MOR Implants are self-tapping titanium threaded screws intended for long-term applications in the bone of the patient's upper or lower arch. The MOR implants may also be used for interradicular transitional applications.

These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulous cases, and employing minimally invasive surgical intervention.

The MOR Implant System is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary.

Device Description

The MOR is a self-tapping, small diameter, screw implant, manufactured from titanium alloy (6% Al, 4% V - ASTM F136). The portion of the implant that is submerged in the bone is grit blasted and acid etched. The implants are manufactured with two body diameters, 2.1 mm and 2.4 mm. They are packaged sterile in a double blister, which contains: the implant in a titanium tube. The MOR implant body is designed with an O-ball denture connection and a separate straight titanium alloy (6% AI, 4% V - ASTM F136) abutment which may be cemented over the O-ball for crown or bridge fixation.

The MOR Implant System is not intended for correction of implants placed at an angle. It is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary.

The MOR Dental Implant will be available in a range of lengths and diameters.

Thread Major Diameter (mm): 2.1mm, 2.4mm
Overall Implant Length (mm): 10mm, 13mm, 15mm

Dimensional requirements for the finished abutment:
Angulation of final abutment: No angles
Minimum and Maximum Gingival Height: 1.0 - 3.0mm
Minimum abutment post height may be fabricated to: 4.0mm

AI/ML Overview

This document is a 510(k) Premarket Notification for the MOR Implant System, a dental implant device. It primarily focuses on demonstrating "substantial equivalence" to predicate devices rather than providing detailed clinical study data or performance metrics for an AI/algorithm-based device.

Therefore, many of the requested elements for describing the acceptance criteria and the study that proves an AI/algorithm-based device meets these criteria cannot be found in this document. This document describes the testing for a physical medical device (dental implants).

However, I can extract the information that is present and explain why other information is missing.

Summary of Information from the Provided Document Regarding Device Acceptance and Performance:

This document is a 510(k) Premarket Notification for a physical medical device (dental implants). The core of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to set new performance criteria or conduct extensive clinical trials that would be typical for novel AI/algorithm-based devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states:

"Performance testing demonstrated that the device performs appropriately for the proposed indications for use." ([Page 4] - under 'Performance Testing')
"Based on our analysis, technological characteristics and performance testing, the MOR Implant System is substantially equivalent in intended use, material, design and performance to its predicates." ([Page 5] - under 'Conclusion')

However, it does not provide a table of quantitative acceptance criteria for a specific performance metric (like accuracy, sensitivity, or specificity, which would be relevant for an AI device) nor does it report specific numerical performance results. The "performance testing" mentioned is non-clinical and likely refers to mechanical, material, and biocompatibility testing to show the physical implant functions as intended and is safe, rather than a clinical outcome or diagnostic performance metric.

2. Sample Size Used for the Test Set and Data Provenance:

Not Applicable/Not Provided for Clinical Performance Data: This document does not describe a "test set" in the context of an AI model's performance on clinical data (e.g., patient images or records). The "performance testing" mentioned refers to non-clinical bench testing of the physical implant.
Data Provenance: Not applicable for an AI test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not Applicable: This process is for validating AI/algorithm performance. The document describes a physical dental implant, not an AI device.

4. Adjudication Method for the Test Set:

Not Applicable: This is relevant for establishing ground truth in clinical data for AI validation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No: This study type is for evaluating human performance (e.g., radiologists) with and without AI assistance. This document describes a physical dental implant, not an AI system. Even if clinical data were mentioned, an MRMC study is not typically required for dental implant 510(k)s focused on substantial equivalence.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

Not Applicable: This is exclusively for AI/algorithm performance. The device is a physical dental implant.

7. The Type of Ground Truth Used:

For the device (dental implant): The "ground truth" for a physical device like this is primarily established through engineering specifications, material science standards (e.g., ASTM F136 for titanium alloy), and non-clinical performance testing (e.g., fatigue testing, sterilization validation, biocompatibility) to ensure it meets mechanical strength, material safety, and functional requirements. It's not "expert consensus" or "pathology" in the diagnostic sense.
The document explicitly references: "Non clinical Testing was performed following 'Guidance for Industry and FDA Staff -Class 11 Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments.'" ([Page 4])

8. The Sample Size for the Training Set:

Not Applicable: This concept applies to the development of AI models. The document is about a physical dental implant, not an AI or algorithm.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable: As above, this pertains to AI model development.

In summary, the provided document is a 510(k) submission for a physical medical device (dental implants). It demonstrates "substantial equivalence" to previously cleared predicate devices based on design, materials, manufacturing processes, and non-clinical performance testing. It does not contain any information related to AI/algorithm performance, clinical study test sets, ground truth establishment by experts, or MRMC studies, as those concepts are not relevant to the type of device and regulatory submission described.

Summary

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Image /page/0/Picture/1 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 image of three stylized human profiles facing to the right, with flowing lines beneath them.

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

February 5, 2016

Sterngold Dental, LLC Ms. Maria Rao Director of QA & Regulatory Affairs 23 Frank Mossberg Dr. Attleboro, Massachusetts 02703

Re: K153173

Trade/Device Name: MOR Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: October 30, 2015 Received: November 3, 2015

Dear Ms. Rao:

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. 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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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 agencies. 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Tina Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K153173 510(k) Number (if known):

Device Name: MOR Implant System

Indications for Use:

The MOR Implant System is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-the -Counter Use (21 CFR 807 Subpart D)

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510(k) Summary

Trade Name: MOR Implant System

Sponsor: Sterngold Dental, LLC 23 Frank Mossberg Drive Attleboro, MA 02703

Contact: Maria Rao. OA/RA Director Ph: 508-226-5660 ext 1206

Date: February 3, 2016

Device Generic Name: Endosseous Dental Implant System

Classification: According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II

Classification Name: Endosseous Dental Implant

Product Code: DZE (21CFR 872.3640) NHA

Predicate Devices:

The MOR Implant System is substantially equivalent to other currently marketed dental implant systems that have been cleared by FDA through the 510(k) Premarket Notification process.

Primary Predicate IMTEC Sendax - MDI and MDI Plus (K031106)
Reference Predicates ● Sterngold - ERA Implant (K021045) Intra-Lock International - Mini Drive-Lock Dental Implant System (K070601)
Sterngold Acid Etch Dental Implant System (K023580)

Product Description:

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The MOR Dental Implant will be available in a range of lengths and diameters.

Thread Major Diameter (mm)	Overall Implant Length (mm)
2.1mm	10mm, 13mm, 15mm
2.4mm	10mm, 13mm, 15mm

Dimensional requirements for the finished abutment:

Angulation of final abutment: No angles Minimum and Maximum Gingival Height: 1.0 - 3.0mm Minimum abutment post height may be fabricated to: 4.0mm

Indications for Use:

The MOR Implant System is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary.

Substantial Equivalence:

The MOR Dental implants are substantially equivalent to other currently marketed dental implant systems that have been cleared by FDA through the 510(k) Premarket Notification process. The intended use, basic design, fundamental operating principles are the same as the predicate devices.

Indications for use are similar to predicates devices. Changes do not affect the intended use of the product. Overall operating principles and mechanism are the same.

Technological Characteristics:

The MOR dental Implant provides the same or similar functions as well as design and technological characteristics as the predicate devices. In addition the surface is identical to the cleared Sterngold Acid Etched Implant (K023580).

The abutment is the same or similar to the predicate devices - intended use, design and function. The materials, technology and processes used to produce the MOR dental implants and abutments are the same as other Sterngold Dental devices previously cleared by the FDA. Any differences between the proposed devices and its predicates do not make the device not substantially equivalent. See chart below for list of similarities and differences.

Performance Testing:

Non clinical Testing was performed following "Guidance for Industry and FDA Staff -Class 11 Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments." Performance testing demonstrated that the device performs appropriately for the proposed indications for use.

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Proposed devices have the same sterilization process and radiation dose, same shelf life and biocompatibility as previous cleared Sterngold devices, therefore sterility, shelf life and biocompatibility testing performed on previous cleared Sterngold devices is applicable to the proposed new devices. As a result, the MOR Implant System is substantial equivalent to its predicates.

Conclusion:

Based on our analysis, technological characteristics and performance testing, the MOR Implant System is substantially equivalent in intended use, material, design and performance to its predicates.

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Sterngold Dental, LLC
Abbreviated 510(k) Premarket Notification

February 3, 2016
MOR Implant System

	MOR Dental Implant SystemSterngold Dental	MDI and MDI Plus Implants(K031106)IMTEC Sendax	ERA Implant(K021045)Sterngold Dental	Mini-Drive Lock DentalImplant (K070601)Intra-Lock Int.	Implant System(K023580)Sterngold Dental
Property	Proposed Device	Primary Predicate	Reference Predicate	Reference Predicate	Reference Predicate
Intended Use	See Indications for UseStatement above	Indicated for long-term intra-bony applications. Additionally,the MDI may also be used forinter-radicular transitionalapplications. These devices willpermit immediate splintingstability and long-term fixationof new or existing crown andbridge installations, for fullpartial endentulism, andemploying minimally invasivesurgical intervention.	Intended for surgical placementin edentulous anterior regions ofmaxillary and/or mandibularyarch to provide temporarysupport and permitimmediate stability and ongoingfixation of new or existing crownand bridge applications for fullor partial dentures with minimalinvasive surgical intervention	Intended for use as a self-tapping titanium screw fortransitional or intra-bony long-term applications. Mini Drive-Lock TM Dental Implants areindicated for long-termmaxillary and mandibulartissue-supported denturestabilization. Multiple implantsshould be used and may berestored after a period of timeor placed in immediatefunction.	Intended for implantation intoany area of the partially or fullyedentulous maxilla andmandible for the support ofremovable or fixed dentalprosthesis. For single tooth ormultiple units
Implant Design	Threaded, Root-form implant	Threaded, Root-form implant	Threaded, Root-form implant	Threaded, Root-form implant	Threaded, Root-form implant
Implant Shape	Cylinder	Cylinder	Cylinder	Cylinder	Cylinder
Implant Body Diameter	2.1mm, 2.4mm	2.1mm, 2.4mm, 2.9mm	2.2mm	2.0mm, 2.5mm	3.3mm, 4.0mm, 5.0mm
Implant Length	10mm, 13mm, 15mm	10mm, 13mm, 15mm, 18mm	10mm, 13mm, 15mm	10mm, 11.5mm, 13mm, 15mmand 18mm	8.5mm, 10mm, 11.5mm, 13mm,15mm
Surface	Blasted with aluminum oxideparticles and acid etched	Roughened - HA blasted	Blasted with aluminum oxideparticles and acid etched	Roughened - HA blasted	Blasted with aluminum oxideparticles and acid etched
Abutment Connection Style	External Connection	N/A	Internal Connection	N/A	External Connection
Prosthetic Platform	Square	Denture O-Ball	Hex	Denture O-Ball	Hex
Implant Material	Wrought Titanium 6AL-4VELI	Wrought Titanium 6AL-4VELI	Wrought Titanium 6AL-4VELI	CP Titanium grade 4	Wrought Titanium 6AL-4VELI
Manufacturing Process	Machining	Machining	Machining	Machining	Machining
Implant Sterilization	Gamma irradiation	Gamma irradiation	Gamma irradiation	Gamma irradiation	Gamma irradiation
Abutment Material	Wrought Titanium 6AL-4VELI	N/A	Wrought Titanium 6AL-4VELI	N/A	CP Titanium grade 4
Manufacturing Process	Machining	Machining	Machining	Machining	Machining
Abutment Sterilization	Moist Heat (Steam)	N/A	Moist Heat (Steam)	N/A	Moist Heat (Steam)
Abutment Angulation	No Angles	No Angles	No Angles	No Angles	No Angles

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.