The Brånemark Integration AB, implants and accessories is intended for surgical placement into the bone of upper /lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function.

The Brånemark Integration implants and accessories are subjected for one or two-stage surgical procedures, and either for cemented or screw retained prosthetic restorations. The implants are intended for immediate placement on a single tooth and/or multiple tooth applications recognizing sufficient bone stability (type I or II bone) and appropriate occlusal loading, to restore chewing and speech function. Multiple tooth applications may be connected with a bar.

Device Description

The Brånemark Integration implant products that are subject of this 510(k) are threaded, root-form implants fabricated from commercially pure titanium, and machined and are commercially available.

AI/ML Overview

The provided text is a 510(k) summary for the Brånemark Integration Dental Implant and Accessories. This document is a premarket notification for a medical device and does not contain a study that proves the device meets acceptance criteria in the format or with the details requested.

Instead, it asserts substantial equivalence to a predicate device. For devices seeking 510(k) clearance, the primary pathway is demonstration of "substantial equivalence" to a legally marketed predicate device, rather than explicit proof of meeting specific acceptance criteria through a clinical study in every case.

Therefore, many of the requested fields regarding a study and its details cannot be directly extracted from this document.

However, based on the provided text, here's what can be gathered or inferred about "acceptance criteria" and "performance data" in the context of this 510(k) submission:

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

Acceptance Criteria (Implied)	Reported Device Performance
As safe and effective as predicate Brånemark System® design.	"The technological characteristics of the Brånemark Integration implants and accessories remain substantially unchanged from the original Brånemark System® design . No design modifications were made that effect safety and effectiveness.""Clinical result show that expanded Indications for Use are as safe and effective as the original Indications for Use."
Permanent anchorage for prosthetic devices.	Intended for "permanent anchorage for prosthetic devices and to restore chewing function." (This is an intended use, and the performance claim suggests it is met as effectively as the predicate).
Restoration of chewing and speech function.	Intended to "restore chewing and speech function." (Again, an intended use, with performance claimed to be equivalent to the predicate).
Suitable for one or two-stage surgical procedures.	Intended for "one or two-stage surgical procedures".
Suitable for cemented or screw-retained prosthetic restorations.	Intended for "cemented or screw retained prosthetic restorations."
Suitable for immediate placement on a single tooth and/or multiple tooth applications recognizing sufficient bone stability (type I or II bone) and appropriate occlusal loading.	Intended for "immediate placement on a single tooth and/or multiple tooth applications recognizing sufficient bone stability (type I or II bone) and appropriate occlusal loading".

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

Not provided. The document refers to "Clinical result show that expanded Indications for Use are as safe and effective as the original Indications for Use," but it does not specify any sample size, design (retrospective/prospective), or data provenance for these "clinical results." This suggests that the clinical data might be derived from existing literature or previous predicate device data, rather than a specific new study with a "test set" for this particular 510(k).

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/Not provided. The document does not describe a study involving expert-established ground truth. The pathway here is substantial equivalence to a known predicate.

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

Not applicable/Not provided. No adjudication method is described as there's no mention of a specific test set requiring such expert evaluation.

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 device is a dental implant, not an AI diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant or described.

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

No. This device is a dental implant, not an algorithm.

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

Implied ground truth related to clinical outcomes and safety/effectiveness. The statement "Clinical result show that expanded Indications for Use are as safe and effective as the original Indications for Use" implies that clinical outcomes (e.g., implant success rates, integration, absence of adverse events) of the Brånemark System® (the predicate and likely the basis for this device's performance claims) are the "ground truth" against which the expanded indications are compared. However, no specific details on how this "ground truth" was established are provided for this 510(k).

8. The sample size for the training set

Not applicable/Not provided. This is not a machine learning/AI device, so there is no concept of a "training set" as typically understood in that context. The "training" for proving equivalence would be based on the extensive existing clinical history of the predicate device.

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

Not applicable/Not provided. (See point 8).

Summary

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K040643

APR - 7 2004

SECTION I.

510(K) SUMMARY

EstablishmentInformation	Brånemark Integration AB1 Lilla BommenGöteborg, Sweden, SE-411 04Phone: +46 31 760 10 60Fax: +46 31 15 52 60
Contact	Jan-Olof DjerfQuality Management & Regulatory Affairs, ManagerPhone: +46 31 760 10 63
ProprietaryDevice Name	Brånemark Integration Dental Implant and Accessories
ClassificationName	Endosseous Dental Implant (21 CFR 872.3640)
DeviceClassification	Class III
Statement	The information supporting claims of substantial equivalence, asdefined under the Federal Food, Drug, and Cosmetic Act, respectingsafety and effectiveness is summarized below.
DeviceDescription	The Brånemark Integration implant products that are subject of this510(k) are threaded, root-form implants fabricated fromcommercially pure titanium, and machined and are commerciallyavailable.
IntendedUse	The BRÅNEMARK INTEGRATION products are intended forsurgical placement into the bone of upper/lower jaw arches as apermanent anchorage for prosthetic devices and to restore chewing

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Indicationsfor use	The Brånemark Integration implants and accessories are subjected forone or two-stage surgical procedures, and either for cemented orscrew retained prosthetic restorations. The implants are intended forimmediate placement on a single tooth and/or multiple toothapplications recognizing sufficient bone stability (type I or II bone)and appropriate occlusal loading, to restore chewing and speechfunction. Multiple tooth applications may be connected with a bar.
TechnologicalCharacteristics	The technological characteristics of the Brånemark Integrationimplants and accessories remain substantially unchanged from theoriginal Brånemark System® design . No design modifications weremade that effect safety and effectiveness.
PerformanceData	Clinical result show that expanded Indications for Use are as safe andeffective as the original Indications for Use.
Conclusion	Based on the 510(k) summaries, 510(k) statements and theinformation provided in this submission, we conclude that theproducts are substantially equivalent to currently marketed devicesunder the Federal Food, Drug and Cosmetic Act.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The symbol is black, and the background is white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 7 2004

Ms. Jan-Olof Djerf Quality management & Regulatory Affairs, Manager Branemark Integration A.B. Lilla Bommen 1 SE-411 04 Gothenburg SWEDEN

Re: K040643

Trade/Device Name: Brånemark Integration Endosseous Dental Implant Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: March 5, 2004 Received: March 11, 2004

Dear Ms. Djerf:

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 ahove) 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 - Ms. Djerf

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) 594-5613. Also, please note the regulation entitled, "Misoranding 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,

feHWunteshen

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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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SECTION 2 INDICATIONS FOR USE

510(k) Number ________________________________________________________________________________________________________________________________________________________________

Device Name: Brånemark Integration Endosseous Dental Implant

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Usc

(Pcr 21 CFR 801.109)

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Over the Counter Use

Robert S. Betz, DDS for Dr. S. Runner

510(k) Number: K040643

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.