Fixture MicroThread™ OsseoSpeed™ is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla where immediate implant stability may be obtained.. The device may be used equally well in a single-stage ) or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded after implantation where immediate implant stability may be obtained.

The fluoride-modified surface, though having a fluoride ion level far below that needed for caries prevention in teeth, provides a favorable substrate for bone attachment and osseointegration. Fixture MicroThread OsseoSpeed is especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective. Because initial stability may be difficult to obtain in Type IV bone, immediate loading of single tooth restorations may not be appropriate in such situations.

Device Description

Fixture MicroThread OsseoSpeed is a threaded, root-formed dental implant intended for supporting prosthetic devices in edentulous or partially dentate patients to restore their esthetics and chewing function. Fixture MicroThread OsseoSpeed is made from titanium with a micro-roughened and fluoride-modified surface, designated OsseoSpeed.

The implant is available with a straight or tapered contour at the implant neck and comes in different diameters and lengths. The abutments are screw-retained.

AI/ML Overview

This 510(k) summary describes a dental implant and does not include an AI/ML device or a study with acceptance criteria and device performance as typically understood for such devices (e.g., sensitivity, specificity, AUC).

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device, which is the primary regulatory pathway for many medical devices. The core argument for acceptance is that the device, "Fixture MicroThread™ OsseoSpeed™," is similar enough to existing, legally marketed devices that it doesn't raise new questions of safety and effectiveness.

Here's an analysis based on the provided text, using the structure of your request but acknowledging that some sections will be non-applicable due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present acceptance criteria or reported device performance in the form of quantitative metrics (e.g., sensitivity, specificity, accuracy) typically associated with AI/ML or diagnostic device studies.

Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device. The "performance" is described qualitatively as:

Acceptance Criterion (implicitly met by substantial equivalence)	Reported Device "Performance" (compared to predicate or general claims)
Intended Use Equivalence: To replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla, with immediate implant stability.	Substantially equivalent to "currently marketed Fixture OsseoSpeed" and "TiUnite implant" in intended use, material, design, and surface characteristics. May be used in single or two-stage procedures, immediate implantation, immediate loading (where stability allows).
Material Equivalence: Made from titanium.	Substantially equivalent to existing devices in material.
Design Equivalence: Threaded, root-formed dental implant, various diameters/lengths, straight/tapered neck contour, screw-retained abutments.	Substantially equivalent to existing devices in design.
Surface Characteristics Equivalence: Micro-roughened and fluoride-modified surface (OsseoSpeed).	Substantially equivalent to existing devices in surface characteristics. The fluoride-modified surface promotes increased and more rapid bone formation and increased bone-to-implant strength early in healing, maintained over time. Allows safe and efficacious use in soft bone and with immediate loading.

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

Sample Size: Not applicable. This submission does not describe a "test set" in the context of an AI/ML algorithm or diagnostic study. The "data" mentioned refers to pre-clinical and clinical data supporting the biological performance of the implant surface.
Data Provenance: The document states "previously submitted data and additional pre-clinical and clinical data with Fixture MicroThread OsseoSpeed." Specifics about country of origin or whether it was retrospective/prospective are not provided in this summary.

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

Not applicable. There is no mention of a "test set" requiring ground truth established by experts in the context of evaluating an AI/ML device's performance. The review and approval process involved FDA scientific review, not expert consensus on image interpretation.

4. Adjudication Method for the Test Set

Not applicable. There is no test set or adjudication method described for performance evaluation 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

Not applicable. This is not an AI-assisted device. The submission pertains to a physical dental implant.

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

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

7. The Type of Ground Truth Used

The "ground truth" here is biological and clinical evidence of bone attachment, osseointegration, and implant stability. This is inferred from pre-clinical (e.g., animal studies, in-vitro) and clinical data (human studies) demonstrating the properties of the implant's surface and overall function. It is not an "expert consensus" or "pathology" in the diagnostic sense, but rather a demonstration of medical efficacy through biological response and clinical outcomes.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for an AI/ML model described in this submission. The "previously submitted data and additional pre-clinical and clinical data" would be analogous to the evidence base considered for justifying substantial equivalence.

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

Not applicable. As there is no AI/ML training set, this question is not relevant to the provided text. The "ground truth" for the device's claims (e.g., "fluoride-modified surface promotes increased and more rapid bone formation") would be established through scientific methods in pre-clinical studies (e.g., histological analysis, biomechanical testing) and clinical trials (e.g., radiographic assessment, implant stability measurements, clinical follow-up), typically evaluated by dental and medical professionals specializing in implantology.

Summary

{0}------------------------------------------------

510(k) Summary

K053384	510(k) Summary
ADMINISTRATIVE INFORMATION
Manufacturer Name:	Astra Tech, Inc.890 Winter Street, Suite 310Waltham, MA 02451-1493Telephone: 1 (800) 531-3481FAX:1 (781) 890-6808
Official Contact:	Scott A. Root
Representative/Consultant:	Floyd G. LarsonPaxMed International, LLC11234 El Camino Real, Suite 200San Diego, CA 92130Telephone: 1 (858) 792-1235FAX: 1 (858) 792-1236
DEVICE NAME
Classification Names:	Implant, Dental, Root-Form
Trade/Proprietary Name:	Fixture MicroThread™ OsseoSpeed™, a component ofthe Astra Tech Implant System
Common Name:	Dental Implant

ESTABLISHMENT REGISTRATION NUMBER

Astra Tech, Inc. has submitted an Establishment Registration to FDA. The Establishment Registration number is 1222802. The owner/operator number for Astra Tech, Inc. is 9003608.

DEVICE CLASSIFICATION

FDA has classified endosseous dental implants as Class II devices (21 CFR 872.3640 according to revision 69 FR 26307, May 12, 2004). The product code for "Implant, Dental, Root-Form" is DZE. Endosseous dental implants and abutments are reviewed by the Dental Products Panel.

INTENDED USE

{1}------------------------------------------------

510(k) Summary

situations. When a one-stage surgical approach is applied, the implant may be immediately loaded after implantation where immediate implant stability may be obtained.

DEVICE DESCRIPTION

The implant is available with a straight or tapered contour at the implant neck and comes in different diameters and lengths. The abutments are screw-retained.

EQUIVALENCE TO MARKETED PRODUCT

The components provided for in this submission are physically equivalent in material, design and surface characteristics to those previously cleared. This submission clarifies the intended use and indications for Fixture MicroThread Osseospeed.

Basis of substantial equivalence:

Fixture MicroThread OsseoSpeed in this application is substantially equivalent to the currently marketed Fixture OsseoSpeed in intended use, material, design and surface characteristics. The indication for use statement is substantially equivalent to TiUnite implant, another implant with a modified surface having properties claimed to facilitate bone deposition and healing.

The previously submitted data and additional pre-clinical and clinical data with Fixture MicroThread OsseoSpeed illustrate that the fluoride-modified surface promotes increased and more rapid bone formation compared to the TiOblast surface, as well as increased boneto-implant strength early in the healing phase, which is also maintained over time. This improved early bone support allows safe and efficacious use in all situations and especially in situations with soft bone and whenever immediate installation and immediate and early loading protocols are applied.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - U.S.A." are arranged in a circular pattern around the eagle.

Public Health Service

MAR 2 4 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Astra Tech, Incorporated C/O Mr. Floyd G. Larson Paxmed International, Limited Liability Company 11234 El Camino Real Suite 200 San Diego, California 92130

Re: K053384

Trade/Device Name: Fixture MicroThread™ OsseoSpeedTM Regulation Number: 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE Dated: March 14, 2006 Received: March 15, 2006

Dear Mr. Larson:

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.

{3}------------------------------------------------

Page 2 -- Mr. Floyd G. Larson

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,

Chin S. Liu, Ph.D.

Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K053384

Device Name: Fixture MicroThread™ OsseoSpeed™, a component of the Astra Tech Implant System

・・・

Indications for Use:

Prescription Use X Prescription Use

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

(PI.EASE PONOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Susan furne

and Conner Conney of CDRH, Office of Device Evaluation (ODE) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

র পরিবার মিত্যা হয়েছেন।

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.