The Neoss Titanium Prepable Abutment 15°and 20° is designed to be modified and secured directly to the implant using an abutment screw and supplied non-sterile. The Neoss Express Abutment requires no modification and allows for abutment level impression taking. The Neoss Locator Abutment system, made by commercially pure titanium, designed to secured directly to the implant using an abutment screw and supplied non-sterile.

AI/ML Overview

The provided document is a 510(k) summary for the Neoss various Titanium Abutments. It details the device's identification, equivalence to predicate devices, description, intended use, technological characteristics, and a discussion of performance testing.

However, the document does not contain the acceptance criteria or a detailed study proving the device meets specific acceptance criteria in the format typically used for AI/ML medical devices. Instead, it refers to general guidelines for dental implant systems and states that the device "fills the recommended requirements."

Therefore, I cannot populate the requested table and answer the study-specific questions as the information is not present in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices through design similarities and adherence to general mechanical testing guidelines, rather than presenting specific quantitative performance metrics against defined
acceptance criteria from a clinical or analytical performance study.

Here's a breakdown of what could be provided based on the document and what is missing:

Information Requested	Provided in Document	Missing from Document
1. Table of Acceptance Criteria & Reported Performance	General Statement: "The Neoss Various Titanium Abutment has, where applicable, been tested in accordance to the Guideline (Doc. No. 0043 - Guidance for industri and FDA staff, Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant Abutments, dated May 12, 2004) and the test results show that the abutment fills the recommended requirements."	Specific quantitative acceptance criteria (e.g., minimum tensile strength, fatigue life, accuracy thresholds) and corresponding measured performance values.
2. Sample Size & Data Provenance (Test Set)	Not applicable, as this is a mechanical device, not an AI/ML diagnostic. The "test set" would typically refer to the number of devices or components tested.	Specific number of abutments or components tested in mechanical testing, and whether the data was from a specific country or retrospective/prospective.
3. Number & Qualifications of Experts (Ground Truth)	Not applicable, as this is a mechanical device, not reliant on expert review for ground truth.	N/A
4. Adjudication Method (Test Set)	Not applicable (no ground truth based on expert review).	N/A
5. MRMC Comparative Effectiveness Study	Not applicable, as this is a mechanical device; an MRMC study is for evaluating human reader performance with and without AI assistance.	N/A
6. Standalone Algorithm Performance	Not applicable, as this is a mechanical device, not an algorithm.	N/A
7. Type of Ground Truth Used	Material/Design-based Ground Truth: Compliance with "design similarities between the predicative device and the devices in this application, since the devices are very similar in terms of material, size, preparation and basic design." Mechanical Performance Ground Truth: Adherence to "recommended requirements" from the "Guidance for industry and FDA staff, Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant Abutments." This implies physical properties and durability standards.	Specific, detailed physical measurements, stresses, and failure points that define the "ground truth" for mechanical integrity.
8. Sample Size for Training Set	Not applicable, as this is a mechanical device, not an AI/ML algorithm.	N/A
9. How Ground Truth for Training Set was Established	Not applicable, as this is a mechanical device.	N/A

Summary regarding the "study that proves the device meets acceptance criteria":

The document refers to "Mechanical testing requested for Dental Implant Systems" described in the "Guidance for industry and FDA staff, Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant Abutments, dated May 12, 2004." It states that the device "has, where applicable, been tested in accordance to the Guideline... and the test results show that the abutment fills the recommended requirements."

This statement indicates that a study (mechanical testing) was conducted in accordance with an FDA guidance document, and the results demonstrated compliance with the requirements outlined in that guidance. However, the specific details of that study (e.g., number of units tested, precise tests performed, quantitative results, and the exact "recommended requirements" or acceptance criteria from the guidance document) are not provided in this 510(k) summary. The conclusion of substantial equivalence is based on these tests and design similarities to predicate devices.

Summary

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Kc71838

SECTION 2.

A. 510(k) SUMMARY

0C7 1 9 2007

Summary of Safety and Effectiveness

In accordance with 21 CFR 807.92, the following information constitutes the Neoss Ltd summary for the Neoss various Titanium Abutments

SUBMITTER'S NAME:	Neoss Ltd
ADDRESS:	Windsor House
	Cornwall Road
	Harrogate, HG1 2PW, UK
CONTACT PERSON:	Fredrik Engman
TELEPHONE NUMBER:	+44 (0) 1423 817733 , +46 (0)709 792 892
FAX NUMBER:	+44(0) 1423 817744
E-MAIL	fredrik.engman@neoss.com
DATE OF SUBMISSION:	June 26, 2007

1. Identification of device

Classification name: Proprietary Name: Common Name: Classification Status: Product Codes:
Abutment, Implant, Dental. Endosseous Neoss Various Titanium Abutments including accessories Dental Abutment Class II per regulations 872.3630 NHA

2. Equivalent devices

Neoss various Titanium Abutments consist of preparable 15° and 20° abutments, Express abutments and the Locator Abutment system,

Neoss Ltd believes the Neoss Titanium Prepable Abutment 15°and 20° is substantially equivalent to the Angulated Abutment previously cleared in K974738 and to the abutment connection in the Neoss Abutments previously cleared in K043195.

The Neoss Express Abutment is substantially equivalent to the Neoss Abutments previously cleared in K043195.

The Neoss Locator Abutment system is substantially equivalent to Zest Anchors Inc. Locator components initially cleared in K994257 by Zest Ancors Inc and also in K012911 submitted by Implant Innovations Inc.

The accessories are equal to Neoss previous K043195.

3. Description of the Device

The Neoss Titanium Prepable Abutment 15°and 20° is designed to be modified and secured directly to the implant using an abutment screw and supplied non-sterile.

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The Neoss Express Abutment requires no modification and allows for abutment level impression taking.

The Neoss Locator Abutment system, made by commercially pure titanium, designed to secured directly to the implant using an abutment screw and supplied non-sterile.

4. Intended use

The Neoss Titanium Preparable Abutment 15°and 20° and Neoss Express abutments are designed to be connected to the Neoss implant and are intended for use as an aid in prosthetic rehabilitation.

The Neoss Locator Abutment system is intended for use with over dentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla.

5. Technological characteristics, comparison to predicate device.

Substantial equivalence of the Neoss Various Titanium Abutments and accessories is based on design similarities between the predicative device and the devices in this application, since the devices are very similar in terms of material, size, preparation and basic design.

6. Discussion of performance testing.

Mechanical testing requested for Dental Implant Systems are described in the Guidance for industry and FDA staff, Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant Abutments, dated May 12, 2004.

The The Neoss Various Titanium Abutment has, where applicable, been tested in accordance to the Guideline (Doc. No. 0043 - Guidance for industri and FDA staff, Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant Abutments, dated May 12, 2004) and the test results show that the abutment fills the recommended requirements.

7. Conclusion

Based on comparison and performed testing, the The Neoss Various Titanium Abutment and accessories are substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like figure above it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the seal.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 9 2007

Mr. Fredrik Engman CTO Neoss Limited Windsor House Cornwall Road Harrogate, HG1 2PW UNITED KINGDOM

Re: K071838

Trade/Device Name: Neoss various Titanium Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 26, 2007 Received: July 24, 2007

Dear Mr. Engman:

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 - Mr. Engman

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(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), please contact 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 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.gov/cdrh/industry/support/index.html.

Sincerely yours,

Eugite G. Michie MD.

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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B. INDICATIONS FOR USE

510(k) Number K071838

Device Name: Neoss various Titanium Abutments

Indications for Use:

The Neoss various Titanium Abutments are designed to be connected to the Neoss implants and intended for use as an aid in prosthetic rehabilitation.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE) --

Prescription Use OR (Per 21 CFR 801.109)

Over the Counter Use

Susan Runov

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K071833

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.)