The Park Dental Research Corporation's LEW O-ball implant system is a self-tapping titanium threaded screw indicated for long-term intra-bony applications. Additionally, the LEW Mini O-ball Implant may be used for inter-radicular 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 edentulism, and employing minimally invasive surgical intervention.

The 2.0mm , 2.5 mm, and 3.0 mm diameter are intended to support single or multi-unit restorations in both long-term and temporary applications throughout the maxillary and mandibular arches.

Device Description

The LEW Mini O-ball implant (MD)) is available with a 1.5 mm gingival collar in three diameters: 2.0mm, and 3.0mm. The LEW Mini O-ball implant (MDI) is also available without a gingival collar in two diameters; 2.0mm and 2.5mm. The implant is made of Titanium alloy (Ti6A4V ELI per ASTM F 136-02), The thread surface is ablated with 50 micron aluminum oxide to remove shiny machined surface. The LEW Mini O-ball implant (MDI) is available in thread lengths ranging from 10mm to 18mm allowing for maximum bone engagement. The system consists of the major component, a root-form, screw type, self-tapping implant, and accessories designed to facilitate placing and using the implant. The accessories contact tissues for less than 1 hour and therefore are exempt from 510(k) requirements are described generally but are of course subject to general controls and are covered by the Quality System documents.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a dental implant, and therefore, the "acceptance criteria" discussed are primarily related to establishing substantial equivalence to existing legally marketed predicate devices, rather than performance criteria as might be seen for a novel device or AI/ML product. The "study" referenced is primarily fatigue testing conducted according to ISO 14801.

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

Acceptance Criteria and Device Performance for LEW Mini O-Ball Implant

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to predicate devices, particularly regarding its physical characteristics, materials, and mechanical performance (fatigue strength).

1. Table of Acceptance Criteria and the Reported Device Performance

Given this is a 510(k) for a dental implant, the "acceptance criteria" are more about demonstrating comparability to predicate devices. The primary performance metric reported is related to fatigue strength.

Acceptance Criteria (Implied)	Reported Device Performance for LEW Mini O-Ball Implant
Material Composition (Substantial equivalence to predicate)	Ti6Al4V ASTM F-136 (Matches predicate devices like IMTEC K031106, Intra-Lock K070601, etc.)
Sterilization Method (Substantial equivalence to predicate)	Delivered sterile (Matches predicate devices)
Packaging (Substantial equivalence to predicate)	Vial in a pouch (Matches predicate devices)
Indications for Use (Substantial equivalence to predicate)	Self-tapping titanium threaded screw indicated for long-term intra-bony applications; inter-radicular transitional applications; permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulism, employing minimally invasive surgical intervention. 2.0mm, 2.5mm, and 3.0mm diameters intended to support single or multi-unit restorations in both long-term and temporary applications throughout the maxillary and mandibular arches. (Consistent with predicate devices, with minor wording variations).
Mechanical Performance: Fatigue Strength (Adherence to ISO 14801 and equivalence/superiority to predicate)	Tested to ISO 14801. The LEW Mini O-Ball implant is "substantially equivalent or stronger" than IMTEC's K031106 MDI implant, citing the use of the same titanium alloy, SE of thread pitch, form and depth, and SE of threaded lengths. Specifically, the IMTEC MDI 1.8mm diameter (a predicate) is approved, and when calculated, has lower fatigue properties than the SE 2.0mm diameter LEW Mini O-Ball implant.

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

Test Set Sample Size: Not explicitly stated as a "sample size" in the context of clinical trials or AI/ML evaluations. For the fatigue testing, the number of implants tested to ISO 14801 is not specified. ISO standards typically define the number of samples required for such tests.
Data Provenance: The fatigue testing data appears to be laboratory-based mechanical testing, not human patient data. As such, there's no country of origin or retrospective/prospective distinction in the typical sense.

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

This information is not applicable to this type of submission. Ground truth, in the context of expert consensus, is typically relevant for diagnostic performance studies (e.g., in radiology or pathology for AI/ML devices), not for mechanical testing of a dental implant. The "ground truth" for fatigue testing is the physical measurement of load and cycles to failure according to the ISO standard.

4. Adjudication method for the test set

This information is not applicable as it pertains to expert disagreement resolution in diagnostic studies. For mechanical testing, the "adjudication" is based on objective measurements against the ISO standard.

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

This information is not applicable. This submission is for a physical medical device (dental implant), not an AI/ML diagnostic or assistive device that would involve human readers.

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

This information is not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used

The "ground truth" for the performance evaluation (fatigue testing) is based on physical measurements and adherence to an international standard (ISO 14801) for dental implant fatigue. For the substantial equivalence argument, the "ground truth" implicitly refers to the characteristics and performance of the legally marketed predicate devices.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of this 510(k) submission for a dental implant.

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

This information is not applicable. No training set exists for this device submission.

Summary

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510(k) Summary

Submitter: Owner - Park Dental Research Corporation, 2401N. Commerce, Ardmore, OK. Office 212.736.3765, Fax 214.233.7279. Point of Contact - Ron Bulard. Submitted 5/18/2012

Proprietary Name: LEW Mini O-Ball Implant

Common/Usual Name : Implants, endosseous implants, SDI's, Small diameter implants

Classification Name and Number : Endosseous Dental Implant (21 CFR 872.3640 DZE)

Devices for Substantial Equivalence: IMTEC MDI K031106, Intra-Lock MDL K070601, Intra-Lock MILO K050970, Prizmatics Inclusive K100932

Device Description

Indications for Use

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

The 2.0mm , 2.5 mm, and 3.0 mm diameter are intended to support single or multi-unit restorations in both long-term and temporary applications throughout the maxillary and mandibular arches.

Testing

Fatigue testing was conducted according to ISO 14801 on both models of 2.0mm implant.

Compliance with Performance Standards No performance standards are applicable, however we followed "Class II Special Controls Guidance - Document: Root-form Endosseous Dental Implant Abutments" issued May 12, 2004. The Ti6AlAV-EU titanium used in these implants meet ASTM F-136 "Standard Specifications for Wrought Titanium-6aluminum-4Vanadium Allow for Surgical Implant Applications"

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Substantial Equivalence

Summary : The LEW Mini O-Ball implant system is substantially equivalent to several small diameter implants systems currently on the market. We have listed five 510(k) implants systems. A detailed chart of more implant systems is included in Section 12

Element ofComparison	LEW Mini O-BallImplant	IMTEC K031106	IMTEC K081653	Intra-Lock K070601	Intra-LockK050970	PrismaticK100932
Diameter(mm)	2.0, 2.5, 3.0	1.8, 2.1, 2.4	2.9	2.0, 2.5	3.0	2.2, 2.5, 3.25
Length (mm)	10,13,15,17,18	10,13,15,18	10,13,15,18	10,11.5,13,15,18	10,11.5,13,15,18	10, 13, 15
Implant headshape	O-ball Connectioncompatible/SE toIMTEC K031106 andIntra-Lock K070601.SE	O-ball Connectioncompatible to ano-ring metalhousing	O-ballConnectioncompatible to ano-ring metalhousing	O-ball Connectioncompatible/SE toIMTEC K031106	O-ball Connectioncompatible/SE toIMTEC K031106	O-Ball ConnectionSE to IMTECK031106
Indications foruse	The Park DentalResearchCorporation's LEWO-ball implantsystem is a self-tapping titaniumthreaded screwindicated for long-term intra-bonyapplications.Additionally, theLEW Mini O-ballImplant may beused for inter-radiculartransitionalapplications.These devices willpermit immediatesplinting stabilityand long-termfixation of new orexisting crown andbridge installations,for full or partialedentulism, andemployingminimally invasivesurgicalintervention.The 2.0mm , 2.5mm, and 3.0 mmdiameter areintended to supportsingle or multi-unitrestorations in bothlong-term andtemporaryapplications	The MDI and MDIPlus are self-tapping titaniumthreaded screwsindicated forlong-term intra-bony applications.Additionally, theMDI may be usedfor inter-radiculartransitionalapplications.These devices willpermit immediatesplinting stabilityand long-termfixation of new orexisting crownand bridgeinstallations, forfull or partialedentulism, andemployingminimallyinvasive surgicalintervention.	The MII Implantis intended tosupport single ormulti-unitrestorations inboth long-termand temporaryapplicationsthroughout themaxillary andmandibulararches. The MIIimplant isindicated forimmediateloading whengood primarystability isachieved.Additionally, thisdevice will permitstability and longterm fixation ofupper and lowerdentures inedentulous cases.	3. Mini Drive-Lock™Dental Implants areintended for use as aself-tapping titaniumscrew fortransitional or intra-bony long-termapplications.4. Mini Drive-Lock™Dental Implants areindicated for long-term maxillary andmandibular tissuesupported denturestabilization.Multiple implantsshould be used andmay be restoredafter a period oftime or placed inimmediate function.	MILO ™ Implantsare indicated forlong-termmaxillary andmandibulartissue-supporteddenturestabilization.Multiple implantsmay be restoredafter a period oftime or placed inimmediatefunction.	Inclusive® MiniImplants are self-tapping threadedtitanium screwsindicated for long-term applications.Inclusive® MiniImplants may alsobe used forprovisionalapplications.These devices willallow immediateloading and long-term stabilizationof dentures andprovisionalstabilization ofdentures whilestandard implantsheal. To be usedfor immediateloading only in thepresence ofprimary stabilityand appropriateocclusal loading.
Element ofComparison	LEW Mini O-BallImplantthroughout themaxillary andmandibular arches.	IMTEC K031106	IMTEC K081653	Intra-Lock K070601	Intra-LockK050970	PrismaticK100932
Material	Ti6Al4V ASTM F-136	Ti6Al4V ASTM F-136	Ti6Al4V ASTM F-136	Ti6Al4V ASTM F-136	Ti6Al4V ASTM F-136	Ti6Al4V ASTM F-136
Sterilization	Delivered sterile	Delivered sterile	Delivered sterile	Delivered sterile	Delivered sterile	Delivered sterile
Packaging	Vial in a pouch	Vial in a pouch	Vial in a pouch	Vial in a pouch	Vial in a pouch	Vial in a pouch
Product Code	dze	dze	dze	dze	dze	dze
Screw pitch &depth ofthread	Thread pitch rangesbetween IMTEC'sfine and coarsepitch as well asthread depth	Fine thread pitchfor 1.8,2.1Diameters.Ccoarser pitch for2.4	Coarse Pitch anddepth	Thread pitch rangesbetween IMTEC'sfine and coarse pitchas well as threaddepth	Coarse Pitch anddepth	Coarse Pitch anddepth
Bone ContactSurface	Blasted and clean(SLA equivalent),machined surface,SE to IMTECK031106	Blasted and clean(SLA equivalent),machined surface	Blasted and clean(SLA equivalent),machined surface	Blasted and clean, ,SE to IMTECK031106, In addiionwith embeddedCaPhos molecules	Blasted and clean,, SE to IMTECK031106, Inaddiion withembeddedCaPhos molecules	Blasted EtchedSurface, SE toIMTEC K031106
DriverConnection	Square 1.65mm SEto IMTEC K031106	Square 1.65mm	Square 1.65mm	Square 1.65mm SEto IMTEC K031106	Square 1.65mmSE to IMTECK031106	Square 1.65mmSE to IMTECK031106
IncludedProsthetic	Metal Housing(s)with o-ring, SE toIMTEC K031106	Metal Housing(s)with o-ring,	Metal Housing(s)with o-ring,	Metal Housing(s)with o-ring, SE toIMTEC K031106	Metal Housing(s)with o-ring, SE toIMTEC K031106	Metal Housing(s)with o-ring, SE toIMTEC K031106
Fatigue testing	Tested to ISO 14801(results attached) .The LEW Mini O-Ballimplant issubstantiallyequivalent orstronger* thanIMTEC's K031106MDI implant. Thesame titanium alloy,a SE of thread pitch,form and depth, aSE of threadedlengths. *TtheIMTEC MDI 1.8mmdiameter isapproved, whencalculated has alower fatigueproperties than a SE2.0mm diameterimplant	In clinical usesince 1998	In clinical usesince 2008	SE to IMTECK031106	SE to IMTECK081653	SE to IMTECK031106

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1999 - 1999 - 1999

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

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

2017

Park Dental Research Corporation Mr. Ronald Bulard President 2401 North Commerce Street, Suite B Ardmore, Oklahoma 73401

Re: K121707

Trade/Device Name: Lew Mini O-Ball Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: August 27, 2012 Received: September 4, 2012

Dear Mr. Bulard:

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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Page 2- Mr. Bulard

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 device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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/ResourcesforYou/Industry/default.htm1.

Sincerely yours,

An 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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Indications for Use

510(k) Number (if known): K121707

Device Name: LEW Mini O-Ball Implant

Indications for Use:

The 2.0mm , 2.5 mm, and 3.0 mm diameter are intended to support single or multi-unit restorations in both long-term and temporary applications throughout the maxillary and mandibular arches.

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 Russo

(Division Sign-Off) (Division Sign-Off)
Division of Anestheslology, General Hospital Infection Control, Dental Devi

510(k) Number:

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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.