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 Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers Apex, Keeled or Pegged Glenoid components as well as the Univers Revers Baseplate component.

The indications for use of the Arthrex shoulder systems with which the Arthex Glenoid IRIS is intended to be used are the same as those described in the labeling for these shoulder systems.

Device Description

The Arthrex Glenoid Intelligent Reusable Instrument System described in this submission is identical to the Glenoid IRIS cleared in K142072, except for the following differences:

The Glenoid IRIS for the K142072 clearance was indicated for use with the DePuy family of shoulder replacement systems. The subject device is indicated for use with the Arthrex family of glenoid components, which includes:
- o Univers™ II and Univers™ Apex Keeled Glenoid,
- O Univers™ II and Univers™ Apex Pegged Glenoid,
- o Univers Revers™ Baseplate.
The DePuy implant models in the OrthoVis planning software have been replaced with Arthrex implant models.
-The OrthoVis User's Manual and User Training Manual contain references to the implant company's instructions as to how their glenoid implants should be placed in patients. For this current submission, the User's Manual and User Training Manual have been changed to reflect the approved labeling for how Arthrex instructs these implants to be placed in patients.

All other elements of the K142072 clearance are identical to this submission.

AI/ML Overview

The provided text is a 510(k) Pre-market Notification for the Arthrex Glenoid Intelligent Reusable Instrument System (Glenoid IRIS). It states that the device is substantially equivalent to a previously cleared device (K142072) and details the non-clinical testing performed to establish this equivalence.

Here's an analysis of the acceptance criteria and the study information based on the provided document:

Acceptance Criteria and Reported Device Performance

The document describes the Arthrex Glenoid Intelligent Reusable Instrument System (Glenoid IRIS) as a patient-specific manual instrument system. Its primary function is to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin for total shoulder systems that use a central guide pin to prepare the glenoid for an implant.

Since this is a 510(k) submission asserting substantial equivalence to a predicate device (Glenoid IRIS cleared in K142072), the acceptance criteria are implicitly tied to demonstrating that the modifications made (changing from DePuy to Arthrex implants in the planning software and user manuals) do not alter the safety and effectiveness of the system.

The document does not explicitly state specific numerical acceptance criteria for performance metrics (e.g., accuracy of pin placement in millimeters, or successful preoperative planning rate). Instead, the performance is evaluated through verification and validation of the software and user testing to confirm accurate implant placement according to approved labeling.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
OrthoVis Software Functionality: The software modules affected by the change from DePuy to Arthrex implants function correctly and without unintended side effects on other parts of OrthoVis.	Verification and Validation of OrthoVis software modules affected by the change from DePuy to Arthrex implants confirmed that the changes had no other effects on any other parts of OrthoVis.
User Capability - Accurate Implant Placement: OrthoVis users can accurately place Arthrex implants according to the Arthrex approved labeling for implant placement. (This relates to the system's ability to facilitate correct surgical planning and guidance.)	OrthoVis inter- and intra-user testing was performed to confirm that OrthoVis users can accurately place the Arthrex implants according to the Arthrex approved labeling for placement of their implants. (Specific performance metrics like accuracy range are not provided in this summary.)

Study Details:

Sample size used for the test set and the data provenance:
- The document mentions "OrthoVis inter- and intra-user testing" but does not specify the sample size (e.g., number of users, number of cases/plans).
- Data provenance is not explicitly stated. Given the nature of software testing and user testing for a medical device aiming for substantial equivalence, this data would likely be collected in a prospective manner during the validation phase, conducted by the manufacturer or a contracted entity. The country of origin is not mentioned, but the manufacturer is based in Cleveland, Ohio, USA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts used to establish the ground truth for the user testing.
- It references "Arthrex approved labeling for placement of their implants," implying that the "ground truth" for correct placement is defined by the manufacturer's established guidelines and potentially by expert consensus within that framework. The qualifications of who would assess "accuracy" during user testing are not detailed.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not mention any specific adjudication method. For "inter- and intra-user testing," it implies an assessment of consistency and correctness by comparing user performance against established guidelines.
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, an MRMC comparative effectiveness study was not done. The device fundamentally is the instrument system designed to assist human users (surgeons/planners). The testing focused on confirming the software and integrated system itself worked as intended, especially with the new implant models. The document states that "Clinical testing was not necessary" to determine substantial equivalence.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document describes the "Glenoid IRIS" as a "patient specific manual instrument system intended to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin." It also refers to "OrthoVis planning software." The core of the system is the combination of software for planning and physical instruments for execution. The validation includes software verification and user testing of the integrated system. Therefore, a standalone algorithm-only performance assessment is unlikely to be fully applicable or performed in isolation for this type of system, as the human-in-the-loop is an integral part of its intended use. The software modules were verified, but their output is used by human operators.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the software's correct function and user's accurate implant placement is based on Arthrex approved labeling for placement of their implants. This can be considered a form of expert consensus and established procedural guidelines set by the implant manufacturer. It's not pathology or outcomes data from patients, but rather adherence to a defined standard of care/technique.
The sample size for the training set:
- This document describes a 510(k) for a medical device instrument system, not a machine learning or AI algorithm in the contemporary sense that would typically involve a "training set" for model development. The "OrthoVis planning software" is a rule-based or calculative software, not a system that learns from data. Therefore, the concept of a "training set" as understood in AI/ML is not applicable here. The software incorporates implant models and rules for planning based on engineering and anatomical principles as defined by the manufacturer.
How the ground truth for the training set was established:
- As established in point 7, there is no "training set" in the AI/ML sense. The "ground truth" for the software's internal workings and the user manuals would be established by engineering design specifications, anatomical data, and the defined placement procedures outlined in Arthrex's approved labeling for their glenoid implants.

Summary

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

October 5, 2015

Custom Orthopaedic Solutions Mr. Keith Grafmeyer Product Engineer 10000 Cedar Avenue Cleveland, Ohio 44106

Re: K151500

Trade/Device Name: Arthrex Glenoid Intelligent Reusable Instrument System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS Dated: September 11, 2015 Received: September 11, 2015

Dear Mr. Grafmeyer:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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Page 2 - Mr. Keith Grafmeyer

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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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

510(k) Number (if known) K151500

Device Name

Arthrex Glenoid Intelligent Reusable Instrument System

Indications for Use (Describe)

The Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers Apex, Keeled or Pegged Glenoid components as well as the Univers Revers Baseplate component.

The indications for use of the Arthrex shoulder systems with which the Arthex Glenoid IRIS is intended to be used are the same as those described in the labeling for these shoulder systems.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

510(k) SPONSOR / MANUFACTURER:	Custom Orthopaedic Solutions, Inc.A subsidiary of Cleveland Clinic10000 Cedar AvenueCleveland, Ohio 44106
CONTACT PERSON:	Keith GrafmeyerProduct EngineerCustom Orthopaedic Solutions10000 Cedar AvenueCleveland, OH 44106Tel: (216) 445-3403Email: kgrafmeyer@customorthopaedics.com
TRADE NAME:	Arthrex Glenoid Intelligent Reusable

DATE PREPARED:

28-May-2015

COMMON NAMES:

Total shoulder replacement instruments

Instrument System (Arthrex Glenoid IRIS)

Product	Product Code	Regulation andClassificationName	Device Class
Arthrex GlenoidIntelligentReusableInstrument System(Arthrex GlenoidIRIS)	KWS, PHX	21 CFR 888.3660Shoulder JointMetal/Polymer,Semi-ConstrainedCementedProsthesis	II

PREDICATE DEVICES:

Glenoid Intelligent Reusable Instrument System (Glenoid IRIS) (K142072)

DEVICE DESCRIPTION:

The Arthrex Glenoid Intelligent Reusable Instrument System described in this submission

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is identical to the Glenoid IRIS cleared in K142072, except for the following differences:

The Glenoid IRIS for the K142072 clearance was indicated for use with the DePuy family of shoulder replacement systems. The subject device is indicated for use with the Arthrex family of glenoid components, which includes:
- o Univers™ II and Univers™ Apex Keeled Glenoid,
- O Univers™ II and Univers™ Apex Pegged Glenoid,
- o Univers Revers™ Baseplate.
The DePuy implant models in the OrthoVis planning software have been replaced with Arthrex implant models.
-The OrthoVis User's Manual and User Training Manual contain references to the implant company's instructions as to how their glenoid implants should be placed in patients. For this current submission, the User's Manual and User Training Manual have been changed to reflect the approved labeling for how Arthrex instructs these implants to be placed in patients.

All other elements of the K142072 clearance are identical to this submission.

INTENDED USE AND INDICATIONS:

The Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers™ II or Arthrex Univers™ Apex, Keeled or Pegged Glenoid components as well as the Univers Revers™ Baseplate component.

The indications for use of the Arthrex shoulder systems with which the Arthex Glenoid IRIS is intended to be used are the same as those described in the labeling for these shoulder systems.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The "Arthrex Glenoid IRIS" is substantially equivalent to the Glenoid Intelligent Reusable Instrument System (Glenoid IRIS) described in K142072 because it is the same system with no modifications, other than the change from one shoulder implant system to another, similar shoulder implant system. Both the DePuy and Arthrex shoulder implant systems use a glenoid center pin to guide the subsequent preparation of the glenoid surface prior to implant placement.

Non-Clinical Testing:

The following testing was performed to demonstrate substantial equivalency of the Arthrex Glenoid IRIS to the predicate device in K142072.

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Verification and Validation of the OrthoVis software modules affected by . the change from DePuy to Arthrex implants, and confirmation that those changes had no other effects on any other parts of OrthoVis.
OrthoVis inter- and intra-user testing, to confirm that OrthoVis users can . accurately place the Arthrex implants according to the Arthrex approved labeling for placement of their implants.

Clinical Testing:

Clinical testing was not necessary to determine substantial equivalence between the modified Glenoid IRIS and the predicate Glenoid IRIS (K142072).

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.”