The implant is designed for use in edentulous sites for support of complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework or partial dentures, or a single tooth replacement, overdenture, or hybrid denture.

Device Description

Laser-Lok™ is a surface technology in which two laser generated patterns of microscopic grooves are applied to the collar of the implant to engineer the biological width and tissue attachment to cither the Silhouette™ (hex-top) or Silhouette ™ IC (internal connection) dental implants.

Soft tissue attachment to the Laser-Lok surface treatment and the alignment of its micro-grooves inhibits epithelial down-growth on Silhouette Implants.

The LaserLok treated collar on the Silhouette Dental Implant has been shown to attach and retain bone adjacent to the implant.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Laser-Lok™ surface treatment for dental implants:

The provided 510(k) summary focuses on establishing substantial equivalence for a line extension (a surface modification) to an already cleared device. As such, the testing and claims are primarily directed at demonstrating that the new surface treatment does not negatively impact the safety and effectiveness of the base implant, and that it maintains or improves certain characteristics.

The summary does not explicitly define specific numerical acceptance criteria in the way a typical diagnostic AI/ML device might (e.g., minimum sensitivity or specificity thresholds). Instead, the acceptance is based on demonstrating mechanical equivalence and beneficial biological responses, primarily through existing literature and animal/clinical testing which is summarized qualitatively.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (as implied)	Reported Device Performance
Mechanical Strength	Sufficient mechanical static and dynamic strength (in accordance with FDA guidance "Information for premarket notification submissions for screw-type endosseous implants" issued on December 9, 1996).	Results from an independent lab confirm the surface treatment has sufficient mechanical static and dynamic strength.
Safety - Inflammation	Does not reduce the safety and inflammation performance of Silhouette Implants.	"The Laser-Lok surface treatment on the collar does not reduce the safety and inflammation performance of Silhouette Implants." (No specific study details or metrics provided here, but likely inferred from animal/clinical testing referenced below).
Biological Width / Tissue Attachment	Engineer the biological width and tissue attachment to the collar.	Soft tissue attachment to the Laser-Lok surface treatment and the alignment of its micro-grooves inhibits epithelial down-growth.
Bone Retention	Attach and retain bone adjacent to the implant.	The LaserLok treated collar on the Silhouette Dental Implant has been shown to attach and retain bone adjacent to the implant.

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

Mechanical Testing: Not explicitly stated. The document refers to "Results from an independent lab" but does not give sample sizes for these tests. Data provenance is implied to be from a testing laboratory.
Animal Studies: Not explicitly stated, but referenced generally as "animal...testing." One literature reference (Ricci et al.) relates to a chapter in "Bone Engineering," and the other (Weiner et al.) is a presentation from a 2003 meeting and pending publication. These are likely retrospective (i.e., refers to previously published or presented work).
Clinical Testing: Not explicitly stated. The document mentions "clinical testing" but provides no details on patient numbers, demographics, or study design. Likely retrospective (referring to existing data/literature).
Finite Element Analysis (FEA): Not applicable for sample size as it is a computational method.

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

This information is not provided in the summary. For a device like this, ground truth would typically be established by objective measurements (e.g., mechanical testing, histological analysis in animal studies, clinical outcomes observed by dental professionals). The summary does not detail the specific methods for ground truth establishment or expert involvement for the test set specifically. The cited literature involves various researchers (Ricci, Charvet, Frenkel, Chang, Nadkarni, Turner, Alexander; Weiner, Simon, Ehrenberg, Zweig, Ricci), who would be considered experts in their respective fields (e.g., biological engineering, oral and maxillofacial implants).

4. Adjudication method for the test set

This information is not provided and is generally not applicable to the types of studies referenced (mechanical, animal, clinical observations/literature review rather than human-read image interpretation).

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic devices where human readers interpret images or data. The Laser-Lok surface treatment is a physical modification to an implant, not an AI/ML diagnostic tool.

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

No, a standalone AI algorithm performance study was not done. This device is a physical medical device, not an algorithm.

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

Based on the references and nature of the device, the ground truth types would likely include:

Mechanical measurements: For static and dynamic strength.
Histological analysis / Biological data: For soft tissue attachment, epithelial down-growth, and bone response (likely from animal studies, pathology).
Clinical observations / Outcomes data: For in-vivo performance regarding tissue integration and overall implant success (implied from "clinical testing").
Literature/Expert consensus: The cited references support the claims, implying that the ground truth is established through accepted scientific and clinical findings.

8. The sample size for the training set

This information is not provided and is not applicable as this device does not involve an AI/ML algorithm that requires a "training set."

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

This information is not provided and is not applicable as this device does not involve an AI/ML algorithm that requires a "training set."

Summary of Limitations in the Provided Text for This Request:

The provided 510(k) summary is typical for a medical device modification rather than an AI/ML diagnostic tool. Therefore, many of the requested elements (like explicit numerical acceptance criteria, specific sample sizes for particular studies, details on expert ground truth establishment and adjudication, or AI-specific studies) are either not present or not fully detailed. The focus is on demonstrating substantial equivalence through a combination of mechanical testing, finite element analysis, and referencing animal and clinical studies, often drawing on existing literature and prior clearances.

Summary

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K04/1136

510(k) Summary

SUBMITTER:

Submitted on behalf of:

	Company Name:	Bio-Lok International Inc.
	Address:	368 South Military TrailDeerfield Beach, FL 33442
	Telephone:	(954) 698-9998
	Fax:	(954) 698-9925
by:	Elaine Duncan, M.S.M.E., RACPresident, Paladin Medical, Inc.PO Box 560Stillwater, MN 55082
Telephone:Fax:	715-549-6035715-549-5380
CONTACT PERSON:	Elaine Duncan
DATE PREPARED:	April 27, 2004
TRADE NAME:	Laser-Lok™ surface treatment for use with Silhouette™ &Silhouette™ IC dental implant system
COMMON NAME:	Dental implant, Endosseous

SUBSTANTIALLY EQUIVALENT TO: Laser-Lok surface treatment is a line extension (optional surface modification) to the Silhouette™ and Silhouette™ IC dental implants. These surface modified implants are substantially equivalent to the predicate the Silhouette™ and Silhouette™ IC dental implants previously cleared under 510(k) # 032454. Additionally, FDA has cleared similar surface treatments for dental implants, such as the surface treatment on the Astra Tech Fixture ST

DESCRIPTION of the DEVICE: Laser-Lok™ is a surface technology in which two laser generated patterns of microscopic grooves are applied to the collar of the implant to engineer the biological width and tissue attachment to cither the Silhouette™ (hex-top) or Silhouette ™ IC (internal connection) dental implants.

Soft tissue attachment to the Laser-Lok surface treatment and the alignment of its micro-grooves inhibits epithelial down-growth on Silhouette Implants.

The LaserLok treated collar on the Silhouette Dental Implant has been shown to attach and retain bone adjacent to the implant 3,b

a. Bone Response to Laser Microtextured Surfaces by Ricci, J.L., Charvet, J., Frenkel, S.R., Chang, R., Nadkarni, P., Turner, J., Alexander, H .: Chapter 25 in: Bone Engineering, ed; JE Davies, 2000, Em2 Inc., Toronto (pages 8 & 9).

b. Advanced Surface Microtexturing Techniques to Enhance Bone and Soft Tissue Response to Dental Implants by Weiner, S., Simon, J., Ehrenberg, D.S., Zweig, B., Ricci, J.L.: presented at the Academy of Osseointegration 2003 Annual Meeting, Boston and pending publication in the International Journal of Oral and Maxillofacial Implants.

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510(k) Summary-Continued

KC4//R6

The Laser-Lok surface treatment on the collar does not reduce the safety and inflammation performance of Silhouette Implants.

INDICATIONS FOR USE: The implant is designed for use in edentulous sites for support of complete INDICATIONS FOR USE. The mipant is designed for fixed bridgework or partial dentures, or a single tooth replacement, overdenture, or hybrid denture.

SUMMARY of TESTING: The Laser-Lok surface treatment does not introduce new issues for SUMMANY of TECTERS of TECH in a summary of all testing conducted to-date.

Mechanical testing was done in accordance with the FDA guidance "Information for premarket notification Mcchanical (c.sting was done in accerdaims) ants" issued on December 9, 1996. Results from an submissions for screw-lype elidossedus implans "Issued on Decombor "1999 of the surface treatment to have sufficient mechanical static and dynamic strength.

Additional test reports include finite element analysis, animal and clinical testing.

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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 image of an eagle or bird-like figure, with three curved lines representing its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2004

Bio-Lok International, Incorporated C/O Ms. Elaine Duncan President Paladin Medial, Incorporated P.O. Box 560 Stillwater, Minnesota 55082-0560

Re: K041136

Trade/Device Name: Laser-Lok Surface Treatment for Silhouette™ and Silhouette™ IC Endosseous Implant Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: August 10, 2004 Received: August 11, 2004

Dear Ms. Duncan:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your was 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinons, or to activend Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvin upprivation (the Act. The general controls provisions of the Act include controls provisions of the ristration, 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 (1 Mr), it may of back of Federal Regulations, Title 21, Parts 800 to 898. In your device can or round in the lev announcements concerning your device in the Federal Register.

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Page 2 – Ms. Duncan

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA $ Issualice of a substance on ples with other requirements
mean that FDA has made a determination that your device complies with other popular mean that FDA has made a decemination that Journinistered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by perstreating of the Act of ally rederal statutes and registerents, including, but not limited to: registration
You must comply with all the Act's requirements and manufacturing proctice You must comply with an the Act 3 requirement 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); group 800'; and i and listing (21 CFR Fart 807), labeling (21 CFR al results) //
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820), and if requirements as set forth in the quality systems (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) This letter will anow you to begin maticoling your and equivalence of your device to a premarket notification. The FDA miding of basical on 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), a if you desire specific advice for your do roll and and and the regulation please contact the Office of Comphanes at (210) = 10 = 10 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 may obtain other general information on your responsibilities under the Act from the may obtain other general miormation on Jour Land Consumer Assistance at its toll-free Division of Binastic or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. 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):

K041136

Device Name: Laser-Lok surface treatment for Silhouette™ and Silhouette™ IC endosseous implant

Indications for Use:

The implant is designed for use in edentulous sites for support of complete denture The implant is designed for use in coonarous of to fixed bridgework or partial dentures,
prosthesis, a terminal or intermediate abutment for fixed bridgework or partial dentu prosulesis, a terminal or ment, overdenture, or hybrid denture.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Pearson

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

Koy 134510(k) Number: _______________________________________________________________________________________________________________________________________________________________And Advertising and the program and the first and the comments of the first and	Page 1 ofAnd and a minimal commend a province for the first to the first to the first to the first the first to the first and
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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.