The AltiVate Anatomic™ Shoulder System is indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:

· Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis of the natural humeral head and/or glenoid, and post traumatic arthritis

· Rheumatoid and other inflammatory arthritis
· Correction of functional deformity, including fracture malunion
Humeral head fracture
· Revision of other devices if sufficient bone stock remains

The AltiVate Anatomic™ Shoulder System is a hemiarthroplasty shoulder replacement for patients with a functional deltoid muscle suffering from pain and dysfunction due to:

· Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis of the natural head and/or glenoid, and post traumatic arthritis

· Rheumatoid and other inflammatory arthritis
· Correction of functional deformity, including fracture malunion
· Humeral head fracture
Rotator cuff tear arthropathy
· Revision of other devices if sufficient bone stock remains

The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for a total shoulder arthroplasty.

Humeral components with a porous coated surface are indicated for either cemented applications. Glenoid components are indicated for cemented use only.

Device Description

The AltiVate Anatomic™ Shoulder System consists of four primary components: humeral stem, neck, head and glenoid. Components are offered for use for either primary or revision surgery applications, in a hemi or total shoulder application.

The proximal body of the stem is rectangular in cross-sectional geometry and tapers proximal to distal. The distal stem is cylindrical. Anterior and posterior fins are located on the proximal body to help provide rotational stability. The anterior and posterior fins have suture holes to allow reattachment of soft tissue and bone fragments in the case of humeral head fracture.

The humeral neck has two male Morse type tapers that differ in size to prevent incorrect installation. The smaller Morse type taper interfaces with the female Morse type taper in the humeral stem, while the larger Morse type taper interfaces with the female Morse type taper in the humeral head.

The humeral heads are available in standard and offset configurations. In the offset configuration, the male Morse type taper on the humeral heads is offset from the center that makes it possible to orient the head in asymmetric positions on the symmetric stem, thus allowing the surgeon to intraoperatively select the position of the humeral head to recreate the anatomy of the individual patient.

The glenoid components are fabricated from vitamin E ultra-high molecular weight polyethylene and ultra-high molecular weight polyethylene. The articulating surface has a radius of curvature greater than the corresponding humeral head. This allows translation in the superior/inferior and anterior/posterior directions. The back surface of the component is spherical in geometry and has four pegs for fixation in the glenoid. The central peg has three annular barbs and the peripheral pegs have machined fixation features, referred to as Tri-lobes, to provide immediate fixation to the patient's glenoid when inserted.

AI/ML Overview

This document (K162024) is a 510(k) premarket notification for a medical device called the AltiVate Anatomic™ Shoulder System, a shoulder joint replacement. A 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific performance acceptance criteria through the kind of studies you describe in the input.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present or applicable in this regulatory document.

Here's a breakdown based on the information provided and the nature of a 510(k) submission:

A table of acceptance criteria and the reported device performance:
A formal table like this is not included in this document. Instead, the submission relies on demonstrating substantial equivalence to predicate devices and presents results from non-clinical mechanical testing to ensure performance under expected conditions. The acceptance "criteria" are implicitly tied to the performance of the predicate devices and the relevant ASTM/ISO standards followed for mechanical testing.
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
For the non-clinical mechanical testing mentioned ("Rocking Horse, Stem/Head Fatigue and Humeral Head Disassociation"), the document does not specify sample sizes or data provenance directly. This is common for summaries of mechanical tests where standard test methods (e.g., ASTM F2028 for 'Rocking Horse' or similar fatigue standards) would dictate sample sizes.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable. The document describes a medical device, not an AI or diagnostic device that requires expert-established ground truth for performance evaluation in the way you've outlined.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as this is a medical device submission, not a study evaluating human reader performance or algorithm output.
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 medical device (shoulder implant), not an AI-assisted diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device (shoulder implant), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable in the context of an AI or diagnostic device's ground truth. For the device itself, its functional "ground truth" would be its mechanical integrity and biocompatibility, demonstrated through material testing, mechanical load testing, and clinical use (post-market, as no clinical study was required for this 510(k)).
The sample size for the training set:
Not applicable. This is a medical device, not a machine learning model.
How the ground truth for the training set was established:
Not applicable. This is a medical device, not a machine learning model.

Summary based on available information for K162024:

Acceptance Criteria/Performance: The submission implies that the device "meets acceptance criteria" by demonstrating substantial equivalence to predicate devices and by successfully undergoing non-clinical mechanical testing.
- Non-Clinical Mechanical Testing: "Rocking Horse, Stem/Head Fatigue and Humeral Head Disassociation" tests were performed.
- Results: "All testing has determined that the device is substantially equivalent to the predicate devices."
- Endotoxin Assessment: Bacterial endotoxin testing was conducted and met expected limits.
Study That Proves Device Meets Criteria: The non-clinical mechanical testing and the demonstration of substantial equivalence serve this purpose for a 510(k) submission.
- Device Performance Reported: The device's ability to perform under expected conditions was demonstrated, with results indicating substantial equivalence to predicate devices based on the mechanical tests.
Sample sizes/Data provenance: Not specified for mechanical tests in this summary.
Clinical Testing: "Clinical testing was not required," indicating that the FDA did not deem a human clinical trial necessary to establish safety and effectiveness for this substantial equivalence submission.

Summary

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

November 21, 2016

Encore Medical, L.P. Desiree Wells Regulatory Affairs Specialist 9800 Metric Blvd. Austin, Texas 78758

Re: K162024

Trade/Device Name: AltiVate Anatomic™ Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, HSD, PAO Dated: October 20, 2016 Received: October 21, 2016

Dear Ms. Desiree Wells:

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 devicerelated 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.

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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/ResourcesforYou/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: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K162024

Device Name

AltiVate Anatomic™ Shoulder System

Indications for Use (Describe)

The AltiVate Anatomic™ Shoulder System is indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:

· Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis of the natural humeral head and/or glenoid, and post traumatic arthritis

· Rheumatoid and other inflammatory arthritis
· Correction of functional deformity, including fracture malunion
Humeral head fracture
· Revision of other devices if sufficient bone stock remains

The AltiVate Anatomic™ Shoulder System is a hemiarthroplasty shoulder replacement for patients with a functional deltoid muscle suffering from pain and dysfunction due to:

· Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis of the natural head and/or glenoid, and post traumatic arthritis

· Rheumatoid and other inflammatory arthritis
· Correction of functional deformity, including fracture malunion
· Humeral head fracture
Rotator cuff tear arthropathy
· Revision of other devices if sufficient bone stock remains

The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for a total shoulder arthroplasty.

Humeral components with a porous coated surface are indicated for either cemented applications. Glenoid components are indicated for cemented use only.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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510(k) Summary

Date: November 16, 2016

Manufacturer: DJO Surgical (Legal Name: Encore Medical, L.P.) 9800 Metric Blvd Austin, TX 78758

Contact Person: Desireé Wells Regulatory Affairs Specialist Phone: (512) 834-6302 Fax: (760) 597-3466 Email: desiree.wells@djoglobal.com

Product	Classification	Product Code	ProductCode	Regulation and Classification Name
AltiVate Anatomic™ Shoulder System	Class II	KWS, HSD, PAO	KWS	Shoulder joint metal/polymer semi-constrained prosthesis per 21 CFR 888.3660
HSD	Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis per CFR 888.3690
PAO	Shoulder joint metal/polymer semi-constrained cemented prosthesis per CFR 888.3660

Description:

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Indications for Use:

AltiVate Anatomic™ Total Shoulder Indications:

The AltiVate Anatomic™ Shoulder System is indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:

Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis ● of the natural humeral head and/or glenoid, and post traumatic arthritis
Rheumatoid and other inflammatory arthritis ●
Correction of functional deformity, including fracture malunion ●
Humeral head fracture
Revision of other devices if sufficient bone stock remains ●

The AltiVate Anatomic™ Shoulder System is a hemiarthroplasty shoulder replacement for patients with a functional deltoid muscle suffering from pain and dysfunction due to:

Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis . of the natural humeral head and/or glenoid, and post traumatic arthritis
Rheumatoid and other inflammatory arthritis ●
Correction of functional deformity, including fracture malunion
Humeral head fracture
Rotator cuff tear arthropathy
Revision of other devices if sufficient bone stock remains

The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for a total shoulder arthroplasty.

Humeral components with a porous coated surface are indicated for either cemented or uncemented applications. Glenoid components are indicated for cemented use only.

Predicate Devices:

Encore® Shoulder System (now called Turon) K080402, K123982 ●
. RSP Monoblock Stem with P2 - K140904
Tornier™ Aequalis Ascend Flex K113413 ●

Comparable Features to Predicate Device(s): This device is comparable to the predicate devices in implant material, basic design of shoulder components, intended use, packaging and sterilization.

Key Differences in Subject Device to Predicate: Shorter humeral stem and modified proximal body geometry, one additional humeral head size offering, collarless neck and fixation features (Tri-Lobe) added to peripheral pegs on the glenoid.

Non-Clinical Testing: Mechanical testing (Rocking Horse, Stem/Head Fatigue and Humeral Head Disassociation) has demonstrated the device's ability to perform under expected conditions. All testing has determined that the device is substantially equivalent to the predicate devices. Endotoxin Assessment: Bacterial endotoxin testing was conducted and was found to meet the expected endotoxin limits.

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Clinical Testing: Clinical testing was not required.

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.”