Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Revision where other devices or treatments have failed
Correction of functional deformity
Fractures of the proximal humerus, where other methods of treatment are deemed inadequate
Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate

The Modular Hybrid Glenoid is intended to be inserted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.

Device Description

The Modular Hybrid Glenoid consists of a base and optional pegs. The polyethylene base has a concave articulating surface. The back side of the base has three outer polyethylene pegs for cement fixation and a central threaded titanium insert for the attachment of a central peg. The device may be used with or without a central peg.

The polyethylene peg has circumferential flanges. A titanium rod is molded within the peg to provide a threaded connection with the base.

The porous titanium peg provides the surgeon with an option for potential tissue ingrowth fixation. The peg is circular in design and tiered. Similar to the polvethylene peg, the porous titanium peg has a central titanium rod to provide a threaded connection.

AI/ML Overview

The provided document is a 510(k) summary for the Biomet Orthopedics, Inc. Modular Hybrid Glenoid device. It describes the device, its indications for use, and a comparison to predicate devices, but does not contain information about studies proving the device meets acceptance criteria in the way a diagnostic AI/ML device would be evaluated.

This document pertains to a medical device, not an AI/ML diagnostic algorithm. Therefore, the specific criteria for evaluating AI/ML algorithms (such as sensitivity, specificity, AUC, sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not relevant to this submission.

Instead, the acceptance criteria for this type of medical device are generally based on non-clinical mechanical testing and establishing substantial equivalence to existing legally marketed devices.

Here's how the provided information relates to acceptance criteria for this specific medical device:

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

Since this is a mechanical orthopedic implant, the "acceptance criteria" are not reported as specific performance metrics like sensitivity or specificity. Instead, the document states:

Acceptance Criteria (Implied / Stated in Document)	Reported Device Performance
Mechanical performance under expected clinical conditions	"Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions."
Material and processing similarity to predicate devices	"The materials, surface finishes and processing of the Modular Hybrid Glenoid are similar to the predicate device."
Porous titanium construct characterization	"A full characterization of the porous titanium construct has been provided."
Substantial Equivalence to predicate devices	FDA's 510(k) clearance letter states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices."

2. Sample size 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. The "testing" here refers to mechanical engineering tests of the device itself, not a clinical study on patients or an evaluation of an algorithm on a dataset.
Data Provenance: Not applicable for clinical data. The mechanical tests would have been performed in a laboratory setting.

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 the context of an AI/ML algorithm evaluation (e.g., radiologist diagnoses) is not relevant for this device's mechanical testing. The "ground truth" for mechanical testing is established by engineering standards and measurement techniques.

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

Not applicable. This refers to consensus methods for interpreting medical images or data, which is not relevant for mechanical device testing.

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:

No. This type of study is specifically for evaluating diagnostic AI/ML algorithms used in conjunction with human readers. This document explicitly states: "Clinical Testing: None provided."

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

Not applicable. This refers to the performance of an AI/ML algorithm by itself.

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

Not applicable in the context of clinical "ground truth." For mechanical tests, the "ground truth" is derived from established engineering principles, material science, and testing methodology to ensure the device meets specified strength, fatigue, and other performance parameters.

8. The sample size for the training set:

Not applicable. The concept of a "training set" is for AI/ML models. This is a physical medical device.

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

Not applicable. (See #8)

Summary regarding AI/ML evaluation:

The provided document details a 510(k) submission for an orthopedic implant. It specifically states "Clinical Testing: None provided." The acceptance criteria and "study" are based on non-clinical mechanical testing and a demonstration of substantial equivalence to predicate devices, which is a different regulatory pathway and set of evaluation criteria than those used for AI/ML diagnostic devices.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for Biomet Orthopedics, Inc. The word "BIOMET" is in large, bold, block letters at the top of the image. Below that, in a smaller font, is the text "ORTHOPEDICS, INC."

510(k) Summary

DEC 1 1 2006

December 8, 2006 Preparation Date:

Applicant/Sponsor:

Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0588

Contact Person:

Patricia Sandborn Beres Senior Regulatory Specialist Phone: (574) 267-6639 FAX: (574) 372-1683

Proprietary Name: Modular Hybrid Gleniod

Common Name: Total shoulder replacement components

Classification Name:

1. Prosthesis, Shoulder, Non-constrained, Metal/Polymer, Cemented (21 CFR Section 888.3650)
1. Prosthesis, Shoulder, Semi-constrained, Metal/Polymer, Comented (21 CFR Section 888.3660)

Legally Marketed Device to which Substantial Equivalence is claimed:

Bio-Modular® Shoulder System (Biomet) .
The Trabecular Metal™ Glenoid (Zimmer) .

K030710, K992119 K043061. K031449, K022377 K052472, K981487

DePuy Global™ Shoulder Glenoid (DePuy) .
Device Description: The Modular Hybrid Glenoid consists of a base and optional pegs. The polyethylene base has a concave articulating surface. The back side of the base has three outer polyethylene pegs for cement fixation and a central threaded titanium insert for the attachment of a central peg. The device may be used with or without a central peg.

The polyethylene peg has circumferential flanges. A titanium rod is molded within the peg to provide a threaded connection with the base.

MAILING ADDRESS	P.O. Box 587Warsaw, IN 46581-0587
	D - 1
SHIPPING ADDRESS	56 E. Bell DriveWarsaw, IN 46582
OFFICE	574.267.6639
FAX	574.267.8137
E-MAIL	biomet@biomet.com

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Indications for Use:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
1. Rheumatoid arthritis
1. Revision where other devices or treatments have failed
1. Correction of functional deformity
1. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate
1. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate

Summary of Technologies: The materials, surface finishes and processing of the Modular Hybrid Glenoid are similar to the predicate device.

Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions. A full characterization of the porous titanium construct has been provided.

Clinical Testing: None provided.

All trademarks of property of Biomet, Inc. except for the following: Global is a trademark of DePuv. Inc. Hedrocel and Trebecular Metal are trademarks of Zimmer Trabecular Metal Technology, Inc.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Manufacturing Corp. % Ms. Patricia Sandborn Beres Senior Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587

DEC 1 1 2006

Re: K060694

Trade/Device Name: Modular Hybrid Glenoid Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer, semi-constrained, cemented prosthesis Regulatory Class: Class II Product Code: KWS, KWS, KWT Dated: November 20, 2006 Received: November 21, 2006

Dear Ms. Beres:

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. Patricia Sandborn Beres

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara MnehuD
fo

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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Indications for Use

510(k) Number (if known):

Device Name: Modular Hybrid Gleniod

Indications For Use:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
1. Rheumatoid arthritis
1. Revision where other devices or treatments have failed
1. Correction of functional deformity
1. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate
1. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (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)

Barbara Buellind Somon

606694

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

510(k) Number

Page 1 of 1

C - 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.”