(124 days)
The Angulated Screw Channel (ASC) Solution Abutments and SI-BASE Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The ASC Solution Abutments and SI-BASE Abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: Scan files from desktop scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.
The intended use for the engaging ASC Solution Abutments and SI-BASE Abutments used with the Ø3.0 External-Hex implants, Ø3.3 PROVATA implants and Ø3.5/Ø4.0 Deep Conical implants are intended for use with a straight mesostructure component.
The intended use for the engaging ASC Solution Abutments and SI-BASE Abutments used with the Ø3.4 and Ø4.0 External-Hex implants. PROVATA implants and 03.5 and 04.3 TRI-NEX implants is limited to replacement of maxillary and mandibular lateral and central incisors.
The ASC Solution Abutments and SI-BASE Abutments for Compact Conical Abutments are intended for use on straight Compact Conical Abutments with a straight mesostructure component.
This submission includes two major components which make up the ASC Solution and SI-BASE Abutments - The ASC Solution and SI-BASE Abutment Base and the mesostructure restoration. Twopiece and three-piece abutments models are included. Two-piece abutments consist of the ti-base abutment and mesostructure. Three-piece abutments consist of the ti-base abutment, mesostructure, and compatible compact conical abutments.
The ASC Solution and SI-BASE Abutments are standard premanufactured titanium alloy abutments for supporting a dental restoration and mesostructure. The dental laboratory is to fabricate the mesostructure restoration by CAD/CAM technique out of zirconia. The ASC Solution and SI-BASE Abutments then serve as the interface between the endosseous implant and the zirconia restoration. The abutments are designed to support the restoration on an endosseous implant in order to restore chewing function for the patient.
The mesostructured restoration is a CAD/CAM designed prosthesis milled out of zirconia, which is designed to fit the abutment base in order to restore chewing function for the patient. Each restoration is custom designed using 3Shape Abutment Designer Software in order to meet the requirements of each patient on a case-by-case basis. Limitations have been put in place in 3Shape Abutment Designer in order to prevent malfunctioning of the restoration.
The ASC Solution and SI-BASE Abutments are compatible with the Southern Implants' Deep Conical, External Hex, Provata and Tri-Nex implants and screws. The abutments are manufactured from Titanium alloy conforming to ASTM F136 and are color coded by Titanium nitride coating (ASC Solution Abutments) or yellow anodizing (SI-BASE Abutments). The TiN coating and anodization processes are the same as used for previously cleared anodized titanium alloy devices in K163634. The Mesostructure restoration is to be manufactured from Zirconia - Sage Max NexxZr which has been previously cleared for use in K130991.
The digital workflow includes the following products (not subject devices to this submission):
- Ceramic material: Sage Max NexxZr Zirconia Restorative material (K130991)
- Cement: Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436)
- Intra-oral scanner: 3Shape E3 Desktop Scanner
- Abutment design software: 3Shape Abutment Designer Software (K151455)
- Milling machine: Roland DWX51D Milling Unit
The provided text describes the Angulated Screw Channel (ASC) Solution Abutments and SI-BASE Abutments for dental implants. The document is a 510(k) summary submitted to the FDA to demonstrate substantial equivalence to legally marketed predicate devices.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative manner with defined thresholds. Instead, it demonstrates compliance through comparison to predicate devices and adherence to relevant standards and guidance documents. The "reported device performance" is largely qualitative and comparative, focusing on demonstrating equivalence rather than meeting specific numerical performance targets.
However, based on the "PERFORMANCE DATA" section and "Table of Substantial Equivalence", we can infer the following:
| Acceptance Criteria (Inferred from regulatory requirements and predicate comparison) | Reported Device Performance (as demonstrated by the study) |
|---|---|
| Biocompatibility: Meet FDA Guidance Document for ISO 10993-1 and ISO 10993-5 (In-Vitro Cytotoxicity) | Materials are identical in formulation, processing, component interactions, and storage conditions to predicate device K193084. Performed biocompatibility testing per ISO 10993-1. |
| Sterilization: Validation per ISO 17665-1 and ISO 17665-2 | Validated sterilization instructions per ISO 17665-1 and ISO 17665-2 (though the device is provided non-sterile, indicating the sterilization protocol is for other components or processes). |
| Software Validation: Meet FDA Guidance Document for Off-The-Shelf Software Use in Medical Devices | Software validation testing performed per FDA Guidance Document. Verification and validation testing conducted for the abutment design library to demonstrate that restrictions prevent design outside allowable limitations. |
| Mechanical Performance (Fatigue): Meet ISO 14801 (dynamic compression-bending) | Dynamic testing performed on worst-case subject device constructs. Results demonstrated fatigue performance exceeding its indication and supported by bench testing previously cleared in K173706 and K222457. |
| MR Safety: Meet FDA Guidance Document "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" | MR safety testing performed on previously cleared devices (K222457). Subject devices compared to predicates and considered "equally MR Safe" as they are not worst-case in terms of material, size, or shape. |
| Design Workflow: Equivalent design and manufacturing workflows to predicates | Uses the same scanners (3Shape E3 Desktop Scanner) and software (3Shape Abutment Designer Software, WorkNC CAM software) and milling unit (Roland DWX51D) as the primary predicate. |
| Material Equivalence: Identical or similar materials to predicates | Titanium Grade 5 Alloy (ASTM F136) for abutments and screws, Zirconia (Sage Maxx NexxZr, K130991) for restoration material, consistent with predicates. |
| Indications for Use: Similar to predicate and reference devices | Indications for use statement is very similar to predicate and reference devices, differing only in device name and specific application paragraphs, but expressing shared intended use. |
2. Sample sizes used for the test set and the data provenance
- Sample Sizes for Test Set:
- Biocompatibility: Not explicitly stated as a number of devices. The statement mentions "materials are identical in formulation, processing, component interactions, and storage conditions to the predicate device" and "biocompatibility testing per the FDA Guidance Document for Use of Standard ISO 10993-1... and ISO 10993-5 'Biological Evaluation of Medical Devices - Part 5: Tests for In-Vitro Cytotoxicity' was performed." This implies biological samples were used for in-vitro cytotoxicity, but the number is not specified.
- Mechanical Performance (Fatigue): "Dynamic testing was performed on worst-case subject device constructs." The exact number is not provided, but typically, mechanical fatigue testing involves a statistically significant number of samples per "worst-case construct" to establish fatigue limits.
- Software Validation: Not explicitly stated as a numerical sample size. It involved verification and validation for the "abutment design library" and screenshots under user verification testing, indicating a functional test rather than a numerical sample size.
- MR Safety: Not explicitly stated for the subject device. It refers to testing performed on "previously cleared devices, K222457, PROVATA Implant System."
- Data Provenance: Not explicitly stated for any of the tests. Given it's a 510(k) summary, the testing was likely conducted by or on behalf of Southern Implants (Pty) Ltd, which is located in "Irene, Gauteng, 0062 South Africa." The studies appear to be non-clinical (bench testing) and retrospective in the sense that they rely on comparisons to previously cleared devices and established standards, rather than new prospective human clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The studies described are primarily non-clinical bench testing, software validation, and biocompatibility assessments, which typically do not involve establishing "ground truth" through expert consensus in the way a diagnostic AI device would. Instead, performance is measured against engineering specifications, standards (like ISO 14801), and equivalence to predicate devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable to the types of non-clinical, hardware-focused studies described. Adjudication methods are typically used in clinical studies or studies evaluating subjective interpretations (e.g., image reading) to establish a consensus ground truth.
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
There was no MRMC comparative effectiveness study and no mention of AI assistance. This device is a component for dental implants (abutments), not a diagnostic AI system or an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical component (dental abutment) and related software for design. While software validation was performed, it's for design limitations and functionality, not for an "algorithm only" performance in a diagnostic or interpretive sense. The "standalone" concept typically applies to AI algorithms that provide a diagnosis or interpretation without human intervention.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as it applies to diagnostic or prognostic data is not directly applicable to these non-clinical studies. Instead, the "truth" or reference for the tests described is:
- Biocompatibility: Established biological safety standards (ISO 10993-1, ISO 10993-5) and comparison to predicate device materials.
- Mechanical Performance: International standard ISO 14801 for dynamic fatigue testing of dental implants and abutments. This involves objective physical measurements.
- Software Validation: Functional specifications of the software and demonstration that defined design limitations are enforced.
- MR Safety: FDA guidance document recommendations and physical testing methods to determine MR compatibility.
8. The sample size for the training set
This information is not applicable. This device is not an AI diagnostic or predictive algorithm that requires a training set in the conventional sense. The "design workflow" involves CAD/CAM software but this refers to a process for custom fabrication, not machine learning model training.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as point 8.
§ 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.)