(134 days)
The Customized Abutments are intended for attachment to dental implants in order to provide support for customized prosthetic restorations. Customized Abutments are indicated for screwretained single restorations or cement-retained single or multi-unit restorations. The Customized Abutment will be attached to a dental implant using the included abutment screw.
Patient-Specific Abutment is compatible with following Implant Systems:
- Zimmer Tapered Screw-Vent®
/ Implant diameter size (mm): 3.7, 4.1, 4.7, 6.0/ Restorative Platform diameter (mm): 3.5, 4.5, 5.7 - Straumann® Bone Level Tapered Implant
/ Implant diameter size (mm): 3.3, 4.1, 4.8/ Restorative Platform diameter (mm): 3.1, 3.7, 4.4
All digitally-designed Customized abutments are intended to be sent to an ARUM DENTISTRY validated milling center for manufacture.
Patient-specific abutment is made from Ti-6Al-4V Eli conforming to ASTM F136 to be used in fabricating patient-specific abutments. The subject devices are indicated for cemented or screwand cement retained prosthesis (SCRP) restorations. Each patient-specific abutment is individually prescribed by the clinician.
The diameters of patient-specific abutment are 3.3, 3.7, 4.1, 4.7, 4.8, 6.0 mm and Hex and square connection design.
Customized abutments are supplied with an abutment screw and provided non-sterile.
The provided text describes the regulatory clearance (K234112) for the ARUM DENTISTRY Co., Ltd. Customized Abutment, particularly focusing on its substantial equivalence to a predicate device (K223634). The information provided does not outline acceptance criteria for an AI/ML powered device, nor does it detail a study proving the device meets AI/ML specific acceptance criteria.
The information provided pertains to a traditional medical device (dental abutments) and focuses on engineering and material performance rather than AI/ML algorithm performance.
Therefore, many of the requested fields regarding AI/ML specific criteria cannot be extracted from the given text.
However, I can provide information on the non-clinical tests conducted for the Customized Abutment device, which are analogous to acceptance criteria and performance data for this type of medical device.
1. Table of Acceptance Criteria and the Reported Device Performance (Non-AI/ML):
| Non-Clinical Test/Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Biocompatibility | Demonstrated by the reference ARUM DENTISTRY submission, K223634, using Ti-6Al-4V Eli conforming to ASTM F136 and the same materials and manufacturing processes. Implied to meet ISO 10993-5 and ANSI/AAMI ST72. |
| Sterilization Validation | The Customized Abutment is delivered non-sterile for end-user sterilization. The recommended sterilization has been validated according to ISO 17655-1 and applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015." The worst-case construct was tested, and results demonstrated equivalence to the predicate devices. |
| MRI Safety | Non-clinical worst-case MRI Review was performed. Evaluation was based on scientific rationale and published literature, considering the entire system (all compatible implant bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque. |
| Mechanical Performance (Static and Fatigue) | Demonstrated through static and fatigue testing according to ISO 14801. (Specific numerical results are not provided in the text, but the successful completion of these tests indicates meeting performance requirements for the device type.) |
| Compatibility with Implant Systems | Reverse engineering of OEM implant bodies, OEM abutments, and OEM abutment screws was performed to confirm compatibility with listed implant systems (Zimmer Tapered Screw-Vent® and Straumann® Bone Level Tapered Implant). |
| Manufacturing Process Control | All digitally-designed Customized abutments are intended to be sent to an ARUM DENTISTRY validated milling center for manufacture. This implies adherence to established quality control for manufacturing precision. |
2. Sample size used for the test set and the data provenance:
- Mechanical Testing (Static and Fatigue): The document mentions "The worst-case construct was tested" for sterilization and that "static and fatigue testing according to ISO 14801" was conducted. Specific sample sizes are not provided.
- Data Provenance: The non-clinical tests were conducted internally or by contractors to ARUM DENTISTRY. The document does not specify a country of origin for the data beyond ARUM DENTISTRY Co., Ltd. being in the Republic of Korea. These are most likely prospective tests conducted specifically for this submission.
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):
This information is not applicable and not provided as the approval is for a physical dental abutment, not an AI/ML algorithm requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. "Adjudication" typically refers to resolving discrepancies in expert labeling or diagnoses for AI/ML ground truth, which is not relevant here.
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:
This is not applicable. No MRMC study was conducted as the device is a physical dental abutment, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical tests, the "ground truth" is defined by the standards and specifications used (e.g., ASTM F136 for material, ISO 14801 for mechanical testing, ISO 17655-1 for sterilization, FDA guidance for MRI safety). The device's performance is compared against the requirements of these established standards.
8. The sample size for the training set:
This is not applicable. The device is a physical product, not an AI/ML model that requires a training set. The device design parameters are "trained" through engineering design principles and verified through physical testing.
9. How the ground truth for the training set was established:
This is not applicable. There is no training set as it's not an AI/ML algorithm. The design of the abutment relies on established engineering principles, material science, and compatibility specifications with existing implant systems.
§ 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.)