The Atlantis Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

This device is compatible with the following manufacturers' implant systems: The titanium abutments are compatible with the Keystone 3.5mm, 4.1mm and 5.0mm Keystone Implants. The zirconia abutments are compatible with the Keystone 3.5mm, 4.1mm and 5.0mm Keystone Implants.

Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.

Highly angled abutments on small diameter implants are intended for the anterior region only.

Device Description

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented or screw retained restorations. The Atlantis™ Abutment for Keystone Implant and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.5mm, 4.0mm, 4.1mm and 5.0mm sizes. In addition, the Atlantis™ Abutment for Keystone Implant for the 3.5mm, 4.1mm and 5.0mm sizes are also made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6972 & 13356). Zirconia may have variation in shade. The titanium and zirconia abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, specifically the Atlantis™ Abutment for Keystone Implant. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with specific acceptance criteria and detailed performance metrics as one might find for a novel device requiring a PMA.

Therefore, the information typically requested in your prompt regarding acceptance criteria and a study proving those criteria are met is not fully applicable in the context of this 510(k) summary. The testing performed is non-clinical and aimed at demonstrating equivalence in performance characteristics to existing, legally marketed devices.

Here's an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (Inferred from Equivalence)	Reported Device Performance
Material Equivalence: Titanium Alloy and Biocompatible Ceramic material (Y-TZP)	Device uses Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) and yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) (meets ISO Standards 6972 & 13356).
Performance Characteristics Equivalence: Allows prosthesis to be cemented or screw-retained to abutment; abutment screw secures abutment to endosseous implant.	Device allows prosthesis to be cemented or screw-retained to abutment; abutment screw secures abutment to endosseous implant.
Intended Use Equivalence: Supports prosthetic device in partially/completely edentulous patients; for single/multiple tooth prosthesis in mandible/maxilla; compatible with specific implant systems (Keystone 3.5mm, 4.0mm, 4.1mm, 5.0mm); early load situations dependent on implant system/protocol; highly angled abutments on small diameter implants for anterior region only.	Device's intended use matches the predicate device's intended use across all specified conditions.
Mechanical Integrity/Durability: Ability to support appropriate static and fatigue test loads ("worst case scenario" implant assemblies).	Static and fatigue compression testing demonstrated that the implant system performs as intended, supporting appropriate static and fatigue test loads.

Explanation: For a 510(k), "acceptance criteria" are implied by demonstrating that the new device's technological characteristics, performance, and intended use are sufficiently similar to a predicate device. The "reported device performance" is the result of non-clinical testing verifying these similarities. There aren't explicit numerical thresholds like accuracy or sensitivity for this type of device and submission.

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

Sample size: Not explicitly stated. The document mentions "worst case scenario" implant assemblies were used for static and fatigue compression testing. The exact number of test samples is not provided.
Data provenance: The testing was "non-clinical testing" conducted by the manufacturer, Astra Tech Inc. There is no mention of country of origin of the data or whether it was retrospective or prospective, as a clinical study was not performed.

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

Not applicable. This was a non-clinical, engineering-based performance study, not a clinical study involving ground truth established by expert clinicians.

4. Adjudication method for the test set:

Not applicable, as this was not a clinical study requiring expert adjudication of results.

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 an endosseous dental implant abutment, a mechanical component, not an AI-driven diagnostic tool.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

For the non-clinical testing, the "ground truth" was adherence to established mechanical testing standards (e.g., ASTM, ISO referenced for materials) and the performance characteristics of the predicate device. The performance was assessed against engineering principles and the functional requirements of an abutment, rather than clinical outcomes or pathology.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study described is a "Summary of Non-clinical Testing." This testing involved:

Study Type: Static and fatigue compression testing.
Purpose: To demonstrate that the Atlantis Abutments are compatible with Keystone implants and perform as intended under mechanical stress.
Methodology: Testing was conducted on "worst case scenario" implant assemblies using Atlantis angled titanium and zirconia abutments with the Keystone implant.
Results: The test results demonstrated that the implant system supported appropriate static and fatigue test loads, indicating that the device performs as intended and is substantially equivalent in performance characteristics to the predicate device.

In the context of a 510(k) for a device like a dental abutment, the "acceptance criteria" are predominantly met through demonstrated material equivalence, functional equivalence, and successful non-clinical mechanical testing that ensures the device is as safe and effective as the predicate device. Clinical trials with human subjects, expert review, or AI performance metrics are generally not required for this type of submission.

Summary

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K103020

FEB - 3 20il

510(k) Summary

Astra Tech Inc. Atlantis™ Abutment for Keystone Implant

ADMINISTRATIVE INFORMATION

510K Summary preparation date:

Manufacturer Name:

September 30, 2010

Astra Tech Inc. 590 Lincoln Street Waltham, Massachusetts 02541 Telephone: 781-810-6462 781-810-6719 Fax:

Official Contact:

Representative/Consultant:

Franklin Uyleman

Betsy A. Brown B.A. Brown and Associates Inc. Telephone: 847-560-4406 Fax: 847-677-0177

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Atlantis™ Abutment for Keystone Implant Common Name: Endosseous dental implant abutment 21 CFR 872.3630 Product Code: NHA Classification Panel: Dental Products Panel Reviewing Branch: Dental Devices Branch

INTENDED USE

This device is compatible with the following manufacturers' implant systems: The titanium abutments are compatible with the Keystone 3.5mm, 4.1mm and 5.0mm Keystone Implants.

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K103020

Premarket Notification Section 5: Page - 5

INTENDED USE (continued)

The zirconia abutments are compatible with the Keystone 3.5mm, 4.1mm and 5.0mm Keystone Implants.

Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.

Highly angled abutments on small diameter implants are intended for the anterior region only.

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED DEVICE

Astra Tech Inc. demonstrated that, for purposes of the FDA's regulations of medical devices, the Atlantis™ Abutment for Keystone Implant is substantially equivalent in indications and design principles to Lifecore's predicate devices: PrimaConnex Internal Connection Implant System cleared under K051614 and PrimConnex Ceramic Abutments cleared under K062876, each of which has been determined by FDA to be substantially equivalent to preamendment devices.

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Premarket Notification
Section 5: Page – 6

Table 1: Substantial Equivalence Summary
TechnologicalCharacteristics	Atlantis™ Abutment forKeystone Implant	Keystone PrimaconnexImplant System
Material	-Titanium Alloy-Biocompatible ceramicmaterial	-Titanium Alloy-Biocompatible ceramicmaterial
Performance characteristics	Allows the prosthesis to becemented or screw retained toabutment. While the abutmentscrew is intended to secure theabutment to the endosseousimplant.	Allows the prosthesis to becemented or screw retained toabutment. While the abutmentscrew is intended to secure theabutment to the endosseousimplant.
Intended Use	The Atlantis Abutment isintended for use with anendosseous implant to supporta prosthetic device in apartially or completelyedentulous patient. It isintended for use to supportsingle and multiple toothprosthesis, in the mandible ormaxilla. The prosthesis can becemented or screw retained tothe abutment. The abutmentscrew is intended to secure theabutment to the endosseousimplant. This device iscompatible with the followingmanufacturers' implantsystems: The titaniumabutments are compatible withthe Keystone 3.5mm, 4.0mm,4.1mm and 5.0mm KeystoneImplants. The zirconiaabutments are compatible withthe Keystone 3.5mm, 4.0mm,4.1mm and 5.0mm KeystoneImplants. Please note: Thisdevice may be used in an earlyload situation, but is depend-ent on the specific implantsystem and protocol used bythe dental professional.	Intended for use with anendosseous implant to supporta prosthetic device in apartially or completelyendentulous patient. Intendedfor use to support single ormultiple tooth prosthesis, inmandible or maxilla. Theprosthesis can be cemented orscrew retained to theabutment. The abutment screwis intended to secure theabutment to the endosseousimplant.
	Highly angled abutments onsmall diameter implants areintended for the anteriorregion only.

Table 1: Substantial Equivalence Summary

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Summary of Non-clinical Testing

Static and fatigue compression testing was conducted on "worst case scenario" implant assemblies using Atlantis angled titanium and zirconia abutments with the Keystone implant. Test results demonstrated that the Atlantis Abutments are compatible with the Keystone implants and the implant system supported appropriate static and fatigue test loads demonstrating that the implant system performs as intended.

Conclusion for Substantial Equivalence:

The Atlantis™ Abutment for Keystone Implant is substantially equivalent to Lifecore's predicate devices: PrimaConnex Internal Connection Implant System cleared under K051614 and PrimConnex Ceramic Abutments cleared under K062876, based on noted similarities in indication, manufacturing material, generated design principle and performance characteristics data.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609. Silver Spring, MD 20993-0002

Astra Tech, Incorporated C/O Ms. Betsy Brown B.A. Brown & Associates 8944 Tamaroa Terrace Skokie, Illinois 60073

FEB - 3 201

Re: K103020

Trade/Device Name: Atlantis™ Abutment for Keystone Implant Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: January 26, 2011 Received: January 27, 2011

Dear: Ms. Brown

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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- Ms. Brown

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 (OS) 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

h for

Anthony D. Watson, B.S., M.S., M.B.A. 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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Premarket Notification Section 4: Page - 3

... .

Indications for Use

510(k) Number (if known)_ K 103020

Device Name: AtlantisTM Abutment for Keystone Implant

Indication for Use:

This device is compatible with the following manufacturers' implant systems:

The titanium abutments are compatible with the Keystone 3.5mm, 4.1mm and 5.0mm Keystone Implants.

The zirconia abutments are compatible with the Keystone 3.5mm, 4.1mm and 5.0mm Keystone Implants.

Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.

Highly angled abutments on small diameter implants are intended for the anterior region only.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-the-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON AND THER PAGE IF All see form NEEDED)

(Oivision of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Concurrence of CDRH, Office of Deffice of Departions (ODE) Division of Anesthoolor of Or

K103020

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)