The Sterngold 3.25mm ERA dental implants are intended for permanent as well as temporary surgical implantation in the bone of the patient's upper or lower arch to provide immediate load or delayed load of prosthetic systems, such as artificial teeth, in order to restore the patient's chewing function. Immediate loading of the ERA Implant should only occur when the position of the implants provides adequate bone quantity and quality to allow proper immediate mechanical stabilization of the self-tapping screw into the bone and where occlusal and lateral forces can be limited with appropriate occlusal design and a soft diet.

Device Description

The Sterngold 3.25mm ERA Dental Implant System consists of a threaded, external-hex, self-tapping, rootform endosseous implant with integral female insert (abutment). The thread major diameter is 3.25 mm; available implant lengths will be 10, 13 & 15 mm. The implants will be available in straight and anglecorrection (5°, 11° & 17°) versions with cuff heights ranging from 0.76-4mm. The implants are manufactured from pure, implant-grade titanium alloy. The external surface of the implants (excluding the neck and the implant head) is lightly acid etched to remove any surface contaminants remaining from the manufacturing operation, and to achieve a slightly roughened microsurface to aid in implant osseointegration. The female insert is titanium nitride coated.

AI/ML Overview

The provided text is a 510(k) summary for the Sterngold 3.25mm ERA Dental Implant System, and a letter from the FDA confirming its substantial equivalence. This type of regulatory submission does not typically include detailed performance studies with acceptance criteria, sample sizes, expert adjudication, or MRMC studies for AI devices. Instead, it relies on demonstrating equivalence to existing predicate devices and compliance with relevant standards.

Therefore, many of the requested fields cannot be directly extracted from the provided text. However, I will populate the table and answer the questions based on the information provided, or indicate when the information is not present.

Acceptance Criteria and Device Performance

As this is a 510(k) submission for a dental implant, the "acceptance criteria" are not reported in terms of statistical metrics (like sensitivity, specificity, etc.) for an AI device. Instead, the acceptance criteria are met by demonstrating substantial equivalence to predicate devices and compliance with FDA guidance and standards for endosseous implants.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Devices	The Sterngold 3.25mm ERA Dental Implants are stated to be substantially equivalent to other currently marketed dental implant systems cleared by FDA through the 510(k) process, including the Sterngold ERA Dental Implant System and the Sterngold Narrow Platform Hex Screw Implants.
Compliance with Regulatory Standards and Guidance Documents	The submission provided information to demonstrate conformity with: - Overview of Information Necessary for Premarket Notification Submissions for Endosseous Implants (FDA Guidance) - Information Necessary for Premarket Notification Submissions for Screw-Type Endosseous Implants (FDA Guidance; December 9, 1996)
Safety and Effectiveness for Intended Use (based on above criteria)	The conclusion states: "Based on their indications for use, technological characteristics, and comparison to predicate devices, the Sterngold 3.25mm ERA Dental Implant System has been shown to be safe and effective for the product's intended use."

Since this is a 510(k) for a physical medical device (dental implant), not a software or AI device, the following questions are not applicable to the submitted document. The document describes a traditional device clearance pathway, not a performance study for an AI algorithm.

Sample size used for the test set and the data provenance: Not applicable. This is a physical device, not an AI algorithm requiring a test set of data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device would be its physical properties, biocompatibility, mechanical strength, and successful osseointegration over time, which are typically assessed through material testing, pre-clinical studies, and clinical experience with predicate devices, rather than a "ground truth" for an algorithmic output.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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SIOCKS

Summary

Koy 127/

Trade Name:	Sterngold 3.25mm ERA Dental Implant System
Sponsor:	Sterngold23 Frank Mossberg DriveAttleboro, MA 02703
Device Generic Name:	Dental endosseous implant system
Classification:	According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II
Product Code:	DZE (21CFR872.3640)

Predicate Devices:

The Sterngold 3.25mm ERA Dental Implants are substantially equivalent to other currently marketed dental implant systems that have been cleared by FDA through the 510(k) Premarket Notification process, including the Sterngold ERA Dental Implant System and the Sterngold Narrow Platform Hex Screw Implants.

Product Description:

Indications for Use:

Safety and Performance:

This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Sterngold has provided information to demonstrate conformity with the following standards:

. Overview of Information Necessary for Premarket Notification Submissions for Endosseous Implants (FDA Guidance)
. Information Necessary for Premarket Notification Submissions for Screw-Type Endosseous Implants (FDA Guidance; December 9, 1996)

Conclusion:

Based on their indications for use, technological characteristics, and comparison to predicate devices, the Sterngold 3.25mm ERA Dental Implant System has been shown to be safe and effective for the product's intended use.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 8 2004

Sterngold C/O Ms. Pamela Papineau Regulatory Affairs Consultant Delphi Medical Device Consulting, Incorporated 5 Whitcomb Avenue Ayer, Massachusetts 01432

Re: K041271

Trade/Device Name: 3.25mm ERA Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: August 20, 2004 Received: August 23, 2004

Dear Ms. Papineau:

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 your device can be found 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.

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Page 2 -- Ms. Papineau

Please be advised that FDA's issuance of a substantial equivalence determination does not I least that FDA has made a determination that your device complies with other requirements mean that I Drimas made a detes and regulations administered by other Federal agencies. of the Act of ally I oderal base survey with and submitted to: registration 1 ou must comply with an are Hooding (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 807), labeling (QS) regulation (21 CFR Part 820); and if requirements as bet form in are qt 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 510(k) IThis letter will and n yourse Finding of substantial equivalence of your device to a premarket notification - 12 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), If you desire speed to the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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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510(k) Number (if known): Ko41271

3.25mm ERA Dental Implant System Device Name:

appropriate occlusal design and a soft diet.

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

× Prescription Use __ (Part 21 CFR 801 Subpart D) AND/OR

Over-the -Counter Use (21 CFR 807 Subpart D)

Susan Rumer

Division of Anesthesiology, General H Infection Control, Dent

510(k) Number: K091271

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.