The Mosaic™ Non-modular Proximal Body and EAS Offset Modular Humeral Heads are for rne in primary and revision shoulder joint replacement procedures in cases of:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
· Revision where other devices or treatments have failed
· Correction of functional deformity
Conceasin of ranicuonal consic fractures with humeral epicondyle (elbow) involvement or humeral head (shoulder), which are unmanageable using other treatment methods
· Oncology applications

Device Description

The Mosaic™ components are made of Co-Cr-Mo per ASTM F 75 and are Device Description: The Prosac componenes and mass offset modular designs are used to wailable in a non-modular proximal body and an EAS offset modular designs are used wallable in a non-modular proximal bone surface or with cleared glenoid components.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Mosaic™ Non-modular Proximal Body and EAS Offset Modular Humeral Head), which is a premarket notification to the FDA.

Based on the content of this 510(k) summary, the device did not undergo clinical testing to establish substantial equivalence. Instead, the substantial equivalence was demonstrated through non-clinical testing. This means that a study proving the device meets acceptance criteria in the clinical context, as outlined in your request, was not performed or described in this document.

The document explicitly states:

"Non-Clinical Testing: Non-clinical testing demonstrated substantial equivalence between this device and the predicate devices." (Page 0)
"Clinical Testing: Clinical testing was not used to establish substantial equivalence." (Page 0)

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving clinical performance, as such a study was not conducted or reported for this 510(k) submission.

To directly answer your numbered points based on the provided text, where applicable:

A table of acceptance criteria and the reported device performance: Not applicable. Clinical acceptance criteria and device performance based on a study proving it meets these criteria are not reported.
Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was used.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set requiring expert ground truth was used.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set was used.
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. No clinical study, including MRMC, was conducted. This device is a shoulder joint prosthesis, not an AI-assisted diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical ground truth was established for a performance study.
The sample size for the training set: Not applicable, as no clinical training set was used for an AI/algorithm.
How the ground truth for the training set was established: Not applicable, as no clinical training set was used.

In summary, this 510(k) relies on substantial equivalence to predicate devices, supported by non-clinical testing, rather than a clinical performance study with acceptance criteria.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Biomet Inc. The logo is in black and white and features a stylized font. The letters are bold and blocky, with the "O" in "Biomet" being a perfect circle.

JAN 2 8 2005

510(k) Summary

Applicant/Sponsor:	Biomet Manufacturing Corporation56 East Bell DriveP.O. Box 587Warsaw, IN 46581-0587
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Kacy Arnold, RN, MBA Contact Person: Regulatory Affairs Specialist Telephone: 574-267-6639 Fax: 574-372-1683

Proprietary Name: Mosaic™ Non-modular Proximal Body and EAS Offset Modular Humeral Head

Common Name: total shoulder replacement components

Classification Name:

assmeation Name.

Shoulder joint metal/polymer non-constrained cemented prosthesis (888.3650)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Hoad

y Marketed Devices TO Willen Budbeant.it Surface (EAS) Humeral Head (Biomet)
. K032895: Bi-Angular® Humeral Head (Biomet) .
K032895: BlPAngular Tianicial Humeral Replacement System (Biomet)
K033280: Mosaic™ Proximal Humeral Replacement System (Biomet) ●
K992899: Bio-Modular® Offset Humeral Head (Biomet) .

Device Description: The Mosaic™ components are made of Co-Cr-Mo per ASTM F 75 and are Device Description: The Prosac componenes and mass offset modular designs are used to
wailable in a non-modular proximal body and an EAS offset modular designs are used wallable in a non-modular proximal bone surface or with cleared glenoid components.

indications for Use: The Mosaic™ Non-modular Proximal Body and EAS Offiset Modular Humeral Indications for Use. The Nosale - Non mouth. I vint replacement procedures in cases of:
Heads are for use in primary and revision shoulder joint replacement of the processor

are for use in primary and revision shoulder Joint replacement of the mascular necrosis .
Rheumatoid arthritis .
Revision where other devices or treatments have failed .
Correction of functional deformity .
Correction of fullchonal Gelonnity
Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement or humeral . head (shoulder), which are unmanageable using other treatment methods
Oncology applications .

Summary of Technologies: Mosaic™ Non-modular Proximal Body and Exticulating Surface Summary of Technologies. Mosale - Non mound. Proximal 2007
(EAS) Offset Modular Humeral Heads is identical in materials and processing as the predicate device.

Non-Clinical Testing: Non-clinical testing demonstrated substantial equivalence between this device and the predicate devices.

Clinical Testing: Clinical testing was not used to establish substantial equivalence.

All trademarks are property of Biomet, Inc.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 8 2005

Kacy Arnold Regulatory Affairs Specialist Biomet Manufacturing Corporation 56 East Bell Drive Warsaw, IN 46581

Re: K042321

Device Name: Mosaic Non Modular Proximal Body and EAS Offset Modular Humeral head Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder joint metal/ polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWT Dated: 1/17/05 Received: 1/18/05

Dear Ms. Arnold:

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. FIDA 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 - Kacy Arnold

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 Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Madin M. Millerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Mosaic™ Non-modular Proximal Body and EAS Offset Modular Humeral Device Name: Heads

Indications For Use:

The Mosaic™ Non-modular Proximal Body and EAS Offset Modular Humeral Heads are for rne in primary and revision shoulder joint replacement procedures in cases of:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
· Revision where other devices or treatments have failed
· Correction of functional deformity
Conceasin of ranicuonal consic fractures with humeral epicondyle (elbow) involvement or humeral head (shoulder), which are unmanageable using other treatment methods
· Oncology applications

Prescription Use	X	AND/OR	Over-The-Counter Use ______
(Part 21 CFR 801 Subpart D)			(21 CFR 807 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	K042321
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Page 1 of 1

Regulation Number and Section

§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation 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, 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”