screw Seat, Anatomical Site, Construction) where the proposed device is shown to be similar to legally marketed predicate devices.

The "reported device performance" is summarized by the outcome of non-clinical testing, which aimed to show implant-to-abutment compatibility and substantial equivalence, rather than meeting specific performance metrics against pre-defined acceptance criteria.

Summary of Comparative Attributes (from pages 6-7):

Study Details:

The study referenced is a non-clinical "Performance Data" study (Section G).

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "testing finished assembled implant/abutment systems of the worst case scenario," implying a limited number of samples chosen to represent the most challenging conditions rather than a statistically powered test set sample size.
• Data Provenance: Not specified, but generally, such non-clinical testing would be conducted in a laboratory setting by the manufacturer (Prismatik Dentalcraft, Inc.), which is based in Irvine, California, USA. It is prospective testing designed to evaluate the physical properties of newly manufactured components.

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)

• Number of Experts & Qualifications: Not applicable for this type of non-clinical, substantial equivalence submission. Ground truth in this context typically refers to objective material properties, mechanical integrity, and compatibility, which are established through standardized engineering tests rather than expert consensus on medical images or clinical outcomes.

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

• Adjudication Method: Not applicable. Non-clinical mechanical testing does not involve adjudication. Results are typically determined by direct measurement and adherence to specifications or established test methods (e.g., ASTM standards).

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

• MRMC Study: No. This submission is for a physical medical device (dental abutments), not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant.

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

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.

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

• Type of Ground Truth: For the non-clinical testing, the "ground truth" would be objective measurements derived from mechanical tests, such as fatigue strength, static load failure, and dimensional compatibility, compared against established engineering standards (e.g., ASTM F136 for material, and potentially other ISO or FDA recognized standards for dental implants/abutments). The document explicitly states testing was "in accordance with FDA Guidance 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments'."

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this device.

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