The intended use of the Replace HA Coated Implants is for restoring chewing function by serving as anchorage for dental restorations.
The Replace HA Coated Implant is both for single-stage or two-stage surgical procedures and cement or screw retained restorations. The Replace HA Coated Implant is intended for immediate placement and function on single tooth and/or multiple tooth applications in good quality bone (type I or type II bone), to restore chewing function.

Device Description

The Replace ™ HA Coated Implant is to serve as a support for prosthetic devices to restore a patient's chewing function. The available diameters are 3.5 mm, 4.3 mm, 5.0 mm and 6.0 mm with lengths of 10 mm, 13 mm, and 16 mm. The titanium alloy implant has an HA coating on the root form portion to within approximately 2 mm of the top.

AI/ML Overview

Here's an analysis of the provided text regarding the Nobel Biocare Replace™ HA Coated Implant (K020646) and the study proving its acceptance criteria:

Summary of Device and Acceptance Criteria Information:

The provided documents are a 510(k) summary and the FDA's clearance letter for the Nobel Biocare Replace™ HA Coated Implant. It describes the device, its intended use, and the FDA's determination of substantial equivalence to previously marketed devices. This clearance (K020646) is specifically for an expanded indication for use, rather than for a new, de novo device.

This means that the acceptance criteria are primarily related to demonstrating that the expanded indication (immediate placement and function in good quality bone) is as safe and effective as the original indications for use, without significant changes to the device's technological characteristics. The "study that proves the device meets the acceptance criteria" is a clinical study that assesses the safety and effectiveness of the device under this expanded indication.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Safety: Device is as safe as predicate devices for expanded indications.	"Clinical results show that the expanded Indications for Use is as safe and effective as the original Indications for Use." (K020646, page 1) The FDA clearance letter's determination of substantial equivalence (K020646, page 2) implies that the device meets safety standards for its expanded use.
Effectiveness: Device is as effective as predicate devices for expanded indications.	"Clinical results show that the expanded Indications for Use is as safe and effective as the original Indications for Use." (K020646, page 1) The device is cleared for its stated indications: "restoring chewing function by serving as anchorage for dental restorations," now including immediate placement and function.
Technological Characteristics: No significant change in device design or materials.	"The technological characteristics of the Replace HA Coated Implants remained unchanged. No design modification was made." (K020646, page 1)

Important Note: The provided document is a 510(k) summary, which is a high-level overview. It typically does not contain the detailed data of the clinical study itself, but rather summarizes its conclusions. The specific quantitative metrics for "safety" and "effectiveness" (e.g., survival rates, bone loss thresholds) would be found in the full 510(k) submission, which is not publicly available in this snippet. The FDA's clearance implicitly confirms these criteria were met.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document states "Clinical results show...", but does not specify the sample size of the clinical study (test set) conducted.
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's a clinical study for FDA clearance, it's highly likely to be a prospective clinical trial, though this is not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not provide information on the number of experts, their qualifications, or their role in establishing ground truth for the test set. This type of detail is typically found in the full clinical study report, not in the 510(k) summary.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers' Improvement with AI vs. Without AI Assistance:

This question is not applicable to the provided document. The device is an endosseous dental implant, not an AI-powered diagnostic tool requiring MRMC studies for human reader performance. The "study" here refers to clinical performance of the physical implant in patients.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This question is not applicable. The device is a physical dental implant, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for a dental implant clinical study would be direct clinical observations and measurements over time, typically including:
- Clinical outcomes data: Implant survival rates, success rates (based on criteria like absence of mobility, absence of peri-implant radiolucency, absence of pain/infection).
- Radiographic analysis: Bone level changes around the implant.
- Patient-reported outcomes: Functionality, comfort, aesthetics.
- Pathology (if applicable): Though less common for a full study, biopsies might be used in specific research scenarios.
The document generically refers to "Clinical results," implying a collection of these types of direct clinical performance measures.

8. The Sample Size for the Training Set:

This question is not explicitly applicable in the context of this 510(k) for a physical medical device. "Training set" usually refers to data used to train an AI algorithm. For a physical implant, there isn't a "training set" in the same sense.
However, if interpreted as previous clinical experience/data that informed the device's design and original indications, the document states the device builds upon earlier models (K962845 and K973423), implying a history of clinical data from these predicate devices. The clinical data informing the current expanded indication would be from the study mentioned under item 1.

9. How the Ground Truth for the Training Set Was Established:

Similar to item 8, this question is not directly applicable to a physical implant. The "ground truth" for the predicate devices would have been established through their own clinical trials and post-market surveillance.

Summary

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K020646

Nobel Biocare

510(k) Summary

EstablishmentInformation	Nobel Biocare USA, Inc.22715 Savi Ranch ParkwayYorba Linda, CA 92887USA
	Phone: 1-800-993-8100, ext 5074Fax: 1-714-998-9348
Contact	Vincent CheungManager, Regulatory Affairs & Quality Assurance(714) 282-5074
Proprietarydevice name	Replace™ HA Coated Implant (K962845)Steri-Oss 3.25 mm Replace™ HA Coated Implant (K973423)
Classificationname	Endosseous Dental Implant (21 CFR 872.3640)
Deviceclassification	Class III
Statement	The information supporting claims of substantial equivalence, asdefined under the Federal Food, Drug, and Cosmetic Act, respectingsafety and effectiveness is summarized below.
Devicedescription	The Replace ™ HA Coated Implant is to serve as a support forprosthetic devices to restore a patient's chewing function. Theavailable diameters are 3.5 mm, 4.3 mm, 5.0 mm and 6.0 mm withlengths of 10 mm, 13 mm, and 16 mm. The titanium alloy implanthas an HA coating on the root form portion to within approximately 2mm of the top.
Intended use	The intended use of the Replace HA Coated Implants is for restoringchewing function by serving as anchorage for dental restorations.

Page 1 of.2

Nobel Biocare USA, Inc.

22715 Savi Runch Parkway, Yorba Linda, CA 92887
Telephone (714) 282-4800)
Fax (714) 282-4800)
Fax (714) 998-9236

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Indications for use	The Replace HA Coated Implant is both for single-stage or two-stage surgical procedures and cement or screw retained restorations. The Replace HA Coated Implant is intended for immediate placement and function on single tooth and/or multiple tooth applications in good quality bone (type I or type II bone), to restore chewing function.
Technological characteristics	The technological characteristics of the Replace HA Coated Implants remained unchanged. No design modification was made.
Performance data	Clinical results show that the expanded Indications for Use is as safe and effective as the original Indications for Use.
Conclusion	Based on the 510(k) summaries, 510(k) statements and the information provided herein, we conclude that the expanded Indications for Use is substantially equivalent to the currently marketed device under the Federal Food, Drug, and Cosmetic Act.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized image of an eagle or bird with three wing-like lines above its head. The bird is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" and is arranged around the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 2002

Mr. Vincent Cheung Manager, Regulatory Affairs & Quality Assurance Nobel Biocare USA, Incorporated 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K020646

Trade/Device Name: Replace HA Coated Implant Models, 35102, 35132, 35162, 43132, 43162 Regulation Number: 876.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: February 26, 2002 Received: February 28, 2002

Dear Mr. Cheung:

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 (1 wr 1), it has ob adjoor 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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Page 2 - Mr. Cheung

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 and instills (21 set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirences as bet form in order 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 110(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

Timot 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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Indications for Use Statement

510(k) Number (if known): K020646 Replace™ HA Coated Implant Device Name:

Indications for Use:

The Replace™ HA Coated Implant is for single-stage or two-stage surgical procedures The Replace TIA Coated migrations. The Replace HA Coated Implant is intended and centent of Screw relation on single tooth and/or multiple tooth applications
for immediate placement and function on single tooth and/or multiple tooth applications in good quality bone (type I or type II bone), to restore chewing function.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) . -Over-the-Counter Use OR Prescription Use Optional Format 1-2-96 (per 21 CFR 801.109) Justan (Division Sign-Off) (Division Sign-Ont)
Division of Dental, Infection Control, Division of Dospital Devices 102010 510(k) Number -

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.