The Aequalis Adjustable Reversed Shoulder System is indicated for patients with a functional deltoid muscle and a massive and non repairable rotator cuff tear as a replacement of Shoulder joints disabled by:

Rheumatoid arthritis with pain
Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
Correction of functional deformity
Fractures of the humeral head
Traumatic arthritis
Revision of the devices if sufficient bone stock remains

Device Description

The Aequalis Adjustable Reverse Shoulder is a modular version of the Aequalis Reverse shoulder system. The Aequalis Adjustable Reverse Shoulder system has the same indications as Tornier Aequalis AscendTM Modular Reverse Shoulder System K110599.

The Aequalis Adjustable Reverse Shoulder system contains a set of anatomically sized metaphyseal, spacers, and tapered stems that will be used in conjunction with the existing Aequalis Reverse glenosphere and polyethylene inserts for reversed total shoulder arthroplasty.

The device will have a series of modular stems and spacers to accommodate a varied patient population. The system will include 10 stems: Five 90mm length (9, 11, 13, 15, 17mm diameter) and five 110mm length stems with 3 options:

Uncoated,
Hydroxylapatite (HAP) coated,
HAP over titanium plasma spray (HAP/Ti PS) coated.

The Aequalis Adjustable Reverse Shoulder assembly must be used in association with the Aequalis Reversed or Aequalis Reversed II glenoid implants, screws and fracture inserts (K030941, K061439, K081059, K050316, and K082120):

The purpose of this 510(k) is to add an additional stem configuration that does not have HAP Coating and that has plasma titanium spray coating on a portion of the stem (20mm proximal portion of stem), and has a fluted surface on a portion of the stem instead of the full length of the stem (i.e., the HAP coating and fluted surface on 20mm proximal portion of stem. In addition, an alternate plasma titanium spray coating supplier has been validated to perform this manufacturing operation.

AI/ML Overview

The provided text from the FDA 510(k) summary (K141029) describes a medical device, the Aequalis Adjustable Reversed Shoulder System, and its substantial equivalence to a predicate device. However, it does not contain the detailed information required to answer your specific questions regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-based medical device.

The document discusses:

Device: Aequalis Adjustable Reversed Shoulder System (a shoulder joint prosthesis).
Predicate Device: Tornier Aequalis Adjustable Reverse Shoulder System, K120739.
Purpose of this 510(k): To add an additional stem configuration (without HAP Coating, with plasma titanium spray coating on a portion, and a fluted surface on a portion) and validate an alternate plasma titanium spray coating supplier.
Non-clinical Tests: Performed to evaluate device performance per design requirements and risk analysis. These included:
- Demonstration of design equivalence
- Fatigue testing
- Shear fatigue strength
- Static shear strength per ASTM F1044
- Static tensile strength per ASTM F1147
- Abrasion resistance per ASTM F1978
- Thickness per ASTM F1854
- Mean void intercept length per ASTM F1854
- Mean volume percent of void per ASTM F1854
Conclusion: "All testing results met pre-established acceptance criteria." and "the Tornier Aequalis Adjustable Reverse Shoulder System was found to be substantially equivalent to the predicate device."

Based on the provided text, I cannot answer your questions because the document describes a mechanical orthopedic implant, not an AI or algorithm-based medical device. Your questions are tailored for evaluating the performance of an AI/algorithm.

Therefore, for each of your specific questions, the answer is that the information is not available in the provided document.

Here's why:

AI/Algorithm Focus: The core of your questions (e.g., test set, ground truth, experts, MRMC studies, standalone performance, training set) directly pertains to the evaluation of AI/machine learning algorithms. The Aequalis Adjustable Reversed Shoulder System is a physical implant, and its evaluation focuses on mechanical and material properties.

I can only extract information that is present in the document.

Summary

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

November 2, 2016

Tornier, Incorporated Ms. Kristine Tucker Regulatory Affairs Director 10801 Nesbitt Avenue South Bloomington, Minnesota 55437

Re: K141029

Trade/Device Name: Aequalis Adjustable Reversed Shoulder System 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: May 22, 2014 Received: May 27, 2014

Dear Ms. Tucker:

This letter corrects our substantially equivalent letter of June 18, 2014.

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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Page 2 - Ms. Kristine Tucker

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/Resourcesfor You/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) K141029

Device Name Aequalis Adjustable Reversed Shoulder System

Indications for Use (Describe)

· Rheumatoid arthritis with pain
· Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
· Correction of functional deformity
· Fractures of the humeral head
· Traumatic arthritis
· Revision of the devices if sufficient bone stock remains

Notes:

All components are single use

The humeral stems:

· The uncoated humeral stems are for cemented or cementless use;
· The titanium plasma spray coated stems are for cemented or cementless use;
· The hydroxylapatite coated stems are for cementless use only
· The hydroxylapatite over titanium plasma spray coated stems are for cementless use only

The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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410728717 ₪11

4 510(k) Summary

510(K) Owner's Name:	Tornier Inc.
Address:	10801 Nesbitt Avenue SouthBloomington, Minnesota 55437
Phone and Fax Numbers:	Phone: 952.426.7600Cell Phone: 952.491.1451Fax: 952.426.7601
Name of Contact Person:	Kristine Tucker
Date Prepared:	June 16, 2014
Trade or Proprietary Name:	Tornier Aequalis Adjustable Reverse Shoulder System
Common or Usual Name:	Shoulder joint metal/polymer prosthesis
Classification Name:	Shoulder joint metal/polymer semi-constrained cemented prosthesisare class II devices under 21 CFR 888.3660 (product code KWS)and are classified by the Orthopedic Devices Panel
Legally Marketed Device toWhich Your Firm Is ClaimingEquivalence:	Tornier Aequalis Adjustable Reverse Shoulder System, K120739,cleared on July 5, 2012.
Description of The Device:	The Aequalis Adjustable Reverse Shoulder is a modular version ofthe Aequalis Reverse shoulder system. The Aequalis AdjustableReverse Shoulder system has the same indications as TornierAequalis AscendTM Modular Reverse Shoulder System K110599.The Aequalis Adjustable Reverse Shoulder system contains a set ofanatomically sized metaphyseal, spacers, and tapered stems thatwill be used in conjunction with the existing Aequalis Reverseglenosphere and polyethylene inserts for reversed total shoulderarthroplasty.The device will have a series of modular stems and spacers toaccommodate a varied patient population. The system will include10 stems: Five 90mm length (9, 11, 13, 15, 17mm diameter) andfive 110mm length stems with 3 options:- Uncoated,- Hydroxylapatite (HAP) coated,- HAP over titanium plasma spray (HAP/Ti PS) coated.The Aequalis Adjustable Reverse Shoulder assembly must be usedin association with the Aequalis Reversed or Aequalis Reversed IIglenoid implants, screws and fracture inserts (K030941, K061439,K081059, K050316, and K082120):The purpose of this 510(k) is to add an additional stemconfiguration that does not have HAP Coating and that has plasmatitanium spray coating on a portion of the stem (20mm proximalportion of stem), and has a fluted surface on a portion of the steminstead of the full length of the stem (i.e., the HAP coating andfluted surface on 20mm proximal portion of stem. In addition, analternate plasma titanium spray coating supplier has been validatedto perform this manufacturing operation.
Intended Use of the Device:	The Aequalis Adjustable Reversed Shoulder System is indicated forpatients with a functional deltoid muscle and a massive and nonrepairable rotator cuff tear as a replacement of Shoulder joints

10801 Nesbitt Avenue South

Phone: (952) 426-7600

Fax: (952) 426-7601

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disabled by:
	Rheumatoid arthritis with pain Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) Correction of functional deformity Fractures of the humeral head Traumatic arthritis Revision of the devices if sufficient bone stock remains
Notes:All components are single useThe humeral stems:
	The uncoated humeral stems are for cemented or cementless usc; The titanium plasma spray coated stems are for cemented or cementless use; The hydroxylapatite coated stems are for cementless use only The hydroxylapatite over titanium plasma spray coated stems are for cementless use only
The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.
Technological CharacteristicsCompared To Predicate Device:	The technological characteristics (material, design, sizing, indications, sterilization, and failure strength) of the TornierAequalis Adjustable Reverse Shoulder System are substantially equivalent to the predicate device.
Summary of the NonclinicalTests Submitted:	Non-clinical laboratory assessment/testing was performed to evaluate the device performance per design requirements and risk analysis, including demonstration of design equivalence, fatigue testing, shear fatigue strength, static shear strength per ASTM F1044, static tensile strength per ASTM F1147, abrasion resistance per ASTM F1978, thickness per ASTM F1854, mean void intercept length per ASTM F1854, and mean volume percent of void per ASTM F1854. All testing results met pre-established acceptance criteria.
Conclusions Drawn From theNonclinical and Clinical Tests:	Based on risk analysis and acceptable results from testing, the Tornier Aequalis Adjustable Reverse Shoulder System was found to be substantially equivalent to the predicate device.

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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.”