Search Results

MIS dental implant systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.

Narrow implants (Ø3.3mm & UNO) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

The long MIS (18 & 20 mm) implants can be used in a tilted manner.

MIS short implants are to be used only with straight abutments.

M4 short implants are indicated for delayed loading only.

Device Description

a. MIS LOCKiT Abutments System
MIS LOCKiT abutments system contains titanium abutments coated with titanium nitride (TiN). MIS LOCKIT abutments system is intended to be used in completely edentulous jaws and connects to an overdenture to allow its insertion and removal.

MIS LOCKiT abutments connect directly to the implant by their threading. MIS LOCKiT abutments are available in three different platforms (narrow platform (NP), standard platform (SP) and wide platform (WP)) and two connection types (conical connection and internal hex connection). LOCKiT abutments system contains straight abutments only.

MIS LOCKiT abutments are provided in the following gingival heights:

. Narrow platform: 1, 2, 3, 4, 5 mm
. Standard platform: 1, 2, 3, 4, 5 mm
Wide platform: . 1, 3, 5 mm

MIS LOCKIT internal hex connection abutments are compatible with MIS internal hex implants cleared under K040807 and K180282 (M4, LANCE and SEVEN Systems).

MIS LOCKiT conical connection abutments are compatible with MIS implants cleared under K112162, K163349 and K172505 (C1 and V3 Systems).

b. OT-Equators and Ball Attachments
Ball Attachments and OT-Equators are used to connect to an overdenture bar to allow its insertion and removal. They are connected directly to the implant by their distal threading, and are mostly used in complete edentulous jaws. The main difference between them is that ball attachments have a higher profile and ball shaped head, while the OT-equators have a lower profile and a truncated head. Both are made from Titanium 6Al-4V ELI and feature a Titanium Nitride (TiN) coating for increased resistance to wear.

Internal hex OT-Equators and Ball Attachments are available in three different platforms (narrow platform (NP), standard platform (SP) and wide platform (WP) and are available in the following gingival heights:

. Narrow platform: 1, 2, 3, 4, 5 mm
. Standard platform: 1, 2, 3, 4, 5 mm
Wide platform: 1, 3, 5 mm .

MIS Internal hex OT-Equators and Ball Attachments are compatible with MIS internal hex implants cleared under K040807 and K180282 (M4, LANCE and SEVEN Systems).

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA for dental implant abutments. It details the device, its intended use, and how it is substantially equivalent to legally marketed predicate devices. The document explicitly states that no clinical performance data was required or conducted for this device submission. Instead, the substantial equivalence was demonstrated through non-clinical performance data, primarily mechanical testing (fatigue testing), and comparisons to predicate devices.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of clinical performance (human-in-the-loop, MRMC, expert ground truth, training/test sets for AI models, etc.) is not applicable to this document. The device in question is a physical dental abutment, not an AI/software device that would typically undergo the kind of clinical validation described in the prompt.

However, I can extract the acceptance criteria and performance data for the mechanical testing which was used to demonstrate substantial equivalence:

Acceptance Criteria and Reported Device Performance (Non-Clinical / Mechanical Testing)

Acceptance Criteria (Equivalent to Predicate)	Reported Device Performance
Withstand 5,000,000 cycles without failure at a substantially equivalent load to cited predicates (for MIS Internal Hex LOCKiT abutments).	The test articles were able to withstand 5,000,000 cycles without failure at a substantially equivalent load to the cited predicates.
Equivalent mechanical properties to MIS Conical Connection CONNECT abutments (K173326) and Zest Locator® Implants Attachments (K072878) in terms of fatigue limit for MIS LOCKiT abutments.	Fatigue testing was conducted on MIS conical connection CONNECT abutments, which represent a worst-case in terms of mechanical properties due to geometric design, supporting the performance of MIS Conical Connection LOCKiT abutments. The endurance limit for the LOCKiT assembly was compared with the corresponding worst case for CONNECT and Zest Locator® systems. (Implicitly, the LOCKiT met or exceeded these limits if "substantially equivalent" was claimed).
Equivalent mechanical strength to narrower emergence profile devices for MIS internal hex OT-Equators and Ball Attachments.	Mechanical performance of MIS internal hex OT-Equators and Ball Attachments is supported by fatigue testing conducted on MIS Internal Hex LOCKIT abutments, which are a worst case in terms of mechanical strength as they have a narrower emergence profile than the OT-Equators and Ball Attachments.
Sterilization validated according to ANSI/AAMI/ISO 17665-1:2006 and ANSI/AAMI/ISO 17665-2:2009 for gravity displacement and pre-vacuum steam sterilization.	Steam sterilization parameters were validated according to ANSI/AAMI/ISO 17665-1:2006 and ANSI/AAMI/ISO 17665-2:2009 for two methods: gravity displacement steam sterilization and pre-vacuum steam sterilization.
Disinfection procedure validated with a reduction of at least 10^6 of the microbiological challenge according to ANSI/AAMI/ISO 11737-1:2006 (R) 2011, AAMI TIR 30:2011 and AAMI TIR 12:2010.	The disinfection procedure was validated in accordance with ANSI/AAMI/ISO 11737-1:2006 (R) 2011, AAMI TIR 30:2011 and AAMI TIR 12:2010 by demonstrating a reduction of at least 10^6 of the microbiological challenge.

Regarding the other points of the prompt, as applied to this document:

Sample size used for the test set and the data provenance: For mechanical testing, the "test set" would be the physical samples of the abutments and implants. The document mentions "worst case implants and abutments" being chosen for testing, such as "narrowest implants loaded with the abutments which have the maximum gingival height." The exact number of samples tested for each configuration is not explicitly stated in this summary, but would be detailed in the full test reports. The provenance is the manufacturer, MIS Implants Technologies Ltd., located in Israel. The studies are prospective in the sense that they were conducted for the purpose of this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by physical measurement and engineering standards (e.g., ISO 14801:2016 for fatigue testing), not expert consensus.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a physical device, not an AI/software for diagnostic imaging interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device.
The type of ground truth used: For mechanical testing, the ground truth is defined by the performance standards (e.g., ISO 14801:2016) and direct physical measurement of fatigue, tensile strength, etc.
The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.
How the ground truth for the training set was established: Not applicable.

In summary, this FDA 510(k) submission focuses on demonstrating substantial equivalence through non-clinical (mechanical and biocompatibility) testing, as is typical for Class II physical medical devices like dental abutments. It does not involve AI/software validation or human-reader studies.

Ask a Question

Ask a specific question about this device

Page 1 of 1