Steri-Oss 3.25 mm Replace Healing Abutment: This device is designed to expand the gingival tissue during the healing phase to maintain the appropriate abutment fit.

Steri-Oss 3.25 mm Replace Abutment: This device is designed to serve as a base for prosthetic devices which restore patient chewing function.

The implants are 3.25 mm in diameter, are 10 to 16 mm in length, and are fabricated from titanium alloy. They are tapered, threaded, and have a superior external hex. The healing screw, healing abutment, and abutment are also fabricated from titanium alloy. Portions of the surface of each of the components are anodized magenta in color.

AI/ML Overview

This looks like a 510(k) summary for a medical device (Steri-Oss 3.25 mm Replace Dental Implant System) seeking substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria based on performance metrics.

Therefore, the requested information elements (acceptance criteria table, sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) are not present in the provided text. The document states "Performance Data: Not applicable" which indicates that a detailed performance study as you've requested was not submitted or deemed necessary for this 510(k) clearance due to the nature of the device and its claimed substantial equivalence to existing predicate devices.

The general structure of a 510(k) summary usually involves comparing the new device to a legally marketed predicate device(s) in terms of intended use, technological characteristics, and safety and effectiveness. If the new device is substantially equivalent to a predicate, specific performance acceptance criteria and detailed study results might not be required in the same way as for a novel device undergoing a PMA (Premarket Approval) process.

Based on the provided text, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance:

Not applicable. The document states "Performance Data: Not applicable." The submission focuses on demonstrating substantial equivalence to predicate devices based on material, surface characteristics, and sterility, rather than meeting specific performance criteria through a new study.

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

Not applicable. No test set or related performance data is mentioned.

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

Not applicable. No test set or ground truth establishment process is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No test set or adjudication method is described.

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 device is a dental implant system, not an AI-powered diagnostic tool, so an MRMC study is not relevant.

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

Not applicable. This is not an algorithm-based device.

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

Not applicable. No ground truth is established for performance testing. Substantial equivalence is claimed based on comparison to predicate devices.

8. The sample size for the training set:

Not applicable. No training set is mentioned as this is a physical medical device, not a machine learning model.

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

Not applicable. No training set or ground truth establishment is mentioned.

Summary of what is provided regarding comparison:

The document focuses on a comparison to predicate devices to establish substantial equivalence.

Specification/Characteristic	Predicate: Steri-Oss Replace Implant	New Product: Steri-Oss 3.25 mm Replace Dental Implant
Material	Titanium	Same
Surface Characteristics	Color-coded	Same
Sterility	Sterile	Sterile

Summary

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Section 6

K973402

510(k) Summary

Manufacturer Information:

Submitter's Name:	Steri-Oss Inc.
Submitter's Address:	22895 Eastpark DriveYorba Linda, CA 92887USA
Contact's Name:	Jeff Hausheer, Ph.D.
Contact's Telephone:	714-282-4800, extension 3815
Date Prepared:	September 1997

Device Name:

Common Name:	Prosthetic Dental Implant System
Trade Name:	Steri-Oss 3.25 mm Replace Dental Implant System
Classification Name:	Endosseous dental implant

Predicate Device:

Substantial equivalence is claimed to Steri-Oss' Replace Implants, Healing Screws, Healing Abutments, and Abutments (K964220) and to Steri-Oss' (3.25 mm diameter) Titanium Plasma Sprayed Cylindrical Implant (K911592).

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Steri-Oss Inc. - September 1997

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Section 6 510(k) Summary

Device Description:

How The Device Functions:

Individual components fulfill the following purposes:

Steri-Oss 3.25 mm Replace Implant: This device is designed to serve as support for prosthetic devices to restore patient chewing function.

Steri-Oss 3.25 mm Replace Healing Screw: This device is designed to protect the internal threads of the implant during healing.

Steri-Oss 3.25 mm Replace Healing Abutment: This device is designed to expand the gingival tissue during the healing phase to maintain the appropriate abutment fit.

Steri-Oss 3.25 mm Replace Abutment: This device is designed to serve as a base for prosthetic devices which restore patient chewing function.

Scientific Concepts:

Natural dentition is composed of a root (subgingival) and a crown (supragingival). Endosseous dental implant designs in existence are intended to mimic this structure to aid the patient in restoring natural masticatory function. The subject implant is designed to serve as the root of the artificial tooth and the abutment/prosthesis is designed to serve as the crown. The healing screw and healing abutment are intermediary devices which serve to permit satisfactory completion of the implant healing/restoration process.

Device Characteristics:

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Steri-Oss Inc. - September 1997

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Section 6

510(k) Summary

Intended Use:

The intended use for this device system is to serve as support for prosthetic devices to restore patient chewing functions.

Comparison to Predicate:

The following table provides a comparison of the principle technological characteristics of the 3.25mm Replace Implant System and the predicate.

Specification/Characteristic	Predicate:Steri-Oss ReplaceImplant	New Product:Steri-Oss 3.25 mmReplace Dental Implant
Material	Titanium	Same
SurfaceCharacteristics	Color-coded	Same
Sterility	Sterile	Sterile

Comparison to Predicates:

Performance Data:

Not applicable.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 26 1997

Jeff Hausheer, Ph.D. ·Regulatory Affairs Specialist Steri-Oss, Incorporated 22895 East Park Drive Yorba Linda, California 92687

K973402 Re : Steri-Oss 3.25mm Replace Dental Implant Trade Name: System Requlatory Class: III Product Code: DZE September 8, 1997 Dated: Received: September 9, 1997

Dear Dr. Hausheer:

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 realour bota 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, qood 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Dr. Hausheer

through 542 of the Act for devices under the Electronic chrough 542 or the not in 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 debtired in form of equivalence of your device to a legally marketed predicate device results in a classification for your marrees 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) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact che office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to the regulation entifica, Mibbianding by Solerseneral 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,

Tim Quy 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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Section 9

Indications for Use

Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

3.25 mm Replace Dental Implant System

Indications For Use: The intended use for this device is to serve as support for prosthetic devices to restore patient chewing function.

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

WGongurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off) Division of Dental, Infection Control. and General Hospital Device

510(k) Number 673402

Prescription Use

OR Over-The-Counter Use (Per 21 CFR 801.109)

Per 21 CFR 801.109)

(Optional Format 1-2-96)

Steri-Oss Inc. - September 1997

- - 49

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.