The Comprehensive® Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

Device Description

The Comprehensive® Reverse Shoulder is intended for total shoulder replacement in a reverse shoulder configuration. Unlike traditional total shoulder replacement, a reverse shoulder employs a ball for articulation on the glenoid side of the joint and a polyethylene bearing surface on the humeral side of the joint. This device configuration increases the lever arm of the deltoid muscle bundle to provide stability and the ability to raise the arm. This is especially useful in cases where a patient has a non-functioning rotator cuff which severely limits traditional joint replacement options.

AI/ML Overview

The provided document details a 510(k) premarket notification for the "Comprehensive® Reverse Shoulder - E1® Humeral Bearings." The focus of the submission is to demonstrate substantial equivalence to a predicate device, K080642, rather than to establish new safety and effectiveness through a comprehensive study meeting specific acceptance criteria as would be typical for an AI/ML device.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, expert involvement, and reader studies for a novel AI/ML device is not applicable to this document. This document pertains to a medical device (humeral bearings for shoulder replacement) that is evaluated based on material characteristics and mechanical performance, not an AI/ML algorithm.

However, I can extract information about the non-clinical tests conducted, which serve a similar purpose of demonstrating performance for this type of medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a physical medical device, not an AI/ML algorithm, the "acceptance criteria" are implied by demonstrating equivalence to a legally marketed predicate device through non-clinical testing. The "reported device performance" refers to the results of these non-clinical tests. Specific numerical acceptance criteria are not explicitly stated as they would be for an AI/ML diagnostic's sensitivity/specificity. Instead, the performance demonstrated that the new device "performed within the intended use" and did not raise new safety or efficacy issues when compared to the predicate.

Acceptance Criteria (Implied for Substantial Equivalence to Predicate)	Reported Device Performance (Summary of Non-Clinical Tests)
Material characteristics are comparable to predicate.	UHMWPE (E1®) using 1050 Resin. (Predicate used UHMWPE (E-Poly™) with 1020 Resin).
Dimensions are comparable to predicate.	Internal Diameter: 31, 36, 41mm. Height: Standard, Standard +3mm, Retentive +3mm. (Identical to predicate).
Attachment mechanism is comparable to predicate.	Ringloc® snap ring. (Identical to predicate).
Tensile properties meet or exceed established standards.	Tensile Testing per ASTM D-638 conducted. Results indicated performance within intended use.
Impact strength properties meet or exceed established standards.	IZOD Impact Strength testing in accordance with ASTM F-648 conducted. Results indicated performance within intended use.
Humeral Bearing pull-out strength is adequate.	Humeral Bearing Pull-out testing conducted. Results indicated performance within intended use.
Humeral Bearing lever-out strength is adequate.	Humeral Bearing Lever-out testing conducted. Results indicated performance within intended use.
Humeral Bearing torque-out strength is adequate.	Humeral Bearing Torque-out testing conducted. Results indicated performance within intended use.
No new safety or efficacy issues are raised.	Testing indicated the material performed within the intended use, did not raise any new safety and efficacy issues.

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

Sample size: Not explicitly stated for specific tests, but generally refers to a sufficient number of test articles/specimens to perform the mechanical tests listed (e.g., multiple specimens for tensile strength, impact strength, pull-out, lever-out, and torque-out tests).
Data provenance: Not explicitly stated, but these are material and mechanical property tests typically conducted in a laboratory setting by the manufacturer (Biomet Manufacturing Corp.) or a qualified testing facility. The data would be prospective to the 510(k) submission.

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

Not applicable. For this type of mechanical device, "ground truth" is established by adherence to recognized ASTM standards for material and mechanical properties, not by expert consensus on clinical findings. The evaluation is based on scientific and engineering principles.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are for clinical evaluations or subjective assessments, not for objective mechanical property testing against standards.

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 medical device, not an AI/ML diagnostic or assistive tool. No MRMC study was conducted.

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

Not applicable. This is a physical medical device, not an AI/ML algorithm.

7. The type of ground truth used

Non-clinical/Mechanical Performance and Material Standards: The "ground truth" for this device's performance is based on established engineering and material science standards (e.g., ASTM D-638 for tensile testing, ASTM F-648 for IZOD impact strength) and the comparative performance against the predicate device.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm. There is no "training set."

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

Not applicable. This is a physical medical device, not an AI/ML algorithm. There is no "training set" or ground truth for one.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Public Health Service

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

November 2, 2016

Biomet Manufacturing Corporation Ms. Patricia Beres Senior Regulatory Specialist 56 East Bell Drive, P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K113121

Trade/Device Name: Comprehensive® Reverse Shoulder- E1® Humeral Bearings Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX. KWS Dated: December 7, 2011 Received: December 9, 2011

Dear Ms. Beres:

This letter corrects our substantially equivalent letter of December 16, 2011.

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.

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

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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-free 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 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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -S

for

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

Enclosure

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Indications for Use

510(k) Number (if known): السلم | 312 | السل

Device Name: Comprehensive® Reverse Shoulder - E10 Humeral Bearings

Indications For Use:

The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Counter Use NO (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

(Division Sign-Off) Division of Surgical, Orthopedic, and/Restorative Devices

K113121 510(k) Number_

Page 1 of 1

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Image /page/3/Picture/1 description: The image shows the logo for Biomet Manufacturing Corp. The word "BIOMET" is in a bold, sans-serif font with a small trademark symbol next to it. Below the logo, the words "MANUFACTURING CORP." are printed in a smaller, sans-serif font.

510(k) SUMMARY

K113121

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92

SUBMITTER INFORMATION
Name	Biomet Manufacturing Corp.
Address	56 East Bell DriveWarsaw, IN 46582
Phone number	(574) 267-6639
Fax number	(574) 371-1027
Establishment Registration Number	1825034
Name of contact person	Patricia Sandborn BeresSenior Regulatory SpecialistBiomet Manufacturing Corp.
Date prepared	December 15, 2011
NAME OF DEVICE
Trade or proprietary name	Comprehensive® Reverse Shoulder - E1® Humeral Bearings
Common or usual name	Shoulder Prosthesis
Classification name	Shoulder joint, metal/polymer, semi-constrained, cementedprosthesis
Classification panel	Orthopedics
Regulation	21 CFR 888.3660
Product Code(s)	KWS
Legally marketed device(s) to which equivalence is claimed	Comprehensive® Reverse Shoulder510(k) K080642
Reason for 510(k) submission	Line Extension
Device description	The Comprehensive® Reverse Shoulder is intended for totalshoulder replacement in a reverse shoulder configuration. Unliketraditional total shoulder replacement, a reverse shoulderemploys a ball for articulation on the glenoid side of the joint anda polyethylene bearing surface on the humeral side of the joint.This device configuration increases the lever arm of the deltoidmuscle bundle to provide stability and the ability to raise the arm.This is especially useful in cases where a patient has a non-functioning rotator cuff which severely limits traditional jointreplacement options.
Intended use of the device	Shoulder Replacement
Indications for use	The Comprehensive® Reverse Shoulder is indicated for use inpatients whose shoulder joint has a grossly deficient rotator cuffwith severe arthropathy and/or previously failed shoulder jointreplacement with a grossly deficient rotator cuff. The patient mustbe anatomically and structurally suited to receive the implantsand a functional deltoid muscle is necessary.The Comprehensive® Reverse Shoulder is indicated for primary,fracture, or revision total shoulder replacement for the relief ofpain and significant disability due to gross rotator cuff deficiency.Glenoid components with Hydroxyapatite (HA) coating applied overthe porous coating are indicated only for uncemented biologicalfixation applications. The Glenoid Baseplate components areintended for cementless application with the addition of screwfixation.Interlok® finish humeral stems are intended for cemented use andthe MacroBond® coated humeral stems are intended for press-fit orcemented applications. Humeral components with porous coatedsurface coating are indicated for either cemented or uncementedbiological fixation applications.
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE HUMERAL BEARINGCOMPARED TO THE PREDICATE
Characteristic	Modified Device	Comprehensive® ReverseShoulder - 510(k) K080642
Material	UHMWPE (E1®)1050 Resin	UHMWPE (E-Poly™)1020 Resin
Internal Diameter	31, 36, 41mm	31, 36, 41mm
Height	Standard, Standard +3mm,Retentive +3mm	Standard, Standard +3mm,Retentive +3mm
Attachment to Humeral Tray	Ringloc® snap ring	Ringloc® snap ring
PERFORMANCE DATA
Summary Of Non-Clinical Tests Conducted For Determination Of Substantial Equivalence
Performance Test Summary-New Device
Tensile Testing per ASTM D-638
IZOD Impact Strength testing in accordance with ASTM F-648
Humeral Bearing Pull-out testing
Humeral Bearing Lever-out testing
Humeral Bearing Torque-out testing

Nation Addross:
P.O. Box 587
Warraw, Box 587
Warraw, Box 587
Dillants British Box 148381-0587
Dillor in 18007 Market 1987
Main Fox: 541267-0137 ww.biomel.com

Shipping Address: 56 East Bed Drive Warsay, IN 46582

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K113121

Summary of Clinical Tests Conducted for Determination of Substantial Equivalence and/or of Clinical Information

No dinical data submitted

CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

No dinical data was necessary for a determination of substantial equivalence.

The results of testing indicated the material performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices.

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”