· To replace missing teeth in single or multiple unit applications within the mandible or maxilla
· For immediate placement in extraction sites and partially or completely healed alveolar ridge situations
· For both one- and two-stage surgical procedures
· Especially well in soft bone applications where implants with other implant surface treatments may be less effective
· Together with immediate loading protocol in all indications, except in single tooth situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate.

Abutments:

Astra Tech Implant System Plus abutments are intended to be used in conjunction with the Astra Tech Implant System Plus in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.

Device Description

OsseoSpeed Plus implants are straight, self-tapping, threaded, root-form dental implants provided in multiple diameters and lengths with the previously cleared OsseoSpeed™ surface. Implants are available in diameters of 3.6 mm, 4.2 mm and lengths of 9 mm, 11 mm and 13 mm. The neck portion of the implant includes the MicroThread™ design. A new anti-rotation interface with 6 keyway cross section connections allows for six abutment positions. All other features and procedures of OsseoSpeed Plus implants are the same as presently cleared OsseoSpeed implants.

OsseoSpeed Plus abutment components consist of cover screws, healing abutments and abutments with corresponding screws. Cover screws and healing abutments are provided in sizes to match the implant platform. Healing abutments are provided in sizes to match the implant platform and various gingival diameters and gingival heights. OsseoSpeed Plus abutments have three design types, cylindrical, asymmetric and angled (20°). Each abutment design type is provided in three platform diameters (3.6, 4.2 and 4.8 mm), two prosthetic margin diameters (4.5 and 5.5 mm or 5.5 and 7.0 mm) and two gingival heights (low = 1.5- 2.5 mm and high = 2.5-3.5 mm) for a total of eleven abutment design combinations.

To assist in preoperative treatment planning of position and direction of implant placement, transparent radiographic implant guide sheets are provided with magnifications from 1.0X to 1.8X. The radiographic implant guides are usable with all OsseoSpeed Plus implants.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary for the Astra Tech Implant System Plus:

Important Note: This 510(k) summary is for a dental implant system. The information provided is typical for medical devices that aim to demonstrate substantial equivalence to previously cleared predicate devices, rather than a clinical study establishing efficacy from scratch. Therefore, many of the typical "AI/algorithm performance study" criteria you listed (like MRMC studies, training set details, or ground truth establishment for a test set in the AI context) are not applicable to this type of device submission.

The "study" in this context refers to performance testing designed to show that the new device's technological changes do not raise new issues of safety or efficacy compared to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The primary acceptance criterion for this 510(k) submission is to demonstrate substantial equivalence to legally marketed predicate devices. This is achieved by showing that the subject device has the same intended use, technological characteristics, materials, and provides similar performance without raising new issues of safety or efficacy. The specific performance test mentioned is compliance with ISO 14801.

Reported Device Performance:
The document states: "Performance testing was provided to demonstrate substantial equivalence and included methods described in ISO 14801."

Acceptance Criteria Category	Specific Criterion	Reported Device Performance
Substantial Equivalence	Same intended use as predicate devices.	The Astra Tech Implant System Plus implants and abutments have the same intended use as the predicate devices: replacing missing teeth, immediate placement, one- and two-stage procedures, soft bone applications, and supporting crowns/bridges/overdentures.
	Same operating principle as predicate devices.	The device "uses the same operating principle" as predicate devices.
	Same basic design (with minor modifications not raising new safety/efficacy concerns).	The device "incorporates the same basic design." The main technological change is a new anti-rotation feature (keyway cross section) which is "similar to the cam anti-rotation mechanism of the CAMLOG Implant System." This difference "does not raise new issues of safety or efficacy."
	Same materials as predicate devices.	The device "incorporates the same materials."
	Similar packaging and sterilization methods as predicate devices.	The device "has similar packaging and is sterilized using the same materials and processes."
Mechanical Performance	Compliance with ISO 14801 (Dynamic loading for endosseous dental implants).	"Performance testing was provided to demonstrate substantial equivalence and included methods described in ISO 14801." (The specific results of this testing are not detailed in this summary, but the inclusion of this testing is noted.)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified in the summary. For mechanical testing under ISO 14801, a specific number of implants would be tested, but this number is not disclosed in the provided text.
Data Provenance: The testing was conducted by or for Astra Tech AB, a Swedish company. The summary doesn't specify if the testing itself was performed in Sweden or elsewhere, nor does it specify if human data (e.g., retrospective or prospective patient data) was used. Given it's ISO 14801, it is almost certainly bench-top mechanical testing, not human patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable as the "test set" in this context refers to mechanical performance testing, not human-interpreted data requiring expert consensus or ground truth establishment in the way it would be for an AI algorithm.

4. Adjudication Method for the Test Set

This information is not applicable for mechanical performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not performed. This type of study is typically done for diagnostic or screening devices, especially those involving human interpretation of images, to assess reader performance with and without an AI aid. This 510(k) is for a physical medical implant device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This device is a physical dental implant, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used

For the mechanical performance testing (ISO 14801), the "ground truth" would be the objective measurements of force, cycles to failure, or displacement as defined by the standard, measured by calibrated equipment. It is not expert consensus, pathology, or outcomes data in the usual sense.

8. The Sample Size for the Training Set

Not Applicable. This 510(k) is for a physical medical device, not an AI algorithm. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set for an AI algorithm, this question is irrelevant to this device submission.

Summary

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510(k) Summary

SEP 2 6 2011

Astra Tech AB Astra Tech Implant System Plus

K11287

September 26, 2011

ADMINISTRATIVE INFORMATION

Manufacturer Name:	Astra Tech AB
	Aminogatan 1, P.O. Box 14
	Mölndal, Sweden SE-431-21
	Telephone: +46 31 776 30 00
	Fax: +46 31 776 30 10
Official Contact:	Christina Lewing
	Head of Regulatory Affairs
Representative/Consultant:	Linda K. Schulz, BSDH, RDH
	Kevin A. Thomas, PhD
	PaxMed International, LLC
	11234 El Camino Real, Suite 200
	San Diego, CA 92130
	Telephone: +1 (858) 792-1235
	Fax: +1 (858) 792-1236
	email: lschulz@paxmed.com
	kthomas@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	Astra Tech Implant System Plus
Component Name:	OsseoSpeed™ Plus implants and abutments
Common Name:	Dental implant and abutment
Classification Regulations:	Implant, endosseous, root formEndosseous dental implant abutmentClass II, 21 CFR 872.3640
Product Code:	DZE, NHA
Classification Panel:	Dental Products Panel
Reviewing Branch:	Dental Devices Branch

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510(k) Summary

INTENDED USE

OsseoSpeed™ Plus implants of the Astra Tech Implant System Plus are intended to be used:

· To replace missing teeth in single or multiple unit applications within the mandible or maxilla
· For immediate placement in extraction sites and partially or completely healed alveolar ridge situations
· For both one- and two-stage surgical procedures
· Especially well in soft bone applications where implants with other implant surface treatments may be less effective
· Together with immediate loading protocol in all indications, except in single tooth situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate.

Abutments:

DEVICE DESCRIPTION

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EQUIVALENCE TO MARKETED DEVICE

Astra Tech AB demonstrated that, for the purposes of FDA 's regulation of medical devices, the Astra Tech Implant System is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices:

Astra Tech AB, Astra Tech Implant System cleared under K101732,

Astra Tech AB, Astra Tech Implant System cleared under K091239.

Astra Tech Inc., Fixture MicroThread™ OsseoSpeed™ cleared under K053384, and

Altatec GmbH, CAMLOG Implant System Modified Implants and Abutments cleared under K083496.

The subject device and the predicate devices have intended use, have the same technological characteristics and are made of the same materials. They encompass the same range of physical dimensions, including diameter and length of the implants, and diameter, height and angle of the abutments. The subject and predicate devices are packaged in similar materials and sterilized using similar methods. The technological change from the Astra Tech Implant System OsseoSpeed implants is the new anti-rotation feature of keyway cross section connections which is similar to the cam anti-rotation mechanism of the CAMLOG Implant System. Any differences in the technological characteristics do not raise new issues of safety or efficacy.

Performance testing was provided to demonstrate substantial equivalence and included methods described in ISO 14801.

The Astra Tech Implant System has the following similarities to the predicate devices:

. has the same intended use.
. uses the same operating principle,
. incorporates the same basic design.
. incorporates the same materials, and
. has similar packaging and is sterilized using the same materials and processes.

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Image /page/3/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 representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.

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

Astra Tech AB C/O Ms. Linda K. Schulz Regulatory Affairs Paxmed International, LLC 11234 Camino Real. Suite 200 San Diego, California 92130

SEP 2 2011

Re: K111287

Trade/Device Name: Astra Tech Implant System Plus Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: DZE, NHA Product Code: 11 Dated: September 13. 2011 Received: September 14, 2011

Dear Ms. Schulz:

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. Schulz

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.

ff 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/ucm 115809.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 10 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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,

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

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Indications for Use

510(k) Number: K111287

Device Name: Astra Tech Implant System Plus

Indications for Use:

Implants:

OsseoSpeed™ Plus implants of the Astra Tech Implant System Plus are intended to be used:

· To replace missing teeth in single or multiple unit applications within the mandible or maxilla
· For immediate placement in extraction sites and partially or completely healed alveolar ridge situations
· For both one- and two-stage surgical procedures
· Especially well in soft bone applications where implants with other implant surface treatments may be less effective
· Together with immediate loading protocol in all indications, except in single tooth situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate.

Abutments:

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

Susan Ruse

Page 1 of 1

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

510(k) Number: K111287

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.