(244 days)
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.
| Acceptance Criteria (Implied by Substantial Equivalence and Testing) | Reported Device Performance (from "Performance Data" & "Clinical Data" sections) |
|---|---|
| Sterility (SAL 10⁻⁶) | Validated according to ISO 17665-1 and ISO 17665-2, demonstrating a sterility assurance level (SAL) of 10⁻⁶. |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation) | Tested according to ISO 10993-5 (cytotoxicity) and ISO 10993-10 (sensitization and irritation), demonstrating acceptable biocompatibility. |
| Electrical Safety (if applicable - though less relevant for an abutment) | Electrical safety analysis according to AAMI / ANSI ES60601-1:2005/(R) 2012 and related IEC standards, demonstrating acceptable electrical safety (though the relevance for a non-powered dental abutment is minimal, it was part of the submission). |
| Thermal Properties | Tested according to ASTM F2004, showing acceptable transition temperatures. |
| Corrosion Resistance | Tested according to ASTM G71 and ASTM F2129, and nickel leaching evaluation, showing acceptable corrosion resistance. |
| Retention Strength | Retention testing, showing acceptable retention strength. |
| Compatibility with OEM Implants | Reverse engineering and dimensional analysis of OEM devices, showing that the Rodo Abutment is compatible with corresponding OEM implants. |
| Mechanical Performance / Dynamic Compression-Bending | Dynamic compression-bending testing according to ISO 14801, showing mechanical performance sufficient for its intended use. |
| Clinical Safety & Effectiveness (for intended use) | A prospective multi-center clinical trial demonstrating safety and effectiveness. Overall conclusion: "Rodo Abutment System provides an appropriate method of attaching prosthetic restorations to dental implant abutments. If necessary, it allows repeated removal of the restoration, as is the case for screw-retained restorations on dental implant abutments." |
| Substantial Equivalence in Indications for Use | "The subject device is substantially equivalent in indications and design principles to the predicate devices shown above." Minor differences in Indications for Use language between the systems do not change the intended use. |
| Substantial Equivalence in Design/Technology | Similar technological characteristics, similar materials, similar range of physical dimensions (diameter, gingival height, angle), similar packaging and sterilization methods compared 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.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)