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 Baseblate 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 is a 510(k) premarket notification for a medical device called the "Comprehensive® Reverse Shoulder Humeral Tray." It is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device. This type of document focuses on mechanical and material testing to show that the new device performs similarly to an already approved device, rather than conducting a study to prove a device meets specific clinical acceptance criteria in terms of diagnostic accuracy or therapeutic outcome.

Therefore, the information requested in the prompt, such as acceptance criteria based on performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes for test sets (in a clinical context), ground truth establishment by experts, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance, is not applicable to this document. This document describes the physical and material characteristics of an orthopedic implant and its non-clinical performance (e.g., fatigue strength, material properties).

Here's a breakdown of the relevant information from the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present acceptance criteria for diagnostic or therapeutic performance as would be relevant for an AI/algorithm-based device. Instead, it details mechanical performance comparisons to a predicate device.

Characteristic	Standard/Test/FDA Guidance	Acceptance Criteria (Implicit from "Results: Summary")	Reported Device Performance (Modified Device)
Fatigue Strength	None	N/A (Compared to predicate)	"The median fatigue strength was greater for the modified devices compared to the predicate device."
Polyethylene Properties	ASTM F-648	Exceeds requirements of ASTM F-648	"All properties exceed the requirements of ASTM F-648."

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

Test Set Sample Size: Not applicable. The "tests" here refer to mechanical and material testing, not clinical data or diagnostic test sets.
Data Provenance: Not applicable in the context of clinical data. The tests performed are laboratory-based mechanical and material characterization.

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

Not applicable. "Ground truth" in this context would refer to material and mechanical standards defined by organizations like ASTM, not expert clinical consensus.

4. Adjudication method for the test set

Not applicable. No clinical adjudication was performed.

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 not an AI/algorithm-based device. 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 (shoulder implant), not an algorithm or AI.

7. The type of ground truth used

For mechanical and material properties: Industry standards (e.g., ASTM F-648) are used to define acceptable material performance. The comparison to a legally marketed predicate device also serves as a "ground truth" for substantial equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm-based device and does not involve training data.

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

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a symbol that resembles a person embracing a bird, representing care and protection. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

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 Sandborn Beres Senior Regulatory Specialist 56 East Bell Drive Warsaw, Indiana 46581-0857

Re: K113069

Trade/Device Name: Comprehensive® Reverse Shoulder Humeral Tray 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: October 13, 2011 Received: October 17, 2011

Dear Ms. Beres:

This letter corrects our substantially equivalent letter of January 11, 2012.

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 of medical

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Page 2 - Ms. Patricia Sandborn Beres

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): KI (3009

Device Name: Comprehensive® Reverse Shoulder Humeral Tray

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 _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth PM

Soc (Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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113069

MANUFACTURING CORP.

-- J

510(k) SUMMARY

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 46581-0857
Phone number	(574):267-6639
Fax number	(574):371-1027
Establishment RegistrationNumber	1825034
Name of contact person	Patricia Sandborn BeresSenior Regulatory SpecialistBiomet Manufacturing Corp.
Date prepared	October 13, 2011
NAME OF DEVICE
Trade or proprietaryname	Comprehensive® Reverse Shoulder Humeral Tray
Common or usual name	Shoulder Prosthesis
Classification name	Shoulder joint, metal/polymer, semi-constrained; cemented prosthesis
Classification panel.	Orthopedics
Regulation	21 CFR 888.3660
Product Code(s)	KWS
Legally marketed device(s) towhich equivalence is claimed	Comprehensive® Reverse Shoulder510(k) K080642
Reason for 510(k) submission	Product improvement
Device description	The Comprehensive® Reverse Shoulder is intended for total shoulderreplacement in a reverse shoulder configuration. Unlike traditional totalshoulder replacement, a reverse shoulder employs a ball for articulationon the glenoid side of the joint and a polyethylene bearing surface onthe humeral side of the joint. This device configuration increases thelever arm of the deltoid muscle bundle to provide stability and the abilityto raise the arm. This is especially useful in cases where a patient has anon-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 in patientswhose shoulder joint has a grossly deficient rotator cuff with severearthropathy and/or previously failed shoulder joint replacement with agrossly deficient rotator cuff. The patient must be anatomically andstructurally suited to receive the implants and a functional deltoidmuscle 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.
Indications for use.(continued)	Glenoid components with Hydroxyapatite (HA) coating applied over theporous coating are indicated only for uncemented biological fixationapplications. The Glenoid Baseplate components are intended forcementless application with the addition of screw fixation.Interlok® finish humeral stems are intended for cemented use and theMacroBond® 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 DEVICE COMPARED TO THE
PREDICATE
Characteristic	Modified Device	Comprehensive® Reverse Shoulder510(k) K080642
Humeral Tray	Sizes: 44mm (std, +5mm, +10mm)Finish: No change.Material: Ti-6Al-4V and Co-Cr-MoAttachment: No changeAngle: No change	Sizes: 44 & 49mm (std, +5mm, +10mm)Finish: SmoothMaterial: Ti-6Al-4VAttachment: TaperAngle: 45°
Humeral Bearing	No Changes	UHMWPE:(ArComXL®, 1020 E-Poly™)31, 36, 41mmStd, Std +3mm, Retentive:+3mmRingloc® snap ring
Glenoid.Baseplate	No Changes	Diameter: 28mmSurface Finish: PPS/HAMaterial: Ti-6Al-4VFixation: Screws
Glenoid Screws	Styles: Fixed/Locking, Fixed Non-LockingMaterial: No changeDiameter: No changeLengths: No changeDrive Slot: 2.5 Hex	Styles: Fixed/Locking, Fixed Non-Locking,Variable LockingMaterial: Ti-6Al-4VDiameter: 4.75mmLengths: 15-45mmDrive Slot: Hexalobular
Glenosphere	No Changes	Diameters: 31, 36, 41mm,Offset: Std, +3mm, +6mmMaterial. Co-Cr-MoAttachment to Base: Taper
PERFORMANCE DATA
Summary Of Non-Clinical Tests Conducted For Determination Of Substantial Equivalence
Performance Test Summary-New Device
Characteristic	Standard/Test/FDA Guidance	Results:Summary
Fatigue Strength	None	The median fatigue strength wasgreater for the modified devicescompared to the predicate device.
Polyethylene Properties	ASTM F-648	All properties exceed therequirements of ASTM F-648
Summary of clinical tests conducted for determination of substantial equivalence and/or ofclinical information
No clinical data submitted

និង Box Address:
ព្រះជាប្រជាជន និងប្រជាជនជាតិនារី បានស្រី
ប្រជាជនជាតិ និងប្រជាជនជាតិនាំ ប្រជាជនជាតិ
ប្រចាំក្រោយ ប្រាសាទនេះ ប្រចាំបន់ក្រោយប្រជាជន
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Shipping Address:
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Warsaw, IN 46582

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KH3069

CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

No clinical data was necessary for a determination of substantial'equivalence.

The results of mechanical testing indicated the device 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.

Page 3 of 3

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.”