The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific manual instrument system intended to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin used in the glenoid in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant.

The Glenoid IRIS is indicated for use in planning and placing the central glenoid guide pin for the DePuy Anchor Peg Glenoid (APG) component of the DePuy AP Shoulder System, the DePuy Global StepTech Glenoid component, or the DePuy Delta Xtend Reverse Shoulder metaglene component as an alternative to the standard instruments provided for placing the guide pin with these implant systems. The Glenoid IRIS is not indicated for use in hemi-shoulder arthroplasty.

The labeling and indications for use for each of these DePuy shoulder systems remain the same as described in DePuy's labeling.

Device Description

The Glenoid Intelligent Reusable Instrument System is composed of two (2) manual instruments intended for use to facilitate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement. CT data and 3D modeling is used to provide preoperative planning of total shoulder glenoid component or reverse shoulder metaglene component orientation according to each patient's glenoid anatomy. The preoperatively planned and surgeon approved component orientation is subsequently transferred to the patient's glenoid during surgery by the use of a patient specific instrument and an adjustable instrument with patient specific settings. A patient specific Glenoid SmartBone - Pin Trajectory instrument is used to set the adjustable reusable instrument, the Glenoid Intelligent Reusable Instrument (Glenoid IRI), with the settings necessary to reflect the guide pin trajectory embedded in the Glenoid SmartBone. The Glenoid IRI is then used to guide the placement of the standard 2.5 mm pin (Steinmann pin) by the surgeon that is used in preparation of the glenoid for implantation of the glenoid component. All other steps of the surgical procedure are accomplished according to each system's standard surgical technique.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Glenoid Intelligent Reusable Instrument System (Glenoid IRIS), based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics for the Glenoid IRIS. Instead, it describes a series of non-clinical tests performed to demonstrate "substantial equivalency" to predicate devices. The implicit acceptance criterion is that the device performs comparably to or within acceptable limits of the established performance of the predicate devices.

However, based on the non-clinical testing performed, we can infer the areas of performance evaluated:

Performance Area	Implicit Acceptance Criteria / Reported Performance
Verification and Validation	Device performs as intended and designed. (Details of specific performance metrics or thresholds are not provided in this summary.)
Biocompatibility and Toxicity	Meets ISO 10993-10 and USP Class VI standards.
Cadaver Study	Demonstrates safe and effective use in a cadaveric setting, confirming its ability to facilitate accurate guide pin placement. (Specific metrics not provided.)
Sawbones Study	Demonstrates safe and effective use in a sawbones model, confirming its ability to facilitate accurate guide pin placement. (Specific metrics not provided.)
Software Validation	Software components (for preoperative planning and 3D modeling) function correctly and reliably. (Specific metrics not provided.)
Packaging Integrity	Packaging maintains sterility and protects the device as required. (Specific metrics not provided.)

Study Details

The provided 510(k) summary focuses on non-clinical testing for substantial equivalence, and explicitly states "Clinical testing was not necessary to determine substantial equivalence between the Glenoid IRIS and the predicate devices." Therefore, the following details pertain to the non-clinical studies.

Sample Size Used for the Test Set and Data Provenance:
- Cadaver Study: The sample size is not specified in the document.
- Sawbones Study: The sample size is not specified in the document.
- Data Provenance: Not explicitly stated for both cadaver and sawbones studies, but typically for such non-clinical studies, they are conducted in a controlled lab environment, likely within the country of the manufacturer or a designated testing facility. The studies are by nature prospective for the device being evaluated.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- This information is not provided in the summary for the non-clinical studies. For cadaver and sawbones studies, "ground truth" would likely be established through precise measurements by trained personnel or independent confirmation of pin placement accuracy relative to the pre-operative plan, but the number and qualifications of these individuals are not detailed.
Adjudication Method for the Test Set:
- This information is not provided in the summary. For non-clinical studies, "adjudication" in the sense of expert consensus on ambiguous cases is less common than for clinical image interpretation studies. Performance is typically assessed against a predefined measurement or technical standard.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states that clinical testing was not necessary. Such studies are typically clinical.
Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
- The device is described as a "patient specific manual instrument system" that uses CT data and 3D modeling for preoperative planning. The software validation listed would likely assess the performance of the algorithm in generating accurate 3D models and planning outputs. However, the final "performance" of the system involves human interaction during surgery to use the instruments for guide pin placement. Therefore, a purely "standalone" algorithmic performance without human interaction regarding the surgical outcome itself is not fully applicable. The "software validation" line item indicates evaluation of the algorithmic component. Details of this validation are not provided.
Type of Ground Truth Used:
- For the cadaver and sawbones studies, the ground truth would typically be established through precise anatomical measurements of the placed guide pin's trajectory and position relative to the pre-operative plan. This would involve highly accurate measurement tools and techniques.
- For software validation, the ground truth would be based on known, correct 3D models and planning parameters, against which the software's output would be compared for accuracy and consistency.
Sample Size for the Training Set:
- The document does not discuss a "training set" in the context of an AI/machine learning model needing to be trained on data. While the device utilizes "CT data and 3D modeling" for preoperative planning, it's presented as a tool, not necessarily an AI system that undergoes a separate training phase in the typical sense of deep learning. Therefore, a sample size for a training set is not applicable or not provided in this context. The 3D modeling likely relies on established anatomical algorithms rather than learning from a large dataset of prior cases.
How the Ground Truth for the Training Set Was Established:
- As a "training set" for AI/ML is not explicitly mentioned or implied, this question is not applicable. The "ground truth" for the preoperative planning software would be derived from accurate anatomical representations and engineering specifications for component placement.

Summary

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510(k) Summary

APR 0 5 2013

510(k) SPONSOR / MANUFACTURER:

Custom Orthopaedic Solutions, Inc. A subsidiary of Cleveland Clinic 10000 Cedar Avenue Cleveland, Ohio 44106

CONTACT PERSON:

Stephen J. Peoples, VMD, MS Peoples & Associates Consulting, LLC 5010 Lodge Pole Lane Fort Wayne, IN 46814 Tele: (260) 645 - 0327 Email: SPeoplesVMD@gmail.com

TRADE NAME:

Glenoid Intelligent Reusable Instrument System (Glenoid IRIS)

COMMON NAMES:

Total shoulder replacement instruments

Product	Product Code	Regulation andClassification Name	Device Class
Glenoid ReusableIntelligent InstrumentSystem (Glenoid IRIS)	KWS	21 CFR 888.3660Shoulder, semi-constrained metal /polymer, cemented	II

PREDICATE DEVICES:

DePuy Global Shoulder AP Shoulder System (K060874 DePuy Global Shoulder Glenoid (K981487) DePuy Global StepTech Anchor Peg Glenoid (K092122) DePuy Delta Xtend Reverse Shoulder System (062250)

DEVICE DESCRIPTION:

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INTENDED USE AND INDICATIONS:

The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific manual instrument system intended to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin used in the preparation of the glenoid in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant.

The labeling and indications for use for each of these DePuy shoulder systems remain the same as described in DePuy's labeling.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is intended to be used as an alternative method and instrument system for placing the 2.5 mm glenoid guide pin that is used for preparing the glenoid for implantation with the DePuy Global AP Shoulder Glenoid component, the DePuy Global StepTech Anchor Peg Glenoid component, or the DePuy Delta Xtend Reverse Shoulder System metaglene component. The Glenoid IRIS replaces the standard instruments and techniques for the placement of the guide pin in these systems as described in each system's surgical technique. The Glenoid IRIS has the same intended use and indications for use and similar function, surgical technique, design." materials, and performance as the standard instruments used for placing the elenoid guide pin in these systems. All other surgical steps are completed according to the steps described in the surgical techniques for each system using the standard instruments supplied for each system. The indications for use of the DePuy shoulder systems, with which the Glenoid IRIS is intended to be used, are not changed by the Glenoid IRIS and remain the same as described in the labeling for these shoulder systems.

Non-Clinical Testing

The following testing was performed to demonstrate substantial equivalency of the Glenoid IRIS to the predicate devices.

. Performance testing - verification and validation testing
. Performance testing - biocompatibility and toxicity (ISO 10993-10; USP Class VI)
. Performance testing - cadaver study
. Performance testing - sawbones study
. Performance testing - software validation
. Performance testing - packaging integrity testing

Clinical Testing

Clinical testing was not necessary to determine substantial equivalence between the Glenoid IRIS and the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Custom Orthopaedic Solutions, Inc. A subsidiary of Cleveland Clinic c/o Stephen J. Peoples, VMD, MS Peoples & Associates Consulting, LLC 5010 Lodge Pole Lane Fort Wayne, IN, 46814

Letter dated: April 5, 2013

Re: K123122

Trade/Device Name: Glenoid Intelligent Reusable Instrument System (Glenoid IRIS) Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS Dated: March 11, 2013 Received: March 14, 2013

Dear Dr. Peoples,

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 iddictions 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, Dr to 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 resustration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contractly and in warranties. We remind you; however, that device labeling must be truthful and not misleding.

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

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Page 2 - Mr. Stephen J. Peoples ·

device-related adverse events) (21 CFR 803); 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.

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 yours.

Mark N. Melkerson -S

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

Enclosure

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Indications for Use Statement

510(k) Number (if known): K123122

Device Name: Glenoid Intelligent Reusable Instrument System

Intended Use and Indications for Use:

The labeling and indications for use for each of these DePuy shoulder systems remain the same as described in DePuy's labeling.

Prescription Use × (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)

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Elizabeth፣២៦Erank -S

Division of Orthopedic Devices

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.”