Prosthetic accessories are used in conjunction with ITI dental implants in the prosthetic restoration of the implant. These prosthetic accessories include abutments, copings and cylinders, and transfer system components. Abutments are placed into the dental implants to provide support for prosthetic restorations such as crowns, bridges, and overdentures. Prefabricated copings and cylinders provide a machined or cast inner surface for mating with the abutment and implant, while the outer surface can be adapted to the individual restoration. Transfer system components are used in the process of transferring the situation in the oral cavity to a precise dental model. Protection caps are used to protect the outer configuration of the abutment and to maintain and condition the soft tissues during the prosthetic phase.

Device Description

The prosthetic accessories to the All-in-One implants include abutments, copings, cylinders, temporary posts, transfer copings, and miscellaneous accessories. These components are composed of titanium, titanium alloy, gold alloy, and plastic (burn-out).

AI/ML Overview

The provided document is a 510(k) summary for prosthetic accessories for dental implants. It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study with specific acceptance criteria and performance data. Therefore, most of the information requested in your prompt is not available in the given text.

Here's a breakdown of what can and cannot be answered based on the provided input:

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

Not available. The document does not describe specific acceptance criteria (e.g., in terms of accuracy, precision, or durability) or reported device performance metrics because it's a submission for substantial equivalence, not a performance study.

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

Not applicable/Not available. No test set or associated data provenance is mentioned as this is not a clinical or performance study that measures specific device outputs.

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 available. No ground truth establishment activity is described.

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

Not applicable/Not available. No adjudication method is described.

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. No MRMC study or AI assistance is mentioned. This device is a set of physical prosthetic accessories, not an AI or imaging diagnostic device.

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

Not applicable. This device is hardware; there is no algorithm for standalone performance.

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

Not applicable/Not available. No ground truth is established for this type of submission. The basis for marketing approval here is "substantial equivalence" to predicate devices, meaning the device is similar enough in intended use, materials, and design to devices already legally marketed.

8. The sample size for the training set

Not applicable/Not available. No training set is mentioned as this is not a machine learning or AI-based device.

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

Not applicable/Not available. No training set or ground truth for it is mentioned.

Summary of available information:

The document is a 510(k) premarket notification for "synOcta Prosthetics®" (prosthetic accessories to dental implants).

Intended Use: To be used in conjunction with ITI dental implants for the prosthetic restoration of the implant, supporting crowns, bridges, or overdentures in edentulous or partially edentulous patients. Components include abutments, copings, cylinders, temporary posts, transfer copings, and miscellaneous accessories, made of titanium, titanium alloy, gold alloy, and plastic.
Basis for Substantial Equivalence: The modified ITI prosthetic accessories are claimed to be "substantially equivalent in intended use, material and design to prosthetic accessories marketed by ITI (Straumann), Nobel Biocare, Implant Innovations, and Friatec." This means the product is shown to be as safe and effective as a legally marketed predicate device, rather than undergoing a new, extensive performance study with acceptance criteria.

The FDA's letter confirms that the device is substantially equivalent for the indications for use stated and allows the applicant to market the device subject to general controls.

Summary

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JUL 20 1999

ATTACHMENT 7 - 510(k) Summary

Applicant's Name and Address

Straumann USA (on behalf of Institut Straumann AG)

Reservoir Place 1601 Trapelo Road Waltham, MA 02451 Telephone Number: Fax Number: Contact Person:

781-890-0001 781-890-6464 Linda Jalbert, Director of Regulatory Affairs

2. Name of the Device

Trade Name: Common Name: Classification Name: (21 CFR 872.3640)

synOcta Prosthetics® Prosthetic Accessories to Dental Implant Accessories to Endosseous Dental Implant

3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices)

ITI Abutments, copings, transfer system components (K894844 and K943720) Nobel Biocare's prosthetic accessories

Implant Innovations' prosthetic accessories Friatec's prosthetic accessories

র্বা Description of the Device

ട. Intended Use of the Device

ITI Dental Implants are intended to be placed in the maxillary and/or mandibular arch to support crowns, bridges or overdentures in edentulous or partially edentulous patients. The prosthetic accessories to dental implants are used either in the process of fabricating the prosthetic restoration for the implant or as part of the prosthetic restoration.

6. Basis for Substantial Equivalence

The modified ITI prosthetic accessories are substantially equivalent in intended use, material and design to prosthetic accessories marketed by ITI (Straumann), Nobel Biocare, Implant Innovations, and Friatec,

510(k) for Prosthetic Accessories for ITI Dental Implants

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Image /page/1/Picture/1 description: The image is a logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 20 1999

Ms. Linda Jalbert Director, Regulatory Affairs Straumann USA Reservoir Place 1601 Trapelo Road Waltham Massachusetts 02154

K990342 Re: SynOcta Prosthetics® Trade Name: Requlatory Class: III Product Code: DZE Dated: May 28, 1999 Received: June 1, 1999

Dear Ms. Jalbert:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Jalbert

this response to your premarket notification Please note: ricabon does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Blectronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as Info recei will as 0 (k) premarket notification. The FDA described in your sia mi puivalence of your device to a legally finalig of babbeandaries, results in a classification for your markets predicator amits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note ene office or compirand, "Misbranding by reference to the regaracion chorousd, "MEFF 807.97", "Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obeaties toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdaggov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

Indications for Use Statement nggo342

Device Name:

Prosthetic Accessories to ITI Dental Implants

Indications for Use:

Prescription Use (Per 21 CFR 801.109)

Susan Quary

Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

510(k) for Prosthetic Accessories for ITI Dental Implants

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.