BIOMET 3i Patient Specific Dental Abutments (Encode®) Designed Using Cadent iTero Scanner and inLab Software v3.5are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. These are intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.

Device Description

Encode® Abutments are designed specifically for a patient in a CAD/CAM system. The abutments are designed from a three-dimensional intra-oral optical scan or resin model scan and then machined/milled according to the parameters created in a digital file which is derived from the scan. The abutments are manufactured from titanium alloy or ceramic.

AI/ML Overview

The provided text is a 510(k) summary for a medical device and does not contain the detailed information required to answer all parts of the request. The document specifically states that "Validation performed on scanning equipment and software to ensure accuracy of scanning models to produce the intended design as cleared in K032263 & K052648." However, it does not provide specific acceptance criteria, study methodologies, sample sizes, ground truth details, or effectiveness study results in the format requested.

Therefore, the following information can be extracted based on the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document. The general criterion is to "ensure accuracy of scanning models to produce the intended design as cleared in K032263 & K052648."	The device design and manufacturing process were validated to ensure accuracy relative to previously cleared products. The submission states, "Validation data demonstrates that the modified process results in a finished device that is as safe and effective as BIOMET 3i 's Patient-Specific Patient-Specific Dental Abutments that are currently cleared with previous scanner systems."

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. The document only mentions "Validation performed on scanning equipment and software."
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified. The document does not describe the establishment of a ground truth by experts for the validation.

4. Adjudication method for the test set:

Not specified.

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 MRMC comparative effectiveness study is mentioned. This device is an accessory to dental implants (abutments) designed using CAD/CAM, not an AI-based diagnostic tool for human readers.

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

The performance validated relates to the accuracy of the CAD/CAM system (scanner and software) in producing the intended design. While the process is largely automated (algorithm only in terms of design generation post-scan), specific standalone algorithm performance metrics are not provided. The phrase "algorithm only" in the context of an "AI" evaluation is not applicable here as it is a CAD/CAM design and manufacturing process, not an AI diagnostic algorithm.

7. The type of ground truth used:

The ground truth explicitly mentioned is "the intended design as cleared in K032263 & K052648." This implies a comparison to a predefined standard or previously cleared designs/specifications, likely through dimensional accuracy measurements or similar engineering validation methods, rather than clinical outcomes or pathology.

8. The sample size for the training set:

Not applicable. This is not a machine learning model that undergoes a "training" phase in the conventional sense. The "training" here would refer to the historical data or engineering principles used to develop the CAD/CAM software, which is not detailed.

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

Not applicable for the reasons mentioned in point 8. The "ground truth" for the CAD/CAM software development would be based on engineering specifications, dental anatomy, and functional requirements for abutments, but the document does not elaborate on this.

Summary

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BIOMET 3i Traditional 510(k)

Patient Specific Dental Abutments (Encode) Designed Using Cadent iTero Scanner and inLab Software v3.5

K102209

DEC 3 2010

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92

510(k) Summary

Submitter:

BIOMET 3i 4555 Riverside Drive Palm Beach Gardens, FL 33410

1038806 Establishment Reg. Number:

Contact Person:

Simeon Simone, Regulatory Affairs Specialists

Contact Phone/Fax/Email:

Tel. 561-776-6831 Fax. 561-383-3407 Email: simeon.simone@biomet.com

Date Prepared:

August 2nd , 2010

Trade/Proprietary Name:

Encode® Patient Specific Abutments

Common/Usual Name:

Classification Name:

Dental Abutment

Endosseous Dental Implant Abutment

Device Classification/Code:

872.3630

Predicate Device(s) :

BIOMET 3i - Encode® Patient Specific Dental Abutments K032263 & K052648

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Patient Specific Dental Abutments (Encode®) Designed Using Cadent iTero Scanner and inLab Software v3.5

Device Description:

Indications for Use:

Performance Data:

Equivalence Data:

BIOMET 3i Patient Specific Dental Abutments (Encode®) Designed Using Cadent iTero Scanner and inLab Software v3.5 are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. These are intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.

Validation performed on scanning equipment and software to ensure accuracy of scanning models to produce the intended design as cleared in K032263 & K052648.

BIOMET 3i Patient-Specific Dental Abutments (Encode ) have the same intended use and indications, principles of operation, and technological characteristics as previously cleared BIOMET 3i Patient-Specific Dental Abutments. The differences in scanning and CAD/CAM processes do not raise any new questions of safety or effectiveness. Validation data demonstrates that the modified process results in a finished device that is as safe and effective as BIOMET 3i 's Patient-Specific Patient-Specific Dental Abutments that are currently cleared with previous scanner systems. Thus, the BIOMET 3i Patient-Specific Dental Abutments are substantially equivalent to its predicate devices.

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Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. To the right of the seal is a stylized symbol featuring three abstract shapes, possibly representing people or services, stacked on top of each other.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Simeon Simone Regulatory Affairs Specialists BIOMET 31, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410

DEC - 3 2010

Re: K102209

Trade/Device Name: BIOMET 3i Patient Specific Dental Abutments (Encode®) Designed Using Cadent iTero Scanner and inLab Software v.3.5 Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 19, 2010 Received: November 23, 2010

Dear Mr. Simone:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Simone

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours. .

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. 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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BIOMET 3i Traditional 510(k)

Patient Specific Dental Abutments (Encode®) Designed Using.Cadent iTero Scanner and inLab Software v3.5

Indications for Use

510(k) Number (if known):

Device Name:

BIOMET 3i Patient Specific Dental Abutments (Encode®) Designed Using Cadent iTero Scanner and inLab Software v.3.5

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device

Page 15 of 393

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.)