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

Device Description

The Modular Total Shoulder System consists of a line of proximal 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 numeral nead may befficient bearing surface, or in conjunction with the glenoid, as a gronold proximal bodies and humeral stems are manufactured from total replacemont: "The and connect together via a Morse type taper. The humeral theads are manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy and are offered in both concentric and eccentric configurations. The humeral head may onered in both contral glenoid bone if it is of sufficient quality, or against the all antionate against the naturanid. The glenoid is manufactured from ultra high polycthylone oomonton gronone (UHMVPE) and is offered in a keeled and pegged molecular weight porychylons (Ornaare designed to function with both the concentric and eccentric heads.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Ascension® Modular Total Shoulder System) and primarily focuses on establishing substantial equivalence to predicate devices through design, function, and laboratory testing. It does not describe a study involving a comparison of device performance against pre-defined acceptance criteria related to a specific diagnostic or clinical efficacy outcome that would typically apply to AI/ML or imaging devices.

Instead, the "acceptance criteria" and "study" in this context refer to the engineering and biocompatibility tests conducted to demonstrate that the new device is as safe and effective as the predicate devices. The "performance" being reported is the outcome of these engineering tests, not a clinical diagnostic performance.

Therefore, many of the requested categories in your prompt related to diagnostic studies (sample size for test set, data provenance, number of experts, adjudication, MRMC, standalone performance, type of ground truth, training set size, how training ground truth was established) are not applicable to this type of device submission.

Here's an adaptation of your requested table and information based on the content available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test / Performance Metric	Predicate Device Reference(s) (Acceptance Level Implied)	Reported Device Performance (Ascension Modular Total Shoulder System)
Mechanical Durability & Connection Integrity	Axial Disassembly Force of Taper Connections	K032126/K063578 (Smith & Nephew/PLUS PROMOS Modular Shoulder System)	Tested to substantiate equivalence. (Specific numerical result not provided in summary, but assumed to meet or exceed predicate.)
Mechanical Durability & Fatigue	Bending Taper Fatigue Endurance	K032126/K063578 (Smith & Nephew/PLUS PROMOS Modular Shoulder System)	Tested to substantiate equivalence. (Specific numerical result not provided in summary, but assumed to meet or exceed predicate.)
Mechanical Stability & Loosening Resistance	Dynamic Evaluation of Glenoid Loosening	K962082 (Osteonics' All Polyethylene Glenoid Shoulder Keeled Components)	Tested to substantiate equivalence. (Specific numerical result not provided in summary, but assumed to meet or exceed predicate.)
Geometrical Comparison	Overall Design, Function, and Intended Use	K032126/K063578, K962082	No significant differences in design, function, and intended use that would adversely affect product use when compared to predicate devices.

Study Description:

The study conducted to demonstrate the device meets the acceptance criteria was primarily a series of benchtop engineering tests and a geometrical comparison to establish substantial equivalence with legally marketed predicate devices.

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

Test Set Sample Size: Not applicable in the context of human subjects or imaging data. The "sample size" refers to the number of device components or assemblies tested for each engineering test. Specific numbers were not provided in the summary, but standard engineering practices would dictate sufficient samples for valid statistical analysis for each test type.
Data Provenance: The data originates from laboratory testing performed by or for Ascension Orthopedics, Inc. The location of the testing facility is not specified, but it's internal to the device development and regulatory submission process. It is prospective in the sense that these tests were specifically designed and executed for the 510(k) submission.

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 is determined by engineering specifications, material properties, and established test standards (e.g., ASTM or ISO standards for orthopedic implants), not by clinical experts interpreting data.

4. Adjudication method for the test set: Not applicable. The "adjudication" is based on objective measurements and comparison against predefined engineering performance limits or performance of predicate devices, not on expert consensus.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or other data, which is not the case for an orthopedic implant's substantial equivalence submission based on mechanical testing.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, a standalone performance study was not done. This concept is specific to AI/ML algorithms, not to mechanical orthopedic implants.

7. The type of ground truth used:

Engineering Specifications: Performance standards derived from industry norms (e.g., ISO, ASTM for orthopedic implants) and the known performance characteristics of the predicate devices.
Predicate Device Performance: The primary "ground truth" for showing substantial equivalence is the established safety and effectiveness profile of the predicate devices (Smith & Nephew/PLUS PROMOS Modular Shoulder System and Osteonics' All Polyethylene Glenoid Shoulder Keeled Components). The new device's performance in mechanical tests is compared against that of these predicates.

8. The sample size for the training set: Not applicable. There is no "training set" in the context of an AI/ML algorithm for this type of device submission. The design and manufacturing process are analogous to "training" in the sense of refinement and optimization, but not in the data-driven AI sense.

9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission is for an orthopedic implant, where substantial equivalence is demonstrated through engineering characterization and comparison to predicate devices, rather than through clinical diagnostic performance studies typically associated with AI/ML or imaging devices. Therefore, many of your specific questions are not relevant to the type of data presented in this document.

Summary

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K100448

510(k) Summary

SUBMITTER NAME:	Ascension Orthopedics, Inc.8700 Cameron RoadAustin, TX 78754-3832	AUG 30 2010
510(k) CONTACT:	Stanley J. HarrisPhone: (512) 836-5001 x1545
DATE:	August 26, 2010
TRADE NAME:	Ascension® Modular Total Shoulder System
COMMON NAME:	Hemi- or Total shoulder
CLASSIFICATION:	21 CFR 888.3690 Shoulder joint humeral (hemi-shoulder)metallic uncemented prosthesis
	21 CFR 888.3660, Shoulder joint metal/polymer semi-constrained cemented prosthesis
PRODUCT CODE:	HSD and KWS
PANEL:	Orthopedic

PREDICATE DEVICES:

K032126/K063578 - Smith & Nephew/Plus Orthopedics PROMOS Modular Shoulder System

K962082: Osteonics' All Polyethylene Glenoid Shoulder Keeled Components

DEVICE DESCRIPTION:

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INTENDED USE:

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

1. Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis.
1. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
1. 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:

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

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

SUMMARY OF TECHNOLOGIES:

There are no significant differences between the Ascension® Modular Total Shoulder System, to the Smith & Nephew/Plus Orthopedics PROMOS Modular Shoulder System (K032126/K063578) currently being marketed which would adversely affect the use of the product. It is substantially equivalent to this device in design, function, and intended use.

SUBSTANTIAL EQUIVALENCE:

Substantial equivalence was based upon testing and a geometrical comparison of the subject and predicate devices. Tests performed to substantiate equivalence were: axial disassembly force of taper connections, bending taper fatigue endurance, and dynamic evaluation of glenoid loosening. Geometrical comparisons were between the subject device, Ascension TITAN Modular Total Shoulder System and predicate devices: Smith & Nephew/PLUS PROMOS Modular Shoulder System (K032126, uons578) and the Osteonics' All Polyethylene Glenoid Shoulder Keeled Components (K962082).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a stylized serpent winding around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular fashion around the caduceus.

Public Health Service

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

Ascension Orthopedics, Inc. % Mr. Stanley J. Harris Vice President, Clinical/Regulatory Affairs 8700 Cameron Road, Suite 100 Austin, Texas 78754

AUG 30 2010

Re: K100448

Trade/Device Name: Ascencion® Modular Total Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS. HSD Dated: August 10, 2010 Received: August 17, 2010

Dear Mr. Harris:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Stanley J. Harris

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 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Sincerely yours,

Carbare Buere

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

Enclosure

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Indications for Use Statement

K100448 510(k) Number.

Ascension® Modular Total Shoulder System Device Name:

Indications for Use:

The Ascension Modular Total Shoulder System is indicated for use 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 indicates that alternative methods of treatment are unsatisfactory.

1. 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:
1. Ununited humeral head fractures.
1. Avascular necrosis of the humeral head.
1. Rotator cuff arthropathy.
1. 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.

Prescription Use x (Part 21 CFR 801Subpart B)

Over-The-Counter Use OR (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)

Knutar der Mom

(Division Sign-(Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number KJ 00448

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.”