noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis of the natural humeral head and/or glenoid;
. rheumatoid arthritis;
correction of functional deformity; .
. humeral fracture.

This device may also be indicated in the salvage of previously failed surgical attempts. The glenoid components are indicated for cemented use only.

Intended Use: Encore Medical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the indications for use. While shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

Device Description

The Encore Shoulder System consists of a humeral stem, neck and head and a glenoid component. Components are offered for use for either primary or revision surgery applications.

The humeral stem consists of proximal body that is rectangular in cross-sectional geometry and tapers proximal to distal. The distal stem is cylindrical with four flutes. 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 proximal humeral fracture. A suture hole is also placed medially through the proximal body just below the collar. A collar is present on the anterior, posterior and medial faces of the proximal body to resist stem subsidence. A neck stem angle is incorporated. The stem has a female Morse type taper to receive modular humeral necks. Also present is a female locating scallop utilized to orient the modular humeral neck and provide additional rotational stability of the neck and head.

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, the larger Morse type taper interfaces with the female Morse type taper in the humeral head. A scalloped collar between the two male tapers interfaces with the female locating scallop in the humeral stem to provide orientation when using the angled neck and to provide additional rotational stability of the neck and 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 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 either a keel or four pegs for fixation in the glenoid. The central peg has three annular barbs to provide immediate fixation to the patient's glenoid when inserted.

AI/ML Overview

The provided document is a 510(k) summary for the Encore Shoulder System, which is a medical device (prosthesis) for shoulder joint replacement. This document describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria in terms of AI/algorithm performance.

The key takeaway from this document regarding performance is under "Non-Clinical Testing": "Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions." and under "Clinical Testing": "None provided."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance in the context of an AI/algorithmic medical device because this document is for a mechanical prosthetic device and no such study is presented.

Here's a breakdown of what can be answered based on the provided text, and what cannot:

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

Cannot be provided. The document does not define specific performance acceptance criteria for the device in the context of an AI/algorithmic system, nor does it report performance metrics against such criteria. The "performance" described is in terms of mechanical testing of the physical prosthesis.

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

Cannot be provided. No clinical testing or AI model testing is mentioned.

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)

Cannot be provided. No clinical testing or AI model testing is mentioned that would involve ground truth establishment by experts.

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

Cannot be provided. No clinical testing or AI model testing is mentioned.

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

Cannot be provided. This is a mechanical device, not an AI-assisted diagnostic or interpretative system. No MRMC study was conducted or is relevant.

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

Cannot be provided. This is a mechanical device, not an algorithm.

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

Cannot be provided. No ground truth for an AI/algorithm is relevant or mentioned.

8. The sample size for the training set

Cannot be provided. No AI model training is mentioned.

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

Cannot be provided. No AI model training is mentioned.

Summary

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Summary of Safety and Effectiveness MAR 2 8 2008

Date: March 28, 2008

Manufacturer: Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758

Contact Person: Teffany Hutto Manager, Regulatory Affairs Phone: (512) 834-6255 Fax: (512) 834-6313 Email: teffany hutto@encoremed.com

Product	Product Code	Regulation and Classification Name
Encore Shoulder System	KWS	Shoulder joint metal/polymer semi-constrainedcemented prosthesis per 21 CFR 888.3660

Description:

The Encore Shoulder System consists of a humeral stem, neck and head and a glenoid component. Components are offered for use for either primary or revision surgery applications.

The glenoid components are fabricated from ultra-high molecular weight polyethylene. The articulating surface has a radius of curvature greater than the corresponding humeral head. This

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

allows translation in the superior/inferior and anterior/posterior directions. The back surface of the component is spherical in geometry and has either a keel or four pegs for fixation in the glenoid. The central peg has three annular barbs to provide immediate fixation to the patient's glenoid when inserted.

Joint replacement is indicated for patients suffering from disability due to:

noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis of the natural humeral head and/or glenoid;
. rheumatoid arthritis;
correction of functional deformity; .
. humeral fracture.

This device may also be indicated in the salvage of previously failed surgical attempts. The glenoid components are indicated for cemented use only.

Predicate Devices:

Bio-Modular Choice Shoulder System - Biomet Orthopedics, Inc. Global Advantage - DePuy

Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same indications, materials, sterilization, and indications for use.

Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions.

Clinical Testing: None provided.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem with three parallel lines forming the body and wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 8 2008

Encore Medical, L.P. % Ms. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Blvd. Austin, TX 78758

Re: K080402

Trade/Device Name: Encore Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS Dated: February 13, 2008 Received: February 14, 2008

Dear Ms. Hutto:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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Page 2 - Ms. Teffany Hutto

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Mark M. Milliman

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

Enclosure

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K080402 510(k) Number (if known): __

Device Name: Shoulder System

Indications for Use:

Encore Shoulder System Indications for Use

Joint replacement is indicated for patients suffering from disability due to:

noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis of the natural humeral head and/or glenoid;
. rheumatoid arthritis;
correction of functional deformity; .
. humeral fracture.

This device may also be indicated in the salvage of previously failed surgical attempts. The glenoid components are indicated for cemented use only.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oputu
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K080402

Page 1 of 1

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.”