Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis.
Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicated that alternative methods of treatment are unsatisfactory.
Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. - revision of a failed primary component).

Shoulder Hemiarthroplasty is also indicated for:

Ununited humeral head fractures.
Avascular necrosis of the humeral head.
Rotator cuff arthropathy.
Deformity and/or limited motion.

The humeral component is intended for cemented or uncemented use. The glenoid component is intended for cemented use only.

Device Description

The TITAN Modular Total Shoulder System consists of a line of metaphyseal bodies, humeral stems, humeral heads and all polyethylene glenoid components. The body, stem and humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The metaphyseal bodies and humeral stems are shaped to provide proximal fixation and optimal fixation area. Their variable length and proximally-filling shape are designed to accommodate the natural humeral geometry and provide stable fixation, proximal bone loading and proper head placement. The humeral heads are offered with both concentric and eccentric articulating surfaces. The humeral head may articulate against the natural glenoid bone, if it is of sufficient quality, or against the all polyethylene cemented glenoid. The glenoid has two options: keeled or standard pegged (3 pegs). All glenoid options are designed to function with both the concentric and eccentric heads.
The humeral components are intended for cemented or uncemented use, while the glenoid component is for use with cement only.

AI/ML Overview

The provided text is a 510(k) Summary for the Ascension® TITAN™ Total Shoulder System. This document is a premarket notification for a medical device and, as such, primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria for a new device's efficacy or diagnostic accuracy.

Therefore, the information required to answer most of your questions (acceptance criteria, device performance, sample sizes, ground truth, experts, adjudication methods, MRMC studies, standalone performance, training set details) is not present in the provided text.

Here is what can be extracted based on the document:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or report device performance in terms of clinical outcomes or diagnostic accuracy. Its primary claim is substantial equivalence to a predicate device (K100448).

Acceptance Criteria	Reported Device Performance
Not specified for clinical or diagnostic performance. The entire submission is based on demonstrating substantial equivalence to a predicate device.	The device is deemed "substantially equivalent" to predicate device K100448, based on similarities in design, materials, and indications, and non-clinical testing.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not applicable. No clinical test set data is presented.
Data provenance: Not applicable. No clinical data is presented.

3. 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. No clinical test set or ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set or adjudication is described.

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-powered device, and no MRMC studies are mentioned.

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

Not applicable. This device is a physical shoulder implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No clinical ground truth is described.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

Not applicable.

What the document does state regarding testing:

Non-clinical Performance Data: "Testing to support the material change and additional lengths for the humeral stems has been completed. The testing conforms to ASTM F1378." (This is a standard for testing metallic implant materials, specifically for implantable materials for surgical implants). This non-clinical data is the basis for proving substantial equivalence for these specific changes.
Clinical Performance Data: "Clinical performance data are not required for the minor changes that are the subject of this Special 510(k)." This explicitly states that clinical data (which would involve patients, outcomes, and likely the other questions you posed) was not deemed necessary for this particular submission, implying previous clinical data for the predicate device might have satisfied regulatory requirements, or the changes were minor enough not to warrant new clinical trials.

Summary

{0}------------------------------------------------

| | | 2438 ( | | 2 )

APR 1 1 2012

510(k) Summary

Sponsor	Ascension Orthopedics, Inc.8700 Cameron RoadAustin, TX 78754-3832
Contact Person	Susan Waltonsusan.walton@integralife.comPhone: (512) 836-5001 x1591Alternate FAX (512) 836-6933
Date	March 22, 2012
Trade Name	Ascension® TITAN™ Total Shoulder System
Common Name	Hemi- or Total Shoulder
Classification	21 CFR 888.3660 - Shoulder joint metal/polymer semi-constrainedcemented prosthesis21 CFR 888.3690 - Shoulder joint humeral (hemi-shoulder)metallic uncemented prosthesis.
Product Code	HSD and KWS
Panel	Orthopedic
Predicate Device	K100448 – Ascension® TITAN™ Total Shoulder System
Device Description	The TITAN Modular Total Shoulder System consists of a line ofmetaphyseal bodies, humeral stems, humeral heads and allpolyethylene glenoid components. The body, stem and humeralhead may be used by themselves, as a hemiarthroplasty, if thenatural glenoid provides a sufficient bearing surface, or inconjunction with the glenoid, as a total replacement. Themetaphyseal bodies and humeral stems are shaped to provideproximal fixation and optimal fixation area. Their variable lengthand proximally-filling shape are designed to accommodate thenatural humeral geometry and provide stable fixation, proximalbone loading and proper head placement. The humeral heads areoffered with both concentric and eccentric articulating surfaces. Thehumeral head may articulate against the natural glenoid bone, if it isof sufficient quality, or against the all polyethylene cementedglenoid. The glenoid has two options: keeled or standard pegged (3pegs). All glenoid options are designed to function with both theconcentric and eccentric heads.The humeral components are intended for cemented or uncementeduse, while the glenoid component is for use with cement only.
Intended Use	A shoulder joint metal/polymer semi-constrained cementedprosthesis is a device intended to be implanted to replace a shoulderjoint.
Intended Use	The Ascension TITAN™ Total Shoulder System is indicated foruse as a hemi or total shoulder replacement for:

{1}------------------------------------------------

Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis.
Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicated that alternativce methods of treatment are unsatisfactory.
Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. - revision of a failed primary component).

Shoulder Hemiarthroplasty is also indicated for:

Ununited humeral head fractures.
Avascular necrosis of the humeral head.
Rotator cuff arthropathy.
Deformity and/or limited motion.

The humeral component is intended for cemented or un-cemented use. The glenoid component is intended for cemented use only.

Ascension Orthopedics believes that this system is substantially equivalent to the legally marketed predicate device based on similarities in design, materials and indications.

Testing to support the material change and additional lengths for the humeral stems has been completed. The testing conforms to ASTM F1378.

Clinical performance data are not required for the minor changes that are the subject of this Special 510(k).

Basis of Substantial Equivalence

Non-clinical Performance Data

Clinical Performance Data

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Public Health Service

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

Ascension Orthopaedics, Incorporated % Ms. Susan Walton Senior Director of Regulatory Affairs 8700 Cameron Road Austin, Texas 78754

APR 1 1 2012

Re: K112438

Trade/Device Name: Ascension® TITANTM Total 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 Dated: March 22, 2012 Received: March 23, 2012

Dear Ms. Walton:

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 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.

{3}------------------------------------------------

Page 2 - Ms. Susan Walton

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,

Mark N. Molkerson

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

Enclosure

{4}------------------------------------------------

112438 (11)

Indications for Use Statement

510(K) Number:

Ascension® TITAN™ Total Shoulder System Device Name:

Indications for Use:

The Ascension TITAN Total Shoulder System is indicated for use as a hemi or total shoulder replacement for:

Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis.
Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicated that alternative methods of treatment are unsatisfactory.
Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. - revision of a failed primary component).

Shoulder Hemiarthroplasty is also indicated for:

Ununited humeral head fractures.
Avascular necrosis of the humeral head.
Rotator cuff arthropathy.
Deformity and/or limited motion. s

The humeral component is intended for cemented or uncemented use. The glenoid component is intended for cemented use only.

Prescription Use __ x (Part 21 CFR 801Subpart B)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ro. Oulil
(Division Sign Off)

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

510(k) Number K112438

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.”