The Intra-Lock Implant System has been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or maxilla and to support removable or fixed prosthesis, from single tooth replacement to full arch reconstruction.

Device Description

The Intra-Lock International Dental Implant System consists of root form dental implants and restorative components which provide the clinician with screw retained and removable overdenutre This system also includes prosthetic instrumentation, surgical drills, hand type restorative options. instruments, surgical trays and handpiece adapters for use in the surgical procedures. The implants are sterile packaged and include cover screws and a placement instrument. Prosthetic devices are packaged separately to allow the clinician to choose the appropriate means for restoration after osseointegration. Implant bodies are subjected to a surface treatment of blasting with resorbable blast media and then acid passivation to roughen the surface.

AI/ML Overview

The provided text does NOT contain information about specific acceptance criteria or a study that rigorously proves the device meets such criteria in terms of performance metrics. Instead, it describes a Special 510(k): Abbreviated 510(k) submission for the Intra-Lock Dental Implant System.

This type of submission relies on demonstrating substantial equivalence to predicate devices and conformity with recognized guidance documents, rather than presenting a standalone performance study with detailed acceptance criteria and reported metrics in the way one might expect for a novel AI/software device.

Here's an analysis of why the requested information cannot be fully provided from the given text:

Device Type: This submission is for a dental implant system, which is a physical medical device, not a software or AI device. The questions in the prompt (e.g., "effect size of how much human readers improve with AI vs without AI assistance," "standalone algorithm only without human-in-the loop performance," "sample size for the training set") are typically relevant for AI/ML-based medical devices.
Approval Pathway: The "Special 510(k)" pathway focuses on demonstrating substantial equivalence to predicate devices (other legally marketed dental implants) and adherence to recognized consensus standards and FDA guidance documents (e.g., "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments Draft Guidance for Industry and FDA"). It does not typically involve the type of clinical performance study with defined, quantitative acceptance criteria and reported device performance metrics in the same vein as an AI/ML device.

Therefore, many of the requested fields are not applicable or cannot be extracted directly from this type of 510(k) summary.

Based on the available information, here's what can be extracted and inferred:

Table of Acceptance Criteria and Reported Device Performance: This information is NOT present. Special 510(k)s typically don't present performance data in this structured way. The "acceptance criteria" here would be conformity to the special controls guidance and substantial equivalence to predicates, not specific quantitative performance metrics like sensitivity/specificity for an AI device.
Sample sized used for the test set and the data provenance: Not applicable in the context of this 510(k) for a physical implant system. There's no "test set" in the sense of a dataset for an algorithm. The "testing" would involve bench testing for mechanical properties (not detailed here) and potentially clinical experience with predicate devices or the device itself, but not a defined test set for performance evaluation as with AI.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical implant would relate to successful osseointegration, long-term stability, lack of adverse events, etc. This is established through clinical practice and follow-up, not a "test set" with expert adjudication in the AI sense.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a dental implant, the "ground truth" for proving safety and effectiveness would implicitly be long-term clinical outcomes (e.g., successful osseointegration, lack of infection, stability, patient satisfaction), supported by a history of safe use of predicate devices and adherence to relevant standards for biocompatibility and mechanical properties. This document does not detail specific ground truth data collection for this specific device within a clinical study described here.
The sample size for the training set: Not applicable. This is not an AI device.
How the ground truth for the training set was established: Not applicable. This is not an AI device.

Summary of what the document does state about proving safety and effectiveness:

Methodology: The submission is a "Special 510(k): Abbreviated 510(k)," meaning it relies on demonstrating conformity with FDA's guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments Draft Guidance for Industry and FDA."
Basis for Conclusion: "Based on the indications for use, technological characteristics, and comparison to predicate devices, the Intra-Lock Dental Implant System has been shown to be safe and effective for its intended use."
Predicate Devices: The submission references several predicate dental implant systems (Branemark Dental Implant System, Branemark MkII Dental Implants, Lifecore Self Tapping Implants, Lifecore Stage 1 RBM Implants, ITI Strauman One Part Implants). The safety and effectiveness of the Intra-Lock system are established by demonstrating its substantial equivalence to these already-marketed devices.
Technological Characteristics: The product description details features like "root form dental implants," "screw retained and removable overdenutre options," "surface treatment of blasting with resorbable blast media and then acid passivation to roughen the surface." These characteristics are compared to those of the predicate devices and conform to accepted standards.

Summary

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JUL 2 4 2002

510(k) Summary

Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, International is required to submit with this Premarket Notification either an "...adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." Intra-Lock International chooses to submit a summary of the safety and effectiveness information. The summary is as follows:

Trade Name:	Intra-Lock System
Sponsor:	Intra-Lock International1200 North Federal HighwaySuite 200Boca Raton, FL 33432Registration No.: 3003631996
Device Generic Name:	Dental Implants
Classification:	According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class III.

Predicate Devices:

Branemark Dental Implant System	K944683
Branemark MkII Dental Implants	K945398
Lifecore Self Tapping Implants	K950624
Lifecore Stage 1 RBM Implants	K003226
ITI Strauman One Part Implants	K994104

Product Description:

Indications for Use:

The Intra-Lock Implant System has 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 prosthesis, from single tooth replacement to full arch reconstruction.

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Safety and Performance:

This submission is a Special 510(k): Abbreviated 510(k) as described in FDA 's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Intra-Lock International has provided information to demonstrate conformity with FDA's guidance document entitled: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments Draft Guidance for Industry and FDA.

Conclusion:

Based on the indications for use, technological characteristics, and comparison to predicate devices, the Intra-Lock Dental Implant System has been shown to be safe and effective for its intended use.

Image /page/1/Picture/4 description: In this image, there is a blurry stamp that says "RECEIVED" and "JUL 16". The stamp is tilted at an angle. The text is in black ink.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 4 2002

Mr. Jeffery Sakoff Director of Operations Intra-Lock International 1200 N. Federal Highway, Suite 200 Boca Raton, Florida 33432

Re: K021322

Trade/Device Name: Intra-Lock Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: April 19, 2002 Received: April 25, 2002

Dear Mr. Sakoff:

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.

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.

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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Intra-Lock Dental Implant System Device Name:

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-the -Counter Use

Robert S. Betz, DDS for Dr. Susan Renner

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital, Innection Con 510(k) Number _ KO2

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.