The Cresco Ti® Implant Concept is intended a) for implantation into the fully edentulous ridge for the support of a dental prosthesis; b) for implantation into the partially edentulous ridge for support of a dental prosthesis; c) for single toolh implantation use.

Device Description

The proposed system which is the subject of this Special 510(k) Notification, is a modification to the existing Cresco Ti implant concept, which has been previously cleared by the FDA under 510(k) Number K981052 on December 18, 2001. This exaced includes a single non-sterile package containing all components necessary for the laboratory work and the prosthetic work to produce bridge supports and related accessories which are compatible with non-Cresco Ti endosseous implants. Modifications have been made to apply the same concept as that used for the Cresco . Hourient system to other inplant interfaces other than those included on page 134 of the original 510(k) Notification K980152. Additional bridge supports are included in this 510(k) Notification which are designed to fit a broader range of implant interfaces. In addition, the Cresco concept can also be used for other metals or metal alloys in addition to Titanium (e.g. procious metal, Co-Cr),

AI/ML Overview

The Cresco Ti® Implant Concept K042354 submission describes a modification to an existing dental implant system. The document focuses on demonstrating substantial equivalence to a predicate device (K981052) and does not contain detailed information on acceptance criteria for device performance as would be found in a clinical study report for an AI/ML medical device.

Therefore, many of your specific questions regarding acceptance criteria, sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies, cannot be directly answered from the provided text. The document describes a traditional medical device modification, not an AI/ML system.

However, I can extract information related to the non-clinical and clinical tests mentioned, which serve as evidence for device performance.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a device modification, the "acceptance criteria" are not reported as numerical performance metrics, but rather as showing that the modified device performs similarly to or better than the predicate, especially regarding mechanical integrity and compatibility.

Acceptance Criteria Category	Reported Device Performance
Non-Clinical Testing (Mechanical/Fatigue)	In vitro testing performed to assess validity of the design and the interface with various implant types (external hex, internal hex, internal/external tapered cone). Detailed torque angle signature analysis confirmed validity and design.
Clinical Testing (Long-term Validity)	Clinical testing demonstrates long-term validity of the concept on Cresco platform and other platforms (Branemark, ITI systems).
Material Compatibility	The Cresco concept can also be used for other metals or metal alloys in addition to Titanium (e.g., precious metal, Co-Cr).
Compatibility with Other Implant Interfaces	Modifications allow compatibility of Cresco TI screws and bridge supports to additional designs of dental implants from manufacturers other than Cresco Ti Systems AB.

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

Sample Size: Not explicitly stated. The document refers to "in vitro testing" and "clinical testing" generally, without providing specific numbers of tests or subjects.
Data Provenance: Not explicitly stated. The "Clinical Test Results" section vaguely mentions "long-term validity of the concept," but gives no details on the study's origin or type (retrospective/prospective).

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 as this is not an AI/ML device or a study involving expert readers for ground truth establishment.

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

Not applicable.

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.

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

Not applicable. This is a physical dental implant system.

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

For non-clinical tests, the "ground truth" would be established by engineering standards and measurement accuracy (e.g., successful retention during fatigue testing, specific torque values achieved).
For clinical tests, the ground truth for "long-term validity" would likely be patient outcomes, such as implant survival rates, lack of complications, and successful integration, assessed over time, but no specifics are provided.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable.

Summary

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SEP 2 1 7004

K042354

510K(k) SUMMARY

SUBMIT TER.

Cresco Tit Systems AB Dobeinsgatan 7 Kristianstad. 29:25 Sweder

DATE PREPARED:

DEVICE NAME:

August 25, 2004

Modification to the CRESCO TI® IMPLANT

CLASSIFICATION NAMES: CONCEPT

CRESCO TI® IMPLANT CONCEPT

Endosseous Dental Implant & AccessoriesT

Device Description:

PREDICATE DEVICE:

Predicate Devices:

There has been a device previously cleared by the FDA in the following 510(K) Notification indicated for use as a endosseous dental implant and associated accessories:

Device	510(k) DocumentNumber	Date Cleared	Indications
Cresco Ti® ImplantConcept	K981052	December 18th,2001	EndosseousDental Implant& Accessories

We therefore consider the proposed devices substantially equivalcet and identical to existing products/predicate devices either currently or in the past, in commercial distribution in the United States

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Intended Ilse:

Cresco Ti" Implant Concept Indications:

The Cresco Tits Implant Concept is intended a) for implantation into the fully edentulous ridge for the support of a dental prosthesis: b) for implantation into the partially edentulous ridge for support of a dental prosthesis: a c) for single tooth implantation use

Technological Characteristics:

Technologically, both the proposed and predicate devices are the same and are indicated for use as endosseous dental implants and accessories. The modification to the above listed endosseous dental implant and accessories, extends the compatibility of the Cresco TI screws and bridge supports to additional designs of dental implants provided by manufacturer's other than Cresco Ti Systems AB. Additionally, both devices utilize accessories for abutnents, screws and bridge supports which are comceted to the endosseous dental implants.

Summary of Non-Clinical Tests:

In vice testing (mechanical and fatigue tests) has neen performed to assess the validity of the design and the validity of the interface with the implace such as external has. internal hex, internal or external tapered conc. Additionally, careful screw design analysis has been carried out and a detailed torque angle signature analysis confirmed the validity and design of Cresco solutions.

Clinical Test Results:

Clinical testing demonstrate the long-term validity of the concept not only on Cresce platform, but also on external hex and internal tapered surface type platforms, such as Branemark and ITI systems.

Conclusions:

Any differences between the two devices do not raise new questions of safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three wavy lines extending from its body, representing the promotion of health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 1 2004

Ms. Jeanette Bengtsson Quality Assurance/ Cresco Ti Systems AB Döbelnsgatan 7 291 25 Kristianstad, Sweden

Re: K042354

Trade/Device Name: Modification to: Cresco T1® Implant Concept Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: June 1, 2004 Received: August 31, 2004

Dear Ms. Bengtsson:

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 - Ms. Bengtsson

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.

Susan Ruano
Chi. L.P., Ph.D.

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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Indications for Use

510(k) Number (if known): K042354 Cresco Tr® Implant Concept Device Name: Indications for Use:

The Cresco Ti® Implant Concept is intended

a) for implantation into the fully edentulous ridge for the support of a dental prosthesis;

b) for implantation into the partially edentulous ridge for support of a dental prosthesis;

c) for single toolh implantation use.

Prescription Use X AND/OR
(Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runn

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

510(k) Number. K02

Page 1 of

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.