Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, and/or traumatic arthritis where one or more compartments are involved.
Correction of varus, valgus, or posttraumatic deformity.
Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

Tibial bearings are indicated for use with both cemented and uncemented Biomet tibial trays.

All-polyethylene patellar components are indicated for cemented use only.

Device Description

The E1® Series A® Patellae is an all-polyethylene, 3-peg patella series intended for replacement of part of the knee joint in conjunction with a femoral and tibial component in primary or revision applications. Patella components are available in standard and asymmetric configurations. The proposed devices are manufactured from UHMWPE per ASTM F648 exposed to 100 kGy gamma irradiation and Vitamin E (α-tocopherol).

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called the E1® Series A® Patellae, a component of a total knee replacement. It describes the device, its intended use, and claims substantial equivalence to previously marketed predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

Key Takeaway: This 510(k) summary is for a medical device (patella component for knee replacement), not an AI/software device. Therefore, many of the requested categories related to AI performance, ground truth, experts, and reader studies are not applicable. The "acceptance criteria" here are related to proving mechanical and material equivalence to existing devices.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" for this mechanical medical device are implicitly defined by the demonstration of "substantial equivalence" to predicate devices through specific engineering analyses and mechanical tests. There are no explicit quantitative performance metrics listed in the way one would see for an AI algorithm (e.g., sensitivity, specificity).

Acceptance Criteria (Implied by Substantial Equivalence Claim)	Reported Device Performance (Summary of Performance Data)
Intended Use: Same as predicate devices	The proposed E1® Series A® Patellae and predicate patella devices have the same intended use.
Indications for Use: Same as predicate devices	The proposed E1® Series A® Patellae and predicate patella devices have the same indications for use.
Materials: Manufactured from UHMWPE per ASTM F648, similar to predicate and existing E1 Tibial Bearings	The proposed E1® Series A® Patellae and predicate patella devices are manufactured from UHMWPE per ASTM F648. Utilizes the same material/manufacturing process as Biomet E1 Tibial Bearings (K080528).
Design Features: Incorporate same design features as predicate devices	The proposed E1® Series A® Patellae incorporate the same design features as the predicate patella devices.
Sterilization: Same methods as predicate devices	The proposed E1® Series A® Patellae and predicate devices are provided sterile via the same sterilization methods for single-use.
Mechanical Performance & Safety: Equivalent mechanical stability, contact area stress, and peg shear strength to predicate devices	Results from mechanical tests and engineering analyses demonstrate the proposed E1® Series A® Patellae are substantially equivalent to the predicate patella devices. These include: - Contact area stress analysis and engineering analysis - Mechanical stability analysis and engineering analysis - Peg shear testing

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable in the context of an AI/software study. For this mechanical device, the "test set" would refer to the physical samples of the device undergoing mechanical testing. The document does not specify the number of units tested.
Data Provenance: Not applicable as there is no data set of patient information or images. The "data" here refers to mechanical test results and engineering analyses. These tests are presumably performed in a lab setting by the device manufacturer, Biomet Inc.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. There is no "ground truth" established by experts in the context of interpreting medical images or clinical outcomes for this device in this submission.
Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This concept is relevant for reconciling discrepancies among expert readers in image interpretation or clinical diagnosis. It does not apply to mechanical testing or engineering analyses of a physical implant.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No.
Effect Size: Not applicable. This type of study and metric are for evaluating the impact of AI assistance on human reader performance, which is not relevant for this device submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Standalone Performance Study: No. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: Not applicable in the traditional sense of AI/software development (e.g., pathology, outcomes data, expert consensus on images). For this device, the "truth" is established by adherence to engineering principles, material specifications (ASTM F648), and comparative mechanical performance metrics against predicate devices. The "ground truth" essentially validates that the device performs mechanically as intended and as safely as equivalent existing devices.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This concept belongs to machine learning and AI model development.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment for Training Set: Not applicable. This concept belongs to machine learning and AI model development.

Summary Context:

This 510(k) submission is for a traditional medical device (a knee implant component). The "study" proving it meets acceptance criteria consists of engineering analyses and mechanical laboratory tests designed to demonstrate that the new device is "substantially equivalent" to predicate devices already on the market. This framework does not involve clinical trials, human reader studies, or AI algorithm performance evaluations. The acceptance criteria are essentially that the device performs mechanically and in terms of material properties, design, and intended use as safely and effectively as legally marketed predicate devices.

Summary

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JUL 0 3 2014

BIOMET

510(k) Summary E1® Series A® Patellae | Traditional 510(k)

510(k) Summary K140902 (pg 1/2)

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the E1® Series A® Patella 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.

Sponsor:

Biomet Inc. 56 East Bell Drive PO Box 587 Warsaw, IN 46581 Establishment Registration Number: 1825034

Contact:

Amy L Walriven Senior Regulatory Affairs Specialist

Date:

Subject Device:

April 3, 2014

Trade Name: E1® Series A® Patella Common Name: Total Knee Replacement - Patella Component

Classification Name:

· JWH Prosthesis, Knee, Patellofemoraltibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (21 CFR 888.3560)
· MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer (21 CFR 888.3565)
· MBV Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, UHMWPE, Pegged, Cemented, Polymer/Metal/Polymer (21 CFR 888.3560)
· OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive (21 CFR 888.3560)

Legally marketed devices to which substantial equivalence is claimed:

Vanguard Asymmetrical Patellar Component (K110362) .
Vanguard Patella Components (K040770)
E-Poly (aka E1) Tibial Bearings (K080528) reference for material and manufacturing . process

Device Description

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BIOME

The E1® Series A® Patellae are compatible with Biomet cruciate retaining (CR), posterior stabilized (PS), and constrained (SSK) knee replacement systems.

Intended Use and Indications for Use

Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, 1. and/or traumatic arthritis where one or more compartments are involved.
1. Correction of varus, valgus, or posttraumatic deformity.
1. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

Tibial bearings are indicated for use with both cemented and uncemented Biomet tibial trays.

All-polyethylene patellar components are indicated for cemented use only.

Summary of Technological Characteristics

The rationale for substantial equivalence is based on consideration of the following characteristics:

Intended Use: The proposed E1® Series A® Patellae and predicate patella devices have . the same intended use.
. Indications for Use: The proposed E1® Series A® Patellae and predicate patella devices have the same indications for use.
. Materials: The proposed E1® Series A® Patellae and predicate patella devices are manufactured from UHMWPE per ASTM F648. The proposed devices utilize the same material and manufacturing process the Biomet E1 Tibial Bearings, K080528.
. Design Features: The proposed E1® Series A® Patellae incorporate the same design features as the predicate patella devices.
Sterilization: The proposed E1® Series A® Patellae and predicate devices are provided . sterile via the same sterilization methods for single-use.

Summary of Performance Data

Results from mechanical tests and engineering analyses demonstrate the proposed E1® Series A® Patellae are substantially equivalent to the predicate patella devices. No animal or clinical testing was required to support substantial equivalence. A description of the tests and analyses is listed below.

. Contact area stress analysis and engineering analysis
. Mechanical stability analysis and engineer analysis
. Peg shear testing

Substantial Equivalence Conclusion

The proposed E1® Series A® Patellae have the same intended use and indications for use as the predicate patella devices. Performance test data and analyses demonstrate the device is as safe and effective and is substantially equivalent to the legally marketed predicate devices.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized caduceus symbol. The caduceus is a symbol of medicine and health, and it is depicted as a staff with two snakes coiled around it and wings at the top.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Comrol Center ~ WO66-G609 Silver Spring, MD 20993-0003

Biomet, Incorporated Ms. Amy Walriven Senior Regulatory Affairs Specialist 56 East Bell Drive P.O. Box 587 Warsaw. Indiana 46581

Re: K140902

Trade/Device Name: E1" Series A" Patellae Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patchofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, MBH, MBV, OIY Dated: April 2, 2014 Received: April 9, 2014

July 3, 2014

Dear Ms. Walriven:

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 warrantics. 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.

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

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Page 2 - Ms. Amy Walriven

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 contact the Division of Industry and Consumer Education at its toll-iree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the requlation 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/ReportalProblem/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 Industry and Consumer Education 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 vours.

Mark N. Melkerson -S

Mark Melkerson Director, Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K140902 (pg 1/1) 510(k) Number (if known):

Device Name: E1® Series A® Patellae

INDICATIONS FOR USE:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, and/or traumatic arthritis where one or more compartments are involved.
1. Correction of varus, valgus, or posttraumatic deformity.
1. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

Tibial bearings are indicated for use with both cemented and uncemented Biomet tibial trays.

All-polyethylene patellar components are indicated for cemented use only.

Prescription Use X (Part 21 CFR 801 Subport 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)

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.