An endosseous dental implant is indicated for surgical placement in the upper or lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on 4 interforaminal placed implants, and not indicated for single, unsplinted implants. Patient must be subject for dental treatment with endosseous implants

Device Description

Ankylos dental implants consist of uncoated pure titanium (grade 2 per ISO 5832/II). The threaded area features a rough structure, the cervical margin is polished. The implants come packaged in a sterile double glass container for contact-free handling. The cover screw has already been mounted in the implant and is only removed prior to placing the abutment.

AI/ML Overview

This document, K012681, is a 510(k) summary for a dental implant system. The purpose of a 510(k) is to demonstrate that a device is "substantially equivalent" to predicate devices already on the market. Therefore, the information provided focuses on this equivalence rather than a detailed study proving performance against defined acceptance criteria.

Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical trial or performance study for a novel device would. The document is a premarket notification to the FDA, stating the device's substantial equivalence to existing products. It does not contain details of a de novo study with acceptance criteria, sample sizes, or ground truth establishment.

Here's a breakdown of why the requested information cannot be fully provided from the given document, and what can be inferred:

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

Acceptance Criteria: Not explicitly stated. For a 510(k) submission, the "acceptance criteria" for going to market is often demonstrating substantial equivalence to a predicate device. This is achieved by showing comparable technological characteristics and intended use, along with safety and effectiveness that are equivalent to the predicate.
Reported Device Performance: Not explicitly reported in a quantitative manner against specific performance metrics. The document describes the device (uncoated pure titanium, rough threaded area, polished cervical margin, sterile packaging) and its intended use, implying its performance is similar to the identified predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not applicable/not provided. This document is a 510(k) premarket notification, not a report of a new clinical or performance study where a test set would be used to evaluate novel performance. The FDA's substantial equivalence review is based on comparing the new device's characteristics and indications for use to legally marketed predicate devices.
Data Provenance: Not applicable. The document refers to predicate devices (Straumann ITI Implant, Branemark System) but does not detail new data generation for the Ankylos system in the context of a "test set."

3. 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. Ground truth for a test set is not mentioned because no new performance study with such a test set is described.

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

Not applicable. No test set or expert adjudication is described in this 510(k) summary.

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

No. This is a dental implant, not an AI-powered diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.

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

No. This is a physical medical device (dental implant), not an algorithm or software. Standalone algorithm performance is not applicable.

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

Not applicable. No new "ground truth" was established in the context of demonstrating performance as described in a clinical study. The "truth" for a 510(k) centers around the established safety and effectiveness of the predicate devices and demonstrating that the new device is substantially equivalent.

8. The sample size for the training set

Not applicable. This relates to machine learning models, which is not relevant for a dental implant 510(k) submission.

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

Not applicable. As above, this pertains to machine learning and not to this type of medical device submission.

Summary of what is provided:

Device Name: Ankylos Implant System
Intended Use: Surgical placement in upper/lower jaw arches to provide root-form means for prosthetic appliance attachment, restoring chewing function. Can be placed via 2-stage or single-stage (immediate loading, restricted to anterior mandible based on 4 interforaminal placed implants, not single unsplinted implants).
Predicate Devices:
- Straumann ITI Implant (510k - 984104)
- Branemark System (510k - 992937)
Device Description: Uncoated pure titanium (grade 2 per ISO 5832/II), threaded area with rough structure, polished cervical margin, sterile packaged.
Substantial Equivalence: The FDA's letter (K012681) confirms that they reviewed the 510(k) and "determined the device is substantially equivalent...to legally marketed predicate devices." This is the "acceptance" in the context of a 510(k) for market clearance.

In essence, the document serves as evidence of the FDA's decision regarding market clearance based on substantial equivalence, not as a detailed report of a performance study with specific acceptance criteria and ground truth methodologies.

Summary

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K012681

AUG 2 2 2003

510k Summary September 12, 2002

Applicant's Name and Address:

Dentsloy Ceramco 6 Terri Lane Burlington, NJ 08016 Fax: 609-386-8282 Contact Person: Thomas B. Cameron, Dir. Q. A.

Name of Device:

Classification Name: Common / Usual Name: Proprietary Name: Establishment Registration Number: Owner - Operator: Classification;

Implant, Endosseous Dental Implant Ankylos 1225486 2246968 Class III

Predicate Devices

Straumann ITI Implant (510k - 984104) Branemark System (510k - 992937)

Description of Device

Intended Use of the Device

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or progress. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2003

Mr. Thomas B. Cameron Director, Quality Assurance Dentsply Ceramco 6 Terri Lane, Suite 100 Burlington, New Jersey 08016

Re: K012681

Trade/Device Name: Ankylos Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: May 28, 2003 Received: June 2, 2003

Dear Mr. Cameron:

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. Cameron

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 (301) 594-4613. 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/dsma/dsmamain.html

Sincerely yours.

Swertfump

Susan Runner, DDS, MA Interim 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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Indications for Use:

K012681 510(k) Number (if known):

Device Name: __

Ankylos Implant System

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription Use

Over-The-Counter Use

(Per 21 CFR 801, 109)

(Optional Format 1-2-96)

Kain Muley La WSR

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

510(k) Number: K012681

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.