An Endosseous dental implant is indicated for surgical placement in the upper or lower jaw arches, to provide a root form means for prosthetic appliance attachment to restore a patient's chewing function. This submission provides information and animal/clinical data to support a clinical performance claim of "Enhanced Performance in Poor Quality Bone".

Device Description

Screw type implant with a "Defined Surface Structure".

AI/ML Overview

The provided text describes a 510(k) submission for the "Osseotite" Dental Implant System, focusing on a claim of "Enhanced Performance in Poor Bone" due to a "Defined Surface Structure." It does not present acceptance criteria in the typical sense of quantitative targets for performance metrics from a formal validation study. Instead, it relies on demonstrating that the "Osseotite" surface performs at least as well as, and in some cases better than, other "non-Osseotite" surfaced implants, particularly in areas with poor quality bone.

Here's an attempt to extract and interpret the information based on your request, understanding that the structure of a 510(k) summary is different from a clinical trial report.

Acceptance Criteria and Reported Device Performance

The document doesn't define explicit numerical acceptance criteria for a new, unproven device's safety and efficacy because it's a 510(k) submission seeking substantial equivalence to a predicate device. The primary "acceptance criterion" for marketing approval through 510(k) is demonstrating substantial equivalence to a legally marketed predicate device, which the "Osseotite" implants had already achieved in terms of design and materials in an earlier K submission (K935544).

This particular submission (K980549) is to support a marketing claim of "Enhanced Performance in Poor Bone" based on new data, not to re-establish fundamental safety and efficacy. Therefore, the "acceptance criteria" here implicitly relate to the sufficiency of evidence to support this performance claim rather than a predefined set of performance thresholds for device approval.

However, we can infer performance indicators and reported findings:

Acceptance Criterion (Inferred from marketing claim)	Reported Device Performance
Performance at least as good as "non-Osseotite" surfaced implants.	"Osseotite" surface performs overall, at least as well as other "non-Osseotite" surfaced implants.
Improved or enhanced performance in areas of poor quality bone (e.g., posterior maxilla).	Appears to offer improved or enhanced performance in areas of the oral cavity known to have poor or poorer quality bone.
Increased bone-to-surface contact (animal studies).	Animal studies demonstrate an increase in bone-to-surface contact for "Osseotite" compared to machined surfaced implants.
Increased resistance to countertorque extraction (animal studies).	Animal studies demonstrate an increase in resistance to countertorque extraction for "Osseotite" compared to machined surfaced implants.
Improved life table curves in poor quality bone (clinical trials).	Life table curves are approximately 8.8% greater for "Osseotite" vs "non-Osseotite" machined surface implants at 24 months when surgically placed in areas known to have poor quality bone.

Study Details to Support "Enhanced Performance" Claim

The document describes several types of studies and data used to support the "Enhanced Performance" claim:

Sample size for the test set and data provenance:
- Animal studies: Unspecified number of animals. Likely from research institutions where the studies were "published." Provenance not specified, but typically animal studies are prospective.
- Clinical trials: Two ongoing prospective clinical trials. The sample size for the clinical trials is not explicitly stated in this summary, but they track "Osseotite" vs "non-Osseotite" (machined surface) implants. The "8.8% greater" outcome is reported for "similar implants at 24 months" in areas of poor quality bone. The specific countries of origin for these clinical trials are not mentioned.
Number of experts used to establish the ground truth for the test set and their qualifications:
- The document mentions "Numerous academic and clinical researchers are involved with a variety of studies." It does not specify the exact number of experts involved in establishing ground truth for individual animal or clinical study outcomes.
- Expert qualifications are inferred from the context of "academic and clinical researchers" but are not explicitly detailed (e.g., years of experience, specific certifications).
Adjudication method for the test set:
- Not specified. This level of detail is typically found in full study protocols or publications, not a 510(k) summary.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study:
- No, an MRMC comparative effectiveness study in the typical sense (e.g., human readers interpreting images with and without AI assistance) was not done. The "Osseotite" is a physical dental implant, and the studies assess its direct performance (e.g., osseointegration, stability, survival rates) rather than observational interpretations.
Standalone (algorithm only without human-in-the-loop performance) study:
- This is not applicable as the device is a physical dental implant, not an AI algorithm. The studies assess the implant's standalone biological and mechanical performance in vivo.
Type of ground truth used:
- Animal studies: Likely direct measurement of biological response (e.g., histology for bone-to-surface contact, mechanical testing for countertorque extraction).
- Clinical trials: Clinical outcomes directly observed and measured (e.g., implant survival, success/failure based on established dental implant criteria, which might include absence of mobility, absence of pain/infection, etc.). These outcomes serve as the ground truth.
Sample size for the training set:
- Not applicable in the typical sense of a machine learning model's training set. The "training" for this physical device would be the iterative design, manufacturing, and preclinical testing phases, which are not specifically quantified as a "training set" here.
How the ground truth for the training set was established:
- Not applicable as described above. The ground truth for evaluating the device's performance (as described in points 1 and 6) is based on direct biological and clinical measurements and observations.

Summary

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K980549

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APR 2 8 1998

510(k) SUMMARY

510(k) SUBMISSION: "Osseotite" Dental Implant System: "Enhanced Performance in Poor Bone"

To the Requestor:

This information is taken directly from the original Pre-Market Notification [510(k)], submission, provided to the United States Food and Drug Administration. No information regarding safety or efficacy has been deleted from that submission, for this summary.

CLASSIFICATION NAME: Endosseous Dental Implant 1.
COMMON/USUAL NAMES: Dental implants, Screw type dental implants, 2.
1. PROPRIETARY NAME: "Osseotite" Dental Implants
CLASSIFICATION: Endosseous implants, per 872.3640 are class III devices. 4. Date PMA or notice of Completion of a PDP is required but no effective date has yet been established for the requirements for pre-market approval .

PERFORMANCE STANDARDS: Unknown ડ.

6. FORM:

Screw type implant with a "Defined Surface Structure". In , the Company submitted information to support distribution clearance for a manufacturing process change, that would produce a "Defined Surface Structure (morphology) to the Company's threaded implants. This design feature, now known as "Osseotite"was cleared for commercial distribution on

Since introduction, "Osseotite" has generated significant interest in the dental implant community. Numerous academic and clinical researchers are involved with a variety of studies to evaluate the unique "Osseotite" surface and bone interface and reaction. Prospective clinical trials are ongoing (to support Class III clinical trial requirements for Pre-market Approval).

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Several studies have recently been published that present significant findings indicating the "Osseotite" surface performs overall, at least as well as other "non-Osseotite" surfaced implants and in some cases, appears to offer improved or enhanced performance in areas of the oral cavity, known (or commonly known) to have poor or poorer quality bone, as defined by Albrektsson ' such as the posterior maxilla.

Published studies are supported by preliminary results reported from clinical trials, using "Osseotite". Published results of animal studies using "Osseotite" implants contained within this report, demonstrate either an increase in bone-tosurface contact or an increase in resistance to countertorque extraction for "Osseotite" compared to machined surfaced implants. In two ongoing clinical trials. It is reported that "Osseotite" implants surgically placed in areas known to have poor quality bone, have life table curves that are approximately 8.8% ( "Osseotite" ys "non-Osseotite", machined surface implants) 0/0 greater than for similar implants at 24 months. This demonstrates improvement in outcomes of implants of similar design but with different surface morphology.

SUBSTANTIAL EQUIVALENCE: 3i "Osseotite" Implants have been 7. determined substantially equivalent in design and materials to 31's standard and self-tapping implants, the and implant systems. Information and materials contained within this submission do not alter the Agency's original determination of substantial equivalence of the "Osseotite" implant, but does provide adequate information to support a marketing claim of "Enhanced performance" as defined herein.

9. LABEL/LABELING MATERIALS:

Product labels will not change from those specified in the original "Osseotite" Pre-Market notification (K ). Marketing materials, including claims for "Enhanced performance in poor bone", "... poor quality bone", or similar wording will be developed and will site, or identify means by which completed. published studies and/or ongoing clinical study results may be obtained that support these "enhanced performance"claims.

"OSSEOTITE" TECHNICAL REPORT: 10.

Branemark PI, Introduction to Osseointegration. In: Branemark PI, Zarb GA, Albrektsson T, editors. Tissue integrated prosthesis: Osseointegration in clinical dentistry: Chicago: Quintessence, 1985. p 202.

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11. INDICATIONS FOR USE:

An Endosseous dental implant is indicated for surgical placement in the upper or lower jaw arches, to provide a root form means for prosthetic appliance attachment to restore a patient's chewing function. A successfully Osseointegrated implant will achieve a firm and direct connection between the living bone and the surface of the titanium alloy implant when surgically implanted under controlled conditions, per well known clinical studies.

There has been no change in the indications for use from those specified in the ). This submission only provides original Pre-Market Notification (K clinical information and data to support a claim of enhanced performance in poor quality bone, using the 3i "Osseotite" Implant.

CONTRAINDICATIONS: 12.

3i implants should not be used in cases where the remaining jaw bone 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 poor bone quality, poor oral hygiene, heavy smoking or tobacco abuse, or medical conditions such as blood disorders, infection(s), 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 which may adversely affect bone or wound healing or cases in which the available bone is too diminished to provide adequate width or height to adequately hold implants and restorative appliances.

13. WARNINGS:

For safe and effective use of 3i implants, it is strongly suggested that specialized training be undertaken since the surgical techniques required to place dental implants are highly specialized and complex procedures. Improper patient selection and technique can cause implant and/or abutment failure with possible loss of supporting bone.

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PRECAUTIONS: 14.

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, parodontal status, and adequacy of bone. Lateral cephalometric radiographs, CT Scans, and tomogram may also be beneficial.

ADVERSE EFFECTS: 15.

Loss of implant anchorage (failure to osseointegrate) 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.

SURGICAL COMPLICATIONS: : 16.

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 it would most probably be 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.

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 1998

Mr. William G. Conety ·Regulatory Affairs Implant Innovations®, Incorporated 4555 Riverside Gardens Palm Beach Gardens, Florida 33410

Re : K980549 Osseotite Dental Implant System Trade Name: Regulatory Class: III Product Code: DZE Dated: January 28, 1998 Received: January 28, 1998

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 regulations affecting your device can be found in the Code of Federal Requlations, 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 regulation 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 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 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.fdp.gov/cdrh/dsmamain.html".

Sincerely yours

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: K980549

Page 1 of 1

Device Name: "Osseotite" Dental Implant System (Original K935544 - Process change) Performance Claim: "Enhanced Performance in Poor Bone"

INDICATIONS FOR USE:

DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE

Concurrence of CDRH, Office of Device Evaluation (ODE)

Llive sus for MSR
(Division Sign-Off)
Division of Denmai, Infection Control,
and General Hospital Devices
510(k) Numoer K980549

Prescription Use: _ OR Over-The-Counter Use: _ Per 21 CFR 801.109)

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.