The Provide Temporary Cylinders are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support single and multiple unit prostheses in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non occlusal loading of single and multiple unit provisional restorations. The prostheses can be cement retained to the abutment.

Device Description

The Provide Temporary Cylinders will be made of the same material (PEEK) as the PreFormance Posts. The cylinder is cemented onto an abutment. An acrylic resin provisional restoration can be built onto the cylinder. The height of these cylinders will be 6.5mm and the platform diameters are 4.8 and 6.5mm. Furthermore, they will be used as single use to support a single-unit restoration and multi use where two or more cylinders are splinted together to support a provisional multi-unit restoration

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Provide Temporary Cylinders" device:

Based on the provided K061177 document, the information available does not describe a study involving detailed acceptance criteria and performance metrics typically associated with AI/software devices or clinical effectiveness studies. This submission is for a physical dental implant component, a device modification, and relies on substantial equivalence to a predicate device.

Therefore, many of the requested categories for AI/software device evaluation (like sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission.

Here's a breakdown of the available information in relation to your request:

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

Acceptance Criteria (Implicit)	Reported Device Performance
Material Equivalence: Made of the same material as predicate device (PEEK).	The Provide Temporary Cylinders are made of the same material (PEEK) as the PreFormance Posts.
Functional Equivalence: Contains features and functions similar to the predicate device.	The Provide Temporary Cylinders contain features and functions which are similar to the currently available PreFormance Posts. This suggests comparable mechanical properties, fit, and intended interaction with other components in the dental implant system.
Intended Use Equivalence: Align with or be a subset of the predicate device's intended uses.	The Indications for Use are similar: "accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. ...support single and multiple unit prostheses in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non occlusal loading..."
Safety and Effectiveness: Demonstrate substantial equivalence to the predicate device, implying comparable safety and effectiveness.	The document explicitly states: "The Provide Temporary Cylinders are substantially equivalent to the legally marketed PreFormance Posts." (K053170)

Study Proving Acceptance Criteria:

The "study" proving the acceptance criteria here is a Substantial Equivalence determination based on comparison with a predicate device (PreFormance Posts, K053170). The submission does not contain explicit details of a clinical study or performance testing with quantitative acceptance criteria for this specific device modification. Instead, it leverages the established safety and effectiveness of the predicate device.

The lack of specific performance standards is explicitly stated: "Performance standards have not been established by the FDA under Section 514 of the Federal Food, Drug, and Cosmetic Act."

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. This submission does not describe a clinical or performance test set in the way an AI/software device would. The evidence is a comparative analysis to a predicate device based on material, function, and indication for use.

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. There's no "ground truth" to be established by experts in the context of a dataset for this type of physical device's substantial equivalence pathway. The "ground truth" is effectively the regulatory approval and established performance of the predicate device.

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

Not Applicable. No test set or adjudication method described for a clinical or performance study.

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 a physical dental implant component, not an AI or imaging device. Therefore, no MRMC study would be performed.

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

Not Applicable. This is a physical dental implant component, not an algorithm or software.

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

For this type of 510(k) submission, the "ground truth" for demonstrating safety and effectiveness is the established safety and effectiveness of the legally marketed predicate device (PreFormance Posts, K053170), to which the new device is compared for substantial equivalence.

8. The sample size for the training set

Not Applicable. This is a physical device, not an AI/ML algorithm requiring a training set.

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

Not Applicable. No training set for an algorithm is involved.

In summary: K061177 describes a submission for a physical medical device modification (dental implant accessory). Its approval is based on demonstrating substantial equivalence to a previously cleared predicate device, rather than a new clinical study with specific acceptance criteria, test sets, or ground truth defined for an AI/software product. The listed "performance" in the document explicitly states that formal performance standards have not been established by the FDA for this class of device under the given section of the Act.

Summary

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K061177

Summary of Safety and Effectiveness

MAY 16 2006

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93

Submitter	Implant Innovations, Inc.4555 RiversidePalm Beach Gardens, FL 33410
Contact	Jim BanicRegulatory Affairs SpecialistImplant Innovations, Inc.4555 RiversidePalm Beach Gardens, FL 33410Tel. 561-776-6932Fax. 561-514 6316Email: jbanic@3implant.com
Date Prepared	25 April 2006
Device Name	Provide Temporary Cylinders
Classification Name	Endosseous Dental Implant Abutment
Device Classification	Class IIDental Devices Panel21 CFR § 872.3630
Predicate Devices	PreFormance Posts -> K053170
Performance	Performance standards have not been established by theFDA under Section 514 of the Federal Food, Drug andCosmetic Act.
Device Description	The Provide Temporary Cylinders will be made of thesame material (PEEK) as the PreFormance Posts. Thecylinder is cemented onto an abutment. An acrylic resinprovisional restoration can be built onto the cylinder. Theheight of these cylinders will be 6.5mm and the platformdiameters are 4.8 and 6.5mm. Furthermore, they will beused as single use to support a single-unit restoration andmulti use where two or more cylinders are splinted togetherto support a provisional multi-unit restoration
Indications for Use	The Provide Temporary Cylinders are intended for use asan accessory to endosseous dental implants to support aprosthetic device in a partially or fully edentulous patient.They are intended for use to support single and multipleunit prostheses in the mandible or maxilla for up to 180days during endosseous and gingival healing, and are fornon occlusal loading of single and multiple unit provisionalrestorations. The prostheses can be cement retained to theabutment.
TechnologicalCharacteristics	The Provide Temporary Cylinders are made of the samematerial and contain features and functions which aresimilar to the currently available PreFormance Posts.
Conclusion	The Provide Temporary Cylinders are substantiallyequivalent to the legally marketed PreFormance Posts.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 16 2005

Mr. Jim Banic Regulatory Affairs Specialist 3i Implant Innovations, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410

Re: K061177

Trade/Device Name: Provide Temporary Cylinders Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: April 25, 2006 Received: April 27, 2006

Dear Mr. Banic:

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 - Mr. Banic

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 (240) 276-0115. 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/industry/support/index.html.

Sincerely yours,

Snytte Y. Mickue Omd.

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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Implant Innovations, Inc. Internal Innovations, Inc.
Special 510(k) Premarket Notification – Provide™ Temporary Cylinders: Device Modification

Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Provide Temporary Cylinders

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: ✓
(Per 21 CFR 801.109)

Over the Counter Use:

Suren Runner

of Arasthesiology, General Hospital,
...n Control, Dental Devices
Numbar: Ko61177

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)