Endosseous implants and abutments are indicated for surgical placement into the upper and Lower jar arches as permanent support for prosthetic appliances, to restore a patient's masticatory fower jur arches as permaint oupport resally coating applied to implants/abutments improves the overall esthetics of the completed restoration.

Device Description

3i proposes to apply a TiN coating to abutment cylinder surfaces with exception of the implant mating surface interface area. On implants, the coating will be applied to coronal. transgingival collar area. Implant/abutment interface surfaces will not be coated. Current dimensional characteristics and specifications for implants and abutments to be TiN coated do not change. Cleaning, packaging and sterilization operations will be accomplished by the same means and under the same controls as non-TiN coated implants and abutments.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (TiN Coated Implants and Abutments). It details the device, its intended use, and evaluations for substantial equivalence, but it does not contain a study that proves the device meets specific acceptance criteria in the format of a clinical trial or performance study with defined metrics, sample sizes, and ground truth.

Instead, the document focuses on:

Biocompatibility: Stating that Titanium Nitride (TiN) is a proven biocompatible material based on existing literature and its widespread use.
Physical Performance Evaluation: Describing a limited set of physical tests to assess adhesion and performance with cement-retained prosthetics.
Substantial Equivalence Argument: Asserting that the TiN-coated devices are substantially equivalent to existing 3i implants/abutments and competitive systems already using TiN coatings, primarily differing only in the TiN coating itself.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, experts, and ground truth cannot be extracted directly from this document in the manner typically associated with studies proving device performance against specific, quantifiable acceptance criteria.

However, I can extract the available information regarding the "device performance evaluation" and present it as acceptance criteria for those specific tests.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from "DEVICE/DESIGN PERFORMANCE EVALUATION")	Reported Device Performance	Comments
Scratch Adhesion (TiN to CP titanium): (Value to demonstrate strong adhesion and prevent delamination under mechanical stress)	2.5 - 2.75 kg	This indicates the force required to cause delamination. A higher value generally means better adhesion. No specific "pass/fail" threshold is explicitly stated, but the values are provided as a measure of performance.
Adhesion of cement retained prosthetic to TiN: (Visual observation criterion for no delamination or loss of coating after removal of cemented copings)	Visual observation of TiN abutments after removal of cemented copings revealed no de-lamination or loss of coating.	This is a qualitative assessment. The acceptance criterion is "no delamination or loss of coating."
Removal force of cemented copings from TiN vs. non-coated abutments: (To ensure the TiN coating does not negatively impact prosthetic retention, ideally equal to or greater than non-coated, and with reduced variability)	Removal of cemented copings from TiN coated abutments was equal to or greater than copings from non-coated abutments with a significantly smaller standard deviation.	This suggests improved and more consistent retention with the TiN coating, which would be a positive performance aspect.
Resistance to scraping with a steel dental curette: (To ensure coating integrity during handling and clinical use)	TiN coating was not removed from substrate, when scraped with a steel dental curette.	This is a qualitative assessment. The acceptance criterion is "coating not removed."

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

Sample Size: Not specified. The document uses phrases like "TiN abutments" and "copings" without providing the number of units tested for any of the physical performance evaluations.
Data Provenance: Not specified, but generally, such tests would be conducted by the manufacturer in a laboratory setting. It is not explicitly stated whether the data were retrospective or prospective, but performance evaluations are typically prospective for new device features.

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

Not applicable/Not specified. The "ground truth" for the physical performance tests (scratch adhesion, visual observation of delamination, removal force) would be the direct measurements or observations from the tests themselves, not expert consensus on clinical outcomes. For qualitative assessments like "no de-lamination" or "not removed," it would be the judgment of the test operator, whose qualifications are not mentioned.

4. Adjudication method for the test set

Not applicable/Not specified. For the physical performance tests, the results are objective measurements or direct observations. There's no mention of a panel or group needing to adjudicate conflicting interpretations of test results.

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. This document does not mention an MRMC study. The device is a physical dental implant coating, not an AI-assisted diagnostic tool.

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

No. This document does not describe an algorithm or AI component.

7. The type of ground truth used

For the physical performance evaluation:
- Scratch Adhesion: Direct measurement of force in kilograms.
- Adhesion of cemented prosthetics (visual observation): Direct visual observation of the coating integrity.
- Removal force of cemented prosthetics: Direct measurement of force.
- Resistance to scraping: Direct visual observation of coating integrity after scraping.
For the overall device: The "ground truth" for its safety and effectiveness is largely based on its substantial equivalence to legally marketed predicate devices and the established biocompatibility of TiN.

8. The sample size for the training set

Not applicable. There is no AI/algorithm being trained, so no training set is mentioned or relevant.

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

Not applicable. No training set is mentioned.

Summary

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OCT 8 1999

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510(k) SUMMARY 3i TiN Coated Implants and Abutments

To 510(k) Summary Requestor:

Information contained in this summary is from an original Pre-Market Notification [510(k)] submission, provided the United States Food and Drug Administration. No pertinent or known releasable information regarding device safety or efficacy has been intentionally or otherwise knowingly delected from thansubmission, for this summary.

William G. Conety

Regulatory Affairs

PRE-MARKET NOTIFICATION: TiN Coating - Implants/Abutments

CLASSIFICATION NAME: 21 CFR Part 872.3640, Endosseous Dental Implant* 01

02 COMMON/USUAL NAMES: Dental implants and fixtures; abutments; transmucosal abutments/elements; restorative/ prosthetic devices/components; abutment posts, cylinders, devices, fixtures, screws, etc.
03 PROPRIETARY NAME: No specific marketing name is established.
CLASSIFICATION: Class III 04
05 PERFORMANCE STANDARDS: Unknown
0€ BACKGROUND:

The company has distributed a wide variety of commercially pure titanium and titanium alloy implants and abutment systems. Recently, there has been increased discussion concerning aesthetic improvements to implant supported restorations. It is reported, titanium implants and abutments under thin mucosal tissue can exhibit an unnatural grayish appearance, considered by some patients to be noticeable and therefore objectionable. Several competitor companies have incorporated TiN coatings to "harden" abutment component surfaces and in so doing, have enhanced esthetics.

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Titanium Nitride ("TiN") coatings are widely used in orthopedic, dental, surgical and other medical device applications. It is a proven biocompatible, "ultra-hard" material that can greatly reduce wear of a variety of metal devices, including devices constructed of titanium. A search of medical/surgical related literature published on use of TiN coatings and tissue compatibility provides information to support a well established understanding that TiN is biocompatible when used in applications in the oral cavity.

FORM and CONSTRUCTION: 07

In clinical application, implant placement, abutment selection/preparation and restorative procedures do not change. With "prep-type" abutments, much of the area containing the TiN coating may actually be removed during the preparation processes in the dental laboratory. Restorative appliances incorporating TiN coated abutment systems will continue to be, screw or cement retained with no additional or other significant revisions in abutment preparation processes. The only visible outcome difference will be the appearance of the gold TiN color, where previously the non-coated titanium showed. Current sterilization means and processes do not change by addition of the TiN coating.

DEVICE/DESIGN PERFORMANCE EVALUATION: 08

The proposed TiN coating has been physically evaluated to determine adhesion to the titanium substrate and performance with cement retained restorative appliances.

Scratch adhesion (TiN to CP titanium): 2.5 - 2.75kg.

Adhesion of cement retained prosthetic to TiN: Visual observation of TiN abutments after removal of cemented copings revealed no de-lamination or loss of coating. Removal of cemented copings from TiN coated abutments was equal to or greater than copings from non-coated abutments with a significantly smaller standard deviation. TiN coating was not removed from substrate, when scraped with a steel dental curette.

09 SUBSTANTIAL EQUIVALENCE:

TiN-coated abutments/implants are substantially equivalent to current 3i implant/ abutments as well as competitive systems using TiN coatings. TiN-coated implants/ abutments differ from original implant/abutment systems only in use of the TiN.

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10 INDICATIONS FOR USE:

Indications for use of TiN coated implants and abutments do not change from non-coated implants and abutments, indicated for surgical placement into upper/lower jaw arches as permanent support for prosthetic attachment, to restore masticatory function.

CONTRAINDICATIONS, WARNINGS, ETC: 11

Implants/abutments should not be used where remaining jawbone is too diminished to provide adequate width or height to surround the implant. Lack of osseointegration or subsequent implant failure may occur in cases where there is: Insufficient available bone or there is poor bone quality, poor oral hygiene, heavy smoking or tobacco use; Medical conditions such as blood disorders, infection(s), or vascular impairment at surgical site, uncontrolled diabetes; Heavy smoking or tobacco abuse, drug or alcohol abuse, chronic high dose steroid therapy; medical conditions such as blood clotting disorders, current or ongoing anticoagulant therapy, metabolic bone disease or other metabolic or systemic disorders may adversely affect bone or wound healing.

For safe/effective use, it is suggested specialized training be undertaken since surgical technique to place dental implants are highly specialized and complex procedures. Improper patient selection and/or surgical technique can cause implant and/or abutment failures with possible loss of supporting bone. Thorough screening of prospective implant candidates must be performed. Visual inspection as well as panoramic and periapical radiographs are essential to determine anatomical landmarks, occlusal conditions, periodontal status, and adequacy of bone. Lateral cephalometric radiographs, CT scans and tomogram may also be beneficial.

Loss of implant anchorage (failure to integrate) and loss of the prosthesis are possible occurrences after surgery. Lack of quantity or quality of remaining bone, infections, poor patient oral hygiene or cooperation, and generalized diseases (diabetes, etc.) are some potential causes for loss of anchorage. The implant procedure has risks, including localized swelling, dehiscence, tenderness of short duration, edema, hematoma, or bleeding. Numbness of the lower lip and chin region following lower jaw surgery, and of the tissue beside the nose following upper jaw surgery, is a possible side effect of the surgery. Though most probably of a temporary nature, in very rare cases, the numbness has been permanent. Gingival/mucosal (gum tissue) ulceration, tissue reaction, or infection may occur, but generally responds to local care.

LABELING:

Specific labeling is not finalized. However appropriate distinction between TiN coated and non-coated devices will be made

End Summary _______________

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 8 1999

Mr. William G. Conety Requlatory Affairs Implants Innovations®, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410

Re : K992334 Endosseous Implants and Abutments- Tin Trade Name: Eoating Requlatory Class: III Product Code: DZE Dated: July 9, 1999 Received: July 13, 1999

Dear Mr. Conety

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Conety

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA debting of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marice and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours, unpos RUFFICK

$\mathcal{f}_{x}$

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K

Page 1 of 1

Device Name: Endosseous Implants and Abutments - TiN Coating

INDICATIONS FOR USE:

DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital, Infection
5100->>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> 510(k) Number

Prescription Use !____________________________________________________________________________________________________________________________________________________________ OR Over-the-Counter Use: _____________________________________________________________________________________________________________________________________________________

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.