The Atlantis Abutment is intended for use as an accessory to 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 cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

Device Description

The Atlantis™ Abutments for Straumann Interface and abutment screws are made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with Straumann Standard Regular Neck (RN) implants with 3.3, 4.1, and 4.8mm diameters; Standard Plus Regular Neck (RN) with 3.3, 4.1, and 4.8mm diameters and the Tapered Effect Regular Neck (RN) with the 3.3 and 4.1mm diameters.

AI/ML Overview

The provided document is limited in scope and does not contain detailed information about acceptance criteria, a specific study proving device performance, or the methodologies typically associated with such studies (like sample sizes, ground truth establishment, or expert involvement).

The document is a pre-market notification (510(k) summary) for the Atlantis™ Abutment for Straumann Interface. It primarily focuses on establishing substantial equivalence to a predicate device (Atlantis Abutment and Abutment Screw, K981858) based on intended use, material, design, and performance.

Therefore, I cannot provide a detailed response to most of your questions as the information is not present in the provided text.

Here's what can be extracted based on the given document:

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

This information is not provided in the document. The filing focuses on substantial equivalence to a predicate device rather than presenting specific quantitative acceptance criteria and performance data from a new study.

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

This information is not provided in the document. No specific test set or study data is presented.

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

This information is not provided in the document. No information about ground truth establishment or expert involvement in a study is mentioned.

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

This information is not provided in the document. No adjudication method is mentioned as there's no described test set or study requiring it.

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

This information is not provided in the document. The device is a dental implant abutment, not an AI-assisted diagnostic tool, so an MRMC study related to AI assistance would not be applicable or expected.

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

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

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

This information is not provided in the document. No ground truth is discussed as there is no mention of a study to validate performance against a ground truth. The basis for clearance is "substantial equivalence" to a predicate device.

8. The sample size for the training set

This information is not provided in the document. There is no mention of a training set as this is not a machine learning device.

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

This information is not provided in the document. There is no training set and thus no ground truth establishment for one.

In summary, the provided document is a 510(k) summary for a physical medical device (dental abutment) seeking clearance based on substantial equivalence to a predicate device. It does not describe a new clinical study with acceptance criteria, performance data, or ground truth establishment in the manner requested by your questions, which are more typically associated with software as a medical device or AI-driven diagnostic tools.

Summary

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Pre-market Notification Page - 000009 MAR 7 - 2005

K050052

SECTION 10 - 510 (K) SUMMARY VII.

This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR Part 807.92.

Applicants Name and Address .

Atlantis Components Inc. 25 First Street Cambridge, Massachusetts 02141 617-661-9799 Telephone Number: 617-661-9063 Fax Number: Franklin Uyleman Contact Person: Manager of Quality and Customer Service

2. Name of Device

Atlantis ™ Abutment for Straumann Interface Trade Name: Endosseous dental implant abutment Common Name: Endosseous dental implant abutment Classification Name: 21 CFR 872.3630 Product code NHA

Legally Marketed Device to which Equivalence is claimed (Predicate Device) 3.

Manufacturer	Device	510(k) Number
Atlantis Components Inc.	Atlantis Abutment andAbutment Screw	K981858

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 restorations.

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Pre-market Notification Page -= = = = = = = = = = = = = = = = =

Description of the Device (continued) 4,

Intended Use of the Device ಳು

The devices covered by this submission are abutments which are placed into a dental implant to provide support for a prosthetic reconstruction. The Atlantis Abutment is intended for use as an accessory to 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 cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

Basis for Substantial Equivalence રું.

The Atlantis™ Abutments for Straumann Interface are substantially equivalent in intended use, material, design and performance to the Atlantis Abutments cleared under K981858.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure. The symbol is composed of three curved lines that converge to form the shape of a bird's head and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 7 - 2005

Atlantis Components, Incorporated C/O Ms. Betsy Brown Consultant B.A. Brown & Associates 8944 Tamaroa Terrace Skokie, Illinois 60076

Re: K050052

K050052
Trade/Device Name: Atlantis™ Abutment for Straumann Interface Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: NHA Dated: January 6, 2005 Received: January 10, 2005

Dear Ms. Brown:

We have reviewed your Section 510(k) premarket notification of intent to market the device the We have reviewed your Scenon 210(tr) promation is substantially equivalent (for the referenced above and have determined the active in analy in the Medical Devices marketed in
indications for use stated in the enclosure) to legally markets of the Medical Dev indications for tise stated in the cherosared to to regulared date of the Medical Device with the provision interstate commerce prior to way 20, 1770, the childed in accordance with the provisions of Amendments, or to devices that have been recurse approval of approval of a prematked the Federal Food, Drug, and Cosmetic Act (71ct) that she ice, subject to the general
approval application (PMA). You may, therefore, market the Aet include approval application (1 MA). 1 od may, macontrols provisions of the Act include controls provisions of the Act. "The genting of devices, good manufacturing practice, requirements for annual regionst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III II your device is classified (see above) into controls. Fxisting major regulations affecting (PMA), it may be subject to such additional controls: Title 21, Tarts 800 to 898. In
your device can be found in the Code of Federal Regulations, Title 21, the Federal your device can be found in the Code of Pederal Regioner of 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 I least that FDA has made a determination that your device complies with other requirements Incall that I DA nas made a determand regulations administered by other Federal agencies. UI the Act of ally i oderal baker and equirements, including, but not limited to: registration 1 ou must comply with and 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 007), labelity systems (QS) regulation (21 CFR Part 820); and if requirements as sectionic product 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) I mis letter will and in you be organization of substantial equivalence of your device to a promatics notification. - The Presults 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), r you desire specific advise 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/industry/support/index.html.

Sincerely yours,

Ching-Lin, Ph.D.

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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Pre-market Notification Page -000205

Indications for Use

1050052 510(k) Number (if Known)

Device Name: Atlantis ™ Abutment for Straumann Interface

Indication for Use:

Prescription Use_X (Part 21 CFR 801 SubpartD)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anesthesiology, General Hospil. on Control, Dental Devices

Number: 1050052

693000

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.)