(118 days)
MIST IC abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single-unit or multi-unit, cement retained prosthesis in the mandible or maxilla. MIST IC abutments are compatible for use with the following implants:
| Compatible Implant Systems | Implant Body Diameter, mm | Implant Platform, mm |
|---|---|---|
| Biomet 3i OSSEOTITE® Certain® | 3.25 | 3.4 |
| 4.0 | 4.1 | |
| 5.0 | 5.0 | |
| 6.0 | 6.0 | |
| NobelActive® (conical connection) | 3.5 | 3.5 (NP) |
| 4.3, 5.0 | 3.9 (RP) | |
| 5.5 | 5.1 (WP) | |
| NobelReplace Conical Connection | 3.5 | 3.5 (NP) |
| 4.3, 5.0 | 3.9 (RP) | |
| NobelParallel Conical Connection | 3.75 | 3.5 (NP) |
| 4.3, 5.0 | 3.9 (RP) | |
| 5.5 | 5.1 (WP) | |
| Replace Select Tapered TiUnite | 3.5 | 3.5 (NP) |
| 4.3 | 4.3 (RP) | |
| 5.0 | 5.0 (WP) | |
| 6.0 | 6.0 | |
| Replace Select Tapered PMC | 3.5 | 3.5 (NP) |
| 4.3 | 4.3 (RP) | |
| 5.0 | 5.0 (WP) | |
| 6.0 | 6.0 | |
| Replace Select TC | 3.5 | 3.5 (NP) |
| 4.0 | 4.3 (RP) | |
| Zimmer Screw-Vent® | 3.7 | 3.5 |
| 4.7 | 4.5 | |
| Zimmer Tapered Screw-Vent® | 3.7, 4.1 | 3.5 |
| 4.7 | 4.5 | |
| 6.0 | 5.7 |
All digitally designed custom abutments for use with MIST IC abutments are to be sent to an Imagine Milling Technologies validated milling center for manufacture.
MIST IC abutments for Biomet 3i Certain 3.25 mm implant bodies are indicated for maxillary lateral and mandbular central/lateral incisors only.
MIST IC from Imagine Milling Technologies, LLC is a line of Ti-base and machinable blank abutments to interface with compatible dental implants from 3 manufacturers, a total of 14 implant-abutment interface compatibilities. The compatible implant body diameters range from 3.25 mm to 6.0 mm and the corresponding implant platform diameters range from 3.4 mm. The subject device prosthetic platform diameters range from 3.8 mm. All stock subject device components (abutments and abutment screws) are made of titanium alloy conforming to ASTM F136. The subject device MIST IC L-LINK abutments have a TiN coating achieved through a physical vapor deposition (PVD) process that is identical to the process used for TiN coating of Imagine Milling Technologies, LLC devices cleared in K 182246. The PVD cathodic arc evaporation process is a high current, low voltage process in which material evaporated from the cathode (Ti) is ionized, transported through the vacuum chamber with reactive gas (N2) and deposited as a non-porous, thin film on the titanium substrate.
Each abutment is supplied with the non-sterile abutment screw designed for attachment to the corresponding compatible OEM implant.
All patient-specific abutment fabrication for all MIST IC abutments is by prescription on the order of the clinician. All MIST IC abutments are intended to be milled at an Imagine Milling Technologies, LLC validated milling center under FDA quality system regulations.
MIST IC L-LINK abutments are two-piece abutments to be used as a base when fabricating a CAD-CAM customized restoration where the superstructure produced will compose the second part of the two-piece abutment; the assembly becoming a final finished medical device after cementation on the subject device abutment. They are provided in straight designs, with engaging and non-engaging connections. The L-LNK abutments and corresponding zirconia superstructure are provided to the clinician either with the superstructure cemented to the abutment by the dental laboratory, or separately for the clinician to bond together chairside using the cement recommended in the labeling (RelyX RMGIP bonding cement, cleared in K022476).
Design parameters for the L-LINK zirconia superstructure are: Minimum wall thickness - 0.5 mm Minimum post height for single-unit restoration - 4.0 mm Minimum gingival height of the coping - 0 mm (all L-LINK bases have minimum gingival height of 0.5 mm) Maximum gingival height – 5.0 mm Maximum angle - 20°
All zirconia copings (superstructures) for use with the subject device MIST IC L-LINK abutments will conform to ISO 13356.
MIST IC PREFIT abutments are cylindrical abutments designed for patient-specific abutment fabrication by a CAD-CAM process and machined into a one-piece, all titanium abutment. The portion of the abutment available for milling is either 9.9 mm in diameter by 20 mm in diameter by 20 mm in diameter by 20 mm in length. MIST IC PREFIT abutments have an engaging connection.
Design parameters for the PREFIT patient specific abutment are: Minimum wall thickness - 0.5 mm Minimum post height for single-unit restoration - 4.0 mm Minimum gingival height - 0.5 mm Maximum gingival height - 5.0 mm Maximum angle - 30°
The provided text describes the regulatory clearance of a dental device, "MIST IC." It outlines the device's intended use and compares it to a predicate device. However, it does not contain explicit information about acceptance criteria or a specific study proving the device meets those criteria, especially in the context of AI performance.
This document focuses on establishing substantial equivalence for regulatory purposes, relying heavily on non-clinical testing and comparison to an existing predicate device. The information provided is primarily relevant to the safety and mechanical performance of the dental implant abutments, not AI/algorithm performance.
Therefore, many of the requested fields cannot be directly answered from the provided text.
Here's a breakdown of what can and cannot be extracted from the document based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of numerical thresholds or performance metrics for an AI algorithm. Instead, it lists non-clinical tests performed to demonstrate substantial equivalence to the predicate device and ensure safety and efficacy.
| Acceptance Criteria Category | Specific Test/Evaluation | Reported Device Performance / Outcome |
|---|---|---|
| Material & Biocompatibility | Biocompatibility according to ISO 10993-5 and ISO 10993-12 | Found compatible |
| Sterilization | Sterilization validation according to ISO 17665-1 and ISO 17665-2 | Validated |
| Mechanical Strength | Static and dynamic compression-bending testing according to ISO 14801 | Fatigue limit data demonstrated sufficient strength for intended use |
| Magnetic Resonance (MR) Safety | Non-clinical analysis of metallic subject devices and compatible OEM implant bodies in MR environment (per FDA guidance) | Addressed parameters including magnetically induced displacement force and torque |
| Compatibility | Reverse engineering of OEM implant bodies, OEM abutments, and OEM abutment screws | Confirmed compatibility for each of the compatible OEM implant system interfaces |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document refers to "non-clinical testing data" but does not detail the sample sizes for these tests or the provenance of any data beyond indicating it's for dental implant abutment compatibility and mechanical strength. There is no mention of an "AI test set."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. The document describes mechanical performance and material compatibility testing, not a study requiring expert-established ground truth for an AI algorithm.
4. Adjudication Method for the Test Set
This information is not provided. As no "test set" for AI or expert review is mentioned, adjudication methods are not applicable here.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical data were included in this submission." This type of study typically involves human readers and is clinical in nature.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document describes a physical medical device (dental implant abutments) and its mechanical and material properties. There is no mention of an AI algorithm or standalone algorithm performance.
7. The Type of Ground Truth Used
For the non-clinical tests mentioned, the "ground truth" is established by objective engineering standards and validated testing protocols (e.g., ISO 14801 for mechanical testing, ISO 10993 for biocompatibility). There is no "expert consensus," "pathology," or "outcomes data" as ground truth for an AI in this context.
8. The Sample Size for the Training Set
This information is not provided. There is no mention of a training set as the document does not concern an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not provided as there is no mention of a training set or AI algorithm in the provided text.
Summary of what the document IS about:
The document is an FDA 510(k) clearance letter for the MIST IC dental abutment. It establishes substantial equivalence to a predicate device (K182246) based on:
- Non-clinical testing: Biocompatibility, sterilization, MR compatibility, reverse engineering for compatibility, and static/dynamic compression-bending.
- Material properties: Both subject and predicate devices are made of Titanium Alloy (ASTM F136), with TiN coating for L-LINK abutments, and use zirconia copings (ISO 13356) and the same bonding cement (RelyX RMGIP).
- Design similarities: Similar CAD-CAM fabrication process, restoration types (single/multi-unit, cement-retained), and design parameters (minimum wall thickness, post height, gingival height, angulation).
- Intended Use: Supports a prosthetic device in partially or completely edentulous patients, compatible with various specified implant systems.
The text does not discuss, describe, or evaluate any AI component of the device.
§ 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.)