The MII Implant is intended to support single or multi-unit restorations in both long-term and temporary applications throughout the maxillary and mandibular arches. The MII implant is indicated for immediate loading when good primary stability is achieved. Additionally, this device will permit stability and long term fixation of upper and lower dentures in edentulous cases.

Device Description

The IMTEC MDI MII 2.9mm one-piece implant is a one piece endosseous dental implant that is a combination of implant and abutment sections. The thread lengths are 10mm, 13mm, 15mm, and 18mm. The implant is composed of Titanium alloy. The MDI MII body has a thread design for bone compression and the implant tip is equipped with our patent pending auto advancing cutting threads similar to those found on the IMTEC Endure Implant system. The implant section surface is blasted & etched to facilitate osseointegration. In addition, the implant has micro-threads at the intra-osseous collar to preserve crestal bone. It has a transgingival collar 2mm in height that includes a platform switching groove for soft tissue stability. The Implant has two prosthetic head design options, O-ball and Tapered Abutment design. The O-ball head on the MDI MII is identical to the O-ball head on the IMTEC MDI implant. Both are designed for fixed and removable applications. The abutment portion of the MII implant is coated with Titanium Nitride.

AI/ML Overview

Here is an analysis of the provided text regarding the acceptance criteria and study for the IMTEC MDI MII One-Piece Implant:

The document is a 510(k) Premarket Notification for the IMTEC MDI MII 2.9mm One-Piece Implant. As such, the purpose is to demonstrate substantial equivalence to predicate devices, not to establish new performance acceptance criteria through clinical trials. The "acceptance criteria" here refers to the demonstration of safety and effectiveness through equivalence, rather than specific performance metrics validated by a clinical study against a predefined threshold.

Based on the provided text, a formal study with detailed acceptance criteria and reported device performance in the way a clinical trial would typically be structured does not appear to have been conducted for this 510(k) submission. Instead, the submission relies on demonstrating substantial equivalence to existing, legally marketed predicate devices.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

Criteria Category	Acceptance Criteria (Demonstrated Equivalence)	Reported Device Performance (as presented for equivalence)
Intended Use	The MDI MII intended use and indications for use were previously cleared by the FDA for the various predicate devices listed. (Matches that of predicate devices).	Supports single or multi-unit restorations, immediate loading when good primary stability is achieved, stability and long-term fixation of dentures.
Technical Characteristics	Similar to those of the predicate devices. Design similarities between the proposed MDI MII implant and currently marketed fixtures within the IMTEC MDI Dental Implant System. Equivalent in terms of size, materials of construction, performance characteristics, and basic design.	Composed of Titanium alloy; thread lengths 10mm, 13mm, 15mm, 18 mm; blasted & etched surface; micro-threads at intra-osseous collar; transgingival collar 2mm; two prosthetic head design options (O-ball and Tapered Abutment); O-ball head identical to IMTEC MDI implant; abutment portion coated with Titanium Nitride. Auto advancing cutting threads (similar to IMTEC Endure Implant system)
Safety and Performance	The addition of auto advancing, cutting threads have no adverse affects on the performance or safety of the IMTEC MDI MII 2.9mm Implant as evaluated in the performance testing conducted by the University of Georgia.	No adverse effects reported from the testing. The same types of safety and effectiveness characteristics are inherent with each of the devices (referring to predicate devices). Does not raise new questions related to safety or efficacy.

Important Note: The "acceptance criteria" here is fundamentally about demonstrating that the new device is as safe and effective as a legally marketed predicate device, not about meeting specific numerical performance targets established through a de novo clinical study.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified in the provided text for "performance testing." The text mentions "performance testing conducted by the University of Georgia" and "Laboratory testing by the Medical College of Georgia," but no details on the sample size (number of implants tested, number of tests performed) are given.
Data Provenance:
- Country of Origin: USA (University of Georgia, Medical College of Georgia).
- Retrospective or Prospective: Unspecified. However, for laboratory performance testing in a 510(k) submission, it would generally be prospective testing of the device prototypes/samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable in the context of this 510(k) submission. The "ground truth" for demonstrating substantial equivalence is established through comparison to predicate devices, adherence to recognized standards (implied by the "performance testing"), and the scientific principles behind dental implant design and materials, rather than expert consensus on a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This type of adjudication method is typically used in clinical trials or studies where human readers/evaluators are assessing outcomes or images against a "ground truth" established by multiple experts. The document describes laboratory performance testing and comparison to predicates, not a reader study.

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

Not applicable. This is a 510(k) for a physical dental implant, not an AI-powered diagnostic device. Therefore, no MRMC study involving human readers or AI assistance would have been conducted or is relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. As noted above, this is a physical medical device, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this 510(k) submission is the established safety and effectiveness of the identified predicate devices. The new device is considered safe and effective if it can demonstrate substantial equivalence to these predicates through comparison of:

Intended use
Technological characteristics (including materials, design, size, etc.)
Performance (demonstrated through laboratory testing where similarities are not direct)

8. The sample size for the training set

Not applicable. There is no "training set" in the context of a 510(k) for a physical device like this. Training sets are typically used for machine learning algorithms.

9. How the ground truth for the training set was established

Not applicable, as there is no training set.

Summary

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Image /page/0/Picture/19 description: The image shows the logo for IMTEC Corporation. The logo consists of a stylized, abstract graphic to the left of the text "IMTEC". Below "IMTEC" is the word "CORPORATION" in a smaller font size. There is a trademark symbol to the right of the word IMTEC.

K681653

SEP 1 9 2008

Traditional 510 (k) Premarket Notification

510(k) Summary (21 CFR 807.92 (a))

1. Submitter's Information

Name: IMTEC Corporation Address: 2401 N. Commerce IMTEC Plaza Ardmore, OK 73401 Phone: 580-223-4456 Glenn Gee Contact: Date Prepared: 30 May 08

2. Device Name

Proprietary Name: MDI MII One-Piece Implant, 2.9mm

Common name:_Dental Implant

Device Classification Name: Endosseous Dental Implant

Regulation No: 872.3640

Class: II

Panel: Dental

1. Predicate Device (s):

Alpha Bio 3.0mm One-Piece Implant	K063364
Zimmer® One-Piece Implant, 3.0mm, Straight	K052997
IMTEC Sendax MDI and MDI Plus	K031106
IMTEC Endure Implant System	K030243

4. Device Description:

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Image /page/1/Picture/1 description: The image shows the logo for IMTEC Corporation. The logo consists of a stylized, abstract shape on the left, resembling a propeller or a stylized letter 'S'. To the right of the shape is the word "IMTEC" in bold, sans-serif font, with the registered trademark symbol. Below "IMTEC" is the word "CORPORATION" in a smaller, sans-serif font.

K081653

body has a thread design for bone compression and the implant tip is equipped with our patent pending auto advancing cutting threads similar to those found on the IMTEC Endure Implant system. The implant section surface is blasted & etched to facilitate osseointegration. In addition, the implant has micro-threads at the intra-osseous collar to preserve crestal bone. It has a transgingival collar 2mm in height that includes a platform switching groove for soft tissue stability. The Implant has two prosthetic head design options, O-ball and Tapered Abutment design. The O-ball head on the MDI MII is identical to the O-ball head on the IMTEC MDI implant. Both are designed for fixed and removable applications. The abutment portion of the MII implant is coated with Titanium Nitride.

న. Intended Use:

The MII Implant is intended to support single unit or multi-unit restorations in both longterm and temporary applications throughout the maxillary and mandibular arches. The MII implant is indicated for immediate loading when good primary stability is achieved. Additionally, this device will permit stability and long term fixation of upper and lower dentures in edentulous cases.

6. Comparison of Technological Characteristics

Substantial equivalence of the MDI MII One-Piece implant is based on:

1. Design similarities between the proposed MDI MII implant and currently marketed fixtures within the IMTEC MDI Dental Implant System.
1. The proposed and currently marketed devices are equivalent in terms of size, materials of construction, performance characteristics, and basic design.

The MDI MI has patent pending, auto advancing, cutting threads, similar to those found on the IMTEC Endure Implant line. The addition to the MDI MII of the auto advancing, cutting threads have no adverse affects on the performance or safety of the IMTEC MDI MII 2.9mm Implant as evaluated in the performance testing conducted by the University of Georgia. The same types of safety and effectiveness characteristics are inherent with each of the devices. The features detailed do not raise new questions related to safety or efficacy of the implant.

The MDI MII implant described in this submission is substantially equivalent to the predicate devices listed and provides the same or similar functions, as well as design and technological characteristics. The intended use, statement of indications, technological characteristics and testing of the IMTEC MDI MII implants support the claim of substantial equivalence.

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Image /page/2/Picture/0 description: The image contains a logo for IMTEC Corporation. The logo features a stylized graphic to the left of the text "IMTEC" in bold, sans-serif font. Below "IMTEC" is the word "CORPORATION" in a smaller, lighter font. The logo is simple and professional in appearance.

There are no unique applications, indications, materials or specifications presented above. Evidence of equivalence has been demonstrated through:

08/653

IMTEC MDI MII intended use and indications for use were previously cleared by ● the FDA for the various predicate devices listed above.
The technical characteristics of the IMTEC MDI MII are similar to those of the . predicate device.
. Safety and performance testing.

Therefore, the IMTEC MDI MII Dental Implant system is substantially equivalent to its predicate devices as cited above and raises no new safety and/or effectiveness issues.

1. Performance Testing
  Laboratory testing by the Medical College of Georgia was conducted to confirm device functionality and conformance to design input requirements.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle design with three stylized wing strokes. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Glenn Gee Regulatory Affairs Manager IMTEC Corporation 2401 North Commerce Ardmore, Oklahoma 73401

Re: K081653

Trade/Device Name: MDI MII 2.9mm Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: September 4, 2008 Received: September 8, 2008

Dear Mr. Gee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Gee

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencics. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

IKAmuele-Rudi,mtr for U

Chiu S. Lin, Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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K08 1653

Indications for Use

Page / of /

1081

510(k) Number (if known): MDI MII 2.9 mm Implants

Device Name:

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Kuano

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K081153

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is 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 a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.