(271 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 System | Implant Body Diameter, mm | Implant Platform Name |
|---|---|---|
| Straumann Bone Level (CrossFit® Morse Taper) | 2.9 | SC |
| 3.3 | NC | |
| 4.1, 4.8 | RC | |
| Straumann® Tissue Level (CrossFit® Connection) | 3.3, 4.1, 4.8 | RN |
| 4.8 | WN | |
| Straumann BLX (TorcFit™ Internal Hexalobular) | 3.5, 3.75, 4.0, 4.5 | RB |
| 5.0, 5.5, 6.5 | WB | |
| Neodent GM (Morse taper) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | Grand Morse (GM) |
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 from Imagine Milling Technologies, LLC is a line of Ti-base and machinable blank abutments to interface with compatible dental implants from four (4) manufacturers, and a total of eight (8) implant-abutment interface compatibilities. The subject device prosthetic platform diameters range from 3.8 mm to 6.9 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 K222368. 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 with engaging and non-engaging connections.
The L-LINK 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 required in the labeling (RelyX RMGIP bonding cement, cleared in K022476).
The design parameters for L-LINK patient-specific abutments are:
- Minimum wall thickness – 0.5 mm
- Minimum cementable post height for single-unit restoration – 4.0 (minimum cementable post height for single-unit restoration is defined as the height above the restorative margin)
- Minimum gingival height – 0.5 mm
- Maximum gingival height (for all except Straumann BLX L-Link) – 5.0 mm
- Maximum gingival height (for Straumann BLX L-LINK) – 6.0 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 length or 13.9 mm in diameter by 20 mm in length. MIST IC PREFIT abutments have an engaging connection.
The design parameters for PREFIT patient-specific abutments are:
- Minimum wall thickness – 0.5 mm
- Minimum cementable post height for single-unit restoration – 4.0 (minimum cementable post height for single-unit restoration is defined as the height above the restorative margin)
- Minimum gingival height – 0.5 mm
- Maximum gingival height (for all except Straumann BLX PREFIT) – 5.0 mm
- Maximum gingival height (for Straumann BLX PREFIT) – 6.0 mm
- Maximum angle – 30°
The provided document is a 510(k) clearance letter for a dental device, specifically dental implant abutments. It details the device's administrative information, predicate devices, indications for use, subject device description, and performance data used to demonstrate substantial equivalence.
However, the document does not contain any information regarding acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm. The performance data section refers to non-clinical analyses, such as MR compatibility, sterilization validation, biocompatibility, mechanical properties testing, reverse engineering, and static/dynamic compression-bending testing conforming to ISO 14801. These are standard tests for mechanical dental devices, not AI/ML performance evaluation.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving an AI device meets them based on the given text. The device described, "Mist IC," is a physical dental implant abutment, not an artificial intelligence/machine learning (AI/ML) powered medical device.
To directly answer your prompt based on the provided text, the following information is missing or not applicable:
- A table of acceptance criteria and the reported device performance: Not applicable. The document describes mechanical and material performance testing for a physical device, not AI/ML performance metrics like sensitivity, specificity, or AUC against defined acceptance criteria for an AI algorithm.
- Sample sizes used for the test set and the data provenance: Not applicable. There is no AI/ML test set. The document refers to testing of physical components (OEM implants, abutments, screws, subject device constructs).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No AI/ML ground truth establishment.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's performance would be the physical properties and mechanical integrity verified by engineering standards (e.g., ISO 14801).
- The sample size for the training set: Not applicable. No AI/ML training set mentioned.
- How the ground truth for the training set was established: Not applicable. No AI/ML training set mentioned.
The document focuses solely on the substantial equivalence of the "Mist IC" dental implant abutments to legally marketed predicate devices based on design, materials, manufacturing, and conventional mechanical/material performance testing.
§ 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.)