Encode® Patient Specific Dental Abutments made from oral scans provided from 3M ESPE Lava Chair Scanner and the 3M Lava COS (2.0) software are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. Encode® Patient Specific Dental Abutments 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

Patient Specific Dental Abutments are Encode® designed specifically for a patient using a CAD/CAM system. The abutments are designed from a threedimensional intra-oral optical scan or resin model scan and then machined/milled according to the parameters created in a digital file which are derived from the scan. The abutments are manufactured from titanium alloy (Ti 6Al-4V ELI) or biocompatible Zirconia TZP. The abutment design is limited according to BIOMET 3i Specifications, as follows:

Description	Min.	Max.
A.) Platform Seating Diameter	3.4 mm	6.0mm
B.) Gingival Margin Diameter	3.8mm	16.0mm
C.) Gingival Margin Height ExternalHex 3.4mm Platform	0.5 mm	N/A
C.) Gingival Margin Height Certain3.4mm Platform	0.25 mm	N/A
C.) Gingival Margin Height4.1mm/5mm/6mmExternal Hex /Certain	0.25 mm	N/A
D.) Total Height	4.75mm	15.0mm
E.) Angulations	0°	30°

AI/ML Overview

The provided text focuses on the 510(k) summary for the Encode® Patient Specific Dental Abutments, particularly the addition of oral scan data input. It describes the device, its intended use, and its equivalence to previously cleared devices.

Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

Acceptance Criteria (Device Specifications)	Reported Device Performance
A.) Platform Seating Diameter	3.4 mm - 6.0 mm
B.) Gingival Margin Diameter	3.8 mm - 16.0 mm
C.) Gingival Margin Height - External Hex 3.4mm Platform	0.5 mm - N/A (minimum only specified)
C.) Gingival Margin Height - Certain 3.4mm Platform	0.25 mm - N/A (minimum only specified)
C.) Gingival Margin Height - 4.1mm/5mm/6mm External Hex /Certain	0.25 mm - N/A (minimum only specified)
D.) Total Height	4.75 mm - 15.0 mm
E.) Angulations	0° - 30°

Reported Device Performance: The document states, "The abutments are manufactured from titanium alloy (Ti 6Al-4V ELI) or biocompatible Zirconia TZP. The abutment design is limited according to BIOMET 3i Specifications, as follows:" and then lists the specifications provided in the table above. This indicates that the device's performance aligns with these specified design parameters.

The "Performance Data" section further states: "Validation performed on scanning equipment and software to ensure accuracy of scanning models to produce the intended design as cleared in K032263 & K052648." This implies that the device successfully produced abutments within the specified design parameters when using the new oral scan input.

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

The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). It generally refers to "validation performed on scanning equipment and software."

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)

The document does not specify the number of experts used or their qualifications for establishing ground truth.

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

The document does not describe any adjudication method used for a test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported. This device is a dental abutment, not an AI-assisted diagnostic tool for human readers. The validation focuses on the accuracy of the CAD/CAM system and oral scanner to produce the intended physical device.

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

This is not a software algorithm that performs a diagnostic task. The "algorithm" here is the CAD/CAM software that designs the dental abutment based on scan data. The performance validation was for the overall system (scanner + software + manufacturing) to produce a physical device that meets pre-defined design specifications. It is a "standalone" performance verification in the sense that the system itself, from input scan to manufactured abutment, was validated to ensure it produces the desired physical outcome.

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

The ground truth for this device appears to be the established design specifications and physical characteristics of the dental abutments as cleared in the predicate devices K032263 & K052648. The "Performance Data" section indicates that "Validation performed on scanning equipment and software to ensure accuracy of scanning models to produce the intended design as cleared in K032263 & K052648." This suggests the ground truth is the "intended design"—meaning the established, accepted dimensions and shapes of the predicate abutments.

8. The sample size for the training set

The document does not mention a specific "training set" or its sample size. The focus is on the integration and validation of a new input method (oral scans) for an existing CAD/CAM system, rather than training a novel AI algorithm.

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

Since no training set is explicitly mentioned for an AI algorithm (as this is not an AI diagnostic device), the concept of ground truth establishment for a training set does not directly apply in the usual sense. The closest equivalent is that the CAD/CAM system's design parameters and the physical characteristics of the manufactured abutments are based on established dental engineering principles and the specifications of the predicate devices.

Summary

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MAR 1 1 2011

K101608 - 510(k) Summary

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

Submitter:	BIOMET 3i 4555 Riverside Drive Palm Beach Gardens, FL 33410
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Establishment Reg. Number: 1038806

Juliana Arias, Regulatory Affairs Specialist Contact Person:

Contact Phone/Fax/Email:

Fax. 561-514-6316 Email: Juliana.Arias@biomet.com

Tel. 561-776-6999 ext.7208

September 28th, 2010 Date Prepared:

Trade/Proprietary Name: Encode® Patient Specific Dental Abutments

Dental Abutment Common/Usual Name:

Root-form Endosseous Dental Abutment

872.3630 Device Classification/Code:

Predicate Device(s) :

Classification Name:

Device Description:

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

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Description	Min.	Max.
A.) Platform Seating Diameter	3.4 mm	6.0mm
B.) Gingival Margin Diameter	3.8mm	16.0mm
C.) Gingival Margin Height ExternalHex 3.4mm Platform	0.5 mm	N/A
C.) Gingival Margin Height Certain3.4mm Platform	0.25 mm	N/A
C.) Gingival Margin Height4.1mm/5mm/6mmExternal Hex /Certain	0.25 mm	N/A
D.) Total Height	4.75mm	15.0mm
E.) Angulations	0°	30°

Indications for Use:

Performance Data:

Equivalence Data:

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

Encode® Patient Specific Dental Abutments made from oral scans provided from 3M ESPE Lava Chair Scanner and the 3M Lava COS (2.0) software have the same intended use and indications, principles of operation, and technological characteristics as previously cleared Encode® Patient Specific Dental BIOMET 3i Abutments. The additional option of oral scans as a source of digital images for existing design CAD/CAM software do not raise any new questions of safety or effectiveness. Validation data demonstrates that the modified process results in a finished device that is just as safe and effective as Encode® Patient Specific Dental Abutments that are currently cleared under K032263 & K052648. Thus, the Encode® Patient Specific Dental Abutments are substantially equivalent to its predicate devices.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol of medicine and health. The caduceus is composed of three wavy lines, representing the three branches of government: executive, legislative, and judicial.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Ms. Juliana Arias Regulatory Affairs Specialist BIOMET 3i 4555 Riverside Drive Palm Beach Gardens, Florida 33410

MAR 1 1 2011

Re: K101608

Trade/Device Name: Encode® Patient Specific Dental Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 24, 2011 Received: February 28, 2011

Dear Ms. Arias:

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- Ms. Arias

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 (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.

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Watson

Anthony B. 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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Indications for Use

510(k) Number (if known): K101608

Device Name:

Encode® Patient Specific Dental Abutments

Indications for Use:

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

· Concurrence of CDRH, Office_of Device Evaluation (ODE)

	Susa Kayer
(Division Sign-Off)
Division of Anesthesiology, General Hospital

Division of Hematology/Oncology
Infection Control, Dental Services

510(K) Number: F101608

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.)