MIS Conical Connection Implants 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 a patient's chewing 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.

Device Description

The conical connection dental implants are self tapping, root-form, two piece screw type dental implants, indicated for use in surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The conical connection dental implants are provided in 3.75, 4.2 and 5.0 mm diameters and with the following lengths:

0 3.75mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm

0 4.2mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm

o 5.0mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm

The implants surface is sand blasted and acid etched.

The conical connection dental implants are two piece devices whereas the implant is to be used in combination with cover screws, healing caps, abutments and superstructures.

The conical connection dental implants are made of Ti6AL4V ELI complying with standard ASTM F 136-08- Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant. The conical connection dental implants were modified to integrate a new type of connection, internal conical connection of 6 degrees with an anti-rotation index of six positions, ensuring a more definite seal and a more stable connection.

AI/ML Overview

This looks like information from a 510(k) premarket notification for a medical device, specifically dental implants. This type of submission is for demonstrating "substantial equivalence" to a predicate device, rather than proving safety and efficacy through clinical trials that would typically involve acceptance criteria and detailed performance studies like those common for PMAs or de novo submissions.

Therefore, many of the requested categories (like "acceptance criteria," "sample size for test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "sample size for training set") are not applicable in the context of this 510(k) submission.

The document focuses on comparing the new device to a legally marketed predicate device based on technological characteristics and non-clinical performance (like fatigue testing), with a brief mention of a preliminary clinical evaluation for stability.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance

Not applicable in the typical sense for a 510(k) submission. The "acceptance criteria" here is "substantial equivalence" to the predicate device. The performance is demonstrated through a comparison of technological characteristics and non-clinical testing.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (Conical Connection Implants)
Material of Construction	Titanium Alloy - Ti6Al4V ELI (Same as predicate)
Sterility	Yes (Same as predicate)
Re-use Status	No (Same as predicate)
Shape	Screw type (Same as predicate)
Thread Diameter	3.75, 4.2 and 5.0 mm (Same as predicate)
Length	8, 10, 11.5, 13 and 16 mm (Same as predicate)
Indications for Use	Expanded slightly from predicate to include immediate loading under good primary stability and appropriate occlusal load, but still within the scope of dental implants.
Fatigue Performance	Fatigue test was performed on MIS conical connection implants and its results were found comparable to those of their predicate devices (MIS Implants Technologies Ltd. dental implants Seven, Biocom and Lance, cleared under 510(k) K040807). This is the key performance acceptance.
Clinical Stability	A preliminary clinical evaluation based on case studies with six months follow up showed good stability of the conical connection implant. (This is more of an observation than a quantified acceptance criterion in this context, but serves to support the overall claim of safety and effectiveness.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set:
- Non-clinical (Fatigue Test): Not explicitly stated. Typically, fatigue tests follow ISO or ASTM standards, which specify sample sizes (e.g., 5-10 samples per group).
- Clinical Evaluation: "case studies" - the specific number of cases is not stated, but "case studies" typically implies a small number.
Data Provenance: Not specified for the non-clinical or preliminary clinical evaluation. Israel, where the company is located, is the likely origin for the internal testing.
Retrospective or Prospective:
- Non-clinical: Likely prospective (tests conducted specifically for this submission).
- Clinical Evaluation: "preliminary clinical evaluation, based on case studies with six months follow up" suggests prospective observation of a small number of patients post-implantation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. For a device like this, the "ground truth" for the non-clinical fatigue test is measured physical parameters, not expert consensus on images. The preliminary clinical evaluation likely involved clinical observations made by the treating clinicians, not multiple independent experts establishing a "ground truth" for a test set in the same way as, for example, a diagnostic AI device.

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

Not applicable. No expert adjudication method is described for either the non-clinical or preliminary clinical evaluation.

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 device is not an AI diagnostic device.

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

Not applicable. This device is not an AI diagnostic device/algorithm.

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

Non-clinical Fatigue Test: The ground truth is the physical measurement of fatigue properties (e.g., cycles to failure, maximum load) according to established engineering standards.
Preliminary Clinical Evaluation: The "good stability" observation would be based on clinical outcomes and examinations by the treating clinician over the six-month follow-up period.

8. The sample size for the training set

Not applicable. This is not an AI device that requires a training set.

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

Not applicable. This is not an AI device that requires a training set.

Summary

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K112162

Image /page/0/Picture/1 description: The image shows the logo for MIS Implants Technologies Ltd. The logo features the letters "MIS" in a stylized font, with the "S" being a curved line. To the right of the letters is the text "Implants Technologies Ltd." in a smaller font. The logo is simple and modern, and the text is clear and easy to read.

AUG 8 2012

510(k) Summary:

Conical Connection Dental Implants

Company Name: MIS Implants Technologies Ltd. P.O. Box 7, Bar Lev Industrial Park, 20156, ISRAEL Telephone: +972-4-9016800 Fax: +972-4-9918623

Establishment Registration Number: 3004203816

Contact Name:	Iman KhorshidVP QA & RATelephone: +972-4-9016800Fax: +972-4-9918623
	E-mail: iman@mis-implants.com
US Agent:	Matti Weisman - VP Marketing

US Agent:

Motti Weisman - VP Marketing MIS Implants Technologies Inc. 14-25 Plaza Rd. Suite S-3-5 Fair Lawn New Jersey; 07410 Phone: (201) 797-9144 (201) 797-9145 Fax: E-mail: service@misimplants.com

Date prepared: July 13, 2011

Trade Name: Conical Connection Implants

Classification name: Implants, Endosseous, Root Form

Common/usual name: Dental Implant

Product Code: DZE; NHA

Regulation No.: 872.3640

Class: II

Panel identification: Dental Devices Panel

510 (k) Conical Connection Implants Section E - Page 1 of 4

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molams Technologies Ltd.

Predicate Device:

MIS Implants Technologies Ltd. dental implants Seven, Biocom and Lance, cleared under 510(k) K040807.

Description of the device:

0 3.75mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm

0 4.2mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm

o 5.0mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm

The implants surface is sand blasted and acid etched .

The conical connection dental implants are two piece devices whereas the implant is to be used in combination with cover screws, healing caps, abutments and superstructures.

510 (k) Conical Connection Implants Section E - Page 2 of 4

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lmplants Technologies Ltd. Indications for Use:

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.

Substantial Equivalence:

Technological characteristics comparative table: .

	Conical Connection Implants fromMIS Implants Technologies Ltd.	Seven, Biocom and LanceImplants from MIS ImplantsTechnologies Ltd.
510(k) number	K112162	K040807
Product Code	DZE/NHA	DZE/NHA
Indications For Use	MIS Conical Connection Implantsare intended to be surgicallyplaced in the bone of the upper orlower jaw arches to providesupport for prosthetic devices,such as artificial teeth, in order torestore a patient's chewingfunction.When a one stage surgicalprocedure is applied, the implantmay be immediately loaded whengood primary stability is achievedand the occlusal load isappropriate.	MIS dental implants areintended to be surgically placedin the bone of the upper or lowerjaw arches to provide support forprosthetic devices, such asartificial teeth, in order to restorea patient's chewing function.
Supplied Sterile	Yes	Yes
Re-use	No	No
Material of Construction	Titanium Alloy - Ti6Al4V ELI	Titanium Alloy - Ti6Al4V ELI
Surface treatment	Sand blasted, acid etched andanodized	Sand blasted and acid etched
Shape	Screw type	Screw type
Thread Diameter	3.75, 4.2 and 5.0 mm	3.75, 4.2 and 5.0 mm
Length	8, 10, 11.5, 13 and 16 mm	8, 10, 11.5, 13 and 16 mm
Internal Connection	Conical	Hexagonal
Abutments	Straight and up to 25° angled	Straight and up to 25° angled

510 (k) Conical Connection Implants Section E - Page 3 of 4

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Implants Technologies Ltd.
	Conical Connection Implants fromMIS Implants Technologies Ltd.	Seven, Biocom and LanceImplants from MIS ImplantsTechnologies Ltd.
Material of Construction ofAbutments	Titanium Alloy – Ti6Al4V ELI	Titanium Alloy – Ti6Al4V ELI
Surface treatment ofAbutments	Anodized	None
Abutments Connection	Conical	Hexagonal

Non clinical tests: .
Fatigue test was performed on MIS conical connection implants and its results were found comparable to those of their predicate devices.
Clinical tests: .
A preliminary clinical evaluation, based on case studies with six months follow up has been performed, showing good stability of the conical connection implant.

Conclusion:

The evaluation of the conical connection dental implants does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to its predicate device.

510 (k) Conical Connection Implants Section E - Page 4 of 4

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

AUG · 8 2012

Ms. Iman Khorshid Vice President of Quality Assurance & Regulatory Affairs MIS Implants Technologies Limited P.O. Box 7, Bar Lev Industrial Park 20156. Israel

Re: K112162

Trade/Device Name: MIS Conical Connection Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: July 26, 2012 Received: July 27, 2012

Dear Ms. Khorshid:

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 I ou may) ateres provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Ms. Khorshid

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I hat 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 agencies. You must or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de rece related adverse overse) (2 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please n you accirc specific ad 1705 coutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

h for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/6/Picture/0 description: The image shows the word "mis" in a bold, sans-serif font. The letters are black against a white background. The "m" is stylized with sharp angles, the "i" is a simple vertical line with a dot above, and the "s" is curved. To the right of the word "mis" is the beginning of another word, "imp".

Implants Technologies Ltd.

INDICATIONS FOR USE

510(k) Number (if known):

K112162

Device Name:

Conical Connection Implants

Indications for Use:

MIS Conical Connection Implants are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for mrule bone of the upper of artificial teeth, in order to restore a patient's chewing function.

When a one stage surgical procedure is applied, the implant may be when a one bago barge barge good primary stability is achieved and the occlusal load is appropriate.

OR X Prescription Use _ (Part 21 CFR 801 Subpart D)

Over the Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Surer Purre

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

510(k) Number: K112162

510 (k) Conical Connection Implants Section D- Page 1 of 1

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.