(271 days)
The HIOSSEN Pre-milled Abutments are intended for use with HIOSSEN dental implants to provide support for prosthetic restorations such as crowns, bridges or overdentures. All digitally designed CAD/CAM customizations for the HIOSSSEN Pre-milled Abutments are intended to be sent to a HIOSSEN validated milling facility.
HIOSSEN Pre-milled Abutments are intended to support prosthetic restorations such as crowns, bridges or overdentures and used only with the Hiossen implant fixtures. HIOSSEN Pre-milled Abutments are customized (Milled) as per the patient specific requirements in the Hiossen validated milling laboratory. The HIOSSEN Pre-milled Abutments are designed and manufactured by Hiossen, Inc.
The HIOSSEN Pre-milled Abutments are Ti-6Al-4V titanium alloy (ASTM F136) cylindrical "blanks" with HIOSSEN dental implant-specific interface (abutment to implant connection and screw channel) to be designed and milled at a HIOSSEN validated milling facility using CAD/CAM technology to fabricate a patient-specific abutment.
The blank cylindrical HIOSSEN Pre-milled Abutments are supplied to the Hiossen validated milling centre. Based on the design requirements provided by the dentist, the lab will design abutment using 510k cleared CAD software and blank cylinders will be milled using the CAM machine. This customized patient specific milled abutment will be sent back to the dentist for implantation into the patient after steam sterilization.
Here's a summary of the acceptance criteria and study information for the HIOSSEN Pre-milled Abutment device, based on the provided FDA 510(k) K241003 submission:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) submission for the HIOSSEN Pre-milled Abutment does not list specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) in the way one might see for AI/software devices. Instead, the acceptance criteria are met by demonstrating compliance with established performance standards and regulations for this type of medical device. The "reported device performance" is demonstrated through successful compliance with these standards and the comparison to legally marketed predicate and reference devices.
| Acceptance Criterion Type | Specific Requirement/Standard | Reported Device Performance (Summary) |
|---|---|---|
| General Controls | 21 CFR 872.3630 (Class II), Annual Registration, Listing, GMP, Labeling, Misbranding/Adulteration prohibitions | Device deemed substantially equivalent to predicate, subject to these general controls. |
| Special Controls | "Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments" | Device complies with requirements of this guidance document. |
| Design Controls | 21 CFR 820 (Quality System Regulation), 21 CFR 820.30 (Design controls), Risk Management, Verification, Validation | Device developed as per 21 CFR 820 and completed design control activities. |
| Labeling and IFU | ISO 15223-1:2021, ISO 20417:2021 | Device complies with these standards. |
| Biocompatibility | ISO 10993-1:2018 | Leveraged from predicate device (K123627) which was evaluated per this standard. |
| Sterilization | ISO 17665-1:2006, ISO TS 17665-2:2009, ANSI/AAMI ST79:2010 | Leveraged from predicate device (K123627) as there are no differences in method/parameters. |
| MR Safety | FDA guidance "Testing and Labelling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" | Non-clinical worst-case MRI review performed using scientific rationale and published literature, addressing displacement force and torque. |
| Substantial Equivalence | Demonstrated similarity in Indications for Use, Design, Materials, Sterility, Manufacturing Process to predicate and reference devices. | Device shown to be substantially equivalent to ET SMARTFit Abutment (K123627) and other reference devices (K221972, K140934, K151626, K153332, K183242, K203360). |
2. Sample Size Used for the Test Set and Data Provenance
The submission does not describe a traditional "test set" in the context of an algorithm or software requiring a dataset for performance evaluation. This device is a physical dental abutment. The "testing" refers to compliance with performance standards for physical properties, materials, and processes, rather than a data-driven performance study.
Therefore, information on sample size for a test set, data provenance (e.g., country of origin, retrospective/prospective), number of experts, adjudication methods, MRMC studies, or standalone algorithm performance is not applicable or not provided for this type of medical device submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as this is a physical medical device clearance, not an AI/software performance study involving ground truth establishment by experts on a dataset.
4. Adjudication Method for the Test Set
Not applicable for the same reasons as above.
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 physical dental abutment, not an AI-assisted diagnostic or therapeutic device for which a MRMC study would be relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical device, and there is no "algorithm only" component in the sense of AI software being evaluated for standalone performance. The CAD/CAM technology is part of the manufacturing process, not an independent diagnostic or interpretive algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this device, "ground truth" is established through engineering specifications, material standards, and validated manufacturing processes (e.g., accuracy of milling, material composition conformity), rather than clinical ground truth from human interpretation of data.
8. The Sample Size for the Training Set
Not applicable. The device is a physical product. While CAD/CAM technology is used in its customization, the submission does not refer to "training sets" in the context of machine learning. The "training" here would refer to the development and validation of the CAD/CAM technical specifications and milling processes.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as above. The "ground truth" for the manufacturing process involves adherence to design specifications, material properties, and validated milling parameters.
§ 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.)