Hemi or Total Arthroplasty Application of the Anatomical Shoulder Humeral Stems and Domelock System
The Anatomical Shoulder Humeral Stems and Domelock System are indicated for

· Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis.
· Avascular necrosis.
· Conditions consequent to earlier operations.
· Omarthrosis.
· Rheumatoid arthritis.
· Revision of shoulder prosthesis.

The Humeral Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used in a total shoulder application, the Anatomical Shoulder Pegged and Keeled Glenoids Cemented and the Biomet all-polyethylene Keeled Glenoid are intended for cemented use only. The Biomet Modular Hybrid Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.

Reverse Application of the Anatomical Shoulder System
· The Anatomical Shoulder Inverse System is indicated for primary, fracture or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
· The patient's joint must be anatomically suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The Humeral Stems Cemented are intented use and the Humeral Stems Uncemented are intended for uncemented use. When used with the Anatomical Shoulder Glenoid Fixation, it is intended for uncemented use and requires two screws for fixation.

Fracture Application of the Anatomical Shoulder Fracture System
The Anatomical Shoulder Fracture System is intended for use in prosthetic replacement of the proximal humerus and the glenoid articular surface of the scapula during total-, hemi and fracture shoulder arthroplasty in treatment of the following:

· Complex 3- and 4-part fractures of the proximal humerus with subluxation of the head fragment
· Complex 3- and 4-part fractures of the proximal humerus with loosening of the spongiosa in the bead fragment
· Complex 3- and 4-part fractures of the proximal humerus with additional cross split of the head fragment
· Fracture instability after osteosynthesis of 3- and 4-part fragments of the proximal humerus
· Posttraumatic necrosis of the humeral head
· Posttraumatic arthrosis after humeral head fracture

The Humeral Fracture Stems are intended for either cemented use. When used in a total shoulder application, the Anatomical Shoulder Pegged and Keeled Glenoids Cemented are intended for cemented use only.

Device Description

The Anatomical Shoulder System is a modular shoulder prosthesis designed to be used in primary o revision, total or hemi shoulder arthroplasty.
Anatomical Shoulder Humeral Stems are available as either cemented or uncemented designs. Cemented stems are available in longer designs to support revision cases. All Humeral Stems possess a female oval taper geometry, which is the basis for all modularity with compatible mating components.
The Anatomical Shoulder Domelock System consists of a Humeral Head which is connected to the Anatomical Shoulder humeral stems using an adjustable Domelock Dome centric including an Expansion Ball and Expansion-pin. The Domelock Dome is used to set the orientation of the Domelock Humeral Heads. The male oval cone taper of the Domelock expansion ball component is compatible with all Humeral Stems of the Anatomical Shoulder System.
The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component of the Anatomical Shoulder System or with the Biomet Modular Hybrid or all-polyethylene Keeled Glenoid for total arthroplasty.

AI/ML Overview

I am sorry, but based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary for a medical device (Anatomical Shoulder Domelock Dome Centric) and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than defining specific performance acceptance criteria and detailing a study to prove they are met.

Here's why I cannot extract the requested information:

No explicit acceptance criteria: The document does not list specific numerical or qualitative acceptance criteria for the device's performance. It describes modifications to an existing device to improve aspects like readability of a laser mark and ease of trialing, implying improvements but not setting quantified thresholds.
No specific study proving criteria: The "Performance Data" section mentions "Functional relationship analysis" and "Finite Element Analysis for fatigue strength." These are analyses rather than comprehensive studies with defined test sets, ground truth, or statistical methods as you've requested.
Emphasis on substantial equivalence: The core of a 510(k) submission is to show the new device is "substantially equivalent" to a legally marketed predicate device. This often relies on comparative technical characteristics and, in this case, a few minor design modifications, rather than a full-scale performance study against pre-defined acceptance criteria for a new type of device.
No clinical data: The document explicitly states "Clinical data and conclusions were not needed to demonstrate substantial equivalence." This means there would be no human reader (MRMC) studies, standalone algorithm performance, or ground truth established from patient outcomes.

Therefore, your request for:

A table of acceptance criteria and the reported device performance
Sample sized used for the test set and the data provenance
Number of experts used to establish the ground truth
Adjudication method
MRMC comparative effectiveness study details
Standalone performance details
Type of ground truth used
Sample size for the training set
How the ground truth for the training set was established

cannot be answered from the provided text. The document describes a physical medical device (shoulder prosthesis components), not an AI/software device that would typically have the kind of performance studies and ground truth establishment you are inquiring about.

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 a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are connected and form a single, abstract shape. The graphic is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

Zimmer GmbH Annemie Rehor Kausch Senior Specialist Regulatory Affairs Sulzerallee 8 Winterthur. 8404 CH

Re: K161620 Trade/Device Name: Anatomical Shoulder Domelock Dome Centric Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder Joint Humeral (Hemi-Shoulder) Metallic Uncemented Prosthesis Regulatory Class: Class II Product Code: HSD, KWS, KWS, KWT, PHX Dated: September 29, 2016 Received: September 30, 2016

Dear Annemie Rehor Kausch:

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. Iisting 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 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" (21 CFR 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/Resourcesfor You/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

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

Form Approved: OMBN1620, Rayge T of 1 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) n/a

Device Name Anatomical Shoulder™ System Anatomical Shoulder™ Domelock® Anatomical Shoulder™ Fracture System

Indications for Use (Describe)

Hemi or Total Arthroplasty Application of the Anatomical Shoulder Humeral Stems and Domelock System

The Anatomical Shoulder Humeral Stems and Domelock System are indicated for

· Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis.
· Avascular necrosis.
· Conditions consequent to earlier operations.
· Omarthrosis.
· Rheumatoid arthritis.
· Revision of shoulder prosthesis.

Reverse Application of the Anatomical Shoulder System

· The Anatomical Shoulder Inverse System is indicated for primary, fracture or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

· The patient's joint must be anatomically suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

Fracture Application of the Anatomical Shoulder Fracture System

The Anatomical Shoulder Fracture System is intended for use in prosthetic replacement of the proximal humerus and the glenoid articular surface of the scapula during total-, hemi and fracture shoulder arthroplasty in treatment of the following:

· Complex 3- and 4-part fractures of the proximal humerus with subluxation of the head fragment
· Complex 3- and 4-part fractures of the proximal humerus with loosening of the spongiosa in the bead fragment
· Complex 3- and 4-part fractures of the proximal humerus with additional cross split of the head fragment
· Fracture instability after osteosynthesis of 3- and 4-part fragments of the proximal humerus
· Posttraumatic necrosis of the humeral head
· Posttraumatic arthrosis after humeral head fracture

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image contains the logo for Zimmer Biomet. The logo features a stylized blue letter Z inside of a blue circle. Below the circle is the word "zimmer" in a lowercase, sans-serif font, also in blue.

Zimmer GmbH
Sulzerallee 8
8404 Winterthur
Switzerland

510(k) Summary

Sponsor:	Zimmer GmbHSulzerallee 8, P.O. Box8404 Winterthur, Switzerland
Contact Person:	Annemie Rehor KauschSenior Specialist, Regulatory AffairsTelephone: +41 58 854 82 61Fax: + 41 52 244 86 58
Date:	June, 10th 2016
Trade Name:	Anatomical ShoulderTM Domelock® Dome centricwhich is part of the Anatomical ShoulderTM Systemand Anatomical ShoulderTM Domelock® System
Classification Product Code /	HSD - Prosthesis, Shoulder, Hemi-, Humeral,Metallic UncementedKWS - Prosthesis, Shoulder, Semi-Constrained,Metal/Polymer CementedKWT - Prosthesis, Shoulder, Non-Constrained,Metal/Polymer CementedPHX – Shoulder Prosthesis, Reverse Configuration
Device Classification Name:	Shoulder Prosthesis
Regulation Number / Description:	21 CFR § 888.3690 – Shoulder joint humeral(hemishoulder) metallic uncemented prosthesis21 CFR § 888.3660 – Shoulder joint metal/polymersemi-constrained cemented prosthesis21 CFR § 888.3650 – Shoulder joint metal/polymernon-constrained cemented prosthesis
Predicate Device:	Anatomical ShoulderTM Domelock® Dome centricwhich is part of the Anatomical ShoulderTM SystemAnatomical ShoulderTM Domelock®

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	Shoulder™ Fracture System, K142403, clearedNovember 24, 2014.Update of the IFU for this system for compatibilitywith Biomet glenoids has been cleared by K160085on March 8, 2016
Device Description:	The Anatomical Shoulder System is a modularshoulder prosthesis designed to be used in primary orevision, total or hemi shoulder arthroplasty.
	Anatomical Shoulder Humeral Stems are available aseither cemented or uncemented designs. Cementedstems are available in longer designs to supportrevision cases. All Humeral Stems possess a femaleoval taper geometry, which is the basis for allmodularity with compatible mating components.
	The Anatomical Shoulder Domelock System consistsof a Humeral Head which is connected to theAnatomical Shoulder humeral stems using anadjustable Domelock Dome centric including anExpansion Ball and Expansion-pin. The DomelockDome is used to set the orientation of the DomelockHumeral Heads. The male oval cone taper of theDomelock expansion ball component is compatiblewith all Humeral Stems of the Anatomical ShoulderSystem.
	The assembled humeral component may be usedalone for hemiarthroplasty or combined with theglenoid component of the Anatomical ShoulderSystem or with the Biomet Modular Hybrid or all-polyethylene Keeled Glenoid for total arthroplasty.
Intended Use of the AS System:	The Anatomical Shoulder Domelock System isintended for long-term implantation into the humanshoulder joint in primary or revision, total or hemishoulder arthroplasty. The system is intended torelieve pain and restore function in patients withadequate bone stock to support the prosthesis.
Indications for Use of the AS System:	Hemi or Total Arthroplasty Application of theAnatomical Shoulder Humeral Stems and DomelockSystemThe Anatomical Shoulder Humeral Stems andDomelock System are indicated for

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· Advanced wear and tear of the shoulder ioint resulting from degenerative, posttraumatic or rheumatoid arthritis.
Avascular necrosis.
· Conditions consequent to earlier operations.
Omarthrosis.
· Rheumatoid arthritis.
· Revision of shoulder prosthesis.

Reverse Application of the Anatomical Shoulder System

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

· The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The Humeral Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used with the Anatomical Shoulder Glenoid Fixation, it is intended for uncemented use and requires two screws for fixation.

Fracture Application of the Anatomical Shoulder Fracture System

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	The Anatomical Shoulder Fracture System is intendedfor use in prosthetic replacement of the proximalhumerus and the glenoid articular surface of thescapula during total-, hemi and fracture shoulderarthroplasty in treatment of the following:• Complex 3- and 4-part fractures of the proximalhumerus with subluxation of the head fragment• Complex 3- and 4-part fractures of the proximalhumerus with loosening of the spongiosa in the headfragment• Complex 3- and 4-part fractures of the proximalhumerus with additional cross split of the headfragment• Fracture instability after osteosynthesis of 3- and 4-part fracture fragments of the proximal humerus• Posttraumatic necrosis of the humeral head• Posttraumatic arthrosis after humeral head fractureThe Humeral Fracture Stems are intended for eithercemented or uncemented use. When used in a totalshoulder application, the Anatomical ShoulderPegged and Keeled Glenoids Cemented are intendedfor cemented use only.
Comparison to Predicate Device:	Three modifications to the Anatomical ShoulderDomelock Dome centric are proposed:1) The oval taper of the expansion ball is splittedinto a 9.3 mm long oval taper and a 2.2 mm longoval cylinder to avoid interference with the raspsduring trialing.2) The thickness of a laser mark line which is usedfor correct alignement of expansion ball and stemis increased for improved readability.3) The inner diameter of the Dome is increased by0.01 mm to improve ease of trialing.
	The indications for use/intended use are unchanged.The materials remain the same and the fundamentaltechnology is unchanged.
Performance Data (Nonclinicaland Clinical)	The results of non-clinical analyses demonstrate thatthe devices are safe and effective and substantiallyequivalent to the predicate devices. Performanceanalyses included:1. Functional relationship analysis2. Finite Element Analysis for fatigue strength.

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Clinical Performance and Conclusions: Clinical data and conclusions were not needed to demonstrate
substantial equivalence.

Regulation Number and Section

§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.