noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis;
. rheumatoid arthritis;
correction of functional deformity; .
other difficult management problems where arthrodesis or resectional arthroplasty are not . acceptable (e.g. revision of a failed primary component);
. cuff tear arthropathy.

Uncemented fixation may be supplemented by optional screw fixation.

Device Description

The Encore Metal-Backed Revision Clenoid is a two piece metal backed polyethylene glenoid component for use in total shoulder arthroplasty. It includes a metal baseplate and polyethylene insert.

Metal Baseplate: The metal baseplate component, manufactured from Ti-6Al-4V per ASTM F136, is porous coated with commercially pure titanium (per ASTM F67 grade 2). It has an integrated central screw that provides initial fixation of the glenoid component as well as compression between the baseplate and the glenoid surface. HA porous coating on the surface of the medial side of the baseplate promotes biological fixation. No enhanced claims regarding the calcium phosphate coating will be made for this device. Additional fixation of the baseplate is achieved using four peripheral screws that can lock to the baseplate or have varying angles. All screws are manufactured from Ti-6Al-4V per ASTM F136.

Polyethylene Insert: The polyethylene inscrt component, molded from Ultra High Molecular Weight Polyethylene (per ASTM F648), snaps into the baseplate and provides a smooth bearing surface with the humeral head.

AI/ML Overview

The provided document is a 510(k) summary for the Encore Shoulder System - Metal-Backed Revision Glenoid. It describes the device, its intended use, predicate devices, and the FDA's substantial equivalence determination.

However, the document does not contain any information about acceptance criteria or specific studies proving the device meets performance criteria beyond non-clinical mechanical testing. This is common for 510(k) submissions of orthopedic implants, where substantial equivalence to a legally marketed predicate device often relies on demonstrating similar materials, design, and mechanical performance, rather than requiring extensive clinical trials with specific performance metrics.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth, and expert involvement cannot be extracted from this document.

Here's a breakdown of what can be extracted and what information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Information Not Present: The document does not define specific quantitative acceptance criteria (e.g., minimum tensile strength, fatigue life thresholds with numerical values) or provide a table summarizing device performance against such criteria. It generally states that "Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions," which is a qualitative statement of compliance rather than a detailed performance report.

2. Sample Size Used for the Test Set and Data Provenance

Information Not Present: Since the document reports "Clinical Testing: None provided" and primarily relies on non-clinical mechanical testing, there is no "test set" of patient data in the typical sense. For mechanical testing, the "sample size" would refer to the number of components tested, but this detail is not provided. Data provenance (country of origin, retrospective/prospective) is also not applicable for non-clinical mechanical tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Information Not Present: This information is relevant for clinical studies where expert consensus might establish ground truth for diagnostic or prognostic outcomes. As no clinical testing is provided and the primary evidence is mechanical testing, there's no mention of experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

Information Not Present: Similar to point 3, adjudication methods are applicable to clinical studies where different experts might disagree on an outcome. This is not reported for the non-clinical mechanical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Information Not Present: No MRMC study was reported. The document explicitly states "Clinical Testing: None provided." Therefore, there is no effect size for human reader improvement with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Information Not Present: This question relates to AI or software-as-a-medical-device. The Encore Shoulder System is a physical orthopedic implant. Therefore, the concept of a "standalone algorithm" performance is not applicable to this device.

7. The Type of Ground Truth Used

Information Present (for non-clinical testing): For the non-clinical mechanical testing, the "ground truth" would implicitly be relevant engineering standards (e.g., ASTM F136 for Ti-6Al-4V, ASTM F67 for commercially pure titanium, ASTM F648 for Ultra High Molecular Weight Polyethylene) and design specifications. The document states materials conform to these ASTM standards. The "ability to perform under expected clinical conditions" (mentioned in "Non-Clinical Testing") serves as a general statement that the device met internal ground truth/specifications.

Information Not Present (for clinical outcomes): No clinical ground truth (e.g., pathology, patient outcomes data) is discussed as no clinical studies were performed or provided.

8. The Sample Size for the Training Set

Information Not Present: As this is a mechanical medical device and not an AI/ML-driven diagnostic or therapeutic tool, the concept of a "training set" in the context of data analysis or model development is not relevant.

9. How the Ground Truth for the Training Set Was Established

Information Not Present: See point 8. Not applicable to this type of device submission.

Summary

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Image /page/0/Picture/1 description: The image shows a series of handwritten alphanumeric characters. The characters appear to be "K081448", written in a cursive style. The handwriting is somewhat uneven, with variations in stroke thickness and letter formation.

Summary of Safety and Effectiveness

Date: September 3, 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 Metal-Backed Revision Clenoid is a two piece metal backed polyethylene glenoid component for use in total shoulder arthroplasty. It includes a metal baseplate and polyethylene insert.

Metal Baseplate

The metal baseplate component, manufactured from Ti-6Al-4V per ASTM F136, is porous coated with commercially pure titanium (per ASTM F67 grade 2). It has an integrated central screw that provides initial fixation of the glenoid component as well as compression between the baseplate and the glenoid surface. HA porous coating on the surface of the medial side of the baseplate promotes biological fixation. No enhanced claims regarding the calcium phosphate coating will be made for this device. Additional fixation of the baseplate is achieved using four peripheral screws that can lock to the baseplate or have varying angles. All screws are manufactured from Ti-6Al-4V per ASTM F136.

Polyethylene Insert

The polyethylene inscrt component, molded from Ultra High Molecular Weight Polyethylene (per ASTM F648), snaps into the baseplate and provides a smooth bearing surface with the humeral head.

The Gemini Revision Glenoid is indicated for un-cemented use for the following indications:

. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
. rheumatoid arthritis:
correction of functional deformity; .
other difficult management problems where arthrodesis or resectional arthroplasty are not . acceptable (e.g. revision of a failed primary component);
. cuff tear arthropathy.

Uncemented fixation may be supplemented by ontional screw fixation.

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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.

Predicate Devices:

Bio-Modular Shoulder System - Biomet Orthopedics, Inc.

Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same 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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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. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

SEP 3 0 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K081448 Trade/Device Name: Encore Shoulder system - Mctal Backed Revision Glenoid Regulation Number: 21 CFR 888.3670 Regulation Name: Shoulder joint metal/poly-mer/metal nonconstrained or semiconstrained porous-coated uncemented prosthesis. Regulatory Class: Class II Product Code: MBF Dated: September 03, 2008 Received: Scptember 04, 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. Iisting 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, plcase note the regulation cntitled, "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 yours,

Mark M. Millman

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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K081448 510(k) Number (if known):

Device Name: Shoulder System

Indications for Use:

Encore Shoulder System - Metal-Backed Revision Glenoid Indications for Use

The Gemini Revision Glenoid is indicated for un-cemented use for the following indications:

noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis;
. rheumatoid arthritis;
correction of functional deformity; .
other difficult management problems where arthrodesis or resectional arthroplasty are not . acceptable (e.g. revision of a failed primary component);
. cuff tear arthropathy.

Uncemented fixation may be supplemented by optional screw fixation.

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)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number `kod/448

Regulation Number and Section

§ 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”