For 3.0mm Intra-Lock® OP Dental Implants:
The 3.0mm Intra-Lock® OP Dental Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. They are also indicated for the rehabilitation of single or maxillary lateral incisors and mandibular lateral incisors. Multiple implants may be restored after a period of delayed loading or placed in immediate function when good primary stability is achieved with appropriate occlusal loading in order to restore normal teeth function.

For 3.75mm, 4.0mm & 4.75mm Intra-Lock® OP Dental Implants:
Intra-Lock® Implants have been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the maxilla and to support removable or fixed prostheses, from single tooth replacement to full arch reconstruction. Intra-Lock® Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore normal teeth functions.

Device Description

The Intra-Lock® OP Dental Implants are threaded dental implants diameter 3.0mm, 3.75mm, 4.0mm and 4.75mm, with an integrated straight abutment (implant and abutment arc one piece).

AI/ML Overview

The provided text is a 510(k) Summary for the Intra-Lock® OP Dental Implants. This type of document is for medical device regulation and describes the device, its intended use, and argues for its substantial equivalence to previously cleared devices. It outlines performance testing performed, but it does not detail specific acceptance criteria or report performance data against those criteria in a quantitative manner that would be typical for an AI/ML device study.

Therefore, I cannot fulfill all parts of your request based on the provided text, particularly those related to a study proving the device meets acceptance criteria, sample sizes, expert ground truth, MRMC studies, or standalone performance for an AI/ML device. The document describes mechanical and material testing for an implant, not an AI software.

However, I can extract the information that is present, especially regarding the performance testing performed and the general approach.

Here's the closest I can get to your request based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of quantitative acceptance criteria or specific numerical performance metrics. Instead, it lists the types of performance testing that were conducted to support the device's intended use and demonstrates substantial equivalence to predicate devices which have implicitly met regulatory acceptance.

Acceptance Criteria Category (Implied)	Reported Device Performance / Assessment
Functional / Mechanical Integrity	Static / Dynamic Fatigue: Testing was reviewed to support the performance. (No specific numerical results or criteria are provided, but the implication is that the implants withstood relevant forces to establish substantial equivalence.)
Material Biocompatibility	Material: TI6AL4V, CP Titanium (These are well-established biocompatible materials for dental implants, aligning with predicate devices.) Differences in material (Titanium Alloy vs. TI6AL4V, CP Titanium) are presented but deemed not to raise new issues of safety or effectiveness.
Surface Properties	Surface Analysis: Testing was reviewed (No specific numerical results are provided, but implied to be acceptable and comparable to predicate 'Blasted' or 'Zimmer MTX Surface').
Sterility	Sterilization Validation: Validation performed (Method: Gamma Irradiation, consistent with predicate devices, implying sterile product).
Longevity / Stability	Shelf Life: 5 years (Consistent with predicate devices, implying long-term stability of the packaged, sterile product).
Design Equivalence	Design Features: Comparisons with predicate devices (Zimmer® One-Piece Implant, MILO® Implant System, Intra-Lock® Implant System with Blossom™) indicate similar materials, intended use, indications, sterilization, and shelf life. "The minor differences between these designs and principals of operation raise no new issues of safety or effectiveness." This implies that the design performs acceptably for its intended use, analogous to the predicate devices. This includes thread patterns, diameter/length sizes, and abutment design.
Risk Mitigation	Risk analysis: Performed. (No specific details, but standard regulatory practice to identify and mitigate risks).
Intended Use Fulfillment	The device's indications for use are described, and the performance testing is stated to "support performance... for their intended use." This is an overarching criterion.

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

The document does not specify a "test set" in the context of an AI/ML study, nor does it provide sample sizes for the performance testing mentioned (risk analysis, shelf life, sterilization validation, surface analysis, static/dynamic fatigue).

The data provenance is not mentioned. These are likely lab-based engineering and biological tests rather than clinical data from human subjects or retrospective/prospective medical data.

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

Not applicable. This is a medical implant, not an AI/ML diagnostic or predictive device that relies on expert interpretation of data to establish ground truth for a test set. The validation is based on engineering and material science principles, and comparison to established predicate devices.

4. Adjudication method for the test set

Not applicable for the reasons stated above.

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 not an AI-assisted diagnostic or interpretation device.

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

Not applicable. This is a physical medical device (dental implant).

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

For this type of device, "ground truth" is established through:

Engineering Standards: Compliance with recognized international and national standards for static and fatigue strength (e.g., ISO standards for dental implants, though not explicitly cited, they are implicit in such submissions).
Material Specifications: Verification of material composition and properties against established biocompatible requirements.
Sterilization Validation: Confirmation that the sterilization process achieves a predefined sterility assurance level (SAL).
Bench Testing: Physical testing results (e.g., fatigue cycles, surface roughness measurements) are compared against safety and performance thresholds derived from predicate devices and regulatory guidance.
Biocompatibility Testing: (Though not explicitly listed in "Performance Testing" for this specific summary, it's a standard requirement for implants and would involve testing for toxicity, sensitization, etc., against biological ground truth).

8. The sample size for the training set

Not applicable. There is no AI/ML component or "training set" in the context of this device.

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

Not applicable for the reasons stated above.

Summary

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510(k) SUMMARY

AUG

Submitter's Name:	Intra-Lock® International6560 West Rogers CircleBoca Raton, FL 33487
Phone:	(561) 447-8282
Facsimile:	(561) 447-8283
Contact Person:	Diana Taylor
Date Prepared:	July 30, 2013
Name of Device:	Intra-Lock® OP Dental Implants
Common Name:	Dental Implant
Classification Name:	Implant, Endosseous, Root-Form
Classification:	Class II
Regulation Number:	872.3640
Product Code:	DZE
Predicate Devices:	K052997 & K062281 Zimmer® One-Piece ImplantK050970, MILO® Implant System,K103194, Intra-Lock® Implant System with Blossom™
Description	The Intra-Lock® OP Dental Implants are threaded dentalimplants diameter 3.0mm, 3.75mm, 4.0mm and 4.75mm, withan integrated straight abutment (implant and abutment arc onepiece).
Intended Use:	The 3.0mm Intra-Lock® OP Dental Implants are indicated forlong-term maxillary and mandibular tissue-supported denturestabilization. They are also indicated for the rehabilitation ofsingle or maxillary lateral incisors and mandibular lateral andcentral incisors. Multiple implants may be restored after aperiod of delayed loading or placed in immediate functionwhen good primary stability is achieved with appropriateocclusal loading in order to restore normal teeth function.
	3.75mm, 4.0mm and 4.75mm Intra-Lock® OP Dental Implants:Intra-Lock® Implants have been designed to restore partiallyor fully edentulous patients. The implants have been designedto be used in either the mandible or the maxilla and to supportremovable or fixed prostheses, from single tooth replacementto full arch reconstruction. Intra-Lock® Implants are intendedfor immediate function on single tooth and/or multiple toothapplications when good primary stability is achieved, withappropriate occlusal loading, in order to restore normal tecthfunctions.
Performance Testing:	The following was reviewed to support performance of theIntra-Lock® OP Dental Implants for their intended use: riskanalysis, shelf life and sterilization validation, surface analysisand static / dynamic fatigue.
	Proposed OP Implants3.0mm 3.75mm, 4.0mm & 4.75mm	Zimmer & One-Piece,K052997 - 3.0mm & 3.7mmK062201 - 4.7mm	Intra-Lock MILO® 3.0mmImplants, K050970	Intra-Lock® Dental ImplantSystem with Blossom™,K103194
Material	TI6AL4V, CP Titanium	Titanium Alloy	TI6AL4V	TI6AL4V, CP Titanium
Surface	Blasted	Zimmer MTX Surface	Blasted	Blasted
ThreadPatterns	- 3.0mm, wide pitch, no cutting flutes- 3.75mm wide pitch w/ cutting flutes- 4.0mm & 4.75mm BlossomAll designs feature horizontal micro threads	cutting flute on the apical end no horizontalmicro threads	Wide pitch, no cutting flutes,horizontal micro threads	Blossom - at least one cuttingsurface on each thread andhorizontal micro threads.
Design sizes	3.0mm.3.75mm 4.0mm& 4.75mm dia;10mm - 15mm lengths	3.0mm dia, 10-13mm lengths3.7mm & 4.7mm dia ; 10 - 16mm lengths	3.0mm, O-Ball implant10mm - 15mm lengths	3.5mm, 4.0mm (& 6.0mm) dia;8mm - 15mm lengths
Abutment	Straight abutment machined on implant	Straight abutment machined on implant	Abutments cemented	Screw retained abutments viainternal connection
Principals ofOperation	Machined abutment has mating features sothe design specific driver fits directly overthe abutment for pick up, delivery(placement) and final seating.The OP transfer is snapped over theabutment to be picked up in the impression.The OP analog is inserted into the transferprior to creating the working model.	Instrumentation engage the implantexternally to pick up deliver and seat theimplant.The impression cap snaps over the abutmentand picked up in the impression.The analog replicates the Zimmer One-PieceImplant in the stone model.	Instrumentation fits over theO-Ball for pick up, deliveryand final seating.MILO impression copingsnaps over the O-Ball to bepicked up in the impression.The MILO analog is insertedinto the transfer prior tocreating working model	Instrumentation pick up theBlossom implant via hexconfiguration which mates withthe internal connection of theimplant.A screw retains the impressioncoping. Analogs are placed inthe transfer and secured withscrew.
Intended use	The 3.0mm Intra-Lock® OP Dental Implantsare indicated for long-term maxillary andmandibular tissue-supported denturestabilization. They are also indicated for therehabilitation of single or maxillary lateralincisors and mandibular lateral and centralincisors. Multiple implants may be restoredafter a period of delayed loading or placed inimmediate function when good primarystability is achieved with appropriateocclusal loading in order to restore normalteeth function.3.75mm 4.0mm and 4.75mm;Intra-Lock® Implants have been designed torestore partially or fully edentulous patients.The implants have been designed to be usedin either the mandible or the maxilla and tosupport removable or fixed prostheses, fromsingle tooth replacement to full archreconstruction. Intra-Lock® Implants areintended for immediate function on singletooth and/or multiple tooth applicationswhen good primary stability is achieved, withappropriate occlusal loading in order torestore normal teeth functions.	Zimmer One-Piece 3.0mm implants areindicated for the support and retention offixed single tooth and fixed partial denturerestorations in the mandibular central andlateral incisor and maxillary lateral incisorregions of partially edentulous jaws. TheZimmer one piece 3.0mm implant must besplinted if two or more are used adjacent toeach other. The Zimmer One Piece 3.0mmimplant may be immediately restored with atemporary prosthesis that is not in functionalocclusion.Zimmer One-Piece 3.7mm & 4.7mm implantsare indicated for the support and retention offixed single tooth and fixed partial denturerestoration in the premolar, cuspid andincisor regions of partially edentulous jaws.Zimmer one-piece implants may be loadedimmediately in the anterior mandibular archif four are splinted together with a bar. TheZimmer one-piece implant may beimmediately restored with a temporaryprosthesis that is not in functional occlusion.	MILO® Dental Implants areindicated for long-termmaxillary and mandibulartissue supporteddenture stabilization. Theyare also indicated for therehabilitation of single ormaxillary lateral incisors andmandibular lateral andcentral incisors. Multipleimplants may be restoredafter a period of time orplaced in immediate function.	Intra-Lock® Implants havebeen designed to restorepartially or fully edentulouspatients. The implants havebeen designed to be used ineither the mandible or themaxilla and to supportremovable or fixed prostheses,from single tooth replacementto full arch reconstruction.Intra-Lock® Implants areintended for immediatefunction on single tooth and/ormultiple tooth applicationswhen good primary stability isachieved, with appropriateocclusal loading, in order torestore normal teeth functions.
Sterilization	Gamma Irradiation	Gamma Irradiation	Gamma Irradiation	Gamma Irradiation
Shelf Life	5 years	5 years	5 years	5 years

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Substantial Equivalence:

The Intra-Lock® Op Implant and Zimmer® One-Picce Implants both have machined abutments that include design features to mate with instrumentation and utilize the same principals of operation. All the predicates have the same or similar matcrials, intended use, indications, sterilization and shelf life as the Intra-Lock® OP Implants. The substantial equivalence summary table follows:

Conclusion:

The comparison confirms that the Intra-Lock® OP Implants are substantially equivalent to the predicate devices. The minor differences between these designs and principals of operation raise no new issues of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

August 1, 2013

Intra-Lock® International, Incorporated Ms. Diana Taylor Regulatory Affairs Manager 6560 West Rogers Circle, #24 Boca Raton, FL 33487

Re: K130140

Trade/Device Name: Intra-Lock® OP Dental Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: June 28, 2013 Received: July 1, 2013

Dear Ms. Taylor:

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 - Ms. Taylor

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 (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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ReportalProblem/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.

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

Sincerely yours,

Mary S. Runner -S

Kwame Ulmer, M.S. Acting Division 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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Page 1 of 1

Indications for Use

510(k) Number (if known): _K | 30/YO

Device Name: Intra-Lock® OP Dental Implants

Indications for Use:

For 3.0mm Intra-Lock® OP Dental Implants:

The 3.0mm Intra-Lock® OP Dental Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. They are also indicated for the rehabilitation of single or maxillary lateral incisors and mandibular lateral incisors. Multiple implants may be restored after a period of delayed loading or placed in immediate function when good primary stability is achieved with appropriate occlusal loading in order to restore normal teeth function.

For 3.75mm, 4.0mm & 4.75mm Intra-Lock® OP Dental Implants:

Intra-Lock® Implants have been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the maxilla and to support removable or fixed prostheses, from single tooth replacement to full arch reconstruction. Intra-Lock® Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore normal teeth functions.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter U
(21 CFR 801 Subpa

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)

Andrew I. Steen -S 2013.08.01 10:39:02 -04'00'

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

1150/40 510(k) Number:________________________________________________________________________________________________________________________________________________________________

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.