The Sterngold 2.2mm Angled ERA dental implants are intended for long term 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 2.2mm Angled Micro ERA Dental Implant System consists of a threaded, external-hex, selftapping, root-form endosseous implant with integral female insert (abutment). The thread major diameter is 2.2 mm; available implant lengths will be 10, 13 & 15 mm. The implants will be available in anglecorrection (0°, 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 document is a 510(k) Premarket Notification for a dental implant system. It describes the device, its indications for use, and asserts substantial equivalence to predicate devices. However, this type of submission (Abbreviated 510(k) in this case) for a device like a dental implant does not typically include detailed performance studies with specific quantitative acceptance criteria and results in the way that software or AI/ML devices do.

Instead, the "acceptance criteria" for a dental implant in this context mostly revolve around:

Showing Substantial Equivalence (SE) to legally marketed predicate devices: This is the primary goal of a 510(k). This is achieved by demonstrating that the new device has the same intended use and technological characteristics as the predicate devices, or if there are differences, that those differences do not raise new questions of safety and effectiveness.
Conformity to recognized standards and guidance documents: The document explicitly states that Sterngold has provided information to demonstrate conformity with "Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." These guidance documents outline the types of testing and analyses typically expected for such devices (e.g., biocompatibility, mechanical testing, fatigue testing, etc.) to ensure safety and effectiveness.

Therefore, many of the requested details about acceptance criteria and study designs for AI/ML devices (like sample sizes, ground truth establishment, MRMC studies, etc.) are not applicable to this particular 510(k) submission for a physical medical device.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Acceptance Criteria Category	Specific Criteria/Goals (Inferred)	Reported Device Performance/Evidence
1. Substantial Equivalence (Core 510(k) requirement)	- Same intended use as predicate devices. - Similar technological characteristics, or differences do not raise new questions of safety/effectiveness. - Safe and effective for its intended use.	- Intended Use: Identical to predicate (dental implant for long-term/temporary surgical implantation to restore chewing function). - Technological Characteristics: The device is described (threaded, external-hex, self-tapping, root-form endosseous implant with integral female insert; titanium alloy; acid-etched surface; TiN coated female insert). - Conclusion: "Based on their indications for use, technological characteristics, and comparison to predicate devices, the Sterngold 2.2mm Angled Micro ERA Dental Implant System has been shown to be safe and effective for the product's intended use."
2. Conformance to Recognized Standards/Guidance (Abbreviated 510(k) approach)	- Device meets the requirements of the "Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." (This guidance would outline specific mechanical, biocompatibility, and other performance tests).	- Evidence: "Sterngold has provided information to demonstrate conformity with the following standards: . Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." (Specific test results are not detailed in this summary document, but would have been submitted to FDA).
3. Materials and Biocompatibility	- Materials used are implant-grade and biocompatible.	- Materials: "Manufactured from pure, implant-grade titanium alloy." "Female insert is titanium nitride coated." (Implied compliance with biocompatibility standards for these materials).
4. Design and Manufacturing Control	- Device manufactured under Good Manufacturing Practices (GMP). - Design specifications effectively met.	- Implied: Through the 510(k) process, it is assumed the manufacturer adheres to 21 CFR Part 820 (Quality System Regulation/GMP) and has appropriate design controls in place. The FDA's clearance letter confirms the assumption that the device may be marketed "subject to the general controls provisions of the Act," including GMP.
5. Sterilization (where applicable)	- Device is sterile or can be sterilized to appropriate standards.	- Not explicitly stated in this summary, but would be a standard requirement for implants and would be covered under the general controls and quality system regulation.

Regarding the other specific questions (primarily relevant for AI/ML or diagnostic devices):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. This is a physical dental implant. There is no "test set" in the sense of a dataset for an algorithm. Performance is demonstrated through mechanical testing, biocompatibility testing, and comparison to predicate devices, not clinical data evaluation in this summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. No ground truth needed for a test set for this physical device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set requiring expert adjudication.
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 is not an AI/ML device or a diagnostic device where MRMC studies are typically performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an software/AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No ground truth in the context of data for an algorithm. The "ground truth" for a physical device like this is its compliance with engineering specifications, material standards, and performance characteristics established through laboratory testing (e.g., fatigue strength, fracture resistance, biocompatibility).
The sample size for the training set:
- Not applicable. No training set for an AI/ML model.
How the ground truth for the training set was established:
- Not applicable. No training set.

Summary

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K092434

Sterngold Abbreviated 510(k) Premarket Notification

August 4, 2009 2.2mm Angled ERA Dental Implant System

510(k) Summary

Trade Name:	Sterngold 2.2mm Angled Micro ERA Dental Implant System
Sponsor:	Sterngold23 Frank Mossberg DriveAttleboro, MA 02703
Device Generic Name:	Dental endosseous implant system	NOV 10 2009
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 2.2mm Angled Micro 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:

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.

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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:

. Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. (Draft FDA Guidance; distributed for comment May 12, 2004)

Conclusion:

Based on their indications for use, technological characteristics, and comparison to predicate devices, the Sterngold 2.2mm Angled Micro ERA Dental Implant System has been shown to be safe and effective for the product's intended use.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird with outstretched wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Mr. Lee Clermont Director of Regulatory Affairs Sterngold Dental LLC 23 Frank Mossberg Drive Attleboro, Massachusetts 02703-0967

NOV 1 0 2009

Re: K092434

Trade/Device Name: 2.2 mm Angled Micro ERA Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: August 4, 2009 Received: August 31, 2009

Dear Mr. Clermont:

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 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 - Mr. Clermont

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. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

far

Susan Runner, D.D.S., M.A. Acting 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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1097434 510(k) Number (if known):

2.2mm Angled Micro ERA Dental Implant System Device Name:

Indications for Use:

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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

AND/OR Prescription (Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices

510(k) Ni

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

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.